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WO2021071269A1 - Composition pour la prévention ou le traitement d'une maladie intestinale inflammatoire comprenant des extraits de plantes médicinales complexes - Google Patents

Composition pour la prévention ou le traitement d'une maladie intestinale inflammatoire comprenant des extraits de plantes médicinales complexes Download PDF

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Publication number
WO2021071269A1
WO2021071269A1 PCT/KR2020/013713 KR2020013713W WO2021071269A1 WO 2021071269 A1 WO2021071269 A1 WO 2021071269A1 KR 2020013713 W KR2020013713 W KR 2020013713W WO 2021071269 A1 WO2021071269 A1 WO 2021071269A1
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Prior art keywords
inflammatory bowel
bowel disease
extract
pharmaceutical composition
group
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English (en)
Korean (ko)
Inventor
이원우
이두석
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Helixmith Co Ltd
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Helixmith Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/30—Animal feeding-stuffs from material of plant origin, e.g. roots, seeds or hay; from material of fungal origin, e.g. mushrooms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538—Schizonepeta
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/324—Foods, ingredients or supplements having a functional effect on health having an effect on the immune system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the present invention is Coptis; Brotherhood; And it provides a pharmaceutical composition for the prevention or treatment of inflammatory bowel disease, comprising a complex herbal extract of nasturtium or baekduong as an active ingredient.
  • the present invention relates to a food composition or feed composition for preventing or improving inflammatory bowel disease comprising the complex herbal extract as an active ingredient.
  • Inflammatory bowel disease is a chronic intractable disease in which chronic inflammation or ulceration occurs in the mucous membranes of the large intestine and small intestine, resulting in diarrhea and bloody stools, temporarily improving symptoms, and recurring.
  • Inflammatory bowel disease is clinically similar, but classified into two diseases, ulcerative colitis and Crohn's disease, which are different in histological findings, endoscopy and immunological aspects.
  • Ulcerative colitis is a disease in which soreness (erosion) or ulcers are continuously formed on the mucous membrane of the large intestine. Symptoms are limited only in the large intestine. Bloody stools, mucous stools, diarrhea, and abdominal pain occur. In severe cases, fever, weight loss, and anemia.
  • Crohn's disease is a disease in which lesions such as ulcers occur discontinuously in any part of the digestive tract from the mouth to the anus.In addition to abdominal pain, diarrhea, and bloody stools, symptoms such as fever, weight loss, systemic malaise, and anemia in severe cases. Appears. The exact etiology of such inflammatory bowel disease has not been fully identified, but it is estimated that activation of inflammatory mediators and immune cells are important pathogens due to autoimmune diseases, along with environmental or genetic factors. Persistent and inappropriate activation of the intestinal immune system leads to chronic mucositis inflammation, especially mucosal destruction and ulcers by infiltration of neutrophils, macrophages, lymphocytes and mast cells.
  • sulfasalazine an aminosalicylic acid
  • side effects such as nausea, vomiting, loss of appetite, rash, headache, liver injury, leukocytosis, abnormal red blood cells, proteinuria, and diarrhea. Strong side effects, such as necrosis of the femoral head, have been reported.
  • Infliximab a TNF- ⁇ monoclonal antibody, was used to treat Crohn's disease patients after being approved by the US FDA as a treatment for Crohn's disease in 1998. Is appearing. Therefore, there is an urgent need to develop a new therapeutic agent for inflammatory bowel disease that is safer and has fewer side effects than the currently used inflammatory bowel disease treatments.
  • Coptis Rhizome is a medicinal herb that is a perennial herbaceous plant of the Ranunculaceae family. The roots are removed as the rootstock. Hwangryeon is to cool heat and dry moisture, detoxification while releasing heat and heat. Self-centeredness, which belongs to the ⁇ ), which removes the burning heat of the heart or stomach (self-heartedness) and at the same time removes the ones that have been dying ( ⁇ ). It is effective in Jebeon ( ⁇ ).
  • methods for use in diseases such as ontoxication and changyang fever are known, and are known to have pharmacological effects such as antimicrobial action, blood pressure lowering action, and anti-inflammatory action.
  • Hyeonggae (Schizonepeta tenuifolia Briquet) is an annual plant belonging to the Lamiaceae family (Labiatae), and its above-ground part, Hyeonggae (Schizonepetae Herba) or the ear of flowers (Schizonepetae Spica), is used for medicinal purposes.
  • Hyeonggae (Schizonepetae Herba) or the ear of flowers (Schizonepetae Spica)
  • oriental medicine it is used for the symptoms of chills, fever, headache and sweating due to external sensitivity.
  • a woman has convulsions and seizures due to a cold after childbirth, it is taken as a single powder and is effective for skin itching. It is used when there is a fever and inflammation spreads in the early stage of the window candle, and if it is roasted black, it has a hemostatic effect on hematopoiesis, bleeding, nosebleeds, urine bleeding and uterine bleeding.
  • Hanryeoncho (Ecliptae Herba) is a perennial plant of the Asteraceae (Compositae), and is an outpost of the Hanryeoncho (Eclipta prostrata Linne). It is also called aejangcho, mokhannyeon, mukducho, and hayeoncho. Hanryeoncho has the effect of hemostasis, boeum ( ⁇ ) and boshin ( ⁇ ), and is known to strengthen muscles and bones.
  • Baek Duong Pulsatillae Radix
  • Nogocho is a perennial plant belonging to the Ranunculaceae family, such as Pulsatilla koreana Nakai or Baek Duong (Pulsatilla chinensis Regel).
  • Amoeba protozoa and Eumdo protozoa inhibitory effect, cardiac toxicity, soothing, analgesic effect, and skin mucosa stimulating effect have been reported.
  • the present inventors performed better treatment than using each single extract when using complex herbal extracts of Hwangryeon, Hyeonggae, Hanryeoncho, and Baekduong. Having found that there is an effect, the present invention was completed.
  • the object of the present invention is Cwangryun; Brotherhood; And it is to provide a pharmaceutical composition for the prevention or treatment of inflammatory bowel disease comprising the herbal extract of nasturtium or baekduong as an active ingredient.
  • Another object of the present invention is Hwangnyeon; Brotherhood; And it is to provide a food composition or feed composition for preventing or improving inflammatory bowel disease, comprising the herbal extract of nasturtium or baekduong as an active ingredient.
  • Another object of the present invention is Hwangnyeon; Brotherhood; And it is to provide a method for preventing, improving, or treating inflammatory bowel disease comprising administering to a subject a pharmaceutical composition or a food composition comprising a herbal extract of nasturtium or baekduong as an active ingredient.
  • the present invention is Coptis; Brotherhood; And it provides a pharmaceutical composition for the prevention or treatment of inflammatory bowel disease comprising the herbal extract of nasturtium or baekduong as an active ingredient.
  • the term "herbal extract” or “combined herbal extract” is an active ingredient of the pharmaceutical composition of the present invention, including each of Coptis chinensis, Hyeonggae, Hanryeoncho or Baekduong extract, or including extracts extracted from each herbal mixture it means.
  • Coptis Rhizome of the present invention means a herbaceous perennial herbaceous plant of Ranunculaceae, Coptis japonica Makino, Coptis chinensis Franchet, Triangular Leaf Coptis deltoidea CY Cheng et Hsiao or Woonryeon ( ⁇ ) It is the rootstock of Coptis teeta Wallich and refers to the root removed.
  • Hyunggae (Schizonepeta tenuifolia Briquet) of the present invention means an annual vegetation belonging to the Lamiaceae family (Labiatae), and includes Hyeonggae (Schizonepetae Herba) or the ear of flowers (Schizonepetae Spica), which is the above-ground part thereof do.
  • Ecliptae Herba of the present invention refers to the annual herb of the chrysanthemum family (Compositae), and refers to what is also called aejangcho, mokhanryeon, mukducho, haliancho, etc. .
  • “Baek Duong (Pulsatillae Radix)” of the present invention is called Nogocho, and refers to the drying of the roots of plants of the same genus such as Pulsatilla koreana Nakai or Pulsatilla chinensis Regel, a perennial plant belonging to Ranunculaceae. .
  • inflammatory bowel disease refers to a disease in which inflammation occurs in the intestine, ie, small intestine, large intestine, etc., and includes a disease in which abnormal chronic inflammation in the intestine repeats improvement and recurrence. In addition, it includes specific enteritis of which the cause has been identified, non-specific enteritis of which the cause is not known, and enteritis caused by other diseases, for example, enteric Behcet's disease, and the like.
  • treatment refers to all actions in which symptoms of inflammatory bowel disease are improved or cured by administration of the composition according to the present invention.
  • prevention refers to any action that suppresses or delays symptoms of inflammatory bowel disease by administration of the composition according to the present invention.
  • the term "including as an active ingredient” means including an amount sufficient to achieve the efficacy or activity of the extract of the present invention.
  • the pharmaceutical composition of the present invention may further include an extract of another herbal medicine known in the art to have the same or similar effect as that of the composition of the present invention.
  • the pharmaceutical composition of the present invention may further contain an active ingredient known to have an effect on treating inflammatory bowel disease in the art. More specifically, the pharmaceutical composition includes steroids such as glucocorticosteroids, 5-aminosalicylic acid (5-ASA) drugs such as sulfasalazine and mesalazine, and TNF - ⁇ may further contain one or more active ingredients selected from the group consisting of monoclonal antibodies.
  • steroids such as glucocorticosteroids
  • 5-aminosalicylic acid (5-ASA) drugs such as sulfasalazine and mesalazine
  • TNF - ⁇ may further contain one or more active ingredients selected from the group consisting of monoclonal antibodies.
  • the pharmaceutical composition of the present invention may further include an active ingredient showing an effect on diseases other than inflammatory bowel disease.
  • the herbal extract of the present invention When used together with an additional active ingredient, the herbal extract and the additional active ingredient may be administered simultaneously as one formulation, or may be administered simultaneously or sequentially as separate formulations.
  • the pharmaceutical composition of the present invention may be used alone or in combination with surgery, hormone therapy, drug therapy, or methods of using a biological response modifier to treat inflammatory bowel disease.
  • the herbal extract used in the present invention can be obtained using a conventional extraction solvent known in the art.
  • a polar solvent or a non-polar solvent may be used.
  • Polar solvents include water, C1 to C6 alcohols (eg, methanol, ethanol, propanol, butanol, normal-propanol, iso-propanol and normal-butanol, etc.), acetic acid, or a mixture of the polar solvents.
  • Non-polar solvents include acetone, acetonitrile, ethyl acetate, methyl acetate, butyl acetate, fluoroalkane, hexane, ether, chloroform, dichloromethane, or mixtures of the above non-polar solvents.
  • the herbal extract is extracted with a solvent selected from the group consisting of water, C1 to C6 alcohol, acetic acid, and a mixed solvent thereof.
  • the herbal extract is extracted with 0.01 to 90% ethanol. More specifically, the herbal extract is 0.01 to 90%, 1 to 90%, 10 to 90%, 20 to 90%, 30 to 90%, 40 to 90%, 50 to 90%, 60 to 90%, 0.01 to It is extracted with 80%, 1 to 80%, 10 to 80%, 20 to 80%, 30 to 80%, 40 to 80%, 50 to 80% ethanol. Most specifically, the herbal extract is extracted with 60 to 80% ethanol.
  • the herbal extract is extracted through hot water extraction, cold needle extraction, reflux cooling extraction, ultrasonic extraction, or conventional extraction methods known in the art.
  • extract has a meaning commonly used as a crude extract in the art, but also includes a fraction obtained by further fractionating the extract in a broad sense. That is, the herbal extract includes not only those obtained by using the above-described solvent, but also those obtained by additionally applying a purification process thereto. For example, fractions obtained by passing the extract through an ultrafiltration membrane having a certain molecular weight cut-off value, separation by various chromatographs (made for different separation in size, charge, hydrophobicity or affinity), etc. Fractions obtained through the purification method are also included in the herbal extract of the present invention.
  • the pharmaceutical composition of the present invention may contain a pharmaceutically acceptable carrier.
  • the pharmaceutically acceptable carrier is commonly used in the formulation, lactose, dextrose, sucrose, sorbitol, mannitol, starch, gum acacia, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, Polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, mineral oil, and the like, but are not limited thereto.
  • the pharmaceutical composition of the present invention may further include a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, and the like in addition to the above components.
  • a lubricant e.g., a talc, a kaolin, a kaolin, a kaolin, a kaolin, a kaolin, kaolin, kaolin, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, sorbitol, a talct, a talct, a talct, a stea, stevia, glycerin, glycerin, glycerin, g
  • the inflammatory bowel disease is Crohn's disease, ulcerative colitis, long Behcet's disease, intestinal tuberculosis, hemorrhagic rectal ulcer, indeterminate colitis, bacterial enteritis, viral enteritis, amoebic enteritis and ischemic It is a disease selected from the group consisting of colitis.
  • the pharmaceutical composition is powder, granule, tablet, coated tablet, pill, dragee, capsule, liquid, suspension, gel, syrup, slurry, suppository, enema, emulsion, It can be formulated as pastes, ointments, creams, lotions, powders, sprays or suspensions.
  • the pharmaceutical composition may be formulated as a solid preparation such as a tablet, a pill, a powder, a granule or a capsule, or a suspension, a liquid solution, an emulsion, or a syrup for oral administration.
  • the pharmaceutical composition may be formulated as a sterilized aqueous solution, a non-aqueous solution, a suspension, an emulsion, a lyophilized agent, or a suppository for parenteral administration.
  • the pharmaceutical composition may further include an appropriate carrier, excipient, or diluent commonly used in the manufacture of pharmaceutical compositions.
  • an appropriate carrier for example, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, mannitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl Pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate or mineral oil.
  • the herbal extract is Hwangnyeon; Brotherhood; And nasturtium or baekduongi are mixed in a weight ratio of 0.05-20: 0.05-20: 0.05-20. More specifically, the herbal extract is Hwangryeon; Brotherhood; And nasturtium or baekduongi 1-10: 1-10: 1-10, 1: 1-10: 1-10, 1-10: 1: 1-10, 1-10: 1-10: 1, 3: 1 -10: 1-10, 1-10: 3: 1-10, 1-10: 1-10: 3, 10: 1-10: 1-10, 1-10: 10: 1-10, 1-10 : 1-10: 10, 1: 1: 1-10, 3: 1: 1-10, 10: 1: 1-10, 1: 3: 1-10, 10: 1: 1-10, 3: 3 : 1-10, 3:10: 1-10, 10:10: 1-10 It is mixed in a weight ratio.
  • the herbal extract is Hwangnyeon; Brotherhood; And nasturtium or baekduongi 10:1: 1-10 is mixed in a weight ratio.
  • the herbal extract is Coptis Coptis; Brotherhood; And when nakryeoncho or baekduong is mixed in a weight ratio of 10:1:1, 10:1:3, and 10:1:10, the effect is excellent.
  • a suitable dosage of the pharmaceutical composition of the present invention varies depending on factors such as formulation method, mode of administration, age, weight, sex, pathological condition, food, administration time, route of administration, excretion rate and response sensitivity of the patient, Usually the skilled practitioner can readily determine and prescribe a dosage effective for the desired treatment or prophylaxis.
  • the daily dosage of the pharmaceutical composition of the present invention is 1-100 mg/kg.
  • the present invention is Coptis; Brotherhood; And it provides a food composition for preventing or improving inflammatory bowel disease, comprising the herbal extract of nasturtium or baekduong as an active ingredient.
  • the term "improvement” refers to all actions of reducing the severity of a parameter, for example, symptoms related to a condition to be treated by administration of a composition comprising an extract of the present invention.
  • the food composition of the present invention may be prepared in the form of powder, granules, tablets, capsules or beverages.
  • various foods such as candy, beverages, gum, tea, vitamin complexes, or health supplement foods.
  • the food composition of the present invention includes health functional foods and health foods.
  • the food composition of the present invention can be taken for a long time.
  • the food composition of the present invention may include ingredients that are commonly added during food production, and include, for example, proteins, carbohydrates, fats, nutrients, flavoring agents, and flavoring agents.
  • examples of the aforementioned carbohydrates include monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, oligosaccharides, and the like; And polysaccharides, for example, common sugars such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol.
  • flavoring agents natural flavoring agents [taumatin, stevia extract (eg, rebaudioside A, glycyrrhizin, etc.]) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used.
  • citric acid liquid fructose, sugar, glucose, acetic acid, malic acid, fruit juice, cephalic extract, jujube extract, licorice extract, etc.
  • the present invention is Coptis; Brotherhood; And it provides a feed composition for preventing or improving inflammatory bowel disease, comprising the herbal extract of nasturtium or baekduong as an active ingredient.
  • the extracts of Coptis Rhizoma, Hyeonggae, Hanryeoncho, and Baekduong contained in the composition of the present invention are natural plant materials, and have been used as edible and folk medicine for a long time, so it is expected that the extract of the present invention extracted from them will also have no problems such as toxicity and side effects. I can. Therefore, the extracts of Coptisaceae, Hyeonggae, Hanryeoncho, and Baekduong can be used as pharmaceuticals, food compositions, and feed compositions.
  • the contents of the extract of Coptis chinensis, Hyeonggae, Hanryeoncho, and Baekduong contained in the food composition and feed composition of the present invention are the same as the contents of the extraction of the mixed extract contained in the pharmaceutical composition, the contents in common between the two are In order to avoid excessive complexity of the present specification, description thereof is omitted.
  • the present invention includes the above-described present Coptis Coptis; Brotherhood; And it provides a method for preventing, improving or treating inflammatory bowel disease comprising administering to a subject a pharmaceutical composition or a food composition comprising a mixed extract of nasturtium or baekduong as an active ingredient.
  • administering refers to a subject by directly administering a therapeutically or prophylactically effective amount of a composition of the present invention to a subject (individual) suffering from or likely to suffer from the subject disease. It means to ensure that the same amount is formed in the body.
  • the administration route of the composition of the present invention may be administered orally or parenterally through any general route as long as it can reach the target tissue.
  • the composition of the present invention may be administered using any device capable of delivering the active ingredient to target cells, tissues or organs.
  • the "therapeutically effective amount” of the composition means an amount of the composition sufficient to provide a therapeutic or prophylactic effect to a subject to which the composition is to be administered, and is meant to include a “prophylactically effective amount”.
  • the subject is selected from the group consisting of humans, monkeys, cows, horses, sheep, pigs, chickens, turkeys, quails, cats, dogs, mice, rats, rabbits, and guinea pigs. It is not limited. More specifically, the subject is a human.
  • Inflammatory bowel disease which is the target disease of the prevention and method of the present invention, is the same as defined in relation to the target disease of the pharmaceutical composition or food composition.
  • the method for preventing or treating inflammatory bowel disease of the present invention is a method comprising administering a pharmaceutical composition, which is an aspect of the present invention, excessive redundancy in the present specification for overlapping contents with respect to the pharmaceutical composition The description is omitted in order to avoid.
  • the pharmaceutical composition comprising the mixed herbal extract of the present invention as an active ingredient exhibits excellent therapeutic effect in inflammatory bowel disease, particularly Crohn's disease or ulcerative colitis, and can be used as a novel therapeutic agent.
  • composition of the present invention can be used as a safe therapeutic agent to reduce side effects of existing therapeutic agents by including a natural product as an active ingredient.
  • 1 shows the DAI value of each administration group measured in the DSS-induced inflammatory bowel disease model.
  • Figure 2 shows the length of the colon of each administration group measured in the DSS-induced inflammatory bowel disease model.
  • Figure 3 shows the survival rate of each administration group measured in the DNBS-induced inflammatory bowel disease model.
  • Figure 4 shows the DAI value of each administration group measured in the DNBS-induced inflammatory bowel disease model.
  • FIG. 6 shows the DAI values of each administration group measured in the DSS-induced inflammatory bowel disease model.
  • % used to indicate the concentration of a specific substance is (weight/weight)% for solids/solids, (weight/volume)% for solids/liquids, and Liquid/liquid is (vol/vol) %.
  • the efficacy of the mixed herbal extract on inflammatory bowel disease was confirmed.
  • the DSS-induced inflammatory bowel disease model is known to exhibit morphological changes and symptoms similar to those of human ulcerative colitis. Accordingly, 8-week-old male mice (C57BL/6) were acclimated and bred for more than a week, and then Dextran Sulfate Sodium (DSS; 36,000-50,000 MW, MP Biomedicals, USA) was administered to induce ulcerative colitis.
  • the normal group without any treatment the DSS and distilled water administration group (negative control), the DSS and 5-Aminosalicylic Acid (5-ASA; Tokyo Chemical Industry Co., Japan) administration group (positive control), and DSS and each mixed herbal extract (The experiment was conducted by classifying it into the group (experimental group) administered with Hwangryeon, Hyeonggae, Baekduong, and Hanryeoncho).
  • DAI Disease Activity Index
  • the weight loss rate, stool condition, and bleeding were measured and DAI was analyzed to compare the normal group, the control group, and the experimental group.
  • the positive control group was orally administered 5-ASA diluted in negative water at a dose of 25 mg/kg once/day for 14 days from the start of the experiment.
  • each herbal extract prepared in Preparation Example was mixed and administered at the dose (mg/kg) shown in Table 2, and oral administration was performed once/day for 14 days from the start of the experiment.
  • DAI Disease Activity Index
  • the inflammatory response in bowel disease can be assessed to the extent that the length of the large intestine is reduced. Accordingly, in this example, the length of the large intestine was measured to compare the normal group, the control group, and the experimental group.
  • mice classified into the administration group as shown in Table 3 were sacrificed with carbon dioxide gas, and then the colon part was removed.
  • the length of the large intestine was measured from the removed large intestine, and the results are shown in Table 3 and FIG. 2 below.
  • the efficacy of the mixed herbal extract on inflammatory bowel disease was confirmed.
  • the DNBS-induced inflammatory bowel disease model is known to be closely related to Crohn's disease in humans in that it induces a T cell-mediated immune response. Accordingly, 8-week-old male mice (C57BL/6) were acclimated and bred for more than a week, and then dinitrobenzene sulfonic acid (DNBS; Sigma-Aldrich, USA) was administered to induce inflammatory bowel disease.
  • DNBS dinitrobenzene sulfonic acid
  • the experiment was conducted by classifying into a normal group without any treatment, a group administered with DNBS and distilled water (negative control group), and a group administered with DNBS and each mixed herbal extract (Hwangryeon, Hyeonggae, Baekduong, Hanryeoncho) (experimental group).
  • the survival rate was compared when DNBS was administered alone, and when DNBS and the complex herbal extract of the present invention were administered.
  • DNBS was dissolved in 50% ethanol aqueous solution to prepare a DNBS solution of 40 mg/mL. 0.1 mL of the prepared DNBS solution was slowly injected into the rectum of the mouse using a catheter.
  • the experimental group was administered once/day for 14 days from the start of the experiment at the dose (mg/kg) of each herbal extract prepared in the above Preparation Example.
  • DAI disease activity index
  • mice were classified into administration groups as shown in Fig. 4, each sample was administered. The next day after the start of the experiment, the weight of the mice in each group was measured and calculated as a weight loss rate, and the stool state and the presence of blood stool were checked. For the three indices, the DAI value was estimated by calculating the score according to the criteria in Table 1 of Example 1.
  • the complex herbal extracts exhibited excellent inflammatory bowel disease improvement or therapeutic effect.
  • the effect of protecting the barrier against inflammatory bowel disease of the mixed herbal medicine extract was confirmed.
  • the normal group without any treatment the DSS and distilled water administration group (negative control group), the DSS and 5-ASA administration group (positive control group), DSS and each mixed herbal medicine
  • the experiment was conducted by classifying the extracts (Hwangnyeon, Hyeonggae, Baekduong, Hanryeoncho) into the group administered (experimental group).
  • the positive control group was orally administered 5-ASA diluted in negative water at a dose of 25 mg/kg once/day for 9 days from the start of the experiment.
  • each herbal extract prepared in Preparation Example was mixed and administered at the dose (mg/kg) shown in Table 6, and was administered orally once/day for 9 days from the start of the experiment.
  • mice Thereafter, intestinal permeability was measured in mice.
  • FITC-dextran Sigma, USA
  • FITC-dextran Sigma, USA
  • mice were water-saved and fasted for 4 hours.
  • blood was collected through an orbital vein plexus, and only serum was separated to measure fluorescence, and the results are shown in Table 6 and FIG. 5.
  • the group (No. 5 and No. 7) administered with Baek Duong (15 mg/kg) or Hanryeoncho (50 mg/kg) to the mixed extract of Coptis Coptisium and Hyeonggae showed the fluorescence transmittance values of the normal group.
  • the barrier protection effect of the simultaneous mixed administration group of Baekduong or Hanryeoncho is superior compared to the mixed extract of Coptis Coptisium and Hyeonggae.
  • the efficacy of the treatment of DSS-induced inflammatory bowel disease was compared and evaluated between a single herbal extract and a mixed herbal extract.
  • the normal group without any treatment the DSS and distilled water administration group (negative control group), the DSS and 5-ASA administration group (positive control group), DSS and each single herbal medicine
  • the experiment was performed by classifying the extract or mixed herbal extracts (Hwangryeon, Hyeonggae, Baekduong, Hanryeoncho) into a group administered (experimental group).
  • the positive control group was orally administered 5-ASA diluted in negative water at a dose of 25 mg/kg once/day for 9 days from the start of the experiment.
  • each herbal extract prepared in Preparation Example was mixed and administered at the dose (mg/kg) shown in Table 7, and it was administered orally once/day for 9 days from the start of the experiment.
  • DAI Disease Activity Index
  • Intestinal permeability was measured in mice. On the 9th day of DSS induction, FITC-dextran (Sigma, USA) was orally administered at a concentration of 150 mg/ml to 100 ⁇ l per head to the mice that were water-saved and fasted for 4 hours. After 3 hours, blood was collected through an orbital vein plexus, and only serum was separated and fluorescence was measured. The results are shown in Table 8 and Fig. 7.
  • the group (No. 8 and No. 9) administered by mixing Baekduong or Hanryeoncho to the mixed extract of Hyeonggae and Hyeonggae showed the fluorescence transmittance values of the normal group.
  • the group administered with Coptis Coptis or Baekduong (No. 8 and No. 9) to the mixed extract of C It can be seen that is excellent.
  • the above ingredients are mixed and filled in an airtight cloth to prepare a powder.
  • tablets are prepared by tableting according to a conventional tablet manufacturing method.
  • the above ingredients are mixed and filled into gelatin capsules to prepare a capsule.
  • liquid formulation According to the usual preparation method of the liquid formulation, add and dissolve each component in purified water, add an appropriate amount of lemon flavor, mix the above ingredients, add purified water, add purified water, adjust the total to 100 ml, and fill in a brown bottle. It is sterilized to prepare a liquid formulation.
  • Vitamin A acetate 70 ⁇ g
  • Vitamin B6 0.5 mg
  • Vitamin B12 0.2 ⁇ g
  • composition ratio of the vitamin and mineral mixture is relatively suitable for health food, but it may be arbitrarily modified, and the above ingredients are mixed according to a conventional health food manufacturing method. , To prepare granules, and can be used for preparing a health food composition according to a conventional method.
  • the resulting solution is filtered and obtained in a sterilized 2 L container, sealed and sterilized, and stored in a refrigerator. It is used in the manufacture of the health beverage composition of the invention.
  • composition ratio is a mixture of ingredients suitable for a relatively preferred beverage in a preferred embodiment, but the mixing ratio may be arbitrarily modified according to regional and ethnic preferences such as the demand class, the country of demand, and the purpose of use.

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Abstract

La présente invention concerne une composition pharmaceutique pour la prévention ou le traitement d'une maladie intestinale inflammatoire, comprenant, en tant que principe actif, un extrait de plante médicinale de : Coptis chinensis ; Schizonepeta ; et Eclipta prostrate L ou Pulsatilla chinensis régel. De plus, la présente invention concerne une composition alimentaire ou une composition d'aliment pour animaux pour la prévention ou le traitement d'une maladie intestinale inflammatoire, comprenant l'extrait de plante médicinale en tant que principe actif.
PCT/KR2020/013713 2019-10-10 2020-10-08 Composition pour la prévention ou le traitement d'une maladie intestinale inflammatoire comprenant des extraits de plantes médicinales complexes Ceased WO2021071269A1 (fr)

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WO2022086127A1 (fr) * 2020-10-21 2022-04-28 주식회사 헬릭스미스 Composition destinée à prévenir ou traiter une affection abdominale inflammatoire comprenant un extrait de plantes médicinal complexe
EP3964222A4 (fr) * 2019-04-29 2022-08-03 Helixmith Co., Ltd. Composition pharmaceutique comprenant un extrait de mélange de coptis deltodea et de schizonepeta tenuifolia en tant que principe actif pour la prévention ou le traitement d'une maladie intestinale inflammatoire

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EP3964222A4 (fr) * 2019-04-29 2022-08-03 Helixmith Co., Ltd. Composition pharmaceutique comprenant un extrait de mélange de coptis deltodea et de schizonepeta tenuifolia en tant que principe actif pour la prévention ou le traitement d'une maladie intestinale inflammatoire
WO2022086127A1 (fr) * 2020-10-21 2022-04-28 주식회사 헬릭스미스 Composition destinée à prévenir ou traiter une affection abdominale inflammatoire comprenant un extrait de plantes médicinal complexe

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