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WO2014134830A1 - Edible composition, food product comprising same, and preparation method for the food product - Google Patents

Edible composition, food product comprising same, and preparation method for the food product Download PDF

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Publication number
WO2014134830A1
WO2014134830A1 PCT/CN2013/072367 CN2013072367W WO2014134830A1 WO 2014134830 A1 WO2014134830 A1 WO 2014134830A1 CN 2013072367 W CN2013072367 W CN 2013072367W WO 2014134830 A1 WO2014134830 A1 WO 2014134830A1
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WO
WIPO (PCT)
Prior art keywords
weight
parts
edible composition
food
group
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2013/072367
Other languages
French (fr)
Chinese (zh)
Inventor
黄璐
杨爽
汪小刚
张海峰
张思佳
朱江阳
熊周权
康辉
汪建
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BGI WUHAN PHARMACEUTICAL Co Ltd
BGI Shenzhen Co Ltd
BGI-LAOS Co Ltd
Original Assignee
BGI WUHAN PHARMACEUTICAL Co Ltd
BGI Shenzhen Co Ltd
BGI-LAOS Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BGI WUHAN PHARMACEUTICAL Co Ltd, BGI Shenzhen Co Ltd, BGI-LAOS Co Ltd filed Critical BGI WUHAN PHARMACEUTICAL Co Ltd
Priority to PCT/CN2013/072367 priority Critical patent/WO2014134830A1/en
Priority to CN201380073941.1A priority patent/CN105050427B/en
Publication of WO2014134830A1 publication Critical patent/WO2014134830A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L21/00Marmalades, jams, jellies or the like; Products from apiculture; Preparation or treatment thereof
    • A23L21/20Products from apiculture, e.g. royal jelly or pollen; Substitutes therefor
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L25/00Food consisting mainly of nutmeat or seeds; Preparation or treatment thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/24Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders

Definitions

  • the invention belongs to the field of health foods, and in particular relates to an edible composition and a food containing the edible composition
  • the immune system in the human body is composed of immune organs and immune cells. It is our natural natural barrier. It not only protects against foreign bacteria and other harmful substances, but also eliminates cells that are aging, mutated, deteriorated or dead in the body. Keep your body healthy. Immunity is the ability of the human body to resist the invasion of external evils and maintain the stability of the internal environment. Immunity is low and vulnerable to disease. Improving human immunity is the basis for overcoming disease.
  • Microorganisms such as bacteria and fungi are widely found in the natural environment in which we live, and also in the body surface and body cavity of the human body. Under normal circumstances, these bacteria are generally harmless to the human body, and some of the bacteria are even beneficial. They form a complex interdependent and mutually constrained micro-ecological system with the human body and the external environment.
  • the intestinal flora is an important part of the intestinal defense barrier, and a balanced intestinal flora is important for human health.
  • the present invention is directed to solving at least some of the above technical problems or at least providing a useful commercial choice. To this end, it is an object of the present invention to provide an edible composition which simultaneously has a regulatory effect of improving gastrointestinal function and enhancing human immunity.
  • the present invention provides an edible composition comprising, according to an embodiment of the present invention, 40 to 120 parts by weight of Inca; 10 to 90 parts by weight Astragalus; 10 to 80 parts by weight of hydrazine; 30 to 100 parts by weight of inulin; 30 to 90 parts by weight of corn pollen; 10 to 90 parts by weight of slag leaves and 20 to 120 parts by weight of functional sugar.
  • Chinese medicines and food ingredients mainly include amino acids, polysaccharides, vitamins, various trace elements and other organic and inorganic substances.
  • these Chinese medicines and many components in foods promote the growth metabolism of bacteria, promote the proliferation of gastrointestinal probiotics, inhibit the growth of pathogenic bacteria, and play an important role in the intestinal flora.
  • probiotics can also promote the absorption and utilization of these traditional Chinese medicines and foods, improve the function of the human gastrointestinal tract, enhance the body's immunity, and enhance the body's ability to resist disease.
  • an edible composition composed of a mixture of Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves and Functional Sugar is improving.
  • the function of the gastrointestinal tract and the function of enhancing the immunity of the human body are obvious, and the combination of the components of the edible composition in improving the function of the gastrointestinal tract and enhancing the immunity of the human body is superior to the effect of the single component, and has obvious effects. Synergies.
  • Inca (P/lessiii vo/ b fc L.Jnca Peanut, sacha inchi) is a large vine, also known as Inca peanut, South American vine, Star vine, and Meito fruit.
  • the seeds are rich in oil, protein, amino acids, vitamin A, vitamin E and some other trace elements.
  • Inca oil contains extremely rich unsaturated fatty acids ( ⁇ -3, ⁇ -6, ⁇ - 9), as well as vitamins, strontium and protein, and the content of three unsaturated fatty acids is as high as 92% or more.
  • Inca fruit is rich in essential fatty acids a-linolenic acid, the mother of omega-3 unsaturated fatty acids, the most basic and primitive substance in the evolution of life.
  • (-Linolenic acid, as the core substance of life is one of the important components of human tissue cells. It is involved in the synthesis and metabolism of phospholipids in the human body, and is transformed into the vital activity factors DHA and sputum necessary for the body.
  • Astragalus membranaceus is the dry root of the leguminous plant Astragalus.
  • the plant is mainly distributed in the northeast, north and northwest of China.
  • the chemical constituents of Astragalus are mainly monosaccharides, polysaccharides, saponins, flavonoids, amino acids and trace elements.
  • Force, anti-fatigue, anti-mutation, liver protection, inhibition of osteoclasts can prevent the immunosuppressive effect of hydrocortisone, and can enhance the phagocytic function of macrophages and promote antibody synthesis; have detoxification effect, can strengthen normal
  • the heart contraction which has a strong heart effect on the failing heart, can dilate the blood vessels of the coronary vessels and kidneys and dilate the blood vessels at the peripheral end of the body.
  • It contains polysaccharides, glucose, protein, amino acids, organic acids, fats, lecithin, adenine, choline, ergosterol, various enzymes and potassium salts. It can enhance the body's immune function, diuretic effect, calming and protecting the liver, inhibiting the occurrence of ulcers, lowering blood sugar, and resisting radiation. It can also be used as an important therapeutic ingredient for glutinous cakes, glutinous rice cakes and alcoholics. It can be eaten regularly to moisturize the spleen, help digestion, and strengthen the body.
  • Inulin is mainly distributed in Compositae, with the highest content in chicory. Inulin is the highest quality, pure natural, soluble fructan mixture found by humans to date. Inulin was approved by the Ministry of Health as a new resource food in 2009. Inulin has the characteristics of low calorie, water solubility and the like, and enhances the proliferation of bifidobacteria, lowers blood sugar and blood lipids, restores gastrointestinal function, and enhances calcium absorption. Feeding inulin every day can greatly increase the number of beneficial bacteria in the colon, reducing pathogens and spoilage bacteria such as Salmonella, Listeria, Staphylococcus aureus, and coliforms.
  • the mechanism is that the inulin is not digested and absorbed, but directly enters the large intestine and is preferentially used by bifidobacteria to produce acetate and lactate, which lowers the pH value of the large intestine, thereby inhibiting the growth of harmful bacteria.
  • Corn is the third largest crop in China, and the northeast is the main producing area of corn in China.
  • the corn pollen resources are abundant. Corn pollen has high nutritional value, large individual size, large yield and easy harvesting. Corn pollen is rich in protein, sugar, amino acids, nucleic acids, vitamins and other nutrients. After the corn pollen is broken, it can separate and extract the active ingredients such as polysaccharides and flavonoids. It can promote the development of immune organs of the spleen, bones, lymph nodes and thymus, enhance the activity of immune cells, improve the body's ability to fight bacteria and viruses, and have anti-radiation and anti-cancer effects. It can enhance immunity, promote growth and development, lower blood pressure and other health care. Features.
  • corn pollen can provide a variety of nutrients needed by the human body, and it also has a good auxiliary effect for diseases caused by lack of certain nutrition. Therefore, corn pollen has a wide range of clinical applications and is a supplement to various diseases and a supplement to daily nutrition.
  • Corn pollen can be processed into health drinks such as oral liquid, pollen capsules, pollen beverages and pollen yoghurt, as well as functional foods such as pollen bread and pollen noodles.
  • Corn pollen is rich in vitamin B group substances, among which vitamin B1 can stimulate the production of digestive enzymes and help digestion; vitamin B6, minerals and methionine can treat intractable constipation and diarrhea; corn pollen also contains natural Antibiotics and growth-promoting substances can control the growth of coliforms and salmonella, repair the parts of gastrointestinal damage, and thus have magical effects on the treatment of gastric and duodenal ulcers and perforations.
  • the slag leaves are the rags of the genus Eucalyptus.
  • the leaves of Microcos paniculata. can be harvested all year round. They are usually picked in summer and autumn, and the stems are removed.
  • the slag leaves are light, slightly acidic, and flat. They have the effects of clearing heat and eliminating stagnation, dampness and yellowing, and phlegm. They are mainly used for colds, heatstroke, loss of appetite, indigestion, dampness and heat stagnation, abdominal pain, and less food. Diarrhea, damp heat, jaundice, etc.
  • the slag leaves contain alkaloids, organic acids, sugars, phenols and tannins. Since ancient times, the slag leaves have been widely used in the folks of Lingnan in China. Folk slag leaves are used as summer drinks, which have thirst-quenching and appetizing effects.
  • a preferred edible composition comprises: 70 to 110 parts by weight of Inca; 30 to 70 parts by weight of xanthine; 20 to 60 parts by weight of hydrazine; 50 to 80 parts by weight of inulin; ⁇ 80 parts by weight of corn pollen; 30 to 70 parts by weight of cloth slag leaves and 40 to 100 parts by weight of functional sugar.
  • the most preferred edible composition comprises: 90 parts by weight of Inca; 60 parts by weight Astragalus; 50 parts by weight of enamel; 70 parts by weight of inulin; 70 parts by weight of corn pollen; 50 parts by weight of cloth slag leaves and 70 parts by weight of functional sugar.
  • the type of functional sugar which can be used in the edible composition of the present invention is not particularly limited.
  • the functional sugar that can be employed is at least selected from the group consisting of konjac glucomannan, yeast glucan, chitooligosaccharide, oligofructose, galactooligosaccharide, xylooligosaccharide, and oligo-isomaltose.
  • konjac glucomannan yeast glucan
  • chitooligosaccharide oligofructose
  • galactooligosaccharide galactooligosaccharide
  • xylooligosaccharide oligo-isomaltose
  • Konjac glucomannan is a high molecular weight water soluble polysaccharide. China and Japan cultivated and consumed konjac since ancient times. In 1997, the US FDA approved konjac glucomannan as a food additive. On February 16, 1998, the Chinese Ministry of Health officially listed Konjac as the new food resource list for general food management. On November 4, 1998, the EU officially approved the use of konjac glucomannan in food. Since konjac glucomannan has many excellent properties, it is widely used as a food and beverage additive.
  • Yeast glucan is derived from Saccharomyces cerevisiae. It has a variety of physiological activities due to its special structure, and it has been widely used in the GRAS (usually considered safe) in the US FDA. In a variety of foods. In China, the Ministry of Health of the People's Republic of China 2010 No. 9 Announcement approved yeast glucan as a new resource food, enabling it to be used in various foods.
  • yeast glucan As a dietary fiber, yeast glucan can be decomposed by intestinal bacteria, promote gastrointestinal motility, stimulate the secretion of digestive juice, and have the function of assisting digestion; it can increase the peristalsis of the intestine and promote defecation, thus effectively preventing constipation; Absorption of calcium, magnesium and zinc by the intestines.
  • the unique ⁇ -(1 ⁇ 3) framework of yeast glucose has a strong immunomodulatory activity. Can significantly improve human immunity.
  • Chitosan oligosaccharide is a product of polymerization degree 2-10 after degradation of chitosan. Its water solubility is better than that of chitosan, and it is easily absorbed and utilized. The absorption rate of chitosan oligosaccharide in human body is nearly 100%, and the biological activity is more than chitosan. Stronger. It inhibits tumor cell growth, strengthens liver function, enhances immunity, prevents stomach ulcers, lowers blood pressure, blood sugar, blood lipids, cholesterol absorption and antibacterial effects.
  • Oligofructose is widely found in onions, honey, aloe vera and wheat plants, but its content is extremely low. At present, fructose transferase produced by Aspergillus can be used in sucrose to produce oligofructose on a large scale. Oligosaccharide fructose can selectively proliferate bifidobacteria, which is metabolized by bifidobacteria to produce acetic acid and lactic acid, which makes the intestinal tract acidic, inhibits the proliferation of harmful bacteria, and promotes intestinal peristalsis. Oligofructose also has many important physiological functions such as regulating human immunity and lowering blood lipids.
  • Oligogalactose is a functional oligosaccharide with natural properties.
  • the high temperature sterilization and the decomposition of human stomach acid lose their original characteristics.
  • the galactooligosaccharide can be effectively utilized by both Bifidobacterium bisporus and C. lactis.
  • Oligosaccharide is the only functional sugar that can be utilized by the eight beneficial bacteria in the human intestine, and can inhibit the growth and reproduction of harmful bacteria in the human intestine.
  • galacto-oligosaccharide has broad market prospects in China.
  • Xylo-oligosaccharide is one of the most potent varieties of proliferating bifidobacteria in polymeric sugars.
  • Organic acids Reduce the pH of the intestines, inhibit the growth of harmful bacteria, and proliferate the probiotics in the intestines.
  • the attached pathogenic bacteria can be excreted through the intestinal tract, thereby preventing the disease from clustering in the intestinal tract and achieving the purpose of preventing diarrhea, thereby achieving health care effects. .
  • the form of the edible composition is not particularly limited as long as it can be used for consumption.
  • the comestible composition may be in the form of a capsule, tablet, granule or granule.
  • the invention proposes a food product.
  • the food product comprises the edible composition described above.
  • the form of the food is not particularly limited as long as it can be used for eating.
  • the food product may be in the form of a capsule, a tablet, a granule or a granule.
  • the food provided by the present invention can be used as a health food, which can be made into a pharmaceutically acceptable capsule, tablet, or granule by a conventional process.
  • the invention proposes a method of preparing a food product.
  • the method comprises: providing the edible composition described above, wherein the Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves, and Functional Sugar are in a granular form;
  • the comestible composition is subjected to a molding process to obtain the food product.
  • the particles have a particle size of from 100 to 300 mesh.
  • the shaping process further comprises: forming the comestible composition in the form of a capsule, tablet, granule or granule.
  • the health food of the present invention is subjected to a safety evaluation test, including a mouse acute toxicity test, a mouse genotoxicity test, a rat 30-day feeding test, and the above test indicates: the health food of the present invention, the acute oral cavity of the mouse
  • the toxicity test is more than 10 g/kg_bw, which is safe and non-toxic.
  • the Ames test result is negative
  • the mouse bone marrow polychromatic erythrocyte micronucleus test result is negative
  • the mouse sperm abnormality test result is negative, indicating The product has no mutagenic effect;
  • the results of the 30-day feeding test in rats indicate that the health food of the present invention has been subjected to a 30-day feeding experiment in rats, and has important indexes such as overall health status, physiological and biochemical functions and organ histomorphology of the rats. No significant impact.
  • Table The health food soft capsule according to the invention is safe to take.
  • the health food of the invention has the function and effect of enhancing immunity, and the health food of the invention has better effect on enhancing immunity than the single component of astragalus, oligofructose, chitosan oligosaccharide and yeast dextran. Effect.
  • the experimental results of the health-improving function of the health food of the present invention showed that there was no significant difference in body weight, thymus/body weight ratio, and spleen/body weight ratio of each batch of mice. In the mouse antibody-producing cell assay, the serum hemolysin assay, and the mouse carbon clearance assay, the results were significantly different.
  • Bifidobacteria are representative of beneficial bacteria, can inhibit the growth of harmful bacteria, and maintain the normal micro-ecological environment in the intestine. Increasing the number of bifidobacteria in the human gut can significantly improve the gastrointestinal function and health of the human body.
  • the animal experiment for regulating the function of the intestinal flora by the health food of the present invention, and the human food experiment for regulating the function of the intestinal flora can be seen that the health food of the present invention has the function of regulating the intestinal flora.
  • the present invention can significantly stimulate the growth and increase of the number of beneficial bacteria (such as bifidobacteria) in the human intestinal tract, and significantly reduce the number of harmful bacteria such as Clostridium perfringens.
  • the number of Bifidobacteria, Enterobacteriaceae, and the number of Clostridium perfringens in the human intestinal tract after taking Inca soft capsules were lower than those after taking Inca fruit oil and taking Xylooligosaccharides.
  • the effect of the subject after the capsule is more obvious, that is, the health care function of the health food of the present invention is superior to the effect of the single component.
  • the present invention has the function of improving gastrointestinal function, and can function as a laxative and prevent constipation, and no adverse reaction is observed during the administration.
  • the invention provides the use of the above edible composition in the preparation of a formulation.
  • any edible preparation can be prepared by using the above edible composition, for example, a pharmaceutically acceptable dosage form such as a capsule, a soft capsule, a tablet, or a granule can be prepared.
  • the above preparation can be used for improving gastrointestinal function and enhancing human immunity and the like.
  • a dosage form can be prepared by using the above edible composition for exerting its function of improving gastrointestinal function, enhancing human immunity, and the like.
  • All the raw materials in the health food according to the present invention are natural, natural, safe and reliable, and the raw materials are widely available.
  • the compatibility of the prescriptions is scientific and reasonable, the curative effect is exact, the preparation process is simple, and the storage and application are safe. Production costs are low.
  • a health food consisting of a mixture of Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves and Functional Sugar,
  • the combination of functions and functions has obvious health care functions and synergistic effects for simultaneously improving the gastrointestinal tract and enhancing human immunity, and the combined effect of the invention in improving gastrointestinal function and enhancing human immunity is better than single The effect of the ingredients.
  • the health food of the invention not only improves the human immunity, but also improves the distribution of the intestinal flora of the human body, significantly stimulates the growth and increase of the number of beneficial bacteria (such as bifidobacteria) in the human intestinal tract, and reduces the harmfulness in the intestinal tract.
  • Bacteria The number of Clostridium perfringens plays a bacteriostatic effect, and at the same time achieves the health benefits of enhancing immunity, regulating intestinal flora, laxative, and preventing constipation.
  • the raw materials are mixed and pulverized into fine powder of 100-230 mesh, which is favorable for uniform dispersion of the active ingredients in the raw materials, and is convenient for absorption in the gastrointestinal tract of the human body.
  • the use of Inca fruit oil as a dispersing agent for soft capsules is advantageous for soft capsule molding, and the soft capsule dosage form is also advantageous for uniformly dispersing other active ingredients in the oil to facilitate absorption by the human body.
  • the health food of the invention has obvious efficacy, good safety, stable quality, long-term preservation of the product, and provides a new choice for daily health care.
  • Example 1-12 The health food formula of the present invention
  • Example 1 Example 2
  • Example 3 Example 4
  • Example 5 Case 6
  • Case 7 Case 8
  • Case 9 Case 10
  • Example 12 Inca 40 70 70 90 120 90 110 120 100 90 110 90 Astragalus 90 50 70 60 60 50 10 80 60 60 30 70 ⁇ 70 60 80 50 50 10 80 70 70 50 20 70 Inulin 40 80 60 70 50 80 100 30 50 70 90 50 50 Corn pollen 60 30 60 70 90 80 50 60 90 70 70 60 slag leaves 40 70 90 50 10 60 60 60 40 50 70 50 Konjac glucomannan 100 25 30
  • Yeast dextran 80 —— 30 70 25 ——
  • Redundant sugar 70 30 60 oligofructose 40 40 oligogalactose 40 20 40 20 xylooligo 60 20
  • Cystic sac According to the above table, the components of the health food according to the present invention can be made into capsules, tablets, or granules in pharmacy by a conventional process.
  • Example 4 For the health food granules described in Example 4 (hereinafter referred to as Inca granules), the preparation process is as follows:
  • Health care function regulate intestinal flora, enhance immunity
  • Suitable for people those with intestinal dysfunction and those with low immunity
  • Storage method sealed, kept in a cool dry place
  • Inca soft capsule For the health food soft capsule (hereinafter referred to as Inca soft capsule) described in Example 10, the preparation process is as follows:
  • the unqualified soft capsules such as the appearance and the joints are sorted and discarded, and the selected qualified soft capsules are packaged in the form of bottles or blister sheets, that is, the finished products (referred to as Inca soft capsules).
  • Health care function regulate intestinal flora, enhance immunity
  • Storage method sealed, kept in a cool dry place
  • Example 13 Determination of acute toxicity by oral administration to rats
  • Acute toxicity tests were performed using 6-week-old SD rats without specific pathogens (SPF).
  • Example 4 The health food prepared in Example 4 was suspended in a 0.5% methylcellulose solution, and orally administered to 5 SD rats in each group at a dose of lg/kg, 5 g/kg, and 10 g/kg, respectively. Rats were tested for death, clinical symptoms, and weight changes, and blood tests and blood biochemical tests were performed. At autopsy, any abnormalities in the gastrointestinal tissue of the chest and abdomen were visually examined.
  • Example 14 Study of enhancing immunity function
  • mice BALB/C 1 month old secondary mice, male and female, weighing 20 ⁇ 2g, in good health, provided by Experimental Animal Center of Wuhan University Medical College, production license number: SCXK (E) 2008-0004. Each batch of animals was randomized.
  • the Indo-Chong granule prepared in Example 6 was used.
  • the recommended dose was 250 mg/kg.BW (body weight) per day, and 0.5, 1, and 2 times of the mice were recommended as low dose group C125 mg/kg. .BW), medium dose group (250 mg/kg. BW), high dose group (500 mg/kg. BW).
  • the positive control group 1 is the Astragalus polysaccharide capsule (the main raw materials: Astragalus, oligo-isomalt, Inner Mongolia Shuangqi Pharmaceutical Co., Ltd., Guoshijianzi G20040082),
  • Positive control group 2 is oligofructose oral solution (main raw materials: oligofructose, Zhuhai Shengyuan Biotechnology Co., Ltd., Guoshijianzi G20050336),
  • the positive control group 3 was chitosan oligosaccharide capsules (main raw materials: chitosan oligosaccharide, Xiamen Lanwan Technology Co., Ltd., Guoshijianzi G20110158),
  • the positive control group 4 is yeast glucan capsule (main raw material: yeast glucan, Nanjing Dayuan Beauty Health Care Co., Ltd. Division, Guoshijianzi G20110445).
  • SRBC sheep red blood cells
  • Hank's solution Hank's solution
  • guinea pig serum ink.
  • NaCl 80.00g
  • KC1 4.00g
  • KH 2 PO 4 0.60g
  • 0.4% phenol red liquid 50.00mL
  • double distilled water plus constant volume to lOOmL autoclaved at 115 °C for 15 min, stored frozen.
  • the test was performed by gavage.
  • the stomach was administered once a day, and the blank control group was filled with the same volume of distilled water.
  • Each group of mice was continuously administered with the test substance for 30 days, and each index was measured.
  • mice 2.1 Effects on body weight, thymus/body weight, spleen/body weight of mice
  • mice were sacrificed by cervical dislocation 30 days later and weighed.
  • the thymus and spleen were taken, and the thymus and spleen weights were weighed separately, and the thymus/body weight value and the spleen/body weight value were measured.
  • mice were immunized by intraperitoneal injection of 0.2 mL of 2% (v/v) SRBC. 5 days after immunization, the mouse spleen is made to take a cell concentration of spleen cells was 5x l0 6 cells / mL. Dissolve the agarose to make a 1% solution, incubate in a 48 ° C water bath, mix with an equal amount of 2 times the concentration of Hank's solution, and dispense into a small tube, 0.5 mL per tube. Add 0.05 mL of 10% SRBC and O.OlmL spleen cell suspension, mix quickly and pour onto the slide. Incubate for 1 h in a 37 ° C incubator, add complement (guinea pig serum) to the slide trough, and incubate for 1.5 h. Count plaques.
  • complement guinea pig serum
  • mice were immunized by intraperitoneal injection of 0.2 mL of 2% (v/v) SRBC. After 5 days of immunization, the eyeballs were taken from the centrifuge tube, placed for 1 h, centrifuged at 3000 rpm for 5 minutes, and serum was collected. The serum was diluted 400-fold with physiological saline, and diluted mouse serum 1.0 mL, 10% (v/v) SRBC 0.5 mL, and complement (diluted with physiological saline 1:10) 1.00 mL were sequentially added. A serum-free control tube replaced with physiological saline was also provided.
  • the reaction was stopped at 0 ° C for 30 minutes, and centrifuged at 3000 rpm for 5 minutes. The supernatant was taken to 1.0 mL, and the optical density value was measured at a wavelength of 540 nm of a spectrophotometer.
  • Each mouse was injected with 4 times diluted ink in the tail vein, 0.1 mL/10 g body weight. Time is counted immediately after the ink is injected. 0.02 mL of blood was taken to 2.0 mL of 0.1% Na 2 C0 3 solution (ie, lg/L) at 1 minute and 10 minutes after injecting the ink, respectively. The optical density value was measured at a wavelength of 600 nm using a Na 2 CO 3 solution as a control. The liver and spleen were weighed. The phagocytic index ((X) is used to indicate the ability of the mouse to clear the carbon.
  • mice The effects of each test substance on the body weight, thymus/body weight ratio, and spleen/body weight ratio of the mice are shown in Tables 2, 3 and 4.
  • the antibody-producing cell (PFC) test results are shown in Table 5.
  • Group Ll amount (mg/kg 'bw) Number of animals (only) Number of antibody-producing cells (x ⁇ s)
  • P value blank control group 0 12 72 ⁇ 22 - Positive control group 1 1 capsule 12 89 ⁇ 19 0.0452
  • Positive control 2 groups 0.5mL 12 83 ⁇ 23 0.1954
  • positive control 3 groups 1 capsule 12 83 ⁇ 21 0.2019 positive control 4
  • Dosage group 500 12 90 ⁇ 21 0.0687 It can be seen from Table 5 that after oral administration of different doses of the test substance to the mice for 30 days, compared with the blank control group, the positive control group
  • the phagocytosis ability of the cells was significantly different (P ⁇ 0.01).
  • the low-dose group, the positive control group 1 and the positive control group 2 had significant differences in the phagocytic ability of mouse macrophages (P ⁇ 0.05), and the other groups were small.
  • the mouse carbon clearance ability has no effect. This indicates that the health food of the present embodiment has an effect of enhancing the phagocytic function of mononuclear macrophages, and can enhance non-specific immune function of mice.
  • the results of experiments before and after improving the immunity function of the health food of the present example showed that there was no significant difference in body weight, thymus/weight ratio, and spleen/body weight ratio of each batch of mice.
  • the health food of the present embodiment can be considered to have the function and effect of enhancing immunity, and the health food of the present embodiment is superior to the single component of jaundice, oligofructose, chitooligosaccharide, and yeast.
  • the effect of the glycan is not limited to the human milk, the serum hemolysin assay, and the mouse carbon clearance assay.
  • the health food granules (hereinafter referred to as Inca granules) used in the present embodiment were prepared in the same manner as in Example 4, and were packed in 5 g/bag aluminum foil.
  • the recommended eating method was 2 times a day, 1 bag each time.
  • the health food soft capsule (hereinafter referred to as Inca soft capsule) used in the present embodiment is prepared by the method of Example 10, and has a specification of 1.0 g/granule.
  • the recommended eating method is 3 times a day, 3 capsules each time.
  • the human food test experiment added two positive control groups, which were:
  • Positive control group 1 Inca fruit oil (from Huada Gene (Laos) Co., Ltd., batch number 20120301), 2 times a day, 5mL each time;
  • Positive control group 2 xylooligosaccharide capsule (Shandong Longli Biotechnology Co., Ltd., Guoshijianzi G20041284), 2 times a day, 3 capsules each time;
  • Bifidobacterium BBL medium, 37 °C, animal experiment 72h anaerobic culture, human food test 48h anaerobic culture; Lactobacillus: LBS medium, 37 ° C, 48h culture;
  • EMB medium 37 ° C, 24 h culture
  • Enterococcus sodium azide - crystal violet - esculin culture medium, 37 ° C, animal experiment 24 h culture, human trial experiment 48 h + Li Guan.
  • Clostridium perfringens TSC medium, 37 ° C, 24 h anaerobic culture.
  • mice 50 male mice were randomly divided into 5 groups, 10 in each group, of which 1 group was the normal control group, and the other 4 groups were given lincomycin hydrochloride.
  • the dosage was 60 mg/10g_bw for 3 days.
  • the mice developed dysbacteriosis, and one group was randomly selected to be administered with normal saline as a natural recovery group, and the other three groups were administered with the granules of the present example.
  • the mouse feces were aseptically taken to detect the number of intestinal flora, and the changes of Bifidobacterium, Lactobacillus, Enterococcus, Enterobacter, Clostridium perfringens before and after the experiment were compared. .
  • the subjects were randomly divided into 3 groups, and the subjects' faeces were aseptically taken before the subjects were tested, and the number of intestinal flora was examined.
  • the first group of subjects took the Inca soft capsule of the present example, 3 times a day, 3 times each time, for 7 days;
  • the second group of subjects took the positive control group 1 of Inca fruit oil, 2 times a day, 5mL each time;
  • the third group of subjects took the positive control group 2 xylooligosaccharide capsules, 2 times a day, 3 capsules each time;
  • the number of bifidobacteria increased significantly, the difference was significant ( ⁇ .05), and the number of lactobacilli increased significantly, and the difference was extremely significant ( ⁇ 0.01).
  • the number of Enterococcus and Clostridium perfringens was significantly increased in the middle dose group, the difference was significant ( ⁇ 0.05), and the number of Enterobacteriaceae was significantly increased.
  • the difference was extremely significant ( ⁇ 0.01).
  • the number of bifidobacteria and lactobacilli increased significantly, and the difference was extremely significant ( ⁇ 0.01).
  • the number of enterococci and Clostridium perfringens increased significantly, and the difference was significant.
  • Bifidobacteria are representative of beneficial bacteria, can inhibit the growth of harmful bacteria, and maintain the normal micro-ecological environment in the intestine. Increasing the number of bifidobacteria in the human gut can significantly improve the gastrointestinal function and health of the human body.
  • the animal experiment of regulating the function of the intestinal flora by the above-mentioned Inka soft capsule and the human food test experiment of regulating the function of the intestinal flora can be seen that the health food of the embodiment has the function of regulating the intestinal flora, and the invention can significantly stimulate the human intestine
  • the number of beneficial bacteria in the tract, Bifidobacteria, Enterobacter, and the number of harmful bacteria Clostridium perfringens were significantly reduced.
  • the number of Bifidobacteria, Enterobacteriaceae, and the number of Clostridium perfringens in the human intestinal tract after taking Inca soft capsules were lower than those after taking Inca fruit oil and taking Xylooligosaccharides.
  • the effect of the subject after the capsule is more obvious, that is, the health care function of the health food of the present invention is superior to the effect of the single component.
  • the present embodiment adopts the Indo-Chong agent (hereinafter referred to as Inca granule) prepared in the fourth embodiment.
  • mild constipation means 2-3 days of bowel movements
  • moderate constipation means 3-6 days of bowel movements
  • severe constipation means more than 7 days of bowel movements or relies on laxatives for defecation, once or twice a day.
  • Patients with mild constipation took Inca granules for 7 days, taking 2 bags a day for the first three days, and then taking 1 bag every day for four days.
  • Patients with moderate constipation took Inca granules for 7 days, taking 4 bags a day for the first three days, and then taking 2 bags a day for four days, brewing in warm water.
  • Patients with severe constipation took Inca granules for 7 days, taking 6 bags a day for the first three days, and then 3 bags a day for four days.
  • the product has the function of improving the function of the gastrointestinal tract, and can function as a laxative and constipation, and no adverse reaction is observed during the administration.
  • the description of the terms “one embodiment”, “some embodiments”, “example”, “specific example”, or “some examples” and the like means a specific feature described in connection with the embodiment or example.
  • a structure, material or feature is included in at least one embodiment or example of the invention.
  • the schematic representation of the above terms does not necessarily mean the same embodiment or example.
  • the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.

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Abstract

Provided are an edible composition, a food product comprising same, and a preparation method for the food product. The edible composition comprises: 120 parts by weight of sacha inchi, 10-90 parts by weight of Astragalus, 10-80 parts by weight of poria, 30-100 parts by weight of inulin, 30-90 parts by weight of corn pollen, 10-90 parts by weight of Strophanthus divaricatus, and 20-120 parts by weight of a functional sugar.

Description

可食用组合物以及包含其的食品、 该食品的制备方法  Edible composition and food containing same, preparation method of the same

技术领域 Technical field

本发明属于保健食品领域, 具体涉及一种可食用组合物以及包含该可食用组合物的食 The invention belongs to the field of health foods, and in particular relates to an edible composition and a food containing the edible composition

ΠΠ

ΡΠ。 Hey.

背景技术 Background technique

人体内的免疫系统是由免疫器官及免疫细胞所组成, 是我们人体自身的天然屏障, 它 不仅能抵御外来细菌和其他有害物质的侵袭, 还能消除体内衰老、 突变、 恶化或死亡的细 胞, 保持肌体的健康。 免疫力则是人体抵御外邪侵袭、 维持内环境稳定的能力。 免疫力低 下就容易受到疾病的侵袭, 提高人体免疫力则是战胜疾病的基础。  The immune system in the human body is composed of immune organs and immune cells. It is our natural natural barrier. It not only protects against foreign bacteria and other harmful substances, but also eliminates cells that are aging, mutated, deteriorated or dead in the body. Keep your body healthy. Immunity is the ability of the human body to resist the invasion of external evils and maintain the stability of the internal environment. Immunity is low and vulnerable to disease. Improving human immunity is the basis for overcoming disease.

细菌、 真菌等微生物广泛存在于我们生活的自然环境中, 同时也寄居在人体的体表和 体腔内。 在正常情况下, 这些细菌一般对人体无害, 有些菌群甚至是有益的, 它们与人体 和外界环境之间构成了一个复杂的相互依存、 相互制约的微生态系统。 肠道菌群是肠道防 御屏障的重要组成部分, 平衡的肠道菌群对人的健康十分重要。  Microorganisms such as bacteria and fungi are widely found in the natural environment in which we live, and also in the body surface and body cavity of the human body. Under normal circumstances, these bacteria are generally harmless to the human body, and some of the bacteria are even beneficial. They form a complex interdependent and mutually constrained micro-ecological system with the human body and the external environment. The intestinal flora is an important part of the intestinal defense barrier, and a balanced intestinal flora is important for human health.

但是在现代社会里,随着生活节奏的增强以及饮食的无规律状态, 以及由于机体衰老、 营养不良、 年老体弱、 肠道与其他系统急慢性疾病、 长期使用抗生素、 激素、 抗肿瘤药、 放疗、 化疗等原因, 往往使人体肠道微生态系统受到破坏, 引起胃肠道功能紊乱及肠道菌 群失调, 消化吸收功能减弱, 严重地影响了身体的免疫系统机能, 造成免疫功能低下, 导 致菌群易位, 诱发内源感染, 造成机体病变, 从而引发多种疾病, 如可引起胃肠道感染、 便秘、 过敏性肠综合征、 炎性肠道疾病等。  However, in modern society, with the improvement of the rhythm of life and the irregular state of diet, as well as due to aging, malnutrition, frail elderly, intestinal and other systemic acute and chronic diseases, long-term use of antibiotics, hormones, antineoplastic drugs , radiotherapy, chemotherapy and other reasons, often cause damage to the human intestinal micro-ecological system, causing gastrointestinal dysfunction and intestinal flora imbalance, digestive and absorption functions are weakened, seriously affecting the body's immune system function, resulting in low immune function , causing translocation of flora, inducing endogenous infections, causing pathological changes, leading to a variety of diseases, such as gastrointestinal infections, constipation, irritable bowel syndrome, inflammatory bowel disease.

大多数人一般采用的治疗方法, 多选用西药的治疗, 然而对于胃肠道的疾病, 能使胃 肠病得到一些缓解, 但西药一般会刺激胃肠道, 本来肠胃病患者胃肠功能较弱, 副作用相 当大, 长时间使用很容易破坏机体的平衡, 使病情加重, 还有可能引起其他疾病的滋生。 当前, 改善胃肠功能的保健食品主要包括调节胃肠道菌群的保健食品、 润肠通便的保健食 品、 保护胃粘膜以及促进消化吸收的保健食品等。 但是这些保健食品功能和效果单一, 仅 限某一功能的提升或者改变, 并没有在更深更广的领域对其进行进一步的研究。  Most people generally use the treatment method, and most of them use western medicine. However, for gastrointestinal diseases, gastrointestinal diseases can be relieved, but western medicine generally stimulates the gastrointestinal tract. The gastrointestinal function of patients with gastrointestinal diseases is weak. The side effects are quite large. It is easy to damage the balance of the body after prolonged use, which may aggravate the condition and may cause other diseases to breed. At present, health foods for improving gastrointestinal function mainly include health foods for regulating gastrointestinal flora, health foods for laxatives, gastric mucosa, and health foods for promoting digestion and absorption. However, these health foods have a single function and effect, and only a certain function is promoted or changed, and no further research is carried out in a deeper and broader field.

然而, 目前的保健食品仍有待改进。 发明内容  However, current health food products still need to be improved. Summary of the invention

本发明旨在至少在一定程度上解决上述技术问题之一或至少提供一种有用的商业选择。 为此, 本发明的一个目的在于提供一种可食用组合物, 该可食用组合物同时具有改善胃肠 道功能和增强人体免疫力的调节作用。 由此, 在本发明的一个方面,本发明提出了一种可食用组合物, 根据本发明的实施例, 该可食用组合物包含: 40〜120重量份的印加果; 10〜90重量份的黄芪; 10〜80重量份的茯苓; 30〜100重量份的菊粉;30〜90 重量份的玉米花粉; 10〜90重量份的布渣叶以及 20〜120重量份 的功能糖。 The present invention is directed to solving at least some of the above technical problems or at least providing a useful commercial choice. To this end, it is an object of the present invention to provide an edible composition which simultaneously has a regulatory effect of improving gastrointestinal function and enhancing human immunity. Thus, in one aspect of the invention, the present invention provides an edible composition comprising, according to an embodiment of the present invention, 40 to 120 parts by weight of Inca; 10 to 90 parts by weight Astragalus; 10 to 80 parts by weight of hydrazine; 30 to 100 parts by weight of inulin; 30 to 90 parts by weight of corn pollen; 10 to 90 parts by weight of slag leaves and 20 to 120 parts by weight of functional sugar.

发明人发现, 某些中药以及食品中的成分主要有氨基酸类、 多糖类、 维生素类、 多种 微量元素及其它有机物和无机物类。 研究证明这些中药以及食品中的许多成分对细菌的生 长代谢有促进作用, 可以促进胃肠道益生菌的增殖, 抑制病原菌的生长, 对肠道菌群有着 重要作用。同时益生菌也可以促进这些中药以及食品的吸收和利用,改善人体胃肠道功能、 增强人体免疫力, 增强人体抵抗疾病的能力。  The inventors have found that certain Chinese medicines and food ingredients mainly include amino acids, polysaccharides, vitamins, various trace elements and other organic and inorganic substances. Studies have shown that these Chinese medicines and many components in foods promote the growth metabolism of bacteria, promote the proliferation of gastrointestinal probiotics, inhibit the growth of pathogenic bacteria, and play an important role in the intestinal flora. At the same time, probiotics can also promote the absorption and utilization of these traditional Chinese medicines and foods, improve the function of the human gastrointestinal tract, enhance the body's immunity, and enhance the body's ability to resist disease.

本申请的发明人经过艰苦的创造性劳动和优化工作, 意外的发现: 由印加果、 黄芪、 茯苓、 菊粉、 玉米花粉、 布渣叶和功能糖混合配制而组成的可食用组合物, 在改善胃肠道 功能及增强人体免疫力功能方面的作用明显, 且该可食用组合物的组分在改善胃肠道功能 及增强人体免疫力方面的组合作用效果优于单一成分的作用效果, 具有明显的协同作用。  After intensive creative labor and optimization work, the inventor of the present application unexpectedly discovered that an edible composition composed of a mixture of Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves and Functional Sugar is improving. The function of the gastrointestinal tract and the function of enhancing the immunity of the human body are obvious, and the combination of the components of the edible composition in improving the function of the gastrointestinal tract and enhancing the immunity of the human body is superior to the effect of the single component, and has obvious effects. Synergies.

印加果 (P/ feweriii vo/ b fc L.Jnca Peanut, sacha inchi) 为大戟科藤本植物, 又称印加 花生、 南美油藤、 星油藤、 美藤果。 多年生油料植物, 原产南美洲亚马逊河流域雨林, 最 初由印加人变野生为家种, 在南美洲印加地区已被当地土著应用了上千年的历史。 当年种 植, 当年可挂果, 种子富含油脂、 蛋白质、 氨基酸, 还有维生素 A, 维生素 E和一些其它 微量元素, 印加果油含有极其丰富的不饱和脂肪酸(ω-3、 ω-6、 ω-9), 以及维生素 Α、 Ε和 蛋白质,且三种不饱和脂肪酸含量高达 92%以上。印加果富含人体必需脂肪酸 a—亚麻酸, 是 ω-3系列不饱和脂肪酸的母体, 是生命进化过程中最基本、 最原始的物质。 (—亚麻酸作 为生命的核心物质,是构成人体组织细胞的重要成份之一,在人体内参与磷脂合成与代谢, 转化为机体必须的生命活性因子 DHA和 ΕΡΑ, 当人体内 ct一亚麻酸不足时, 会因免疫能力 低下而引发各类疾病。当人体补充了足量的 ct一亚麻酸后,这些疾病症状就会得到明显改善。  Inca (P/lessiii vo/ b fc L.Jnca Peanut, sacha inchi) is a large vine, also known as Inca peanut, South American vine, Star vine, and Meito fruit. The perennial oil plant, native to the Amazonian rainforest of South America, was originally transformed from the Incas to the wild, and has been used by local indigenous people for thousands of years in the Inca region of South America. When planted in the same year, the fruit can be hung. The seeds are rich in oil, protein, amino acids, vitamin A, vitamin E and some other trace elements. Inca oil contains extremely rich unsaturated fatty acids (ω-3, ω-6, ω- 9), as well as vitamins, strontium and protein, and the content of three unsaturated fatty acids is as high as 92% or more. Inca fruit is rich in essential fatty acids a-linolenic acid, the mother of omega-3 unsaturated fatty acids, the most basic and primitive substance in the evolution of life. (-Linolenic acid, as the core substance of life, is one of the important components of human tissue cells. It is involved in the synthesis and metabolism of phospholipids in the human body, and is transformed into the vital activity factors DHA and sputum necessary for the body. When ct-linolenic acid is insufficient in human body When the immune system is low, it will cause various diseases. When the body is supplemented with a sufficient amount of ct-linolenic acid, the symptoms of these diseases will be significantly improved.

黄芪为豆科植物黄芪的干燥根, 该植物主要分布于我国东北、 华北和西北等地区, 黄 芪属植物的化学成分主要为单糖、 多糖、 皂甙、 黄酮、 氨基酸和微量元素等; 具有增强免 疫力、抗疲劳、 抗突变、保肝、 抑制破骨细胞的作用, 能对抗氢化可的松的免疫抑制作用, 并能增强巨噬细胞的吞噬功能, 促进抗体合成; 具有解毒作用, 能加强正常心脏收縮, 对 衰竭的心脏有强心作用, 能使冠状血管和肾脏血管扩张, 并使全身末梢血管扩张。  Astragalus membranaceus is the dry root of the leguminous plant Astragalus. The plant is mainly distributed in the northeast, north and northwest of China. The chemical constituents of Astragalus are mainly monosaccharides, polysaccharides, saponins, flavonoids, amino acids and trace elements. Force, anti-fatigue, anti-mutation, liver protection, inhibition of osteoclasts, can prevent the immunosuppressive effect of hydrocortisone, and can enhance the phagocytic function of macrophages and promote antibody synthesis; have detoxification effect, can strengthen normal The heart contraction, which has a strong heart effect on the failing heart, can dilate the blood vessels of the coronary vessels and kidneys and dilate the blood vessels at the peripheral end of the body.

茯苓含茯苓多糖、 葡萄糖、 蛋白质、 氨基酸、 有机酸、 脂肪、 卵磷脂、 腺嘌呤、 胆碱、 麦角 醇、 多种酶和钾盐。 能增强机体免疫功能, 有利尿作用, 有镇静及保护 肝脏、 抑制溃疡的发生、 降血糖、 抗放射等作用。 茯苓也可作为重要的食疗品种, 用 作茯苓饼、 茯苓酥和茯苓酒等, 经常食用可健脾去湿, 助消化, 壮体质。 总之, 茯苓 性质平和, 利水而不伤正气, 健脾益胃, 养心安神, 能有效的增强机体免疫能力, 帮助消 化, 强壮体质。 It contains polysaccharides, glucose, protein, amino acids, organic acids, fats, lecithin, adenine, choline, ergosterol, various enzymes and potassium salts. It can enhance the body's immune function, diuretic effect, calming and protecting the liver, inhibiting the occurrence of ulcers, lowering blood sugar, and resisting radiation. It can also be used as an important therapeutic ingredient for glutinous cakes, glutinous rice cakes and alcoholics. It can be eaten regularly to moisturize the spleen, help digestion, and strengthen the body. In short, 茯苓 The nature is peaceful, the water is good without hurting the righteousness, the spleen and the stomach are spleen, the heart is calming and calming, the body immunity can be effectively enhanced, the digestion can be enhanced, and the body can be strengthened.

菊粉主要分布在菊科植物中, 其中菊苣中含量最高。 菊粉是迄今为止人类发现的最 优质、 纯天然、 可溶性的果聚糖混合物。 菊粉于 2009年被卫生部批准为新资源食品。 菊粉 具有低热量、 水溶性等特性及增强双歧杆菌增殖、 降低血糖血脂、 恢复胃肠功能、 增强钙 质吸收等诸多功效。每天摄食菊粉能使结肠中的有益菌大大增多,减少病原菌和腐败菌, 如沙门氏菌、 李斯特菌、 金黄色葡萄球菌、 大肠菌群等。 其机理是菊粉不被消化吸收 而直接进入大肠优先被双歧杆菌利用, 产生醋酸盐和乳酸盐, 降低了大肠的 PH值, 从而抑制了有害菌的生长。  Inulin is mainly distributed in Compositae, with the highest content in chicory. Inulin is the highest quality, pure natural, soluble fructan mixture found by humans to date. Inulin was approved by the Ministry of Health as a new resource food in 2009. Inulin has the characteristics of low calorie, water solubility and the like, and enhances the proliferation of bifidobacteria, lowers blood sugar and blood lipids, restores gastrointestinal function, and enhances calcium absorption. Feeding inulin every day can greatly increase the number of beneficial bacteria in the colon, reducing pathogens and spoilage bacteria such as Salmonella, Listeria, Staphylococcus aureus, and coliforms. The mechanism is that the inulin is not digested and absorbed, but directly enters the large intestine and is preferentially used by bifidobacteria to produce acetate and lactate, which lowers the pH value of the large intestine, thereby inhibiting the growth of harmful bacteria.

玉米是我国第三大农作物, 东北是我国玉米的主产区, 玉米花粉资源丰富。 玉米花粉 营养价值高、 个体大、 产量大、 易于采收。 玉米花粉富含蛋白质、 糖类、 氨基酸、 核酸、 维生素等营养成分, 玉米花粉经过破壁处理后, 可以分离提取其中的多糖、 黄酮类等活性 成分。 能促进脾脏、 骨骼、 淋巴结和胸腺免疫器官的发育, 增强免疫细胞的活性, 提 高机体对抗细菌和病毒的能力, 并有抗辐射、抗癌作用, 具有增强免疫、促进生长发育、 降血压等保健功能。 同时玉米花粉能提供人体所需的多种营养成份, 对于因缺少某种营 养所引起的疾病, 亦有良好的辅助疗效。 因此玉米花粉在临床上有广泛的应用, 并作 为多种疾病的补充治疗品和日常营养的补充品。 玉米花粉既可以加工成口服液、 花粉胶 囊、 花粉饮料和花粉酸奶等保健饮品, 也可以开发出花粉面包、 花粉面条等功能性食品。 玉米花粉中含有丰富的维生素 B族物质, 其中的维生素 Bl, 能刺激消化酶的产生, 帮 助消化; 维生素 B6、 矿物质和蛋氨酸等成份可以治疗顽固性便秘及泻痢; 玉米花粉中 还含有天然抗生素及促进生长的物质, 可控制大肠菌、 沙门氏菌的繁殖, 修复胃肠损 伤的部分, 从而对治疗胃和十二指肠溃疡、 穿孔有神奇的效果。  Corn is the third largest crop in China, and the northeast is the main producing area of corn in China. The corn pollen resources are abundant. Corn pollen has high nutritional value, large individual size, large yield and easy harvesting. Corn pollen is rich in protein, sugar, amino acids, nucleic acids, vitamins and other nutrients. After the corn pollen is broken, it can separate and extract the active ingredients such as polysaccharides and flavonoids. It can promote the development of immune organs of the spleen, bones, lymph nodes and thymus, enhance the activity of immune cells, improve the body's ability to fight bacteria and viruses, and have anti-radiation and anti-cancer effects. It can enhance immunity, promote growth and development, lower blood pressure and other health care. Features. At the same time, corn pollen can provide a variety of nutrients needed by the human body, and it also has a good auxiliary effect for diseases caused by lack of certain nutrition. Therefore, corn pollen has a wide range of clinical applications and is a supplement to various diseases and a supplement to daily nutrition. Corn pollen can be processed into health drinks such as oral liquid, pollen capsules, pollen beverages and pollen yoghurt, as well as functional foods such as pollen bread and pollen noodles. Corn pollen is rich in vitamin B group substances, among which vitamin B1 can stimulate the production of digestive enzymes and help digestion; vitamin B6, minerals and methionine can treat intractable constipation and diarrhea; corn pollen also contains natural Antibiotics and growth-promoting substances can control the growth of coliforms and salmonella, repair the parts of gastrointestinal damage, and thus have magical effects on the treatment of gastric and duodenal ulcers and perforations.

布渣叶为椴树科破布叶属植物破布树 Microcos paniculata.的叶全年可采收,一般夏、 秋季采摘, 去净枝梗, 阴干。 布渣叶味淡、 微酸, 性平, 具有清热消滞, 利湿退黄, 化痰 之功效, 主要用于感冒, 中暑, 食欲不振, 消化不良, 湿热食滞之脘腹痛, 食少泄泻, 湿 热黄疸等。 布渣叶含有生物碱、 有机酸、 糖类、 酚类和鞣质。 自古以来, 布渣叶在就我国 岭南地区的民间广泛应用, 民间常用布渣叶煎茶作夏季饮料, 有解渴, 开胃作用。  The slag leaves are the rags of the genus Eucalyptus. The leaves of Microcos paniculata. can be harvested all year round. They are usually picked in summer and autumn, and the stems are removed. The slag leaves are light, slightly acidic, and flat. They have the effects of clearing heat and eliminating stagnation, dampness and yellowing, and phlegm. They are mainly used for colds, heatstroke, loss of appetite, indigestion, dampness and heat stagnation, abdominal pain, and less food. Diarrhea, damp heat, jaundice, etc. The slag leaves contain alkaloids, organic acids, sugars, phenols and tannins. Since ancient times, the slag leaves have been widely used in the folks of Lingnan in China. Folk slag leaves are used as summer drinks, which have thirst-quenching and appetizing effects.

根据本发明的实施例, 优选的可食用组合物包含: 70〜110重量份的印加果; 30〜70重 量份的黄芪; 20〜60重量份的茯苓; 50〜80重量份的菊粉; 50〜80重量份的玉米花粉; 30〜70 重量份的布渣叶以及 40〜100重量份的功能糖。 由此, 可以进一步提高可食用组合物改善胃 肠道功能和增强人体免疫力的调节作用。  According to an embodiment of the present invention, a preferred edible composition comprises: 70 to 110 parts by weight of Inca; 30 to 70 parts by weight of xanthine; 20 to 60 parts by weight of hydrazine; 50 to 80 parts by weight of inulin; ~80 parts by weight of corn pollen; 30 to 70 parts by weight of cloth slag leaves and 40 to 100 parts by weight of functional sugar. Thereby, the regulating effect of the edible composition for improving the function of the stomach and the intestine and enhancing the immunity of the human body can be further improved.

根据本发明的实施例, 最优选的可食用组合物包含: 90重量份的印加果; 60重量份的 黄芪; 50重量份的茯苓; 70重量份的菊粉; 70重量份的玉米花粉; 50重量份的布渣叶以 及 70重量份的功能糖。 由此, 可以进一步提高可食用组合物改善胃肠道功能和增强人体免 疫力的调节作用。 According to an embodiment of the invention, the most preferred edible composition comprises: 90 parts by weight of Inca; 60 parts by weight Astragalus; 50 parts by weight of enamel; 70 parts by weight of inulin; 70 parts by weight of corn pollen; 50 parts by weight of cloth slag leaves and 70 parts by weight of functional sugar. Thereby, the regulating effect of the edible composition for improving gastrointestinal function and enhancing human immunity can be further improved.

根据本发明的实施例, 可以用于本发明可食用组合物的功能糖的类型并不受特别限制。 根据本发明的具体示例, 可以采用的功能糖为选自魔芋葡甘聚糖、 酵母葡聚糖、 壳寡糖、 低聚果糖、 低聚半乳糖、 低聚木糖、 低聚异麦芽糖的至少一种。 由此, 可以进一步提高可 食用组合物改善胃肠道功能和增强人体免疫力的调节作用。  According to an embodiment of the present invention, the type of functional sugar which can be used in the edible composition of the present invention is not particularly limited. According to a specific example of the present invention, the functional sugar that can be employed is at least selected from the group consisting of konjac glucomannan, yeast glucan, chitooligosaccharide, oligofructose, galactooligosaccharide, xylooligosaccharide, and oligo-isomaltose. One. Thereby, the regulating effect of the edible composition for improving gastrointestinal function and enhancing human immunity can be further improved.

魔芋葡甘聚糖是一种高分子量的水溶性多糖。 中国及日本自古栽培和食用魔芋。 1997 年美国 FDA批准魔芋葡甘聚糖作为食品添加剂。中国卫生部于 1998年 2月 16日卫监发 [1998] 第 9号文件正式将魔芋列入作为普通食品管理的食品新资源名单。 欧盟于 1998年 11月 4 日官方正式批准魔芋葡甘聚糖用于食品中。 由于魔芋葡甘聚糖具有许多优良特性, 作为食 品、 饮料添加剂的用途极广泛。  Konjac glucomannan is a high molecular weight water soluble polysaccharide. China and Japan cultivated and consumed konjac since ancient times. In 1997, the US FDA approved konjac glucomannan as a food additive. On February 16, 1998, the Chinese Ministry of Health officially listed Konjac as the new food resource list for general food management. On November 4, 1998, the EU officially approved the use of konjac glucomannan in food. Since konjac glucomannan has many excellent properties, it is widely used as a food and beverage additive.

酵母葡聚糖来源于酿酒酵母 (Saccharomyces cerevisiae), 由于其特殊的结构具有多种生 理活性, 并且在美国 FDA已将它列入 GRAS (通常认为是安全的) 中, 作为食品原料, 被 广泛运用于各种食品中。在我国, 2010年中华人民共和国卫生部 2010第 9号公告批准酵母 葡聚糖作为新资源食品, 使其能在各类食品中得到运用。 酵母葡聚糖作为膳食纤维, 能被 肠道细菌分解, 促进胃肠蠕动, 刺激消化液的分泌, 具有辅助消化的功能; 可增加肠道的 蠕动, 促进排便, 从而有效防止便秘; 可以增加人体肠道对钙、 镁和锌的吸收。 酵母葡聚 糖独特的 β-(1→3)骨架结构使其具有较强的免疫调节活性。 能显著提高人体免疫力。  Yeast glucan is derived from Saccharomyces cerevisiae. It has a variety of physiological activities due to its special structure, and it has been widely used in the GRAS (usually considered safe) in the US FDA. In a variety of foods. In China, the Ministry of Health of the People's Republic of China 2010 No. 9 Announcement approved yeast glucan as a new resource food, enabling it to be used in various foods. As a dietary fiber, yeast glucan can be decomposed by intestinal bacteria, promote gastrointestinal motility, stimulate the secretion of digestive juice, and have the function of assisting digestion; it can increase the peristalsis of the intestine and promote defecation, thus effectively preventing constipation; Absorption of calcium, magnesium and zinc by the intestines. The unique β-(1→3) framework of yeast glucose has a strong immunomodulatory activity. Can significantly improve human immunity.

壳寡糖是壳聚糖降解以后聚合度 2-10 的产物,其水溶性比壳聚糖好,容易被吸收利用, 壳寡糖在人体内吸收率近 100%, 且生物活性比壳聚糖更强。 它能够抑制肿瘤细胞生长, 强 化肝功能, 增强免疫力, 防止胃溃疡, 降低血压、 血糖、 血脂、 吸收胆固醇及抗菌作用等。  Chitosan oligosaccharide is a product of polymerization degree 2-10 after degradation of chitosan. Its water solubility is better than that of chitosan, and it is easily absorbed and utilized. The absorption rate of chitosan oligosaccharide in human body is nearly 100%, and the biological activity is more than chitosan. Stronger. It inhibits tumor cell growth, strengthens liver function, enhances immunity, prevents stomach ulcers, lowers blood pressure, blood sugar, blood lipids, cholesterol absorption and antibacterial effects.

低聚果糖广泛存在于洋葱、 蜂蜜、 芦荟及麦类植物中, 但含量极低, 目前国内已可利 用曲霉产生的果糖转移酶作用于蔗糖, 规模化生产低聚果糖。 低聚果糖可选择性增殖双歧 杆菌, 被双歧杆菌代谢后会产生醋酸及乳酸, 使肠道呈酸性, 抑制有害菌的增殖, 促进肠 道的蠕动。 低聚果糖还具有调节人体免疫力, 降低血脂等多种重要生理功能。  Oligofructose is widely found in onions, honey, aloe vera and wheat plants, but its content is extremely low. At present, fructose transferase produced by Aspergillus can be used in sucrose to produce oligofructose on a large scale. Oligosaccharide fructose can selectively proliferate bifidobacteria, which is metabolized by bifidobacteria to produce acetic acid and lactic acid, which makes the intestinal tract acidic, inhibits the proliferation of harmful bacteria, and promotes intestinal peristalsis. Oligofructose also has many important physiological functions such as regulating human immunity and lowering blood lipids.

低聚半乳糖是一种具有天然属性的功能性低聚糖,卫生部 2008年第 20号公告批准其 为新资源食品, 其具有较强的耐酸性、 耐热性, 不会因为在加工过程中的高温杀菌及 人体胃酸所分解而失去其本来应有之特性。 低聚半乳糖能有效地被双歧杆 Β菌和乳酸 杆 Α菌同时利用。 低聚半乳糖是唯一都能够被人体肠内 8大有益菌所利用的功能糖, 而且能够抑制人体肠内有害菌的生长繁殖。 低聚半乳糖作为一种新的功能性食品, 在 我国具有广阔的市场前景。 低聚木糖是聚合糖类中增殖双歧杆菌功能最强的品种之一, 卫生部 2008 年第 12 号公告批准其为新资源食品。 它的功效性是其他聚合糖类的近 20倍, 人体胃肠道内没 有水解低聚木糖的酶, 所以其可直接进入大肠内优先为双歧杆菌所利用, 促进双歧杆 菌增殖同时产生多种有机酸。 降低肠道 PH值, 抑制有害菌生长, 使益生菌在肠道大量 增殖。 由于低聚木糖对大肠杆菌、 肠炎门氏菌等病原菌较强的吸附力, 可携带附着的 病原菌通过肠道排出体外, 从而防止疾病在肠道中集群, 达到防止腹泻的目的, 从而 达到保健功效。 Oligogalactose is a functional oligosaccharide with natural properties. The Ministry of Health announced in 2008 No. 20 of the Ministry of Health that it is a new resource food, which has strong acid resistance and heat resistance and will not be in the process. The high temperature sterilization and the decomposition of human stomach acid lose their original characteristics. The galactooligosaccharide can be effectively utilized by both Bifidobacterium bisporus and C. lactis. Oligosaccharide is the only functional sugar that can be utilized by the eight beneficial bacteria in the human intestine, and can inhibit the growth and reproduction of harmful bacteria in the human intestine. As a new functional food, galacto-oligosaccharide has broad market prospects in China. Xylo-oligosaccharide is one of the most potent varieties of proliferating bifidobacteria in polymeric sugars. The Ministry of Health announced in 2008 No. 12 of the Ministry of Health that it is a new resource food. Its efficacy is nearly 20 times that of other polymeric sugars. There is no enzyme for hydrolyzing xylooligosaccharides in the human gastrointestinal tract, so it can be directly used in the large intestine to be used by bifidobacteria to promote the proliferation of bifidobacteria. Organic acids. Reduce the pH of the intestines, inhibit the growth of harmful bacteria, and proliferate the probiotics in the intestines. Due to the strong adsorption capacity of xylooligosaccharides on pathogenic bacteria such as Escherichia coli and Enterobacter elegans, the attached pathogenic bacteria can be excreted through the intestinal tract, thereby preventing the disease from clustering in the intestinal tract and achieving the purpose of preventing diarrhea, thereby achieving health care effects. .

根据本发明的实施例, 可食用组合物的形式并不受特别限制, 只要可以用于食用即可。 根据本发明的具体示例, 可食用组合物可以呈胶囊剂、 片剂、 冲剂或颗粒剂的形式。 由此, 便于人食用, 从而提高可食用组合物更有效地改善胃肠道功能和增强人体免疫力的调节作 用。  According to an embodiment of the present invention, the form of the edible composition is not particularly limited as long as it can be used for consumption. According to a specific example of the invention, the comestible composition may be in the form of a capsule, tablet, granule or granule. Thereby, it is convenient for human consumption, thereby improving the regulating effect of the edible composition to more effectively improve the function of the gastrointestinal tract and enhance the immunity of the human body.

在本发明的第二方面, 本发明提出了一种食品。 根据本发明的实施例, 该食品包括前 面所述的可食用组合物。 根据本发明的实施例, 该食品的形式并不受特别限制, 只要可以 用于食用即可。 根据本发明的具体示例, 该食品可以呈胶囊剂、 片剂、 冲剂或颗粒剂的形 式。 由此, 便于人食用, 从而提高可食用组合物更有效地改善胃肠道功能和增强人体免疫 力的调节作用。 可以理解, 前面关于可食用组合物特征和优点的描述, 均适用于该食品, 在此不再赘述。  In a second aspect of the invention, the invention proposes a food product. According to an embodiment of the invention, the food product comprises the edible composition described above. According to an embodiment of the present invention, the form of the food is not particularly limited as long as it can be used for eating. According to a specific example of the invention, the food product may be in the form of a capsule, a tablet, a granule or a granule. Thereby, it is convenient for human consumption, thereby improving the regulating effect of the edible composition to more effectively improve the function of the gastrointestinal tract and enhance the immunity of the human body. It will be understood that the foregoing description of the features and advantages of the edible compositions applies to the food product and will not be described again.

由此, 本发明所提供的食品可以作为保健食品, 其可以通过常规工艺, 制成药剂学 上所说的胶囊剂、 片剂、 或冲剂。  Thus, the food provided by the present invention can be used as a health food, which can be made into a pharmaceutically acceptable capsule, tablet, or granule by a conventional process.

为此, 在本发明的第三方面, 本发明提出了一种制备食品的方法。 根据本发明的实施 例, 该方法包括: 提供前面所述的可食用组合物, 其中, 所述印加果、黄芪、茯苓、 菊粉、 玉米花粉、 布渣叶和功能糖呈颗粒状; 以及将所述可食用组合物进行成型处理, 以便获得 所述食品。 根据本发明的实施例, 所述颗粒的粒度为 100-300 目。 根据本发明的具体示例, 所述成型处理进一步包括: 将所述可食用组合物制成胶囊剂、片剂、冲剂或颗粒剂的形式。 可以理解, 前面, 关于可食用组合物以及食品的特征和优点的描述, 均适用于该方法, 在 此不再赘述。  To this end, in a third aspect of the invention, the invention proposes a method of preparing a food product. According to an embodiment of the present invention, the method comprises: providing the edible composition described above, wherein the Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves, and Functional Sugar are in a granular form; The comestible composition is subjected to a molding process to obtain the food product. According to an embodiment of the invention, the particles have a particle size of from 100 to 300 mesh. According to a specific example of the invention, the shaping process further comprises: forming the comestible composition in the form of a capsule, tablet, granule or granule. It will be understood that the foregoing description of the characteristics and advantages of the edible composition and the food product applies to the method and will not be described again.

将本发明所述保健食品进行安全性评价试验, 包括小鼠急性毒性试验、 小鼠遗传毒性 试验、 大鼠 30天喂养试验, 上述试验表明: 本发明所述保健食品, 小鼠的急性经口毒性试 验均大于 10 g/kg_bw, 属于安全无毒物质; 遗传毒性试验中, Ames试验结果呈阴性, 小鼠 骨髓嗜多染红细胞微核试验结果呈阴性, 小鼠精子畸形试验结果呈阴性, 表明本产品无致 突变作用; 大鼠 30天喂养试验结果表明, 本发明所述保健食品经大鼠 30天喂养实验, 对 大鼠整体健康状况、 生理生化功能和器官组织形态学等各项重要指标未产生明显影响。 表 明本发明所述保健食品软胶囊服用安全。 The health food of the present invention is subjected to a safety evaluation test, including a mouse acute toxicity test, a mouse genotoxicity test, a rat 30-day feeding test, and the above test indicates: the health food of the present invention, the acute oral cavity of the mouse The toxicity test is more than 10 g/kg_bw, which is safe and non-toxic. In the genotoxicity test, the Ames test result is negative, the mouse bone marrow polychromatic erythrocyte micronucleus test result is negative, and the mouse sperm abnormality test result is negative, indicating The product has no mutagenic effect; the results of the 30-day feeding test in rats indicate that the health food of the present invention has been subjected to a 30-day feeding experiment in rats, and has important indexes such as overall health status, physiological and biochemical functions and organ histomorphology of the rats. No significant impact. Table The health food soft capsule according to the invention is safe to take.

本发明所述的保健食品具有增强免疫力的功能和作用, 而且本发明所述的保健食品对 增强免疫力的作用优于单一成分的黄芪、 低聚果糖、 壳寡糖、 酵母葡聚糖的作用效果。 本 发明所述的保健食品进行提高免疫力功能的实验结果表明,各批小鼠体重、胸腺 /体重比值、 脾脏 /体重比值均无显著差异。 在小鼠抗体生成细胞检测实验、 血清溶血素测定实验、 以及 小鼠碳廓清实验中, 其结果有显著性差异。  The health food of the invention has the function and effect of enhancing immunity, and the health food of the invention has better effect on enhancing immunity than the single component of astragalus, oligofructose, chitosan oligosaccharide and yeast dextran. Effect. The experimental results of the health-improving function of the health food of the present invention showed that there was no significant difference in body weight, thymus/body weight ratio, and spleen/body weight ratio of each batch of mice. In the mouse antibody-producing cell assay, the serum hemolysin assay, and the mouse carbon clearance assay, the results were significantly different.

双歧杆菌是有益菌的代表, 可以抑制有害菌生长, 维持肠道内正常的微生态环境。 增 加人体肠道内双歧杆菌数量, 可以显著改善人体的胃肠道功能以及健康状况。 由本发明所 述的保健食品进行的调节肠道菌群功能的动物实验, 以及进行的调节肠道菌群功能的人体 试食实验可见, 本发明所述的保健食品具有调节肠道菌群的功能。 本发明可显著刺激人体 肠道内有益菌 (比如双歧杆菌) 的数量生长及增加, 以及显著降低有害菌 (比如产气荚膜 梭菌) 的数量。 而且, 服用印加软胶囊后的受试者人群, 人体肠道内双歧杆菌、 肠杆菌增 加的数量、 以及产气荚膜梭菌的降低数量均比服用印加果油后、 以及服用低聚木糖胶囊后 的受试者效果更明显, 即本发明保健食品所起的保健功能效果优于单一的成分所起的作用 效果。  Bifidobacteria are representative of beneficial bacteria, can inhibit the growth of harmful bacteria, and maintain the normal micro-ecological environment in the intestine. Increasing the number of bifidobacteria in the human gut can significantly improve the gastrointestinal function and health of the human body. The animal experiment for regulating the function of the intestinal flora by the health food of the present invention, and the human food experiment for regulating the function of the intestinal flora can be seen that the health food of the present invention has the function of regulating the intestinal flora. . The present invention can significantly stimulate the growth and increase of the number of beneficial bacteria (such as bifidobacteria) in the human intestinal tract, and significantly reduce the number of harmful bacteria such as Clostridium perfringens. Moreover, the number of Bifidobacteria, Enterobacteriaceae, and the number of Clostridium perfringens in the human intestinal tract after taking Inca soft capsules were lower than those after taking Inca fruit oil and taking Xylooligosaccharides. The effect of the subject after the capsule is more obvious, that is, the health care function of the health food of the present invention is superior to the effect of the single component.

从本发明所述的保健食品对便秘患者的治疗效果试验来看, 本发明具有改善胃肠道功 能, 能起到润肠通便、 防治便秘的作用, 服用期间未见不良反应。  From the test of the therapeutic effect of the health food of the present invention on constipation patients, the present invention has the function of improving gastrointestinal function, and can function as a laxative and prevent constipation, and no adverse reaction is observed during the administration.

在本发明的第四个方面, 本发明提出了上述可食用组合物在制备制剂中的用途。 根据 本发明的具体实施例, 利用上述可食用组合物可以制备任意便于食用的制剂, 例如可以制 成药剂学上所说的剂型, 例如胶囊、 软胶囊、 片剂、 或颗粒剂。 根据本发明的具体实施例, 上述制剂可以用于改善胃肠道功能和增强人体免疫力等。 由此, 可以通过利用上述可食用 组合物制备剂型用于发挥其改善胃肠道功能和增强人体免疫力等。  In a fourth aspect of the invention, the invention provides the use of the above edible composition in the preparation of a formulation. According to a specific embodiment of the present invention, any edible preparation can be prepared by using the above edible composition, for example, a pharmaceutically acceptable dosage form such as a capsule, a soft capsule, a tablet, or a granule can be prepared. According to a specific embodiment of the present invention, the above preparation can be used for improving gastrointestinal function and enhancing human immunity and the like. Thus, a dosage form can be prepared by using the above edible composition for exerting its function of improving gastrointestinal function, enhancing human immunity, and the like.

本发明的有益效果在于:  The beneficial effects of the invention are:

1、 本发明所述的保健食品中的所有原料取于自然、 源于天然、 安全可靠, 且原料来源 广泛易得, 组方配伍科学合理, 疗效确切, 制备工艺简单, 贮运和应用安全, 生产成本低 廉。  1. All the raw materials in the health food according to the present invention are natural, natural, safe and reliable, and the raw materials are widely available. The compatibility of the prescriptions is scientific and reasonable, the curative effect is exact, the preparation process is simple, and the storage and application are safe. Production costs are low.

2、本申请的发明人经过艰苦的创造性劳动和优化工作,意外的发现: 由印加果、黄芪、 茯苓、 菊粉、 玉米花粉、 布渣叶和功能糖混合配制而组成的保健食品, 将物质及其功能合 为一体, 具有明显的同时改善胃肠道以及增强人体免疫力的保健功能及相互协同作用, 且 本发明在改善胃肠道功能及增强人体免疫力方面的组合作用效果优于单一成分的作用效果。  2. The inventor of the present application discovered through accidental labor and optimization work: a health food consisting of a mixture of Inca, Astragalus, Poria, Inulin, Corn Pollen, Cloth Leaves and Functional Sugar, The combination of functions and functions has obvious health care functions and synergistic effects for simultaneously improving the gastrointestinal tract and enhancing human immunity, and the combined effect of the invention in improving gastrointestinal function and enhancing human immunity is better than single The effect of the ingredients.

3、 本发明所述的保健食品不仅提高了人体免疫力, 而且还能改善人体肠道菌群分布, 显著刺激人体肠道内有益菌 (如双歧杆菌) 的数量生长及增加, 降低肠道内有害菌 (如产 气荚膜梭菌) 的数量, 且发挥了抑菌作用, 同时实现了增强免疫力、 调节肠道菌群、 润肠 通便、 防治便秘的保健功效。 3. The health food of the invention not only improves the human immunity, but also improves the distribution of the intestinal flora of the human body, significantly stimulates the growth and increase of the number of beneficial bacteria (such as bifidobacteria) in the human intestinal tract, and reduces the harmfulness in the intestinal tract. Bacteria The number of Clostridium perfringens plays a bacteriostatic effect, and at the same time achieves the health benefits of enhancing immunity, regulating intestinal flora, laxative, and preventing constipation.

4、 在本发明所述的保健食品冲剂, 以及软胶囊中, 原料均混合粉碎成 100-230目的细 粉, 有利于原料中的有效成分均匀分散, 便于在人体的胃肠道吸收。 并且, 以印加果油作 为软胶囊的分散剂, 有利于软胶囊成型, 软胶囊剂型也有利于其他有效成分均匀分散于油 液中, 便于人体吸收。  4. In the health food granules and soft capsules of the present invention, the raw materials are mixed and pulverized into fine powder of 100-230 mesh, which is favorable for uniform dispersion of the active ingredients in the raw materials, and is convenient for absorption in the gastrointestinal tract of the human body. Moreover, the use of Inca fruit oil as a dispersing agent for soft capsules is advantageous for soft capsule molding, and the soft capsule dosage form is also advantageous for uniformly dispersing other active ingredients in the oil to facilitate absorption by the human body.

5、 本发明所述的保健食品药效明显、 安全性好, 质量稳定, 产品可长期保存, 为人们 日常保健提供了新的选择。  5. The health food of the invention has obvious efficacy, good safety, stable quality, long-term preservation of the product, and provides a new choice for daily health care.

本发明的优点将在下面的描述中部分给出, 部分将从下面的描述中变得明显, 或通过 本发明的实践了解到。  The advantages of the invention will be set forth in part in the description which follows.

具体实施方式  detailed description

下面实施例是对本发明的进一步说明,而不是限制本发明的保护范围。需要说明的是, 除非明确指出, 下面实施例中所采用的原材料均为市售可得的。  The following examples are intended to further illustrate the invention and are not intended to limit the scope of the invention. It should be noted that the raw materials used in the following examples are commercially available unless explicitly stated.

实施例 1-12: 本发明所述的保健食品配方  Example 1-12: The health food formula of the present invention

表 1 本发明所述实施例 1-12的保健食品配方 (原料的重量单位: 重量份)  Table 1 Health food formula of Examples 1-12 of the present invention (weight unit of raw materials: parts by weight)

^施例 实施 实施 实施 实施 实施 实施 实施 实施 实施 实施 实施 实施 原料 例 1 例 2 例 3 例 4 例 5 例 6 例 7 例 8 例 9 例 10 例 11 例 12 印加果 40 70 70 90 120 90 110 120 100 90 110 90 黄芪 90 50 70 60 60 50 10 80 60 60 30 70 茯苓 70 60 80 50 50 10 80 70 70 50 20 70 菊粉 40 80 60 70 50 80 100 30 50 70 90 50 玉米花粉 60 30 60 70 90 80 50 60 90 70 70 60 布渣叶 40 70 90 50 10 60 60 60 40 50 70 50 魔芋葡甘聚糖 100 25 30  ^Example Implementation Implementation Implementation Implementation Implementation Implementation Implementation Implementation Implementation Implementation Implementation Material Example 1 Example 2 Example 3 Example 4 Example 5 Case 6 Case 7 Case 8 Case 9 Case 10 Case 11 Example 12 Inca 40 70 70 90 120 90 110 120 100 90 110 90 Astragalus 90 50 70 60 60 50 10 80 60 60 30 70 茯苓70 60 80 50 50 10 80 70 70 50 20 70 Inulin 40 80 60 70 50 80 100 30 50 70 90 50 Corn pollen 60 30 60 70 90 80 50 60 90 70 70 60 slag leaves 40 70 90 50 10 60 60 60 40 50 70 50 Konjac glucomannan 100 25 30

酵母葡聚糖 80 —— 30 70 25 ——  Yeast dextran 80 —— 30 70 25 ——

冗募糖 70 30 60 低聚果糖 40 40 低聚半乳糖 40 20 40 20 低聚木糖 60 20  Redundant sugar 70 30 60 oligofructose 40 40 oligogalactose 40 20 40 20 xylooligo 60 20

200 140 230 170 200 200 120 170 140  200 140 230 170 200 200 120 170 140

粉碎成目数 200目 170目 230目  Smash into 200 mesh, 170 mesh, 230 mesh

@ 目 @ @ @  @目 @ @ @

软胶 软胶 软胶 软胶 软胶 剂型 片剂 冲剂 冲剂 冲剂 片剂 冲剂 片剂  Soft rubber soft rubber soft rubber soft gel dosage form tablets granules granules granules tablets granules tablets

囊 囊 囊 囊 本发明所述的保健食品各组分按上表用量, 通过常规工艺, 可以制成药剂学上所说的 胶囊剂、 片剂、 或冲剂。 Cystic sac According to the above table, the components of the health food according to the present invention can be made into capsules, tablets, or granules in pharmacy by a conventional process.

下面列举冲剂的制备工艺。  The preparation process of the granule is listed below.

对于实施例 4所述的保健食品冲剂 (以下简称印加冲剂) , 其制备工艺如下:  For the health food granules described in Example 4 (hereinafter referred to as Inca granules), the preparation process is as follows:

1、 称取印加果 90 重量份, 将印加果用去皮机脱壳, 晒干, 备用;  1. Weigh 90 parts by weight of Inca fruit, remove the Inca fruit with a peeling machine, dry it, and set aside;

2、分别称取黄芪 60 重量份、茯苓 50重量份、菊粉 70重量份、玉米花粉 70重量份、 布渣叶 50重量份、壳寡糖 70重量份, 将上述这 7种原料混合投入粉碎机中, 混合粉碎 30 分钟, 成 170目的细粉, 分装, 即得印加冲剂。  2. Weigh 60 parts by weight of Astragalus, 50 parts by weight of enamel, 70 parts by weight of inulin, 70 parts by weight of corn pollen, 50 parts by weight of slag leaves, and 70 parts by weight of chitosan oligosaccharides, and the above seven raw materials are mixed and crushed. In the machine, the mixture is pulverized for 30 minutes, and the fine powder of 170 mesh is dispensed.

保健功能: 调节肠道菌群、 增强免疫力  Health care function: regulate intestinal flora, enhance immunity

适宜人群: 肠道功能紊乱者、 免疫力低下者  Suitable for people: those with intestinal dysfunction and those with low immunity

不适宜人群: 无  Not suitable for the crowd: None

食用方法及食用量: 每日 2次, 每次 1袋  How to eat and how to eat: 2 times a day, 1 bag each time

产品规格: 5g/袋  Product specifications: 5g / bag

保质期: 24个月  Shelf life: 24 months

贮藏方法: 密封, 置阴凉干燥处保存  Storage method: sealed, kept in a cool dry place

注意事项: 本品不能代替药物  Note: This product is not a substitute for drugs

下面列举胶囊剂的制备工艺。  The preparation process of the capsules is listed below.

对于实施例 10所述的保健食品软胶囊 (以下简称印加软胶囊) , 其制备工艺如下: For the health food soft capsule (hereinafter referred to as Inca soft capsule) described in Example 10, the preparation process is as follows:

1、 称取黄芪 60 重量份、 茯苓 50重量份、 菊粉 70重量份、 玉米花粉 70重量份、 布 渣叶 50重量份、 魔芋葡甘聚糖 30重量份、 低聚半乳糖 40 重量份, 将这 6种原料混合投 入粉碎机中, 混合粉碎 30分钟, 成 200目的细粉, 备用; 1. Weigh 60 parts by weight of Astragalus, 50 parts by weight of enamel, 70 parts by weight of inulin, 70 parts by weight of corn pollen, 50 parts by weight of slag leaves, 30 parts by weight of konjac glucomannan, and 40 parts by weight of galactooligosaccharide. The six kinds of raw materials are mixed and put into a pulverizer, mixed and pulverized for 30 minutes to form a fine powder of 200 mesh, and used;

2、 称取印加果 90重量份, 将印加果用去皮机脱壳, 晒干, 将果实经低温冷搾得印加 果油, 将印加果油、 适量大豆油混合置于配料罐中, 匀速搅拌, 并加入上述步骤 (1 ) 得到 的 200 目细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后抽真空脱尽气泡, 制成内容物料液, 待用;  2. Weigh 90 parts by weight of Inca fruit, peel the Inca fruit with a peeling machine, dry it, and cold-press the fruit to obtain the printing fruit oil. Mix the Indo fruit oil and the appropriate amount of soybean oil in the ingredient tank. Stir, and add the 200 mesh fine powder obtained in the above step (1), stir for 30 minutes, mix the liquid mixture and grind the mixture for three times. After the grinding, vacuum the air bubbles to remove the air bubbles, and prepare the content material liquid for use;

3、 将明胶、 甘油、 水化胶, 制胶带。 将内容物料液置于软胶囊压丸机中, 填充压制成 软胶囊, 进入滚筒干燥设备进行吹风干燥, 使软胶囊硬化成型, 再经过乙醇杀菌、擦洗丸, 通过控制干燥室环境温度与湿度 (50 %以下), 使胶囊囊壳水分和乙醇自然蒸发掉, 干燥时间 不低于 20 小时, 至囊皮表面干燥光洁、 稍有弹性, 干燥完成。 最后将外型、 合缝等不合格 的软胶囊拣选出来弃掉, 将拣选出来的合格软胶囊采用瓶装或泡罩板等形式进行包装, 即 得成品 (简称印加软胶囊) 。 保健功能: 调节肠道菌群、 增强免疫力  3. Put gelatin, glycerin, hydration glue, and tape. The content material liquid is placed in a soft capsule pilling machine, filled into soft capsules, and then put into a drum drying device for drying by blowing, so that the soft capsules are hardened, and then subjected to ethanol sterilization and scrubbing, by controlling the temperature and humidity of the drying chamber ( 50% or less), the capsule shell moisture and ethanol are naturally evaporated, the drying time is not less than 20 hours, until the surface of the capsule is dry and smooth, slightly elastic, and the drying is completed. Finally, the unqualified soft capsules such as the appearance and the joints are sorted and discarded, and the selected qualified soft capsules are packaged in the form of bottles or blister sheets, that is, the finished products (referred to as Inca soft capsules). Health care function: regulate intestinal flora, enhance immunity

适宜人群: 肠道功能紊乱者、 免疫力低下者 不适宜人群: 无 Suitable for people: those with intestinal dysfunction and those with low immunity Not suitable for the crowd: None

食用方法及食用量: 每日 3次, 每次 3粒  How to eat and how to eat: 3 times a day, 3 capsules each time

产品规格: l.Og/粒  Product specifications: l.Og / grain

保质期: 24个月  Shelf life: 24 months

贮藏方法: 密封, 置阴凉干燥处保存  Storage method: sealed, kept in a cool dry place

注意事项: 本品不能代替药物。 以下通过试验进一步说明本发明的有益效果。  Note: This product is not a substitute for drugs. The beneficial effects of the present invention are further illustrated by experiments below.

实施例 13: 经口服施用于大鼠测定急性毒性  Example 13: Determination of acute toxicity by oral administration to rats

利用 6周龄无特殊病原体 (SPF) SD大鼠进行急性毒性试验。  Acute toxicity tests were performed using 6-week-old SD rats without specific pathogens (SPF).

将实施例 4制备得到的保健食品悬浮于 0.5%的甲基纤维素溶液中,分别以 lg/kg、 5g/kg 和 10g/kg的剂量一次口服施用于每组的 5只 SD大鼠, 观察大鼠的死亡、 临床症状以及体 重变化, 并进行血液试验和血液生化试验, 在尸检时, 肉眼检查胸腹部胃肠组织的任何异 常现象。  The health food prepared in Example 4 was suspended in a 0.5% methylcellulose solution, and orally administered to 5 SD rats in each group at a dose of lg/kg, 5 g/kg, and 10 g/kg, respectively. Rats were tested for death, clinical symptoms, and weight changes, and blood tests and blood biochemical tests were performed. At autopsy, any abnormalities in the gastrointestinal tissue of the chest and abdomen were visually examined.

结果显示: 本实施例所述的保健食品未引起任何特定的临床症状、 体重变化或死亡, 血液试验、 血液生化试验和尸检也没有变化。 因此, 由于直至 10g/kg的剂量不会引起大鼠 的任何中毒变化, 可判断其半数致死量 (LD50) 远远大于 10g/kg, 本实施例涉及的保健食 品被评定为安全无毒物质。  The results showed that the health food described in this example did not cause any specific clinical symptoms, weight changes or death, and blood tests, blood biochemical tests and autopsy did not change. Therefore, since the dose up to 10 g/kg does not cause any poisoning change in the rat, it can be judged that the median lethal dose (LD50) is much larger than 10 g/kg, and the health food of the present embodiment is evaluated as a safe non-toxic substance.

实施例 14: 增强免疫力功能的研究  Example 14: Study of enhancing immunity function

一、 试验材料  First, the test materials

实验动物: BALB/C 1月龄二级小鼠, 雌雄各半, 体重 20±2g, 健康状况良好, 由武汉 大学医学院实验动物中心提供, 生产许可证号: SCXK (鄂) 2008-0004。 每批动物随机分 组。  Experimental animals: BALB/C 1 month old secondary mice, male and female, weighing 20±2g, in good health, provided by Experimental Animal Center of Wuhan University Medical College, production license number: SCXK (E) 2008-0004. Each batch of animals was randomized.

本实施例采用实施例 6制备得到的印加冲剂,推荐剂量为小鼠每日 250mg/kg.BW (体重), 分别以小鼠推荐 0.5倍、 1倍和 2倍作为低剂量组 C125 mg/kg.BW)、中剂量组 (;250 mg/kg.BW)、 高剂量组 (500 mg/kg.BW)。  In this example, the Indo-Chong granule prepared in Example 6 was used. The recommended dose was 250 mg/kg.BW (body weight) per day, and 0.5, 1, and 2 times of the mice were recommended as low dose group C125 mg/kg. .BW), medium dose group (250 mg/kg. BW), high dose group (500 mg/kg. BW).

设 4个阳性对照组,  Set 4 positive control groups,

阳性对照 1 组为黄芪多糖胶囊 (主要原料: 黄芪、 低聚异麦芽糖, 内蒙古双奇药业股 份有限公司, 国食健字 G20040082),  The positive control group 1 is the Astragalus polysaccharide capsule (the main raw materials: Astragalus, oligo-isomalt, Inner Mongolia Shuangqi Pharmaceutical Co., Ltd., Guoshijianzi G20040082),

阳性对照 2组为低聚果糖口服液(主要原料: 低聚果糖, 珠海圣原生物科技有限公司, 国食健字 G20050336) ,  Positive control group 2 is oligofructose oral solution (main raw materials: oligofructose, Zhuhai Shengyuan Biotechnology Co., Ltd., Guoshijianzi G20050336),

阳性对照 3 组为壳寡糖胶囊 (主要原料: 壳寡糖, 厦门蓝湾科技有限公司, 国食健字 G20110158),  The positive control group 3 was chitosan oligosaccharide capsules (main raw materials: chitosan oligosaccharide, Xiamen Lanwan Technology Co., Ltd., Guoshijianzi G20110158),

阳性对照 4组为酵母葡聚糖胶囊 (主要原料: 酵母葡聚糖, 南京大渊美容保健有限公 司, 国食健字 G20110445 )。 The positive control group 4 is yeast glucan capsule (main raw material: yeast glucan, Nanjing Dayuan Beauty Health Care Co., Ltd. Division, Guoshijianzi G20110445).

其它主要的试剂试药为: 绵羊红细胞 (SRBC ) 、 Hank's液、 豚鼠血清、 墨汁。  Other major reagents are: sheep red blood cells (SRBC), Hank's solution, guinea pig serum, ink.

其中 Hank's液的配制方法:  The preparation method of Hank's liquid:

( 1 ) 贮存液:  (1) Stock solution:

NaCl: 80.00g, KC1: 4.00g, Na2HP04 12H20: 1.52 g, KH2PO4:0.60g, 葡萄糖: 4.0g, 0.4 %酚红液: 50.00mL, 双馏水加定容至 lOOmL, 115 °C高压灭菌 15min, 冰冻保存。 NaCl: 80.00g, KC1: 4.00g, Na 2 HP0 4 12H 2 0: 1.52 g, KH 2 PO 4 : 0.60g, glucose: 4.0g, 0.4% phenol red liquid: 50.00mL, double distilled water plus constant volume to lOOmL, autoclaved at 115 °C for 15 min, stored frozen.

(2) 工作液:  (2) Working fluid:

向贮存液加入 9倍体积的双馏水, 115 °C高压灭菌 15 min。临用时用灭菌的 5.6% NaHC03 溶液调 pH值至 7.2-7.4(溶液呈橙红色)。 9 volumes of double-distilled water were added to the stock solution and autoclaved at 115 °C for 15 min. When used, the pH was adjusted to 7.2-7.4 (the solution was orange-red) with a sterile 5.6% NaHC0 3 solution.

生理盐水的配制: 将 9.00克 NaCl溶于 991克双馏水中即得 0.9 %的 NaCl溶液。  Preparation of physiological saline: 9.00 g of NaCl was dissolved in 991 g of double-distilled water to obtain a 0.9% NaCl solution.

二、 试验方法  Second, the test method

试验采取灌胃法。 每日灌胃一次, 空白对照组灌同等体积蒸馏水。 各组小鼠连续给予 受试物 30天后, 测定各项指标。  The test was performed by gavage. The stomach was administered once a day, and the blank control group was filled with the same volume of distilled water. Each group of mice was continuously administered with the test substance for 30 days, and each index was measured.

2.1对小鼠体重、 胸腺 /体重、 脾脏 /体重的影响  2.1 Effects on body weight, thymus/body weight, spleen/body weight of mice

小鼠灌胃 30天后脱颈处死, 称重。 取胸腺和脾脏, 分别称量胸腺和脾脏重量, 测定胸 腺 /体重值, 以及脾脏 /体重值。  The mice were sacrificed by cervical dislocation 30 days later and weighed. The thymus and spleen were taken, and the thymus and spleen weights were weighed separately, and the thymus/body weight value and the spleen/body weight value were measured.

2.2对小鼠抗体生成细胞 (PFC) 的影响 (抗体生成细胞的测定, 溶血空斑试验, 是一 种体外检测单个抗体形成细胞 (浆细胞) 的方法)  2.2 Effect on mouse antibody-producing cells (PFC) (Measurement of antibody-producing cells, hemolytic plaque assay, is a method for detecting single antibody-forming cells (plasma cells) in vitro)

腹腔注射 0.2mL 2 % (v/v)SRBC免疫每只小鼠。 免疫 5天后, 取小鼠脾脏制成细胞浓度 为 5x l06个 /mL的脾细胞液。 溶解琼脂糖制成 1%的溶液, 于 48°C水浴保温, 与等量 2倍浓 度的 Hank's液混合, 分装至小试管中, 每管 0.5mL。 加入 0.05mL 10 % SRBC和 O.OlmL脾 细胞悬液, 迅速混匀, 倾倒在玻片上。 于 37°C恒温箱中温育 l h, 将补体 (豚鼠血清) 加在 玻片槽中, 再温育 1.5 h。 计数空斑。 Each mouse was immunized by intraperitoneal injection of 0.2 mL of 2% (v/v) SRBC. 5 days after immunization, the mouse spleen is made to take a cell concentration of spleen cells was 5x l0 6 cells / mL. Dissolve the agarose to make a 1% solution, incubate in a 48 ° C water bath, mix with an equal amount of 2 times the concentration of Hank's solution, and dispense into a small tube, 0.5 mL per tube. Add 0.05 mL of 10% SRBC and O.OlmL spleen cell suspension, mix quickly and pour onto the slide. Incubate for 1 h in a 37 ° C incubator, add complement (guinea pig serum) to the slide trough, and incubate for 1.5 h. Count plaques.

2.3对小鼠溶血素抗体生成作用的影响 (血清溶血素的测定)  2.3 Effect on the production of hemolysin antibody in mice (measurement of serum hemolysin)

腹腔注射 0.2mL 2 %(v/v)SRBC免疫每只小鼠。 免疫 5天后, 摘眼球取血于离心管内, 放置 l h, 3000 rpm离心 5分钟, 收集血清。 血清用生理盐水稀释 400倍, 依次加入稀释的 小鼠血清 1.0mL、 10 % (v/v)的 SRBC 0.5mL、 补体 (用生理盐水 1 : 10稀释) 1.00mL。 另设用 生理盐水代替的不加血清的对照管。 置 37°C水浴 20分钟后置 0°C冰箱 30分钟中止反应, 3000 rpm离心 5分钟。 取上清液 1.0mL, 于分光光度计 540nm波长处测定光密度值。  Each mouse was immunized by intraperitoneal injection of 0.2 mL of 2% (v/v) SRBC. After 5 days of immunization, the eyeballs were taken from the centrifuge tube, placed for 1 h, centrifuged at 3000 rpm for 5 minutes, and serum was collected. The serum was diluted 400-fold with physiological saline, and diluted mouse serum 1.0 mL, 10% (v/v) SRBC 0.5 mL, and complement (diluted with physiological saline 1:10) 1.00 mL were sequentially added. A serum-free control tube replaced with physiological saline was also provided. After setting the water bath at 37 ° C for 20 minutes, the reaction was stopped at 0 ° C for 30 minutes, and centrifuged at 3000 rpm for 5 minutes. The supernatant was taken to 1.0 mL, and the optical density value was measured at a wavelength of 540 nm of a spectrophotometer.

2.4对小鼠碳廓清的影响  2.4 Effects on carbon clearance in mice

对每只小鼠尾静脉注射稀释 4倍的墨汁, 0.1mL/10g体重。 待墨汁注入后立即计时。 分 别于注入墨汁后 1分钟、 10分钟取血 0.02mL加至 2.0mL 0.1% Na2C03溶液 (即 lg/L) 中, 于 600nm波长处测定光密度值, 以 Na2C03溶液作对照。 另取肝脏和脾脏称重。 以吞噬指数 ((X)来表示小鼠碳廓清的能力。 Each mouse was injected with 4 times diluted ink in the tail vein, 0.1 mL/10 g body weight. Time is counted immediately after the ink is injected. 0.02 mL of blood was taken to 2.0 mL of 0.1% Na 2 C0 3 solution (ie, lg/L) at 1 minute and 10 minutes after injecting the ink, respectively. The optical density value was measured at a wavelength of 600 nm using a Na 2 CO 3 solution as a control. The liver and spleen were weighed. The phagocytic index ((X) is used to indicate the ability of the mouse to clear the carbon.

三、 试验结果  Third, the test results

3.1体重、 胸腺 /体重、 脾脏 /体重的测定结果  3.1 Determination of body weight, thymus / body weight, spleen / body weight

各受试物对小鼠体重、 胸腺 /体重比值, 以及脾脏 /体重比值的影响, 测定结果如表 2、 3 和 4所示。  The effects of each test substance on the body weight, thymus/body weight ratio, and spleen/body weight ratio of the mice are shown in Tables 2, 3 and 4.

表 2 各受试物对小鼠体重的影响  Table 2 Effect of each test substance on body weight of mice

剂量 动物数  Dosage number of animals

组别 实验前体重 (g) P值 实验后体重 (g) P值  Group Weight before experiment (g) P value Weight after experiment (g) P value

(mg/kg-bw) (只)  (mg/kg-bw) (only)

空白对照组 0 48 19.5±1.9 - 23.5±2.7 - 阳性对照 1组 1粒 48 19.4±1.7 0.8524 23.0±2.9 0.9006 阳性对照 2组 0.5mL 48 19.5±1.8 0.4983 23.1±3.0 0.7759 阳性对照 3组 1粒 48 19.3±1.8 0.7781 23.3±2.7 0.6210 阳性对照 4组 1粒 48 19.2±1.7 0.4850 23.2±2.8 0.5547 低剂量组 125 48 19.5±1.7 0.8065 23.4±3.0 0.6884 中剂量组 250 48 19.4±1.8 0.7251 23.3±2.9 0.6241 高剂量组 500 48 19.5±1.8 0.8559 23.2±2.7 0.7997 由表 2可知, 经口给予小鼠不同剂量的受试物前, 以及 30天后, 低、 中、 高 3个剂量 组与空白对照组以及阳性对照组相比, 体重均无显著差异 (P>0.05), 即给小鼠伺喂 3 个低、 中、 高剂量组和 4个阳性对照组的样品对小鼠的体重无影响。  Blank control group 0 48 19.5±1.9 - 23.5±2.7 - positive control group 1 1 capsule 48 19.4±1.7 0.8524 23.0±2.9 0.9006 positive control group 2 0.5mL 48 19.5±1.8 0.4983 23.1±3.0 0.7759 positive control group 3 group 1 48 19.3±1.8 0.7781 23.3±2.7 0.6210 Positive control group 4 1 capsule 48 19.2±1.7 0.4850 23.2±2.8 0.5547 Low dose group 125 48 19.5±1.7 0.8065 23.4±3.0 0.6884 medium dose group 250 48 19.4±1.8 0.7251 23.3±2.9 0.6241 high Dosage group 500 48 19.5±1.8 0.8559 23.2±2.7 0.7997 It can be seen from Table 2 that the mice were given different doses of the test substance orally, and after 30 days, the low, medium and high dose groups were blank control group and positive control. There was no significant difference in body weight between the groups (P>0.05), that is, the mice fed three low, medium and high dose groups and four positive control groups had no effect on the body weight of the mice.

表 3 受试物对小鼠胸腺 /体重比值的影响  Table 3 Effect of test substance on mouse thymus/body weight ratio

组别 齐 Ll量 (mg/kg'bw) 动物数 (只) 胸腺 /体重比值 fe/g) P值 空白对照组 0 12 0.0017±0.0004 - 阳性对照 1组 1粒 12 0.0019±0.0003 0.4042 阳性对照 2组 0.5mL 12 0.0018±0.0004 0.4631 阳性对照 3组 1粒 12 0.0017±0.0004 0.3856 阳性对照 4组 1粒 12 0.0018±0.0003 0.3213 低剂量组 125 12 0.0018±0.0004 0.4570 中剂量组 250 12 0.0018±0.0004 0.3687 高剂量组 500 12 0.0018±0.0003 0.4049 由表 3可知, 经口给予小鼠不同剂量的受试物 30天后, 与空白对照组比较, 各剂量组 胸腺 /体重比值均无显著差异 (P>0.05),即给小鼠伺喂 3个剂量组和 4个阳性对照组的样品对 小鼠的胸腺 /体重比值均无影响 < Group Ll amount (mg/kg 'bw) number of animals (only) thymus / body weight ratio fe / g) P value blank control group 0 12 0.0017 ± 0.0004 - positive control group 1 1 capsule 12 0.0019 ± 0.0003 0.4042 positive control 2 Group 0.5mL 12 0.0018±0.0004 0.4631 Positive control 3 group 1 capsule 12 0.0017±0.0004 0.3856 Positive control 4 group 1 capsule 12 0.0018±0.0003 0.3213 Low dose group 125 12 0.0018±0.0004 0.4570 Medium dose group 250 12 0.0018±0.0004 0.3687 High dose Group 500 12 0.0018±0.0003 0.4049 It can be seen from Table 3 that after 30 days of oral administration of different doses of the test article, there was no significant difference in thymus/body weight ratio between the dose groups (P>0.05). The mice were fed a sample pair of 3 dose groups and 4 positive control groups. Mice have no effect on thymus/body weight ratio<

表 4 受试物对小鼠脾脏 /体重比值的影响  Table 4 Effect of test substance on spleen/body weight ratio in mice

组别 齐 Ll量 (mg/kg'bw) 动物数 (只) 胸腺 /体重比值 fe/g) P值 空白对照组 0 12 0.0043±0.0006 - 阳性对照 1组 1粒 12 0.0040±0.0008 0.7028 阳性对照 2组 0.5mL 12 0.0039±0.0006 0.3358 阳性对照 3组 1粒 12 0.0038±0.0005 0.1756 阳性对照 4组 1粒 12 0.0041±0.0006 0.3047 低剂量组 125 12 0.0040±0.0004 0.3361 中剂量组 250 12 0.0042±0.0005 0.2273 高剂量组 500 12 0.0039±0.0005 0.4546 由表 4可知, 经口给予小鼠不同剂量的受试物 30天后, 与空白对照组比较, 各剂量组 脾脏 /体重比值均无显著差异 (P>0.05),即给小鼠伺喂 3个剂量组和 4个阳性对照组的样品对 小鼠的脾脏 /体重比值均无影响。  Group Ll amount (mg/kg 'bw) number of animals (only) thymus / body weight ratio fe / g) P value blank control group 0 12 0.0043 ± 0.0006 - positive control group 1 1 capsule 12 0.0040 ± 0.0008 0.7028 positive control 2 Group 0.5mL 12 0.0039±0.0006 0.3358 Positive control 3 group 1 capsule 12 0.0038±0.0005 0.1756 Positive control 4 group 1 capsule 12 0.0041±0.0006 0.3047 Low dose group 125 12 0.0040±0.0004 0.3361 Medium dose group 250 12 0.0042±0.0005 0.2273 High dose Group 500 12 0.0039±0.0005 0.4546 It can be seen from Table 4 that after 30 days of oral administration of different doses of the test article, there was no significant difference in spleen/body weight ratio between the dose groups (P>0.05). Samples fed to the mice in three dose groups and four positive control groups had no effect on the spleen/body weight ratio of the mice.

3.2抗体生成细胞 (PFC ) 测定结果  3.2 Antibody-producing cells (PFC) determination results

抗体生成细胞 (PFC ) 检测结果表 5所示。  The antibody-producing cell (PFC) test results are shown in Table 5.

表 5 受试物对小鼠抗体生成细胞数的影响  Table 5 Effect of test substance on the number of mouse antibody-producing cells

组别 齐 Ll量 (mg/kg'bw) 动物数 (只) 抗体生成细胞数 (x±s) P值 空白对照组 0 12 72±22 - 阳性对照 1组 1粒 12 89±19 0.0452 阳性对照 2组 0.5mL 12 83±23 0.1954 阳性对照 3组 1粒 12 83±21 0.2019 阳性对照 4组 1粒 12 85±22 0.1686 低剂量组 125 12 92±21 0.0341 中剂量组 250 12 99±20 0.0408 高剂量组 500 12 90±21 0.0687 由表 5可知, 经口给予小鼠不同剂量的受试物 30天后, 与空白对照组比较, 阳性对照 Group Ll amount (mg/kg 'bw) Number of animals (only) Number of antibody-producing cells (x±s) P value blank control group 0 12 72±22 - Positive control group 1 1 capsule 12 89±19 0.0452 Positive control 2 groups 0.5mL 12 83±23 0.1954 positive control 3 groups 1 capsule 12 83±21 0.2019 positive control 4 group 1 capsule 12 85±22 0.1686 low dose group 125 12 92±21 0.0341 medium dose group 250 12 99±20 0.0408 high Dosage group 500 12 90±21 0.0687 It can be seen from Table 5 that after oral administration of different doses of the test substance to the mice for 30 days, compared with the blank control group, the positive control

1组以及低、 中剂量组的 PFC数量有显著差异 (P<0.05), 说明高剂量组以及 3个阳性对照 组对小鼠 PFC无影响, 而阳性对照 1组、 低剂量组、 中剂量组对小鼠 PFC有显著影响。 There was a significant difference in the number of PFCs between the 1 group and the low and middle dose groups (P<0.05), indicating that the high dose group and the three positive control groups had no effect on the PFC of the mice, while the positive control group 1, the low dose group, and the middle dose group. It has a significant effect on mouse PFC.

3.3血清溶血素的测定结果  3.3 Determination of serum hemolysin

血清溶血素的测定结果如表 6所示。 表 6 受试物对小鼠血清溶血素的影响 The results of measurement of serum hemolysin are shown in Table 6. Table 6 Effect of test substance on serum hemolysin in mice

组别 齐 Ll量 (mg/kg'bw) 动物数 (只) HC50 P值 空白对照组 0 12 115±28 - 阳性对照 1组 1粒 12 141±36 0.1951 阳性对照 2组 0.5mL 12 139±31 0.3554 阳性对照 3组 1粒 12 130±19 0.0246 阳性对照 4组 1粒 12 134±20 0.1739 低剂量组 125 12 154±20 0.0080 中剂量组 250 12 166±19 0.0067 高剂量组 500 12 148±21 0.0894 由表 6可知,经口给予小鼠不同剂量的受试物 30天后,与空白对照组比较,低剂量组、 中剂量组的 HC5Q均有极显著差异 (P<0.01), 阳性对照 3组的 HC5Q有显著差异 (P<0.05),说 明本实施例所述的低剂量组以及中剂量组, 均能够极显著地提高小鼠血清溶血素 HC5Q, 阳 性对照 3组能够显著提高小鼠血清溶血素 HC5Q, 而阳性对照 1组、 阳性对照 2组、 阳性对 照 4组、 高剂量组对小鼠血清溶血素 HC5Q无影响。 Group Ll amount (mg/kg 'bw) number of animals (only) HC50 P value blank control group 0 12 115±28 - positive control group 1 1 capsule 12 141±36 0.1951 positive control group 2 0.5mL 12 139±31 0.3554 Positive control 3 groups 1 capsule 12 130±19 0.0246 Positive control 4 group 1 capsule 12 134±20 0.1739 Low dose group 125 12 154±20 0.0080 Medium dose group 250 12 166±19 0.0067 High dose group 500 12 148±21 0.0894 As can be seen from Table 6, after 30 days of oral administration of different doses of the test article, compared with the blank control group, the HC 5Q of the low dose group and the middle dose group were significantly different (P<0.01), and the positive control group 3 The HC 5Q was significantly different (P<0.05), indicating that the low-dose and medium-dose groups described in this example were able to significantly increase the serum hemolysin HC 5Q in mice, and the positive control group 3 significantly increased the mice. Serum hemolysin HC 5Q , while positive control group 1, positive control group 2, positive control group 4, high dose group had no effect on serum hemolysin HC 5Q .

3.4小鼠碳廓清实验结果  3.4 Mouse carbon clearance test results

小鼠碳廓清实验结果如表 7所示。  The results of the mouse carbon clearance test are shown in Table 7.

表 7 受试物对小鼠碳廓清的影响  Table 7 Effect of test substance on carbon profile of mice

组别 齐 Ll量 (mg/kg'bw) 动物数 (只) 吞噬指数 a(X±S) P值 空白对照组 0 12 3.24±0.39 - 阳性对照 1组 1粒 12 4.26±0.47 0.0351 阳性对照 2组 0.5mL 12 4.29±0.48 0.0492 阳性对照 3组 1粒 12 3.56±0.53 0.2255 阳性对照 4组 1粒 12 3.45±0.64 0.4390 低剂量组 125 12 3.86±0.49 0.0433 中剂量组 250 12 4.52±0.58 0.0074 高剂量组 500 12 4.83±0.79 0.0088 由表 7可知, 经口给予小鼠不同剂量的受试物 30天后, 与空白对照组比较, 本实施例保 健食品的中剂量组、 高剂量组对小鼠巨噬细胞吞噬能力具有极显著性差异 (P<0.01), 低剂量 组、 阳性对照 1组、 阳性对照 2组对小鼠巨噬细胞吞噬能力具有显著性差异 (P<0.05), 其余的 组对小鼠碳廓清能力均无影响。 这表明本实施例的保健食品具有增强单核巨噬细胞吞噬功 能的作用, 可增强小鼠的非特异性免疫功能。 由本实施例的保健食品提高免疫力功能性的实验前后结果表明, 各批小鼠体重、 胸腺 / 体重比值、 脾脏 /体重比值均无显著差异。 在小鼠抗体生成细胞检测实验、 血清溶血素测定 实验、 以及小鼠碳廓清实验中, 其结果有显著性差异。 根据评价标准可认为本实施例的保 健食品具有增强免疫力的功能和作用, 而且本实施例的保健食品对增强免疫力的作用优于 单一成分的黄芪、 低聚果糖、 壳寡糖、 酵母葡聚糖的作用效果。 Group Ll amount (mg/kg 'bw) number of animals (only) phagocytic index a (X ± S) P value blank control group 0 12 3.24 ± 0.39 - positive control group 1 1 12 4.26 ± 0.47 0.0351 positive control 2 Group 0.5mL 12 4.29±0.48 0.0492 Positive control 3 groups 1 capsule 12 3.56±0.53 0.2255 Positive control 4 groups 1 capsule 12 3.45±0.64 0.4390 Low dose group 125 12 3.86±0.49 0.0433 Medium dose group 250 12 4.52±0.58 0.0074 High dose Group 500 12 4.83±0.79 0.0088 As can be seen from Table 7, after 30 days of oral administration of different doses of the test article, the medium dose group and the high dose group of the health food of the present example were compared with the blank control group. The phagocytosis ability of the cells was significantly different (P<0.01). The low-dose group, the positive control group 1 and the positive control group 2 had significant differences in the phagocytic ability of mouse macrophages (P<0.05), and the other groups were small. The mouse carbon clearance ability has no effect. This indicates that the health food of the present embodiment has an effect of enhancing the phagocytic function of mononuclear macrophages, and can enhance non-specific immune function of mice. The results of experiments before and after improving the immunity function of the health food of the present example showed that there was no significant difference in body weight, thymus/weight ratio, and spleen/body weight ratio of each batch of mice. In the mouse antibody-producing cell assay, the serum hemolysin assay, and the mouse carbon clearance assay, the results were significantly different. According to the evaluation criteria, the health food of the present embodiment can be considered to have the function and effect of enhancing immunity, and the health food of the present embodiment is superior to the single component of jaundice, oligofructose, chitooligosaccharide, and yeast. The effect of the glycan.

实施例 15: 调节肠道菌群功能实验  Example 15: Regulation of intestinal flora function

依据卫生部 《保健食品检验与评价技术规范 (2003年) 》 , 进行调节肠道菌群功能的 动物实验以及人体试食实验。  According to the Ministry of Health's “Technical Specification for Health Food Inspection and Evaluation (2003)”, animal experiments and human feeding experiments were conducted to regulate the function of intestinal flora.

一、 材料  First, the material

实验动物: 昆明雄性小鼠 50只, 体重 20±2 g, 健康状况良好, 由武汉大学医学院实验 动物中心提供, 生产许可证号: SCXK (鄂) 2008-0004。  Experimental animals: 50 male Kunming mice weighing 20±2 g, in good health, provided by the Experimental Animal Center of Wuhan University Medical College, production license number: SCXK (E) 2008-0004.

本实施例采用的保健食品冲剂 (以下简称印加冲剂) , 由实施例 4制备得到, 用 5g/袋 的铝箔袋装, 推荐食用方法为每日 2次, 每次 1袋。  The health food granules (hereinafter referred to as Inca granules) used in the present embodiment were prepared in the same manner as in Example 4, and were packed in 5 g/bag aluminum foil. The recommended eating method was 2 times a day, 1 bag each time.

本实施例采用的保健食品软胶囊 (以下简称印加软胶囊) , 由实施例 10制备得到, 规 格 l .Og/粒, 推荐食用方法为每日 3次, 每次 3粒。  The health food soft capsule (hereinafter referred to as Inca soft capsule) used in the present embodiment is prepared by the method of Example 10, and has a specification of 1.0 g/granule. The recommended eating method is 3 times a day, 3 capsules each time.

人体试食实验增加 2个阳性对照组, 分别为:  The human food test experiment added two positive control groups, which were:

阳性对照 1组: 印加果油 (来源于华大基因 (老挝) 有限公司, 批号 20120301 ) , 每 日 2次, 每次 5mL;  Positive control group 1: Inca fruit oil (from Huada Gene (Laos) Co., Ltd., batch number 20120301), 2 times a day, 5mL each time;

阳性对照 2组: 低聚木糖胶囊(山东龙力生物科技有限公司, 国食健字 G20041284) , 每日 2次, 每次 3粒;  Positive control group 2: xylooligosaccharide capsule (Shandong Longli Biotechnology Co., Ltd., Guoshijianzi G20041284), 2 times a day, 3 capsules each time;

二、 方法  Second, the method

2.1培养基和肠道菌群检验方法:  2.1 medium and intestinal flora test methods:

双歧杆菌: BBL培养基, 37 °C , 动物实验 72h厌氧培养, 人体试食实验 48h厌氧培养; 乳杆菌: LBS培养基, 37°C, 48h培养;  Bifidobacterium: BBL medium, 37 °C, animal experiment 72h anaerobic culture, human food test 48h anaerobic culture; Lactobacillus: LBS medium, 37 ° C, 48h culture;

肠杆菌: EMB培养基, 37°C, 24h培养;  Enterobacter: EMB medium, 37 ° C, 24 h culture;

肠球菌: 叠氮钠 -结晶紫-七叶苷培养基, 37°C, 动物实验 24h培养, 人体试食实验 48h +立关.  Enterococcus: sodium azide - crystal violet - esculin culture medium, 37 ° C, animal experiment 24 h culture, human trial experiment 48 h + Li Guan.

产气荚膜梭菌: TSC培养基, 37°C, 24h厌氧培养。  Clostridium perfringens: TSC medium, 37 ° C, 24 h anaerobic culture.

2.2调节肠道菌群动物实验方法:  2.2 Experimental methods for regulating intestinal flora:

选用 50 只雄性小鼠随机分成 5 组, 每组 10 只, 其中 1 组为正常对照组, 另 4组灌 服盐酸林可霉素, 灌服量按 60mg/10g_bw, 连续 3 d。 经检验, 小鼠出现菌群失调, 随机选 取 1 组以生理盐水灌胃, 作为自然恢复组, 其余 3 组以本实施例的冲剂灌胃, 其灌服剂量 分为 0.5g/kg_bw、 2.5g/kg-bw 5g/kg_bw 3个剂量组。 每日 1 次, 连续 7 d。 于给受试物最后 一次 24 h后, 无菌采取小鼠粪便, 检测肠道菌群数, 比较实验前后双歧杆菌、 乳杆菌、 肠 球菌、 肠杆菌、 产气荚膜梭菌的变化情况。 50 male mice were randomly divided into 5 groups, 10 in each group, of which 1 group was the normal control group, and the other 4 groups were given lincomycin hydrochloride. The dosage was 60 mg/10g_bw for 3 days. After testing, the mice developed dysbacteriosis, and one group was randomly selected to be administered with normal saline as a natural recovery group, and the other three groups were administered with the granules of the present example. Divided into 0.5g/kg_bw, 2.5g/kg-bw 5g/kg_bw 3 dose groups. Once a day for 7 days. After the last 24 h of the test object, the mouse feces were aseptically taken to detect the number of intestinal flora, and the changes of Bifidobacterium, Lactobacillus, Enterococcus, Enterobacter, Clostridium perfringens before and after the experiment were compared. .

2.3人体试食实验方法:  2.3 human test experiment method:

将受试者随机分成 3 个组, 在受试者试食之前, 均无菌采取受试者粪便, 检验肠道菌 群数。  The subjects were randomly divided into 3 groups, and the subjects' faeces were aseptically taken before the subjects were tested, and the number of intestinal flora was examined.

第一组受试者服用本实施例的印加软胶囊, 每日 3次, 每次 3粒, 连续 7d;  The first group of subjects took the Inca soft capsule of the present example, 3 times a day, 3 times each time, for 7 days;

第二组受试者服用阳性对照 1组的印加果油, 每日 2次, 每次 5mL;  The second group of subjects took the positive control group 1 of Inca fruit oil, 2 times a day, 5mL each time;

第三组受试者服用阳性对照 2组的低聚木糖胶囊, 每日 2次, 每次 3粒;  The third group of subjects took the positive control group 2 xylooligosaccharide capsules, 2 times a day, 3 capsules each time;

分别观察、 记录受试者食用前后自觉症状, 于给受试物最后一次 24 h后, 无菌采取受 试者粪便, 检测肠道菌群数。  Subjects were observed and recorded separately before and after eating. After the last 24 hours of the test, the stool of the subject was aseptically taken and the number of intestinal flora was detected.

三、 结果  Third, the results

3.1本实施例的保健食品冲剂对小鼠肠道菌群调节作用的实验结果, 见表 8。  3.1 Experimental results of the regulation effect of the health food granules of the present example on the intestinal flora of mice, see Table 8.

表 8 调节肠道菌群组小鼠肠道菌群检测结果 ( X±S, n=10) logCFU/g  Table 8 Test results of intestinal flora in mice with intestinal flora (X±S, n=10) logCFU/g

^菌 双歧杆菌 乳杆菌 肠杆菌 肠球菌 产气荚膜梭 组别 囷 正常对照组 9.36±0.88 8.86±0.92 6.58±1.45 6.44±1.11 7.72±0.98 灌服抗生素后 8.28±0.83 8.22±0.70 8.21±0.69 <2 <2 自然恢复组 8.25±0.24 8.24±0.35 8.85±0.42 6.79±0.46 8.13±0.67 低剂量组 8.91±0.55* 9.18±0.39** 8.74±0.50Δ 6.23±0.62 7.27±0.55 中剂量组 9.31±0.37** 9.59±0.23** 9.17±0.32ΔΔ 7.43±0.70Δ 8.26±0.41Δ 高剂量组 8.74±0.32* 8.93±0.22** 8.78±0.53Δ 6.52±0.92 7.80±0.84 注: (1 ) 与自然恢复组比较 *Ρ<0.05 ; (2) 与自然恢复组比较 **Ρ<0.01 ; ^ Bacillus lentus Enterobacter enterococcal gastrosporic group: normal control group 9.36 ± 0.88 8.86 ± 0.92 6.58 ± 1.45 6.44 ± 1.11 7.72 ± 0.98 8.82 ± 0.83 8.22 ± 0.70 8.21 ± 0.69 after oral administration of antibiotics <2 <2 Natural recovery group 8.25±0.24 8.24±0.35 8.85±0.42 6.79±0.46 8.13±0.67 Low dose group 8.91±0.55* 9.18±0.39** 8.74±0.50 Δ 6.23±0.62 7.27±0.55 medium dose group 9.31±0.37 ** 9.59±0.23** 9.17±0.32 ΔΔ 7.43±0.70 Δ 8.26±0.41 Δ high dose group 8.74±0.32* 8.93±0.22** 8.78±0.53 Δ 6.52±0.92 7.80±0.84 Note: (1) and natural recovery group Comparison *Ρ<0.05; (2) Compared with the natural recovery group **Ρ<0.01;

( 3 ) 与正常对照组比较 ΔΡ<0.05 ; (4) 与正常对照组比较 ΔΔΡ<0.01。 (3) Δ Ρ < 0.05 compared with the normal control group; (4) ΔΔ Ρ < 0.01 compared with the normal control group.

由表 8 可知, 灌服抗生素后小鼠肠道内的双歧杆菌、 乳杆菌、 肠球菌、 产气荚膜梭菌 这四种细菌的数量比正常对照组明显减少, 说明小鼠肠道内菌群失调。 经口给予小鼠受试 物后, 小鼠肠道内的五种细菌数量增加, 低剂量组与正常对照组比较, 肠杆菌的数量明显 增加, 差异有显著性 (Ρ<0.05 ) 。 与自然恢复组比较, 双歧杆菌的数量明显增加, 差异有显 著性 (ΡΟ.05 ) , 乳杆菌的数量明显增加, 差异有极显著性 (Ρ<0.01 ) 。 中剂量组与正常对 照组比较, 肠球菌、 产气荚膜梭菌的数量明显增加, 差异有显著性 (Ρ<0.05 ) , 肠杆菌的数 量明显增加, 差异有极显著性 (Ρ<0.01 ) ; 与自然恢复组比较, 双歧杆菌、 乳杆菌的数量明 显增加, 差异有极显著性 (Ρ<0.01 ) , 肠球菌、 产气荚膜梭菌的数量明显增加, 差异有显著 性 (P<0.05 ) ;高剂量组与正常对照组比较,肠杆菌的数量明显增加,差异有显著性 (P<0.05 ) ; 与自然恢复组比较, 乳杆菌的数量明显增加, 差异有极显著性 (P<0.01 ) 。 It can be seen from Table 8 that the number of Bifidobacteria, Lactobacillus, Enterococcus, Clostridium perfringens, and the number of bacteria in the intestine of the mice after administration of antibiotics was significantly lower than that of the normal control group, indicating that the intestinal flora of the mice Disorder. After oral administration of the test substance to the mice, the number of five bacteria in the intestine of the mice increased, and the number of enterobacteria increased significantly in the low dose group compared with the normal control group, and the difference was significant (Ρ<0.05). Compared with the natural recovery group, the number of bifidobacteria increased significantly, the difference was significant (ΡΟ.05), and the number of lactobacilli increased significantly, and the difference was extremely significant (Ρ<0.01). Compared with the normal control group, the number of Enterococcus and Clostridium perfringens was significantly increased in the middle dose group, the difference was significant (Ρ<0.05), and the number of Enterobacteriaceae was significantly increased. The difference was extremely significant (Ρ<0.01). Compared with the natural recovery group, the number of bifidobacteria and lactobacilli increased significantly, and the difference was extremely significant (Ρ<0.01). The number of enterococci and Clostridium perfringens increased significantly, and the difference was significant. Sexuality (P<0.05); the number of Enterobacteriaceae was significantly increased in the high-dose group compared with the normal control group, the difference was significant (P<0.05). Compared with the natural recovery group, the number of Lactobacilli increased significantly, and the difference was extremely significant. Sex (P<0.01).

3. 2 本实施例所述保健食品软胶囊人体试食实验结果  3. 2 Experimental results of human food test of soft food capsules of the present embodiment

服用印加软胶囊前后人体肠道菌群的变化, 结果见表 3。  The changes in human intestinal flora before and after taking Inka soft capsules are shown in Table 3.

Figure imgf000017_0001
Figure imgf000017_0001

服用前 9.03±0.58 8.36±0.85 5.18±1.43 6.24±1.25 6.56±1.58 服用印加果油后 10.05±0.55** 8.40±0.96 5.85±0.99** 6.15±1.33 4.80±1.42** 服用低聚木糖胶囊后 10.36±0.48** 8.44±1.13 6.16±1.04** 6.09±1.35 3.98±1.35** 服用印加软胶囊后 11.32±0.37* 8.52±1.07 6.67±1.29* 6.01±1.49 3.20±1.29* 9.03±0.58 8.36±0.85 5.18±1.43 6.24±1.25 6.56±1.58 before taking Inca fruit oil 10.05±0.55** 8.40±0.96 5.85±0.99** 6.15±1.33 4.80±1.42** After taking xylooligosaccharide capsules 10.36±0.48** 8.44±1.13 6.16±1.04** 6.09±1.35 3.98±1.35** After taking Inka soft capsule 11.32±0.37* 8.52±1.07 6.67±1.29* 6.01±1.49 3.20±1.29*

( 1 ) 服用后与服用前比较 *P<0.01 (1) Comparison after taking with *P<0.01

(2) 服用后与服用前比较 **P<0.05  (2) Comparison after taking with **P<0.05

由表 9可知, 受试人群服用印加软胶囊后, 双歧杆菌、 肠杆菌的数量明显增加, 差异 有极显著性 (P<0.01 ) ; 乳杆菌的数量有增加的趋势, 差异无显著性 (P>0.05 ) ; 肠球菌有 减少的趋势, 差异无显著性 (P>0.05); 产气荚膜梭菌的数量明显减少, 差异有极显著性 (P< 0.01) 。 受试人群服用印加果油后、 以及服用低聚木糖胶囊后, 双歧杆菌、 肠杆菌的数量明 显增加, 差异有显著性(P<0.01 ); 乳杆菌的数量有增加的趋势, 差异无显著性(P>0.05 ); 肠球菌有减少的趋势, 差异无显著性 (P>0.05); 产气荚膜梭菌的数量明显减少, 差异有显著 性 (P < 0.01)。  It can be seen from Table 9 that the number of Bifidobacteria and Enterobacteriaceae increased significantly after taking Inka soft capsules, and the difference was extremely significant (P<0.01). The number of Lactobacilli increased, and the difference was not significant ( P>0.05); Enterococcus had a decreasing trend, the difference was not significant (P>0.05); the number of Clostridium perfringens was significantly reduced, the difference was extremely significant (P<0.01). After taking Inca fruit oil and taking xylo-oligosaccharide capsules, the number of Bifidobacteria and Enterobacteriaceae increased significantly, the difference was significant (P<0.01); the number of Lactobacilli increased, the difference was not Significant (P>0.05); Enterococcus had a decreasing trend, the difference was not significant (P>0.05); the number of Clostridium perfringens was significantly reduced, the difference was significant (P < 0.01).

双歧杆菌是有益菌的代表, 可以抑制有害菌生长, 维持肠道内正常的微生态环境。 增 加人体肠道内双歧杆菌数量, 可以显著改善人体的胃肠道功能以及健康状况。 由上述印加 软胶囊调节肠道菌群功能的动物实验以及调节肠道菌群功能的人体试食实验可见, 本实施 例的保健食品具有调节肠道菌群的功能, 本发明可显著刺激人体肠道内有益菌双歧杆菌、 肠杆菌的数量增加, 以及显著降低有害菌产气荚膜梭菌的数量。 而且, 服用印加软胶囊后 的受试者人群, 人体肠道内双歧杆菌、 肠杆菌增加的数量、 以及产气荚膜梭菌的降低数量 均比服用印加果油后、 以及服用低聚木糖胶囊后的受试者效果更明显, 即本发明保健食品 所起的保健功能效果优于单一的成分所起的作用效果。  Bifidobacteria are representative of beneficial bacteria, can inhibit the growth of harmful bacteria, and maintain the normal micro-ecological environment in the intestine. Increasing the number of bifidobacteria in the human gut can significantly improve the gastrointestinal function and health of the human body. The animal experiment of regulating the function of the intestinal flora by the above-mentioned Inka soft capsule and the human food test experiment of regulating the function of the intestinal flora can be seen that the health food of the embodiment has the function of regulating the intestinal flora, and the invention can significantly stimulate the human intestine The number of beneficial bacteria in the tract, Bifidobacteria, Enterobacter, and the number of harmful bacteria Clostridium perfringens were significantly reduced. Moreover, the number of Bifidobacteria, Enterobacteriaceae, and the number of Clostridium perfringens in the human intestinal tract after taking Inca soft capsules were lower than those after taking Inca fruit oil and taking Xylooligosaccharides. The effect of the subject after the capsule is more obvious, that is, the health care function of the health food of the present invention is superior to the effect of the single component.

实施例 16: 治疗便秘效果试验  Example 16: Treatment of constipation effect test

依据卫生部 《保健食品检验与评价技术规范 (2003年) 》 , 本发明在进行深入的有效 性和安全性研究后, 本实施例采用实施例 4 制备得到的印加冲剂 (以下简称印加冲剂) 对 便秘患者的进行治疗试验。 试验对象: According to the “Technical Specification for Health Food Inspection and Evaluation (2003)” of the Ministry of Health, after the in-depth effectiveness and safety study of the present invention, the present embodiment adopts the Indo-Chong agent (hereinafter referred to as Inca granule) prepared in the fourth embodiment. Treatment trials for patients with constipation. Test subject:

抽取轻度便秘患者 50例, 年龄为 40-60岁; 中度便秘患者 50例, 年龄为 40-60岁; 重 度便秘患者 50例, 年龄为 40-60岁。 其中轻度便秘是指 2-3天排便一次, 中度便秘是指 3-6 天排便一次, 重度便秘是指 7天以上排便一次或依靠泻药排便, 每天一次或两天一次。  50 patients with mild constipation were enrolled, aged 40-60 years; 50 patients with moderate constipation, aged 40-60 years; 50 patients with severe constipation, aged 40-60 years. Among them, mild constipation means 2-3 days of bowel movements, moderate constipation means 3-6 days of bowel movements, and severe constipation means more than 7 days of bowel movements or relies on laxatives for defecation, once or twice a day.

试验方法:  experiment method:

采用印加冲剂对便秘患者进行治疗。  Treatment of constipation patients with Inca granules.

轻度便秘患者服用印加冲剂 7天, 前三天每天服用 2袋, 之后四天每天 1袋, 温水冲饮。 中度便秘患者服用印加冲剂 7天, 前三天每天服用 4袋, 之后四天每天 2袋, 温水冲饮。 重度便秘患者服用印加冲剂 7天, 前三天每天服用 6袋, 之后四天每天 3袋, 温水冲饮。 Patients with mild constipation took Inca granules for 7 days, taking 2 bags a day for the first three days, and then taking 1 bag every day for four days. Patients with moderate constipation took Inca granules for 7 days, taking 4 bags a day for the first three days, and then taking 2 bags a day for four days, brewing in warm water. Patients with severe constipation took Inca granules for 7 days, taking 6 bags a day for the first three days, and then 3 bags a day for four days.

试验效果:  Test effect:

轻度便秘患者在服用印加冲剂的前三天内, 每天排两到三次松软偏松散大便, 便秘情 况得到显著改善, 第 4-7 天减量服用后, 每天排一到两次松软大便。  In patients with mild constipation, the loose and loose stools were removed two to three times a day during the first three days of Inca granules, and constipation was significantly improved. After the reduction on the 4th to 7th day, one or two soft stools were discharged every day.

中度便秘患者在服用印加冲剂的前三天内,其中有 43 例患者每天排两到三次松软偏松 散大便, 7 例患者每天排一到两次松软大便, 第 4-7 天减量服用后, 50 例患者均每天排一 到两次松软大便。  In the first three days of taking Inga granules, 43 patients had loose or loose loose stools every day, 7 patients had loose stools once or twice a day, and after 4-7 days of reduction, Fifty patients had one or two soft stools per day.

重度便秘患者在服用印加冲剂的前三天内,其中有 27 例患者每天排两到三次松软偏松 散大便, 20 例患者每天排一到两次松软大便, 其余 3 例患者 3 天内排便一次, 便秘情况 也有所改善, 第 4-7 天减量服用后, 48 例患者均每天排一到两次大便, 2 例患者 2 天排便 一次。 不同程度的便秘患者均得到了有效治疗。  In the first three days of taking Yinka granules, 27 patients had loose or loose loose stools every day, 20 patients had loose stools once or twice a day, and the remaining 3 patients had bowel movements within 3 days. Constipation There was also improvement. After taking the dose on days 4-7, 48 patients had one or two bowel movements per day, and 2 patients had bowel movements once every 2 days. Patients with different degrees of constipation have been treated effectively.

从本实施例的保健食品对便秘患者的治疗效果试验来看, 该产品具有改善胃肠道功能, 能起到润肠通便、 防治便秘的作用, 服用期间未见不良反应。 在本说明书的描述中, 参考术语"一个实施例"、 "一些实施例"、 "示例"、 "具体示例"、 或"一些示例"等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含 于本发明的至少一个实施例或示例中。 在本说明书中, 对上述术语的示意性表述不一定指 的是相同的实施例或示例。 而且, 描述的具体特征、 结构、 材料或者特点可以在任何的一 个或多个实施例或示例中以合适的方式结合。  From the test of the therapeutic effect of the health food of the present embodiment on constipation patients, the product has the function of improving the function of the gastrointestinal tract, and can function as a laxative and constipation, and no adverse reaction is observed during the administration. In the description of the present specification, the description of the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" and the like means a specific feature described in connection with the embodiment or example. A structure, material or feature is included in at least one embodiment or example of the invention. In the present specification, the schematic representation of the above terms does not necessarily mean the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.

尽管上面已经示出和描述了本发明的实施例,可以理解的是,上述实施例是示例性的, 不能理解为对本发明的限制, 本领域的普通技术人员在不脱离本发明的原理和宗旨的情况 下在本发明的范围内可以对上述实施例进行变化、 修改、 替换和变型。  Although the embodiments of the present invention have been shown and described, it is understood that the foregoing embodiments are illustrative and not restrictive Variations, modifications, alterations and variations of the above-described embodiments are possible within the scope of the invention.

Claims

权利要求书 claims 1、 一种可食用组合物, 其特征在于, 包含: 1. An edible composition, characterized in that it contains: 40-120重量份的印加果; 40-120 parts by weight of Sacha Inchi; 10-90重量份的黄芪; 10-90 parts by weight of Astragalus membranaceus; 10-80重量份的茯苓; 10-80 parts by weight of Poria cocos; 30-100重量份的菊粉; 30-100 parts by weight of inulin; 30-90 重量份的玉米花粉; 30-90 parts by weight of corn pollen; 10〜90重量份的布渣叶; 以及 10 to 90 parts by weight of cloth residue leaves; and 20-120重量份的功能糖。 20-120 parts by weight of functional sugar. 2、 根据权利要求 1 所述的可食用组合物, 其特征在于, 包含: 2. The edible composition according to claim 1, characterized in that, comprising: 70〜110重量份的印加果; 70 to 110 parts by weight of Sacha Inchi; 30-70重量份的黄芪; 30-70 parts by weight of Astragalus membranaceus; 20-60重量份的茯苓; 20-60 parts by weight of Poria cocos; 50-80重量份的菊粉; 50-80 parts by weight of inulin; 50-80重量份的玉米花粉: 50-80 parts by weight of corn pollen: 30〜70重量份的布渣叶; 以及 30 to 70 parts by weight of cloth residue leaves; and 40-100重量份的功能糖。 40-100 parts by weight of functional sugar. 3、 根据权利要求 1 所述的可食用组合物, 其特征在于, 包含: 3. The edible composition according to claim 1, characterized in that, comprising: 90重量份的印加果; 90 parts by weight of Sacha Inchi; 60重量份的黄芪: 60 parts by weight of astragalus: 50重量份的茯苓; 50 parts by weight of Poria; 70重量份的菊粉; 70 parts by weight of inulin; 70重量份的玉米花粉; 70 parts by weight of corn pollen; 50重量份的布渣叶; 以及 50 parts by weight of cloth residue leaves; and 70重量份的功能糖。 70 parts by weight of functional sugar. 4、 根据权利要求 1〜3任意一项所述的可食用组合物, 其特征在于, 所述功能糖为选自 魔芋葡甘聚糖、 酵母葡聚糖、 壳寡糖、 低聚果糖、 低聚半乳糖、 低聚木糖、 低聚异麦芽糖 的至少一种。 4. The edible composition according to any one of claims 1 to 3, characterized in that the functional sugar is selected from the group consisting of konjac glucomannan, yeast glucan, chitosan oligosaccharide, fructooligosaccharide, and low-glucomannan. At least one of polygalactose, xylo-oligosaccharide and isomaltooligosaccharide. 5、 根据权利要求 1〜4任意一项所述的可食用组合物, 其特征在于, 所述可食用组合物 呈胶囊剂、 片剂、 冲剂或颗粒剂的形式。 5. The edible composition according to any one of claims 1 to 4, characterized in that the edible composition is in the form of capsules, tablets, granules or granules. 6、 一种食品, 其特征在于, 包括权利要求 1〜5所述的可食用组合物。 6. A food, characterized in that it includes the edible composition according to claims 1 to 5. 7、 根据权利要求 6所述的食品, 其特征在于, 所述食品呈胶囊剂、 片剂、 冲剂或颗粒 剂的形式。 7. The food according to claim 6, characterized in that the food is in the form of capsules, tablets, granules or granules. 8、 一种制备食品的方法, 其特征在于, 包括: 8. A method of preparing food, characterized in that it includes: 提供权利要求 1〜5任意一项所述的可食用组合物, 其中, 所述印加果、 黄芪、 茯苓、 菊粉、 玉米花粉、 布渣叶和功能糖呈颗粒状; 以及 The edible composition according to any one of claims 1 to 5 is provided, wherein the Inchi Inchi, Astragalus, Poria, inulin, corn pollen, Buji leaves and functional sugar are in granular form; and 将所述可食用组合物进行成型处理, 以便获得所述食品, subjecting said edible composition to a shaping process in order to obtain said food product, 9、 根据权利要求 8所述的方法, 其特征在于, 所述颗粒的粒度为 100-300目。 9. The method according to claim 8, characterized in that the particle size of the particles is 100-300 mesh. 10、 根据权利要求 8所述的方法, 其特征在于, 所述成型进一步包括: 将所述可食用 组合物制成胶囊剂、 片剂、 冲剂或颗粒剂的形式。 10. The method according to claim 8, wherein the forming further comprises: making the edible composition into the form of capsules, tablets, granules or granules. 11、 权利要求 1〜5任一项所述的可食用组合物在制备制剂中的用途, 所述制剂用于改 善胃肠道功能和增强人体免疫力的至少之一。 11. Use of the edible composition according to any one of claims 1 to 5 in preparing a preparation for at least one of improving gastrointestinal function and enhancing human immunity.
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