KR20210120733A - Composition for preventing, ameliorating or treating type 2 diabetes mellitus or dyslipidemia comprising bangpungtongseongsan extract as effective component - Google Patents

Abstract

The present invention relates to a composition for preventing, alleviating or treating type 2 diabetes and dyslipidemia comprising an extract of Bangpungtongseong-san as an active ingredient. More particularly, the present invention relates to a pharmaceutical composition for preventing or treating type 2 diabetes and dyslipidemia and a food composition for preventing or alleviating type 2 diabetes and dyslipidemia, which comprises, as an active ingredient, an extract of Bangpungtongseong-san consisting of licorice, gypsum, Scutellaria baicalensis, Platycodon grandiflorum, Ledebouriella seseloides, Paeonia lactiflora, Cnidium officinale, Angelica gigas, Rheum rhabarbarum, Ephedra sinica, peppermint, Forsythia viridissima Lindley fruits, Glauber salt, Schizonepeta tenuifolia, Atractylodes japonica Koidz. root, Gardenia jasminoides seeds, and talcum. The extract of Bangpungtongseong-san, and more particularly, a composition containing, as an as active ingredient, an extract of Bangpungtongseong-san consisting of licorice, gypsum, Scutellaria baicalensis, Platycodon grandiflorum, Ledebouriella seseloides, Paeonia lactiflora, Cnidium officinale, Angelica gigas, Rheum rhabarbarum, Ephedra sinica, peppermint, Forsythia viridissima Lindley fruits, Glauber salt, Schizonepeta tenuifolia, Atractylodes japonica Koidz. root, Gardenia jasminoides seeds, and talcum, reduces blood sugar, glycated hemoglobin and low-density lipoprotein (LDL-C) levels when applied to an animal model of type 2 diabetes, and inhibits fat accumulation in the liver, and thus can be advantageously used for pharmaceuticals, food and the like for preventing, alleviating or treating type 2 diabetes and dyslipidemia.

Description

A composition for preventing, ameliorating or treating type 2 diabetes mellitus or dyslipidemia comprising bangpungtongseongsan extract as effective component }

The present invention relates to a composition for preventing, improving or treating type 2 diabetes mellitus and dyslipidemia, comprising an extract of windbreaktongseong acid as an active ingredient. More specifically, a formulation comprising, as an active ingredient, an extract made from licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, Yeongyo, mangcho, hyeonggae, baekchul, gardenia and talc. It relates to a pharmaceutical composition for preventing or treating type 2 diabetes and dyslipidemia, and a food composition for preventing or improving type 2 diabetes and dyslipidemia.

Diabetes mellitus is a condition in which insulin, a hormone that regulates glucose, secreted by beta cells of the pancreas, does not produce the required amount in the body or insulin does not work properly on cells, so that glucose in the blood is not used as energy and accumulates in the blood. It is a symptom in which sugar is detected in the urine. In general, diabetes is divided into insulin-dependent diabetes mellitus (type 1 diabetes) and non-insulin-dependent diabetes mellitus (type 2 diabetes) depending on whether or not insulin is essential for treatment. Type 2 diabetes is non-insulin-dependent diabetes mellitus, which occurs due to insufficient insulin action or relatively insufficient insulin due to insulin resistance. It is also called adult-type diabetes mellitus.

The American Diabetes Association (ADA) recommends initiating treatment or administering a new hypoglycemic agent if the HbA1c is 6.5% or higher in type 2 diabetes patients, and adjusts HbA1c as close to the non-diabetic range as possible or at least less than 7%. It was recommended as a treatment goal to reduce

According to the UKPDS, a large-scale clinical study conducted in the UK, myocardial infarction, stroke or angina pectoris occurred in about 22% of patients 10 years after diagnosis of type 2 diabetes, and about 30% died from macrovascular complications. was investigated. As a result of analyzing the risk factors for the occurrence of cardiovascular disease in this study, the most correlated was LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol), HbA1c, and systolic Blood pressure and smoking were found to be related in that order.

Currently known treatment for type 2 diabetes can be divided into four major categories: sulfonylureas-based drugs that induce insulin secretion, and acetabular drugs that move sugar to muscle cells and inhibit sugar synthesis in the liver. Biguanides, α-glucosidase inhibitors that inhibit the enzyme that makes glucose in the small intestine, thias that activate PPAR-γ (Peroxisome proliferator-activated receptors-γ) involved in adipocyte differentiation There are zolidione (TZD, thiazolidinedione) drugs. However, these oral hypoglycemic agents have many side effects such as hypoglycemia induction (sulfonylurea drugs), nephrotoxicity (biguanide drugs), lactic acidosis (biguanide drugs), diarrhea and upset stomach (alpha-glucosidase inhibitors). accompanying

Dyslipidemia refers to a state in which total cholesterol, triglyceride, and LDL-cholesterol concentrations in the blood are high or HDL-cholesterol concentrations are low. In general, LDL-cholesterol is known as bad cholesterol because it has the property of being deposited on the blood vessel wall, whereas HDL-cholesterol is called good cholesterol because it inhibits the deposition of fat components on the blood vessel wall. Therefore, when lipid components such as LDL-cholesterol or triglycerides in the blood increase, blood flow is not smooth, lipid components are attached to the arterial wall, causing a chronic inflammatory reaction, and arteriosclerosis, in which blood vessels become hardened as the inner wall of the arteries narrows. (arteriosclerosis) is induced. In the long term, the resulting thrombus blocks the coronary arteries or cerebral blood vessels, causing myocardial infarction, stroke, or cerebral infarction. Currently, as a treatment for hypercholesterolemia, 'statin' drugs with inhibitory activity of HMG-CoA reductase, which plays an important role in the synthesis of cholesterol in the liver, are used. It is known to have side effects such as toxicity. In addition, when LDL-cholesterol is high or there is hypertriglyceridemia, fibric acid derivatives are generally administered, but digestive disorders are often accompanied, and side effects such as myopathy may occur.

On the other hand, Bangpungtongseongsan (防防通性散) is a herbal prescription for decoction of licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, peppermint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc. As such, it is first recorded in 'Seonmyeongbang' between the Geumdae and Ryuhagan. Punggongseongsan is an obese type of paralyzed person with high blood pressure and arteriosclerosis, but has a strong heart, but food poisoning, which is an intestinal self-poisoning substance, and water poisoning, a renal self-poisoning substance. used when

As a technique for using windbreaktongseongsan, Korea Patent No. 10-1199961 discloses a composition for preventing or treating osteoporosis comprising windbreaktongseongsan or a lactic acid bacterium fermented product thereof, and Korean Patent No. 10-1013940 from herbal medicine of windbreaktongseongsan. Although a method of extracting an aromatic substance has been disclosed, there is no disclosure of a composition for preventing, improving or treating type 2 diabetes or dyslipidemia comprising the extract of the present invention as an active ingredient.

Korean Patent No. 10-1199961 Korean Patent No. 10-1013940

It is an object of the present invention to provide a pharmaceutical composition for the prevention or treatment of type 2 diabetes or dyslipidemia comprising an extract of Bangpungtongseongsan as an active ingredient.

Another object of the present invention is to provide a food composition for the prevention or improvement of type 2 diabetes or dyslipidemia comprising an extract of Pungbangtongseongsan as an active ingredient.

In order to achieve the above object, the present invention is effective as an extract of licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc. It provides a pharmaceutical composition for preventing or treating type 2 diabetes or dyslipidemia comprising as a component.

In addition, the present invention is a formulation comprising, as an active ingredient, an extract of licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc. It provides a food composition for preventing or improving type 2 diabetes or dyslipidemia.

The windbreak-tongseongsan extract of the present invention, more specifically, the windbreaktongseongsan water extract consisting of licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, Yeongyo, mangcho, hyeonggae, baekchul, gardenia and talc When applied to an animal model of type 2 diabetes, the composition containing It can be usefully used in medicines and foods for prevention, improvement or treatment.

1 is a graph showing the measurement of the fasting blood glucose level using a road and a blood glucose meter, which is shown by analyzing the effect of an extract of the present invention on fasting blood sugar in an animal model of type 2 diabetes.
Figure 2 is a road showing the effect of an extract of the present invention on glycated hemoglobin (HbA1c) in a type 2 diabetic animal model. A graph showing the blood glycated hemoglobin level measured using the HbA1c assay kit. It is also
Figure 3 is a road showing the analysis of the effect of the water extract of the present invention on low-density lipoprotein (LDL-C) in an animal model of type 2 diabetes, the LDL-C concentration measured using the LDL-C assay kit It is a diagram showing a graph.
4 is a micrograph of the degree of fat accumulation in the liver by H&E staining, which is a road showing the effect of the extract of the present invention on fatty liver in an animal model of type 2 diabetes.

As a result of the present inventors' diligent efforts to find a natural product with few side effects while exhibiting the prevention, improvement or treatment effect of type 2 diabetes and dyslipidemia, when the water extract of windbreak-resistant product is applied to an animal model of type 2 diabetes, blood sugar, glycated hemoglobin and low density By reducing the lipoprotein (LDL-C) level and confirming the improvement or therapeutic effect of type 2 diabetes and dyslipidemia, such as inhibiting the accumulation of fat in the liver, the present invention was completed.

In one embodiment, the present invention is an extract of licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc as an active ingredient. It provides a pharmaceutical composition for preventing or treating type 2 diabetes or dyslipidemia, including.

As used herein, the term "Bangpungtongseongsan" refers to licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, Yeongyo, mangcho, hyeonggae, baekchul, gardenia and talc. It is a herbal prescription to drink as a decoction. It is used when there is high blood pressure and arteriosclerosis of the obese person with paralytic constitution, but has a strong pulse, but has a fatty heart and food poisoning, which is an intestinal self-poisoning substance, and water poisoning, a renal self-poisoning substance. is known to be

The term "diabetes (diabetes mellitus)" refers to a disease in which the body does not produce or properly use insulin, and the blood sugar level remains high above a certain level, and is classified into type 1 and type 2 diabetes. . A high blood sugar level means that the glycated hemoglobin is 6.5% or more or the fasting blood sugar is 126 mg/dL or more.

The term "glycated hemoglobin (HbA1c)" refers to a combination of a portion of hemoglobin and blood glucose, and the higher the blood glucose level, the more glycated hemoglobin is produced. That is, if the amount of glycated hemoglobin is high, it means that the blood sugar is high.

The term “type 2 diabetes mellitus” refers to non-insulin-dependent diabetes mellitus, which is caused by insufficient insulin secretion after a meal or insulin resistance.

The term "insulin tolerance" is used interchangeably with insulin resistance, and the insulin resistance refers to the inability of cells to effectively burn glucose because the insulin's ability to lower blood sugar is poor. When insulin resistance is high, the body makes too much insulin, which can lead to high blood pressure or dyslipidemia, as well as heart disease and diabetes. In particular, in type 2 diabetes mellitus, an increase in insulin in muscle and adipose tissue is not noticed, and the action of insulin does not occur.

The term "dyslipidemia" is a concept including hyperlipidemia, high LDL-cholesterol (LDL-C)emia, hypertriglyceridemia, low HDL-cholesterol (HDL-C) It refers to an abnormal lipid state caused by problems such as lipoprotein metabolism in addition to blood. People with chronic dyslipidemia are more likely to develop fatty liver, and if the inflammation caused by fatty liver worsens, not only liver-specific complications such as cirrhosis and liver cancer, but also chronic diseases such as cardiovascular disease and diabetes can lead to death.

The term "extract" in the present invention refers to a liquid component obtained by immersing a target substance in various solvents and then extracting it for a certain period of time at room temperature or in a heated state, and a solid obtained by removing the solvent from the liquid component. results, etc. In addition, in addition to the result, it can be comprehensively interpreted as including all of the diluent of the result, the concentrate thereof, the prepared product thereof, the purified product, and the like.

In the present invention, the extract is licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, mint, yeonkyo, mangcho, hyunggae, baekchul, gardenia and talc means an extract made of windbreaktongseongsan.

The windbreaktongseongsan extract is not limited thereto, but licorice 10 to 13% by weight, gypsum 5 to 8% by weight, gold 5 to 8% by weight, gilgyeong 5 to 8% by weight, windbreak 3 to 6% by weight, peony 3 to 6 wt%, cheongung 3 to 6 wt%, angelica 3 to 6 wt%, rhubarb 3 to 6 wt%, ephedra 3 to 6 wt%, mint 3 to 6 wt%, annual gyoza 3 to 6 wt%, horseradish 3 to 6 wt% %, Hyeonggae 2 to 5% by weight, Baekchul 2 to 5% by weight, gardenia 2 to 5% by weight, and may be a mixed extract of 15 to 18% by weight of talc.

The windbreaktongseongsan extract is preferably 11 to 12.5% by weight of licorice, 6 to 7.5% by weight of gypsum, 6 to 7.5% by weight of gold, 6 to 7.5% by weight of gilgyeong, 4 to 5% by weight of windbreak, 4 to 5% by weight of peony, Cheongung 4-5 wt%, Angelica 4-5 wt%, Rhubarb 4-5 wt%, Ephedra 4-5 wt%, Mint 4-5 wt%, Yeongyo 4-5 wt%, Mangochoe 4-5 wt%, Hyeonggae It may be a mixed extract of 3 to 4% by weight, 3 to 4% by weight of baekchul, 3 to 4% by weight of gardenia and 16 to 17.5% by weight of talc.

The windbreaktongseongsan extract is more preferably licorice 11.9% by weight, gypsum 6.9% by weight, gold 6.9% by weight, gilgyeong 6.9% by weight, windproof 4.5% by weight, peony 4.5% by weight, cheongung 4.5% by weight, Angelica 4.5% by weight, rhubarb It may be a mixed extract of 4.5 wt%, ephedra 4.5 wt%, mint 4.5 wt%, annual bridge 4.5 wt%, horseradish 4.5 wt%, hyeonggae 3.5 wt%, baekchul 3.5 wt%, gardenia 3.5 wt% and talc 16.8 wt%.

The windbreaktongseongsan extract can be obtained by extraction with water or various organic solvents. At this time, the organic solvent used is not particularly limited as long as an extract having a preventive or therapeutic effect for type 2 diabetes or dyslipidemia can be obtained, but preferably water, a polar solvent or a non-polar solvent. , more preferably water, a lower alcohol having 1 to 4 carbon atoms (methanol, ethanol, propanol or butanol, etc.), a mixed solvent thereof, and the like, and most preferably water.

In addition, the method for obtaining the extract is also not particularly limited thereto, as long as an extract having a preventive or therapeutic effect for type 2 diabetes or dyslipidemia can be obtained, but preferably the licorice, gypsum, gold, and gilgyeong. , windbreak, peony, cheongung, angelica rhubarb, rhubarb, ephedra, mint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc, immersed in the solvent, that is, water, 90 to 110 ℃, preferably 105 A method of heat extraction in which extraction is performed by heating to ℃ can be used. On the other hand, the extraction time is preferably 3 to 12 hours, more preferably 4 to 8 hours, and most preferably 5 hours, but is not limited thereto. In addition, the number of extractions is preferably 1 to 5 times, more preferably repeating extraction 1 to 3 times, and most preferably 2 times, but is not limited thereto.

The obtained hot water extract of Bangpungtongseongsan is not limited thereto, but may be concentrated under reduced pressure using a vacuum concentrator or a vacuum rotary evaporator. In addition, after concentration under reduced pressure, but not limited thereto, it may be dried through freeze drying, reduced pressure drying, vacuum drying, boiling drying, or spray drying.

The term "prevention" in the present invention refers to any action that suppresses or delays the onset of type 2 diabetes or dyslipidemia by administration of the pharmaceutical composition according to the present invention, and "treatment" refers to any action of the pharmaceutical composition. It refers to any action in which the symptoms of the suspected and onset subject of type 2 diabetes or dyslipidemia are improved or beneficially changed by administration.

In the present invention, the prevention or treatment of type 2 diabetes or dyslipidemia reduces blood sugar, glycated hemoglobin and low-density lipoprotein (LDL-C) levels in an animal model of type 2 diabetes by the extract, and significantly reduces fat accumulation in the liver It may be achieved by exhibiting a reducing effect.

As described above, the antiperspirant acid extract provided by the present invention, and more specifically, the windproof acidic acid water extract, reduces blood sugar, glycosylated hemoglobin and low-density lipoprotein (LDL-C) levels in an animal model of type 2 diabetes, and reduces fat accumulation in the liver. can hinder

In one embodiment of the present invention, in order to confirm the improvement or therapeutic effect of the water extract of windbreak-related products for type 2 diabetes and dyslipidemia, fasting blood glucose, glycated hemoglobin (HbA1c) in an animal model of type 2 diabetes mellitus ), the level of low density lipoprotein-cholesterol (LDL-C) in the blood, and the degree of fat accumulation in the liver through H&E staining. ), and it was found that the fat accumulation in the liver was significantly reduced ( FIGS. 1 to 4 ).

In addition to the active ingredient of the composition of the present invention, Pungbangseongsan extract, other useful treatment drugs for type 2 diabetes or dyslipidemia, such as hypoglycemic agents, statins, etc. can be formulated and administered in the form of a mixed formulation.

The composition of the present invention may be used alone or in combination with methods such as insulin treatment and exercise therapy for the prevention or treatment of type 2 diabetes or dyslipidemia.

The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient and diluent. As used herein, the term “pharmaceutically acceptable” means exhibiting non-toxic properties to cells or humans exposed to the composition. The carrier may be used without limitation as long as it is known in the art, such as buffers, preservatives, soothing agents, solubilizers, isotonic agents, stabilizers, bases, excipients, lubricants, and the like.

In addition, the pharmaceutical composition of the present invention is formulated in the form of oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, external preparations, suppositories, and sterile injection solutions according to conventional methods, respectively. can be used Carriers, excipients and diluents that may be included in the composition of the present invention include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. In the case of formulation, it is prepared using diluents or excipients, such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and these solid preparations include at least one excipient in the windproof acid extract, for example, starch, calcium carbonate, sucrose (sucrose) or lactose (lactose), gelatin, etc. are mixed and prepared. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid preparations for oral use include suspensions, solutions, emulsions, syrups, etc., which are commonly used simple diluents such as water and liquid paraffin, as well as various excipients, such as wetting agents, sweeteners, fragrances, and preservatives. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Non-aqueous solvents and suspending agents include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like can be used.

On the other hand, the pharmaceutical composition of the present invention is administered in a pharmaceutically effective amount. As used herein, the term “administration” refers to introducing a predetermined substance into an individual by an appropriate method, and the administration route of the composition may be administered through any general route as long as it can reach a target tissue. Intraperitoneal administration, intravenous administration, intramuscular administration, subcutaneous administration, intradermal administration, oral administration, topical administration, intranasal administration, intrapulmonary administration, may be administered intrarectally, but is not limited thereto.

The term “individual” refers to all animals including humans, rats, mice, livestock, and the like. Preferably, it may be a mammal including a human.

The term "pharmaceutically effective amount" refers to an amount sufficient to treat a disease with a reasonable benefit/risk ratio applicable to medical treatment and not to cause side effects, and the effective dose level is determined by the sex, age, and weight of the patient. , health condition, disease type, severity, drug activity, drug sensitivity, administration method, administration time, administration route, and excretion rate, treatment period, factors including drugs used in combination or concomitantly, and other medical fields. It can be readily determined by one of ordinary skill in the art according to known factors. However, for a desirable effect, for adults, the composition of the present invention may contain 1 to 4000 mg/kg (body weight) as a single dose. For administration, the recommended dosage may be administered once a day, or divided into several administrations.

On the other hand, the extract of Pungongtongseong acid in the composition may be included in an amount of 100 to 2000 mg/kg, 150 to 1500 mg/kg, or 170 to 1700 mg/kg, based on oral administration to a mouse.

The above dosage does not limit the scope of the present invention in any way.

As another aspect, the present invention is a licorice, gypsum, gold, gilgyeong, windbreak, peony, cheongung, angelica, rhubarb, ephedra, peppermint, yeonkyo, mangcho, hyeonggae, baekchul, gardenia and talc containing a windbreaktongseongsan extract consisting of an active ingredient. It provides a food composition for preventing or improving type 2 diabetes or dyslipidemia, comprising a.

The windbreaktongseongsan extract is not limited thereto, but licorice 10 to 13% by weight, gypsum 5 to 8% by weight, gold 5 to 8% by weight, gilgyeong 5 to 8% by weight, windbreak 3 to 6% by weight, peony 3 to 6 wt%, cheongung 3 to 6 wt%, angelica 3 to 6 wt%, rhubarb 3 to 6 wt%, ephedra 3 to 6 wt%, mint 3 to 6 wt%, annual gyoza 3 to 6 wt%, horseradish 3 to 6 wt% %, Hyeonggae 2 to 5% by weight, Baekchul 2 to 5% by weight, gardenia 2 to 5% by weight and 15 to 18% by weight of talc may be a mixed extract.

The windbreaktongseongsan extract is preferably 11 to 12.5% by weight of licorice, 6 to 7.5% by weight of gypsum, 6 to 7.5% by weight of gold, 6 to 7.5% by weight of gilgyeong, 4 to 5% by weight of windbreak, 4 to 5% by weight of peony, Cheongung 4-5 wt%, Angelica 4-5 wt%, Rhubarb 4-5 wt%, Ephedra 4-5 wt%, Mint 4-5 wt%, Yeongyo 4-5 wt%, Mangochoe 4-5 wt%, Hyeonggae It may be a mixed extract of 3 to 4% by weight, 3 to 4% by weight of baekchul, 3 to 4% by weight of gardenia and 16 to 17.5% by weight of talc.

The windbreaktongseongsan extract is more preferably licorice 11.9% by weight, gypsum 6.9% by weight, gold 6.9% by weight, gilgyeong 6.9% by weight, windproof 4.5% by weight, peony 4.5% by weight, cheongung 4.5% by weight, Angelica 4.5% by weight, rhubarb It may be a mixed extract of 4.5 wt%, ephedra 4.5 wt%, mint 4.5 wt%, annual bridge 4.5 wt%, horseradish 4.5 wt%, hyeonggae 3.5 wt%, baekchul 3.5 wt%, gardenia 3.5 wt% and talc 16.8 wt%.

The improvement effect of type 2 diabetes or dyslipidemia by the windproof acid extract is as described above, and when the composition of the present invention is used as a food additive, the windproof acid extract is added as it is or together with other foods or food ingredients. It can be used, and it can be used suitably according to a conventional method. The mixing amount of the active ingredient may be appropriately determined depending on the purpose of use (prophylactic, health or therapeutic treatment), and may further include a food pharmaceutically acceptable food supplement additive. Since the composition of the present invention uses an extract derived from a natural product and a fraction thereof as an active ingredient, there is no problem in terms of stability, so there is no major limitation on the mixing amount.

The food composition of the present invention may include all foods in a conventional sense, and may be used interchangeably with terms known in the art, such as functional food and health functional food.

The term "functional food" as used in the present invention means a food manufactured and processed using raw materials or ingredients useful for the human body according to Health Functional Food Act No. 6727, and "functionality" refers to the structure of the human body. And it refers to ingestion for the purpose of obtaining useful effects for health purposes such as regulating nutrients for function or physiological action.

In addition, the term "health functional food" as used herein refers to a food manufactured and processed using a specific ingredient as a raw material for the purpose of health supplementation or by extracting, concentrating, refining, or mixing a specific ingredient contained in the food raw material, It refers to food designed and processed to sufficiently exert biological control functions such as biological defense, regulation of biological rhythm, prevention and recovery of disease, etc., by the above ingredients, and the composition for health food is used for prevention of diseases and prevention of diseases. It can perform functions related to recovery, etc.

There is no limitation on the kind of food in which the composition of the present invention can be used. In addition, the composition comprising the extract of Pungongtongseongsan as an active ingredient of the present invention can be prepared by mixing known additives with other suitable auxiliary ingredients that may be contained in food according to the selection of those skilled in the art. Examples of foods that can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages and There are vitamin complexes and the like, and it can be prepared by adding the extract according to the present invention and its fractions as main components to juice, tea, jelly, juice, and the like.

In addition, foods that can be applied to the present invention include, for example, special nutritional foods (eg, formula milk, infant food, etc.), processed meat products, fish meat products, tofu, jelly, noodles (eg, ramen, noodles, etc.), health supplements , Seasoned foods (eg soy sauce, soybean paste, red pepper paste, mixed soy sauce, etc.), sauces, sweets (eg snacks), dairy products (eg fermented milk, cheese, etc.), other processed foods, kimchi, pickled foods (various kimchi, pickles, etc.) ), beverages (eg, fruit, vegetable beverages, soy milk, fermented beverages, etc.), and natural seasonings (eg, ramen soup, etc.).

When the health functional food composition of the present invention is used in the form of a beverage, it may contain various sweeteners, flavoring agents, or natural carbohydrates as additional ingredients, as in a conventional beverage. In addition to the above, the health functional food composition of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, coloring agents, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin , alcohol, a carbonation agent used in carbonated beverages, and the like. In addition, it may contain the pulp for the production of natural fruit juice, fruit juice beverage and vegetable beverage.

Since the antiperspirant acid extract of the present invention, and more specifically, the windbreak fruit water extract is made from natural medicinal plants, even when used as a pharmaceutical composition or a food composition, it may have fewer side effects compared to general synthetic compounds, so it can be safely included and usefully used have.

Hereinafter, the configuration and effects of the present invention will be described in more detail through examples. These examples are only for illustrating the present invention, and the scope of the present invention is not limited by these examples.

Example 1: Preparation of Experimental Materials and Experimental Methods

Example 1-1: Preparation of Bangpungtongseongsan extract

The medicinal crops used in the present invention were purchased from Gwangmyeongdang Pharmaceutical Wholesale (onherb) certified by the Ministry of Food and Drug Safety's good manufacturing practice (GMP) on the basis of the Korean Pharmacopoeia. After washing all medicinal crops individually with the content (wt%) shown in Table 1 below, add water 10 times the weight of the sample, and use the reflux cooling extraction method to extract hot water at 105° C. for 5 hours and repeat twice. did. The extracted sample was concentrated at 55°C using a large rotary vacuum concentrator (Eyela, NVC-2200, ToKyo, Japan), and then filtered using a filter paper (filter paper; Thermo, Waltham, MA, USA). The filtered Pungongtongseongsan extract (BPS) was dried using a freeze dryer.

Herbal medicine ingredients and content ratio (wt%) constituting the extract of Pungbongtongseongsan extract herbal medicine ingredients scientific name Content (g) weight(%) licorice Glycyrrhiza uralensis Fischer 4.8 11.9 gypsum Gypsum Fibrosum 2.8 6.9 Gold Scutellaria baicalensis Georgi 2.8 6.9 Gilkyung Platycodon grandiflorum A. De Candolle 2.8 6.9 windbreak Saposhnikovia divaricata Schischkin 1.8 4.5 peony Paeonia lactiflora Pallas 1.8 4.5 celestial palace Cnidium officinale Makino, Ligusticum chuanxiong Hort. 1.8 4.5 donkey Angelica gigas Nakai 1.8 4.5 rhubarb Rheum palmatum Linne 1.8 4.5 ephedra Ephedra sinica Stepf 1.8 4.5 mint Mentha arvensis Linne var. piperascens Malinvaud ex Holmes 1.8 4.5 annual school Forsythia viridissima Lindley 1.8 4.5 sulphate of soda Erigeron canadensis 1.8 4.5 Hyunggae Schizonepeta tenuifolia Briquet 1.4 3.5 Baekchul Atractylodes japonica Koidzumi 1.4 3.5 gardenia Gardenia jasminoides Ellis 1.4 3.5 talc Talcum 6.8 16.8 Sum 40.4 100

151 g of the test material was obtained, confirming a yield of about 31.1%, and the dried powder was dissolved in sterile tertiary distilled water (sterile distilled water for perfusion, Daehan Pharmaceutical Industry) and used.

Example 1-2: Experimental animals and treatment

Male 7-week-old BKS.Cg-m+/Leprdb/+/J and BKS.Cg-m+/Leprdb/db/J mice were purchased from Orient Bio (Jeongeup, Korea), and were divided into 6 groups of 5 mice in each group. Divided into 2 and tested.

group medication number of individuals NOR (normal control) unprocessed 5 CON (Negative Control) sterile tertiary distilled water 5 POS (positive control) 10 mg/kg sitagliptin and
20mg/kg metformin administration 5 BPL 170mg/kg Punggongseongsan water extract administration 5 BPM Administration of 750mg/kg Punggongseongsan water extract 5 BPH Administration of 1700 mg/kg Punggongseongsan water extract 5

The composition of Bangpungtongseongsan used in the animal experiment was referenced in the Dictionary of Oriental Medicine (Kim, 2001), and the ADI (Acceptable Daily Intake) calculation method was used to calculate the allowable daily intake at the concentration of 1 tablet based on an adult body weight of 70 kg. applied to experiments (Nestmann ER. et.al. , Regulatory Toxicology and Pharmacology , 47(3):232-239, 2007).

The test period was 13 weeks, and the positive control group was combined with 10 mg/kg sitagliptin and 20 mg/kg metformin, referring to the results of other studies related to type 2 diabetes. During oral administration (Hayes J. et al ., Drug Design, Development and Therapy , 10:2263-2270, 2016). The group administered with the water extract of Pungbangtongseongsan was orally administered at a concentration of 170 mg/kg, 750 mg/kg, or 1700 mg/kg, respectively. After the end of the experiment, all experimental animals were euthanized by hyperventilation of _{CO 2} according to the experimental animal management standards of the Institutional Animal Care and Use Committee (IACUC).

Example 1-3: Final fasting blood glucose measurement

The final fasting blood glucose was measured on the day of the end of the test, and after fasting for at least 8 hours, it was measured in the tail vein using an Accu-Check guide blood glucose meter (Roche Diagnostics Korea, Seoul, Korea).

Example 1-4: Final glycated hemoglobin measurement

Glycated hemoglobin was measured using HbA1c assay kits (Mouse hemoglobin A1c assay kits; 80310, Crystal Chem, Schaumburg, IL, USA) from whole blood obtained from the tail vein.

Example 1-5: Low-density lipoprotein analysis

The collected whole blood was centrifuged at 3,000 rpm for 10 minutes, and serum was collected and used. Low-density lipoprotein (LDL) was analyzed using a mouse LDL-Cholesterol assay kit (Mouse LDL-Cholesterol assay kit; 79980, Crystal Chem, Schaumburg, IL, USA).

Example 1-6: hematoxylin and eosin staining

The extracted liver was fixed in 10% neutral buffered formalin (NBF) and embedded in paraffin through tissue processing. After embedding, sections were prepared with a thickness of 5㎛, and hematoxylin (Dako Mayer' Hematoxylin; Agilent, Santa clara, California, USA) and eosin Y (Eosin Y; Sigma, St. Louis, Missouri, USA) were used. After staining using a light microscope, it was observed.

Example 1-7: Statistical processing

Statistical processing was performed using SPSS (Chicago, IL, USA), and the mean value and standard deviation were calculated. After one-way ANOVA was performed to verify the mean difference between the experimental groups, statistical differences were evaluated at the significance level p < 0.05 using the Tukey-Kramer Multiple Comparison Test. verified.

Example 2: Analysis of the effect of wind-fungal acid on fasting blood sugar in an animal model of type 2 diabetes

The db/db mouse is a strain with a mutation in a gene that produces a receptor for leptin, a hormone involved in diet and energy homeostasis, and is commonly used in the study of various metabolic diseases related to diabetes (Bruke SJ. et. al ., J Diabetes Res). ., 2017: 8,503,754, 2017). In an animal model of type 2 diabetes, an experiment was conducted to find out what effect the antiperspirant water extract (BPS) had on blood sugar and glycated hemoglobin. As a result of measuring fasting blood glucose, the fasting blood glucose of the normal control group was 109.8±10.8 mg/dL and that of the negative control group was 372.8±44.3 mg/dL. The positive control group was reduced to 185.4±35.3 mg/dL compared to the negative control group, and the group administered with 170 mg/kg, 850 mg/kg or 1700 mg/kg of windbreak-tongseong acid water extract was 214.0±27.1 mg/dL and 282.4±11.2 mg/dL, respectively. dL and 385.0±21.1 mg/dL. Interestingly, the effect of reducing fasting blood sugar was high in the 170 mg/kg group (BPL) administered with windbreak-resistant acid, and the higher the concentration, the less the effect of reducing blood sugar was observed ( FIG. 1 ). The low concentration of ephedrine contained in ephedra has been reported to lower fasting blood sugar and postprandial blood sugar in the obese state (Song MK. et. al ., Exp Ther Med. , 3(4):707-712, 2012) ), it is reported that it rather raises blood sugar in the clinical results of healthy elderly without disease, so the results seem to work differently depending on obesity status and age.

Example 3: Analysis of the effect of windbreak-resistant acid on glycated hemoglobin in an animal model of type 2 diabetes

The glycated hemoglobin is a blood sugar-reflecting index that can determine at what level blood sugar has been maintained for a long period of time. Accordingly, as a result of measuring the glycated hemoglobin in the blood, the glycated hemoglobin in the normal control group was 5.2±0.3%, and that of the negative control group was 12.2±0.6%. The positive control group was reduced to 7.8±0.6% compared to the negative control group, and the groups administered with 170 mg/kg, 850 mg/kg, or 1700 mg/kg of windbreak-resistant acid water extract were 8.5±0.5%, 10.4±0.4%, and 12.5±0.7%, respectively. As shown in the fasting blood glucose analysis, it was found that the effect was good at low concentrations (FIG. 2).

Example 4: Analysis of the Effect of Punggongseong Acid on Low Density Lipoprotein in an Animal Model of Type 2 Diabetes

It is known that improving low density lipoprotein (LDL-C) is the most important for the treatment of hyperlipidemia accompanying type 2 diabetes. This is because cardiovascular disease is classified as a very high risk group (Razi F. et. al ., J Diabetes Metab Disord. , 16:43, 2017). Accordingly, as a result of measuring to find out what effect on LDL-C when Punggongseong acid was administered, the LDL-C concentration of the normal control group was 16.5±5.1 mg/dL, and the negative control group was 61.0±6.2 mg/dL. appear. The positive control group was reduced to 23.2±3.4 mg/dL compared to the negative control group, and the groups administered with 170 mg/kg, 850 mg/kg or 1700 mg/kg of windbreak-tongseong acid water extract were 36.0±3.6 mg/dL and 26.3±6.9 mg/dL, respectively. dL and 13.7±4.0 mg/dL ( FIG. 3 ).

Example 5: Analysis of the effect of Punggongseong acid on fatty liver in an animal model of type 2 diabetes

It is known that 50 to 70% of patients with type 2 diabetes have fatty liver. Therefore, when administered with Pungtongseong acid, the results were measured to find out what effect the fat accumulated on the liver. In comparison, fat droplets were significantly increased, and the positive control group significantly decreased compared to the negative control group. It was found that 170 mg/kg, 850 mg/kg or 1700 mg/kg of Punggongseongsan water extract administration group inhibited liver fat accumulation in a concentration-dependent manner (FIG. 4).

Summarizing the above series of results, the levels of blood sugar (FIG. 1), glycated hemoglobin (FIG. 2), and low-density lipoprotein (LDL-C) (FIG. 3) are reduced when the water extract from windbreak is applied to an animal model of type 2 diabetes. And by confirming that the fat accumulation in the liver (FIG. 4) was significantly reduced, it was found that the Punggongseongsan extract can be usefully used to prevent or treat type 2 diabetes and dyslipidemia.

Preparation Example 1: Preparation of a pharmaceutical composition for preventing or treating type 2 diabetes mellitus and dyslipidemia containing an extract of windbreak and dyslipidemia as an active ingredient

Preparation Example 1-1: Preparation of powder

A powder was prepared by mixing 1 g of lactose with 2 g of the water extract of Pungongtongseong acid of the present invention, and filling the airtight cloth.

Preparation Example 1-2: Preparation of tablets

A tablet was prepared by mixing 100 mg of the water extract of the present invention, 100 mg of cornstarch, 100 mg of lactose, and 2 mg of magnesium stearate, followed by tableting according to a conventional tablet manufacturing method.

Preparation Example 1-3: Preparation of capsules

After mixing 100 mg of the water extract of the present invention, 100 mg of cornstarch, 100 mg of lactose, and 2 mg of magnesium stearate, the capsules were prepared by filling in gelatin capsules according to a conventional capsule preparation method.

Preparation Example 1-4: Preparation of a ring

After mixing 1 g of the water extract of the present invention, 1.5 g of lactose, 1 g of glycerin and 0.5 g of xylitol, it was prepared so as to be 4 g per ring according to a conventional method.

Preparation Example 1-5: Preparation of granules

After mixing 150 mg of the water extract of windbreak-tongseong acid of the present invention, 50 mg of soybean extract, 200 mg of glucose and 600 mg of starch, 100 mg of 30% ethanol was added and dried at 60 ° C. to form granules, and then filled in a bag .

Preparation Example 2: Preparation of a food for preventing or improving type 2 diabetes and dyslipidemia containing an extract of windbreak and dyslipidemia as an active ingredient

Preparation Example 2-1: Preparation of wheat flour food

0.5 to 5.0 parts by weight of the water extract of the present invention was added to wheat flour, and bread, cakes, cookies, crackers and noodles were prepared using this mixture.

Preparation Example 2-2: Preparation of soups and gravies

By adding 0.1 to 5.0 parts by weight of the water extract of Bangpungtongseongsan of the present invention to soup and broth, processed meat products for health promotion, soups and broths of noodles were prepared.

Preparation Example 2-3: Preparation of ground beef

Ground beef for health promotion was prepared by adding 10 parts by weight of the water extract of the present invention to ground beef.

Preparation Example 2-4: Preparation of dairy products

5 to 10 parts by weight of the water extract of the present invention was added to milk, and various dairy products such as butter and ice cream were prepared using the milk.

Preparation Example 2-5: Preparation of wire

Brown rice, barley, glutinous rice, and barley radish were pregelatinized by a known method and dried, and then roasted and prepared as a powder having a particle size of 60 mesh with a grinder.

Black soybeans, black sesame, and perilla were also steamed and dried by a known method, and then roasted and prepared as a powder having a particle size of 60 mesh with a grinder.

The dried product obtained by concentrating the water extract of Pungongtongseongsan of the present invention in a vacuum concentrator under reduced pressure, spraying and drying with a hot air dryer was pulverized to a particle size of 60 mesh with a pulverizer to obtain a dry powder.

It was prepared by mixing the grains, seeds and water extract of the present invention in the following ratios:

Cereals (30 parts by weight of brown rice, 15 parts by weight of barley radish, 20 parts by weight of barley), seeds (7 parts by weight of perilla, 8 parts by weight of black beans, 7 parts by weight of black sesame), water extract of the present invention (3 parts by weight) , Reishi (0.5 parts by weight), Rehmannia (0.5 parts by weight).

Preparation Example 2-6: Preparation of health drinks

Instant sterilization is achieved by homogeneously mixing 5 g of the water extract of the present invention with auxiliary materials such as high fructose (0.5%), oligosaccharide (2%), sugar (2%), salt (0.5%), and water (75%). Then, it was prepared by packaging it in a small packaging container such as a glass bottle or a plastic bottle.

Preparation Example 2-7: Preparation of vegetable juice

Vegetable juice was prepared by adding 5 g of the water extract of Pungongtongseong acid of the present invention to 1,000 ml of tomato or carrot juice.

Preparation Example 2-8: Preparation of fruit juice

Fruit juice was prepared by adding 1 g of the water extract of Pungongtongseong acid of the present invention to 1,000 ml of apple or grape juice.

Claims (6)

Type 2 diabetes or A pharmaceutical composition for preventing or treating dyslipidemia.
The method according to claim 1, wherein the windbreaktongseongsan extract is not limited thereto, but 10 to 13% by weight of licorice, 5 to 8% by weight of gypsum, 5 to 8% by weight of gold, 5 to 8% by weight of gilgyeong, 3 to 6% by weight of windbreak. %, peony 3 to 6% by weight, cheongung 3 to 6% by weight, angelica 3 to 6% by weight, rhubarb 3 to 6% by weight, ephedra 3 to 6% by weight, mint 3 to 6% by weight, annual school 3 to 6% by weight , 3 to 6% by weight of sagebrush, 2 to 5% by weight of hyeonggae, 2 to 5% by weight of baekchul, 2 to 5% by weight of gardenia, and 15 to 18% by weight of talc, which is a mixed extract, prevention of type 2 diabetes or dyslipidemia or a therapeutic pharmaceutical composition.
The pharmaceutical composition for preventing or treating type 2 diabetes or dyslipidemia according to claim 1, wherein the extraction solvent of the windbreaktongseong acid extract is water, C ₁ ~ C _{4 lower alcohol or a mixture thereof.}
The pharmaceutical for preventing or treating type 2 diabetes or dyslipidemia according to claim 1, wherein the composition reduces blood sugar, glycated hemoglobin and low-density lipoprotein (LDL-C) levels, and inhibits fat accumulation in the liver. composition.
Type 2 diabetes or A food composition for preventing or improving dyslipidemia.
According to claim 5, wherein the extract is not limited thereto, licorice 10 to 13% by weight, gypsum 5 to 8% by weight, gold 5 to 8% by weight, gilgyeong 5 to 8% by weight, windbreak 3 to 6% by weight %, peony 3 to 6% by weight, cheongung 3 to 6% by weight, angelica 3 to 6% by weight, rhubarb 3 to 6% by weight, ephedra 3 to 6% by weight, mint 3 to 6% by weight, annual school 3 to 6% by weight , 3 to 6% by weight of sagebrush, 2 to 5% by weight of hyeonggae, 2 to 5% by weight of baekchul, 2 to 5% by weight of gardenia, and 15 to 18% by weight of talc, which is a mixed extract, prevention of type 2 diabetes or dyslipidemia or a food composition for improvement.

Images