KR20250083662A - Pharmaceutical composition for the prevention or treatment of obesity, lipid-related metabolic disease, or muscle weakness-related disease containing fermented Polygonum cuspidatum extract as an active ingredient - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating obesity, lipid-related metabolic disease or muscle weakness-related disease, comprising a fermented extract of Hojanggeun as an effective ingredient. The composition comprising the fermented extract of Hojanggeun according to the present invention has effects of improving fatty liver and obesity, reducing blood sugar, improving liver damage, improving blood lipid metabolism and improving muscle function, and thus can be usefully used as a pharmaceutical composition for preventing or treating obesity, lipid-related metabolic disease or muscle weakness-related disease, and a health functional food composition.

Description

{Pharmaceutical composition for the prevention or treatment of obesity, lipid-related metabolic disease, or muscle weakness-related disease containing fermented Polygonum cuspidatum extract as an active ingredient}

The present invention relates to a pharmaceutical composition for preventing or treating obesity, lipid-related metabolic disease, or muscle weakness-related disease, comprising a fermented extract of Hojanggeun as an effective ingredient.

Obesity is caused by a disruption of the energy balance between energy intake, consumption, and storage, and is associated with chronic systemic inflammation. The causes of obesity are diverse and include both genetic and environmental factors.

Recently, as our country's economic growth and westernized eating habits have led to an increase in calorie intake, the number of obese people has also increased. This obesity itself causes inconvenience in daily life due to weight gain and body size enlargement, but the bigger problem is that it increases blood lipid concentration, causing arteriosclerosis and heart disease, increases insulin resistance, causing complications such as diabetes, menstrual irregularities, and cancer, and causes chronic adult diseases such as hyperlipidemia, hypertension, coronary artery disease, and stroke, so treatment and prevention of obesity are essential.

Polygonum cuspidatum is a perennial herbaceous plant in the Polygonaceae family that grows in mountainous areas in Korea, Japan, Taiwan, and China. Its rhizome grows sideways, sprouts, and forms clumps. Its leaves are alternate and ovate. It has been used as a medicinal herb since ancient times to treat dysentery, diuresis, diaphoresis, irregular menstruation, and hepatitis.

Accordingly, the inventors of the present invention confirmed that the fermented extract of Polygonum cuspidatum has effects of improving fatty liver and obesity, reducing blood sugar, improving liver damage, improving blood lipid metabolism, and improving muscle function, and thus completed the present invention.

Republic of Korea Patent Publication No. 10-2231383

The purpose of the present invention is to provide a pharmaceutical composition for preventing or treating obesity or lipid-related metabolic diseases, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

In addition, another object of the present invention is to provide a pharmaceutical composition for preventing or treating a disease related to muscle weakness, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

In addition, another object of the present invention is to provide a health functional food composition for preventing or improving obesity or lipid-related metabolic diseases, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

In addition, another object of the present invention is to provide a health functional food composition for improving muscle function containing a fermented extract of Polygonum cuspidatum as an effective ingredient.

To achieve the above purpose, the present invention provides a pharmaceutical composition for preventing or treating obesity or lipid-related metabolic disease, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

Next, the present invention provides a pharmaceutical composition for preventing or treating a disease related to muscle weakness, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

In addition, the present invention provides a health functional food composition for preventing or improving obesity or lipid-related metabolic diseases, which contains a fermented extract of Polygonum cuspidatum as an effective ingredient.

Lastly, the present invention provides a health functional food composition for improving muscle function containing a fermented extract of Polygonum cuspidatum as an effective ingredient.

The composition containing the fermented extract of Hojanggeun according to the present invention has effects of improving fatty liver and obesity, reducing blood sugar, improving liver damage, improving blood lipid metabolism, and improving muscle function, and thus can be usefully used as a pharmaceutical composition and a health functional food composition for preventing or treating obesity, lipid-related metabolic diseases, or diseases related to muscle weakness.

Figure 1 is a diagram showing the change in body weight of experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
Figure 2 is a diagram showing the weight of liver and fat tissue of experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
FIG. 3 is a diagram showing the results of microscopic examination after H&E staining (haematoxylin and eosin stain) of liver tissue of an experimental animal fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
FIG. 4 is a diagram showing the results of microscopic examination after H&E staining (haematoxylin and eosin stain) of adipose tissue of an experimental animal fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
FIG. 5 is a diagram showing the effect of improving hyperglycemia according to fasting and feeding conditions in experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
FIG. 6 is a diagram showing changes in blood sugar levels over time in experimental animals fed a test substance including a fermented extract of Hojanggeun according to one embodiment of the present invention.
FIG. 7 is a diagram showing the concentrations of AST and ALT in the blood of experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
Figure 8 is a diagram showing the cholesterol concentration of experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.
FIG. 9 is a diagram showing the results of evaluating the ability to improve muscle function decline in experimental animals fed a test substance including a fermented extract of Hojanggeun in one embodiment of the present invention.

Hereinafter, the present invention will be described in detail with reference to the attached drawings as implementation examples of the present invention. However, the following implementation examples are presented as examples of the present invention, and if it is judged that a detailed description of a technology or configuration well known to those skilled in the art may unnecessarily obscure the gist of the present invention, the detailed description may be omitted, and the present invention is not limited thereby. The present invention is capable of various modifications and applications within the scope of the following claims and equivalents interpreted therefrom.

In addition, the terminology used in this specification is a term used to appropriately express preferred embodiments of the present invention, and this may vary depending on the intention of the user or operator, or the customs of the field to which the present invention belongs. Therefore, the definition of these terms should be determined based on the contents throughout this specification. Throughout the specification, when a part is said to “include” a certain component, this does not mean that other components are excluded, but rather that other components can be included, unless specifically stated otherwise.

Throughout this specification, '%' used to indicate the concentration of a particular substance, unless otherwise stated, is solid/solid (w/w) %, solid/liquid (w/v) %, and liquid/liquid (v/v) %.

In one aspect, the present invention provides a pharmaceutical composition for preventing or treating obesity or lipid-related metabolic diseases, comprising a fermented extract of Polygonum cuspidatum as an active ingredient.

The fermented extract of Hojanggeun according to the present invention can be obtained by extracting and separating from nature using extraction and separation methods known in the art, and the "extract" defined in the present invention is extracted from Hojanggeun using an appropriate solvent, and includes, for example, a crude extract, a polar solvent-soluble extract, or a non-polar solvent-soluble extract. Any pharmaceutically acceptable organic solvent may be used as a suitable solvent for extracting the extract from the above-mentioned Hojanggeun, and water or an organic solvent may be used, but is not limited thereto, and examples thereof include purified water, alcohols having 1 to 4 carbon atoms including methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane, and cyclohexane, and various solvents may be used alone or in mixtures. As an extraction method, any one of a hot water extraction method, a cold immersion extraction method, a reflux cooling extraction method, a solvent extraction method, a steam distillation method, an ultrasonic extraction method, an extraction method, and a pressing method may be selected and used. Additionally, the desired extract may be subjected to additional conventional fractionation processes and purified using conventional purification methods.

There is no limitation on the method for producing the fermented extract of Hojanggeun of the present invention, and any known method can be used. For example, the extract included in the composition of the present invention can be produced in a powdered state by additional processes such as reduced pressure distillation and freeze drying or spray drying of the primary extract extracted by the above-mentioned hot water extraction or solvent extraction method. In addition, the primary extract can be obtained by further purifying fractions using various chromatography such as silica gel column chromatography, thin layer chromatography, high performance liquid chromatography, etc. Therefore, in the present invention, the extract is a concept including all extracts, fractions, and purified products obtained at each stage of extraction, fractionation, or purification, and their dilutions, concentrates, or dried products.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be at least one selected from the leaves, stems, seeds, fruits and roots of Hojanggeun, preferably the stems, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be obtained by extracting Hojanggeun at 80 to 120°C, preferably 90 to 110°C, more preferably 100°C for 1 hour, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be obtained by, but is not limited to, filtering through a sieve of 80 mesh, preferably 75 mesh, and more preferably 70 mesh or less after extraction to obtain an extract.

In one embodiment of the present invention, after concentrating the extract, the extract may be diluted 8 to 12 times, preferably 9 to 11 times, more preferably 10 times, and sterilized at 110 to 130° C., preferably 115 to 125° C., more preferably 121° C. for 10 to 20 minutes, preferably 13 to 17 minutes, more preferably 15 minutes, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be a fermented extract obtained by fermenting Hojanggeun extract with a strain, but is not limited thereto.

In one embodiment of the present invention, the fermentation may be carried out in an incubator at 20 to 35°C, preferably 25 to 30°C, more preferably 28°C, for 8 to 16 days, preferably 10 to 14 days, more preferably 12 days, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of the Korean ginseng root may be a mixed culture solution of a Saccharomyces genus strain, a Lactobacillus genus strain, a Streptococcus genus strain, a Bacillus genus strain, and a Rhodopseudomonas genus strain inoculated into a Korean ginseng root extract, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be a fermented extract of Hojanggeun inoculated with a mixed culture of Saccharomyces cerevisiae , Lactobacillus acidophilus , Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus , Streptococcus thermophilus, Bacillus subtilis , and Rhodopseudomonas capsulata, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be at least one selected from the group consisting of purified water, alcohols having 1 to 4 carbon atoms including methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane, and cyclohexane, preferably, but not limited to, extracted with purified water.

In one embodiment of the present invention, the lipid-related metabolic disease may be selected from the group consisting of diabetes, hyperlipidemia, arteriosclerosis, hypertension, cardiovascular disease, and fatty liver, but is not limited thereto.

In one embodiment of the present invention, the composition may be, but is not limited to, a blood sugar reducing agent.

In one embodiment of the present invention, the composition may improve liver damage, but is not limited thereto.

In one aspect, the present invention provides a pharmaceutical composition for preventing or treating a disease related to muscle weakness, comprising a fermented extract of Polygonum cuspidatum as an active ingredient.

In one embodiment of the present invention, the fermented extract of the Korean ginseng root may be a mixed culture solution of a Saccharomyces genus strain, a Lactobacillus genus strain, a Streptococcus genus strain, a Bacillus genus strain, and a Rhodopseudomonas genus strain inoculated into a Korean ginseng root extract, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be a fermented extract of Hojanggeun inoculated with a mixed culture of Saccharomyces cerevisiae , Lactobacillus acidophilus , Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus , Streptococcus thermophilus, Bacillus subtilis , and Rhodopseudomonas capsulata, but is not limited thereto.

In one embodiment of the present invention, the fermented extract of Hojanggeun may be at least one selected from the group consisting of purified water, alcohols having 1 to 4 carbon atoms including methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane, and cyclohexane, preferably, but not limited to, extracted with purified water.

In one embodiment of the present invention, the disease related to muscle weakness may be selected from the group consisting of sarcopenia, muscular atrophy, muscle dystrophy, and cardiac atrophy, but is not limited thereto.

In one embodiment of the present invention, the sarcopenia may be, but is not limited to, obese sarcopenia.

In one embodiment of the present invention, the composition may improve, but is not limited to, muscle function decline.

The pharmaceutical composition of the present invention may additionally include an adjuvant in addition to the fermented extract of Hojanggeun. Any adjuvant known in the art may be used without limitation, but, for example, Freund's complete adjuvant or incomplete adjuvant may be further included to increase the immunity.

The pharmaceutical composition according to the present invention can be prepared in a form in which the fermented extract of Hojanggeun is mixed with a pharmaceutically acceptable carrier. Here, the pharmaceutically acceptable carrier includes carriers, excipients, and diluents commonly used in the pharmaceutical field. Pharmaceutically acceptable carriers that can be used in the pharmaceutical composition of the present invention include, but are not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil.

The pharmaceutical composition of the present invention can be formulated and used in the form of oral formulations such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, external preparations, suppositories, or sterile injectable solutions, respectively, according to conventional methods.

When formulated, it can be prepared using diluents or excipients such as fillers, bulking agents, binders, wetting agents, disintegrating agents, and surfactants that are commonly used. Solid preparations for oral administration include tablets, pills, powders, granules, and capsules, and such solid preparations can be prepared by mixing the active ingredient with at least one excipient, such as starch, calcium carbonate, sucrose, lactose, and gelatin. In addition to simple excipients, lubricants such as magnesium stearate and talc can also be used. Liquid preparations for oral administration include suspensions, oral solutions, emulsions, and syrups, and in addition to commonly used diluents such as water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances, and preservatives can be included. Preparations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories. Non-aqueous solvents and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. Suppository bases may include witepsol, Tween 61, cocoa butter, laurin butter, and glycerogelatin.

The pharmaceutical composition according to the present invention can be administered to a subject by various routes. All modes of administration are contemplated, for example, oral, intravenous, intramuscular, subcutaneous, and intraperitoneal injection.

The dosage of the pharmaceutical composition according to the present invention is selected in consideration of the age, weight, sex, physical condition, etc. of the subject. It is obvious that the concentration of the effective ingredient included in the pharmaceutical composition can be selected in various ways depending on the subject, and is preferably included in the pharmaceutical composition at a concentration of 0.01 to 5,000 ㎍/ml. If the concentration is less than 0.01 ㎍/ml, pharmaceutical activity may not be observed, and if it exceeds 5,000 ㎍/ml, toxicity to the human body may occur.

The above pharmaceutical composition can be formulated into various oral or parenteral dosage forms.

Oral dosage forms include, for example, tablets, pills, hard and soft capsules, solutions, suspensions, emulsions, syrups, granules, etc., and these dosage forms may further contain, in addition to the active ingredient, a diluent (for example, lactose, dextrose, sucrose, mannitol, sorbitol, cellulose, and/or glycine), a lubricant (for example, silica, talc, stearic acid and its magnesium or calcium salts, and/or polyethylene glycol). In addition, the tablets may contain a binder such as magnesium aluminum silicate, starch paste, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, and/or polyvinylpyrrolidine, and, if desired, a disintegrating agent or an effervescent mixture such as starch, agar, alginic acid or its sodium salt, and/or an absorbent, a coloring agent, a flavoring agent, and a sweetening agent. The above formulation can be prepared by conventional mixing, granulating or coating methods.

In addition, a representative example of a formulation for parenteral administration is an injectable preparation, and water, Ringer's solution, isotonic saline solution, or suspension can be used as a solvent for the injectable preparation. The sterile fixed oil of the injectable preparation can be used as a solvent or suspending medium, and any non-irritating fixed oil, including mono- and di-glycerides, can be used for this purpose.

Additionally, the above injectable preparation may use a fatty acid such as oleic acid.

In one aspect, the present invention provides a health functional food composition for preventing or improving obesity or lipid-related metabolic diseases, comprising a fermented extract of Polygonum cuspidatum as an effective ingredient.

In one aspect, the present invention provides a health functional food composition for improving muscle function comprising a fermented extract of Polygonum cuspidatum as an effective ingredient.

The food composition of the present invention may contain, in addition to containing the fermented extract of Hojanggeun as an effective ingredient, various flavoring agents or natural carbohydrates as additional ingredients, like a conventional food composition.

Examples of the natural carbohydrates mentioned above are monosaccharides such as glucose, fructose, etc.; disaccharides such as maltose, sucrose, etc.; and polysaccharides such as dextrin, cyclodextrin, etc., and common sugars, and sugar alcohols such as xylitol, sorbitol, erythritol, etc. As the flavoring agent mentioned above, natural flavoring agent (thaumatin), stevia extract (e.g., rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agent (saccharin, aspartame, etc.) can be advantageously used. The food composition of the present invention can be formulated in the same manner as the pharmaceutical composition and used as a functional food or added to various foods. Foods to which the composition of the present invention can be added include, for example, beverages, meat, chocolate, foods, confectionery, pizza, ramen, other noodles, gum, candy, ice cream, alcoholic beverages, vitamin complexes, and health supplements.

In addition, the food composition may contain, in addition to the effective ingredient, the fermented extract of Hojanggeun, various nutrients, vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and thickeners (cheese, chocolate, etc.), pectic acid and its salts, alginic acid and its salts, organic acids, protective colloid thickeners, pH regulators, stabilizers, preservatives, glycerin, alcohol, carbonating agents used in carbonated beverages, etc. In addition, the food composition of the present invention may contain fruit pulp for the production of natural fruit juice, fruit juice drinks, and vegetable drinks.

The functional food composition of the present invention can be manufactured and processed in the form of tablets, capsules, powder, granules, liquid, pills, etc. The term "health functional food composition" in the present invention refers to a food manufactured and processed using raw materials or ingredients having functionality useful to the human body according to Act No. 6727 on Health Functional Foods, and means being consumed for the purpose of obtaining useful effects for health purposes such as regulating nutrients for the structure and function of the human body or physiological effects. The health functional food of the present invention may include conventional food additives, and whether it is suitable as a food additive is determined by the specifications and standards for the relevant item according to the general provisions and general test methods of the Food Additives Codex approved by the Ministry of Food and Drug Safety, unless otherwise specified. Items listed in the "Food Additives Codex" include, for example, chemical synthetic substances such as ketones, glycine, calcium citrate, nicotinic acid, and cinnamic acid; natural additives such as persimmon pigment, licorice extract, crystalline cellulose, sulphate pigment, and guar gum; Examples thereof include mixed preparations such as sodium glutamate preparations, noodle additive alkaline agents, preservative preparations, and tar color preparations. For example, a health functional food in the form of a tablet can be prepared by mixing the fermented extract of the Korean ginseng of the present invention with excipients, binders, disintegrants, and other additives, granulating a mixture using a conventional method, then adding a lubricant, etc. and compressing and molding the mixture, or by directly compressing and molding the mixture. In addition, the health functional food in the form of a tablet can contain a coupling agent, etc., if necessary. Among the health functional foods in the form of a capsule, a hard capsule can be prepared by filling a mixture of the fermented extract of the Korean ginseng of the present invention with additives such as excipients into a conventional hard capsule, and a soft capsule can be prepared by filling a mixture of the fermented extract of the Korean ginseng of the present invention with additives such as excipients into a capsule base such as gelatin. The soft capsule can contain a plasticizer such as glycerin or sorbitol, a colorant, a preservative, etc., if necessary. The ring-shaped health functional food can be prepared by mixing the fermented extract of the Korean ginseng root of the present invention with excipients, binders, disintegrants, etc., and molding the mixture using a conventionally known method, and if necessary, coating can be performed with white sugar or other coating agents, or the surface can be coated with a material such as starch or talc. The granular health functional food can be manufactured into a granular form using a conventionally known method, mixing the fermented extract of the Korean ginseng root of the present invention with excipients, binders, disintegrants, etc., and can contain flavoring agents, flavoring agents, etc., if necessary.

As described above, specific embodiments of the present invention have been described in detail; however, those skilled in the art who understand the spirit of the present invention will be able to easily suggest other backward inventions or other embodiments included within the scope of the spirit of the present invention by adding, changing, deleting, etc. other components within the scope of the same spirit. Therefore, it should be understood that the embodiments described above are exemplary and not restrictive in all respects. The scope of the present invention is indicated by the scope of the claims described below rather than the detailed description described above, and all changes or modifications derived from the meaning and scope of the claims and the equivalent concept should be interpreted as being included in the scope of the present invention.

<Example 1> Preparation of fermented extract of Hojanggeun

To prepare a fermented extract of Polygonum cuspidatum, 100 g of dried Polygonum cuspidatum stems were placed in an extractor with 2 L of purified water, extracted at 100°C for 1 hour, and left to stand at room temperature for 24 hours. After that, the extract was filtered through a sieve of 70 mesh or smaller to obtain an extract, which was then transferred to a rotary vacuum evaporator and concentrated to 200 mL. This Polygonum cuspidatum extract/concentration solution was diluted 10-fold in purified water, sterilized at 121°C for 15 minutes, and then used as a medium, inoculated with 10% of the secondary culture (JM-microbe), and cultured in an incubator at 28°C for 12 days. The above JM-microbe is a mixed culture of Saccharomyces cerevisiae , Lactobacillus acidophilus , Lactobacillus bulgaricus, Lactobacillus casei , Lactobacillus plantarum , Lactobacillus rhamnosus , Streptococcus thermophilus , Bacillus subtilis , and Rhodopseudomonas capsulata. The strains were purchased from the Central Microbiological Research Institute and used. After cultivation, the culture was filtered to obtain the culture, which was concentrated to 1/10. The concentrated product was freeze-dried in a freeze dryer at -40°C or lower for 72 hours to obtain the final extract sample, which was stored at -20°C and used in the experiment.

<Example 2> Feeding of experimental animals

The experimental mice for the animal experiments of the present invention were 4-week-old male C57BL/6, and the animals were purchased from Central Laboratory Animal (south Korea). After acclimatizing the experimental mice for one week, they were fed the test materials in Table 1 below freely, and the feed was replaced with new feed twice a week on the day of feed measurement. Table 2 below shows the composition of the test materials in Table 1.

Experimental group Test substance Number of animals G1 Normal chow diet (NCD; AIN-93G) 9 G2 NCD + Fermented Hojanggeun Extract (Pc-Ex) 4% 9 G3 High fat diet (HFD; 45kcal%) 9 G4 HFD + Fermented Hojanggeun Extract (Pc-Ex) 4% 9

Nutrition G1(NCD) G2(NCD-Pc) G3(HFD) G4(HFD-Pc) Casein(g) 200 189.93 200 191.36 Corn starch(g) 397.486 368.33 72.8 47.78 Dextrose(g) 132 132 - - Maltodextrin(g) - - 100 100 Sucrose(g) 100 100 172.8 172.8 Cellulose(g) 50 50 50 50 Soybean Oil(g) 70 69.23 25 24.34 t-Butylhydroquinone(g) 0.014 0.014 - - Lard(g) - - 177.5 177.5 Mineral mix S10022G(g) 35 35 - - Mineral mix S10026B(g) - - 10 10 DiCalcium phosphate(g) - - 13 13 Calcium carbonate(g) - - 5.5 5.5 Potassium citrate(g) - - 16.5 16.5 Vitamin Mix V10037(g) 10 10 - - Vitamin Mix V10001C(g) - - 10 10 L-cystine(g) 3 3 3 3 Choline Bitartrate(g) 2.5 2.5 2 2 FD&C red dye(g) - - 0.05 0.05 Pc-Ex(g) - 40 - 34.33 Total(g) 1000 1000 858.15 858.15

<Example 3> Obtaining blood and tissue from experimental animals

3-1. Obtaining blood from laboratory animals

After the end of the dietary experiment of the experimental animals fed in Example 2 above, the blood and tissues of the experimental animals were obtained.

To obtain a large amount of mouse blood, serum samples were collected from the heart. After anesthetizing the mouse with 2% Isoflurane using an inhaler, an incision was made in the skin of the central part of the chest using scissors and forceps, and a 1 mL syringe was inserted vertically into the area between the 2nd and 3rd ribs on the left side, about 0.5 cm to the left of the sternum, to collect blood from the heart. The collected blood was transferred to a micro SST (Serum-separating tube), centrifuged at 3,000 rpm for 10 minutes, and the serum was divided into two tubes, one of 250 ㎕ in a 1.5 mL micro tube and the remainder in a total of two tubes.

3-2. Obtaining experimental animal tissue samples

Tissue samples were extracted from all lobes of the liver, weighed, the middle lobe was fixed in 10% Neutral Buffered Formalin (NBF), and the left lobe and the remaining lobes were cryopreserved. Inguinal White Adipose Tissue (ingWAT) was extracted from both the left and right sides, weighed, and the left lobe was fixed in 10% NBF and the right lobe was cryopreserved for use in the analysis. The separated tissues were preprocessed to produce paraffin blocks and H&E-stained slides.

<Experimental Example 1> Confirmation of the effect of fermented Hojanggeun extract on improving fatty liver and obesity

In order to confirm the effect of fermented extract of Hojanggeun on improving fatty liver and obesity induced by a high-fat diet, the weights of experimental animals and tissue samples were measured, and the separated liver and fat tissues were stained with H&E (Haematoxylin and Eosin stain) to measure histological morphological changes. The results of the measurements are shown in Figures 1 to 4.

As shown in Fig. 1, the change in body weight of the experimental animals after the test substance was supplied was measured, and the body weight was measured three times a week from the date of group separation and the date of administration. As a result, the body weight of the experimental animals that consumed the test substances (G2, G4) containing the fermented extract of Hojanggeun was lower than the body weight of the experimental animals that consumed the test substances (G1, G3) that did not contain the fermented extract of Hojanggeun.

As shown in Fig. 2, the weights of the liver and inguinal fat tissue (ingWAT) of the experimental animals supplied with the test substance were measured, and there was no change in the experimental animals (G1, G2) that consumed the normal diet (NCD), and in the case of the experimental animals (G3, G4) that consumed the high-fat diet (HFD), the tissue weight of the experimental animals that consumed the test substance (G4) containing the fermented extract of Hojanggeun was lower than the tissue weight of the experimental animals that consumed the test substance (G3) that did not contain the fermented extract of Hojanggeun.

Through this, it was confirmed that the fermented extract of Hojanggeun suppressed the increase in body weight, liver tissue, and inguinal fat tissue of experimental animals, indicating that the fermented extract of Hojanggeun has an effect in improving fatty liver and obesity.

As shown in Fig. 3, the histological morphological changes in the liver tissue of experimental animals supplied with the test substance were measured, and there was no change in the experimental animals (G1, G2) that consumed the normal diet (NCD), whereas in the case of experimental animals (G3, G4) that consumed the high-fat diet (HFD), the change to fatty liver was found to be reduced in the experimental animals that consumed the test substance (G4) containing the fermented extract of Hojanggeun compared to the experimental animals that consumed the test substance (G3) that did not contain the fermented extract of Hojanggeun.

As shown in Fig. 4, the histological morphological changes in the inguinal fat tissue (ingWAT) of the experimental animals supplied with the test substance were measured, and there was no change in the experimental animals (G1, G2) that consumed the normal diet (NCD), whereas in the case of the experimental animals (G3, G4) that consumed the high-fat diet (HFD), the change toward inguinal fat tissue hypertrophy was reduced in the experimental animals that consumed the test substance (G4) containing the fermented extract of Hojanggeun compared to the experimental animals that consumed the test substance (G3) that did not contain the fermented extract of Hojanggeun.

Through this, it was confirmed that the fermented extract of Hojanggeun inhibited fatty liver of the liver tissue and hypertrophy of the adipose tissue of the inguinal region in experimental animals, indicating that the fermented extract of Hojanggeun has an effect in improving fatty liver and obesity.

<Experimental Example 2> Confirmation of the effect of fermented Hojanggeun extract on improving hyperglycemia

To confirm the effect of fermented extract of Hojanggeun on improving hyperglycemia induced by a high-fat diet, blood blood sugar levels were measured, and the results are shown in Figures 5 and 6.

As shown in Fig. 5, the blood sugar changes according to the fasting and feeding conditions of the experimental animals fed the test substance including the fermented extract of Hojanggeun were measured. As a result, the blood sugar of the experimental animals fed the high-fat diet test substance (G4) including the fermented extract of Hojanggeun was lower in hyperglycemia in both the fasting and feeding conditions compared to the blood sugar of the experimental animals fed the high-fat diet test substance (G3).

Through this, the effect of fermented extract of Hojanggeun on improving hyperglycemia under fasting and feeding conditions was confirmed.

As shown in Fig. 6, changes in blood sugar levels according to test substances over time were measured. As a result, the blood sugar levels of experimental animals that consumed the high-fat diet test substance (G4) containing the fermented extract of Hojanggeun decreased more quickly than the blood sugar levels of experimental animals that consumed the high-fat diet test substance (G3).

Through this, the effect of fermented Hojanggeun extract on improving hyperglycemia over time was confirmed.

<Experimental Example 3> Confirmation of the effect of fermented Hojanggeun extract on improving liver damage

In order to confirm the effect of fermented extract of Hojanggeun on improving liver damage induced by a high-fat diet, a serum biochemical analysis of the blood obtained in Experimental Example 3-1 was performed, and the results are shown in Figure 7.

As shown in Fig. 7, the concentrations of blood AST (Aspartate Transaminase) and ALT (Alanine Transaminase) were measured, and the concentrations of blood AST and ALT in the experimental animals that consumed the high-fat diet test substance (G4) containing the fermented extract of Hojanggeun decreased compared to the concentrations of blood AST and ALT in the experimental animals that consumed the high-fat diet test substance (G3).

Through this, the liver damage improvement effect of fermented Hojanggeun extract was confirmed.

<Experimental Example 4> Confirmation of the effect of fermented extract of Hojanggeun on improving hyperlipidemia

In order to confirm the hyperlipidemia-improving effect of the fermented extract of Hojanggeun, the cholesterol level was measured through serum biochemical analysis of the blood obtained in Experimental Example 3-1, and the results are shown in Figure 8.

LDL (Low-Density Lipoprotein) cholesterol can accumulate on the walls of blood vessels and cause ischemic heart disease (acute myocardial infarction, angina pectoris) and ischemic cerebral disease (cerebral infarction), while HDL (High-Density Lipoprotein) cholesterol transports LDL cholesterol accumulated on the walls of blood vessels to the liver and then breaks it down, lowering the blood concentration.

As shown in Fig. 8, the concentration of LDL cholesterol in the blood of the experimental animals that consumed the high-fat diet test substance (G4) containing the fermented extract of Hojanggeun decreased compared to the concentration of LDL cholesterol in the blood of the experimental animals that consumed the high-fat diet test substance (G3). In addition, the concentration of total cholesterol in the experimental animals that consumed the high-fat diet test substance (G4) containing the fermented extract of Hojanggeun decreased compared to the concentration of total cholesterol in the experimental animals that consumed the high-fat diet test substance (G3).

Through this, the effect of fermented Hojanggeun extract on blood lipid metabolism was confirmed, and it was confirmed that fermented Hojanggeun extract has a hyperlipidemia-improving effect.

<Experimental Example 5> Confirmation of the effect of fermented Hojanggeun extract on improving muscle function reduction due to obesity

In order to confirm the effect of fermented extract of Hojanggeun on improving muscle function reduction caused by obesity, the mobility of experimental animals was measured using the measuring equipment in Table 3 below, and the results are shown in Figure 9.

Evaluation items Rotarod test standard 70x36x46cm program X-PAD manufacturing company UGO BASILE

The Rotarod test was evaluated 1 day before necropsy after the feeding of the test animals was completed. The mice were placed in the opposite direction of the rotating treadmill, and the speed of the treadmill was gradually increased (4–40 rpm) to measure the time until the mice lost their balance and fell to the floor. A detector was placed on the floor to measure the time to fall.

As shown in Fig. 9, the experiment was conducted three times in total, and in all three experiments, the time taken for the experimental animals that consumed the test substances (G3, G4) containing the fermented extract of Hojanggeun to fall was longer than the time taken for the experimental animals that consumed the test substances (G1, G3) not containing the fermented extract of Hojanggeun.

Through this, the effect of fermented Hojanggeun extract on improving muscle function (exercise ability) for muscle function weakening caused by obesity was confirmed.

The present invention has been described so far with reference to preferred embodiments and experimental examples. Those skilled in the art will understand that the present invention can be implemented in modified forms without departing from the essential characteristics of the present invention. Therefore, the disclosed embodiments should be considered from an illustrative rather than a restrictive perspective. The scope of the present invention is indicated by the claims, not the above description, and all differences within the scope equivalent thereto should be interpreted as being included in the present invention.

Claims (14)

A pharmaceutical composition for preventing or treating obesity or lipid-related metabolic diseases, comprising a fermented extract of Polygonum cuspidatum as an active ingredient.
In the first paragraph,
The above fermented extract of Hojanggeun is a pharmaceutical composition for preventing or treating obesity or lipid-related metabolic diseases, characterized in that the Hojanggeun extract is inoculated with a mixed culture of a Saccharomyces genus strain, a Lactobacillus genus strain, a Streptococcus genus strain, a Bacillus genus strain, and a Rhodopseudomonas genus strain.
In the first paragraph,
A pharmaceutical composition for preventing or treating obesity or lipid-related metabolic diseases, characterized in that the fermented extract of the above-mentioned Hojanggeun is extracted with at least one selected from the group consisting of purified water, alcohols having 1 to 4 carbon atoms including methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane, and cyclohexane.
In the first paragraph,
A pharmaceutical composition for preventing or treating a disease related to obesity or lipid metabolism abnormality, characterized in that the lipid-related metabolic disease is selected from the group consisting of diabetes, hyperlipidemia, arteriosclerosis, hypertension, cardiovascular disease, and fatty liver.
In the first paragraph,
The composition is a pharmaceutical composition for preventing or treating diseases related to obesity or lipid metabolism disorders, characterized in that it reduces blood sugar.
In the first paragraph,
A pharmaceutical composition for preventing or treating diseases related to obesity or lipid metabolism disorders, characterized in that the composition improves liver damage.
A pharmaceutical composition for preventing or treating diseases related to muscle weakness, comprising a fermented extract of Polygonum cuspidatum as an active ingredient.
In Article 7,
The above fermented extract of Hojanggeun is a pharmaceutical composition for preventing or treating a disease related to muscle weakness, characterized in that the Hojanggeun extract is inoculated with a mixed culture of a Saccharomyces strain, a Lactobacillus strain, a Streptococcus strain, a Bacillus strain, and a Rhodopseudomonas strain.
In Article 7,
A pharmaceutical composition for preventing or treating a disease related to muscle weakness, characterized in that the fermented extract of the above-mentioned Hojanggeun is extracted with at least one selected from the group consisting of purified water, alcohols having 1 to 4 carbon atoms including methanol, ethanol, propanol, isopropanol, butanol, acetone, ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane, and cyclohexane.
In Article 7,
A pharmaceutical composition for preventing or treating a disease related to muscle weakness, characterized in that the disease related to muscle weakness is selected from the group consisting of sarcopenia, muscular atrophy, muscle dystrophy, and cardiac atrophy.
In Article 10,
A pharmaceutical composition for the prevention or treatment of a disease related to muscle weakness, characterized in that the sarcopenia above is obesity-related sarcopenia.
In Article 7,
A pharmaceutical composition for preventing or treating a disease related to muscle weakness, characterized in that the composition improves a decrease in muscle function.
A health functional food composition for preventing or improving obesity or lipid-related metabolic diseases, comprising a fermented extract of Polygonum cuspidatum as an effective ingredient.
A health functional food composition for improving muscle function, containing a fermented extract of Polygonum cuspidatum as an effective ingredient.