KR20210157521A - Composition for preventing or treating type 2 diabetes mellitus comprising bo extract as effective component - Google Patents

Abstract

The present invention relates to a composition for preventing, alleviating, or treating type 2 diabetes, containing an extract of Bojungikki-tang (type of herbal medicine) as an active component. More specifically, the present invention relates to a pharmaceutical composition for preventing or treating type 2 diabetes and a food composition for preventing or alleviating type 2 diabetes, containing, as an active component, an extract of Bojungikki-tang which is composed of Astragalus membranaceus, Panax ginseng, Atractylodes lancea, Glycyrrhiza uralensis, Angelica gigas, Citrus unshiu peel, Actaea racemosa, Bupleurum falcatum, Zingiber officinale, and jujube. The composition containing the extract of Bojungikki-tang according to the present invention increases fasting blood glucose and insulin consumption when applied to an animal model of type 2 diabetes, thereby being able to be usefully used in medicines and foods for the prevention, alleviation or treatment of type 2 diabetes.

Description

A composition for preventing or treating type 2 diabetes, comprising an extract of Bojungikgi-tang as an active ingredient {Composition for preventing or treating type 2 diabetes mellitus comprising bo extract as effective component}

The present invention relates to a composition for preventing, improving, or treating type 2 diabetes, comprising an extract of Bojungikgi-tang as an active ingredient. More specifically, a pharmaceutical composition for the prevention or treatment of type 2 diabetes, comprising, as an active ingredient, a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube, and It relates to a food composition for preventing or improving type 2 diabetes.

Diabetes mellitus is when the body does not produce the required amount of insulin, a hormone that regulates glucose, secreted by beta cells of the pancreas, or the insulin does not work properly on the cells. 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 a relatively insufficient insulin action due to insulin resistance. It is also referred to as adult-type diabetes mellitus.

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

According to the UKPDS, a large-scale clinical study conducted in the UK, myocardial infarction, stroke, and 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 highly correlated were low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), 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, an α-glucosidase inhibitor that inhibits the enzyme that makes glucose in the small intestine, and a thia that activates 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 (sulfonylurea drug), nephrotoxicity (biguanide drug), lactic acidosis (biguanide drug), diarrhea and upset stomach (alpha-glucosidase inhibitor). accompanying

On the other hand, Bojungikgi-tang (補中益气湯) is described as follows as three different ingredients in the Dictionary of Oriental Medicine.

), 일련의 출혈 등에 쓸 수 있다. 위의 약을 1첩으로 하여 물에 달여서 먹거나 가루 내어 꿀로 환제를 만들어 한 번에 8~12g씩 하루 3번 먹기도 한다.① Hwangki (黃耆) 6g, ginseng (人參), baekchul (白朮), licorice (甘草) 4g each, Angelica root, dermis 2g each, horseback riding (升麻), Shiho (柴胡) 1.2 each It is composed of g (Donguibogam (東醫寶鑑)) and the whole body is tired from giheo fever (气虛發熱), a slight fever every afternoon, a cold sweat, a headache, loss of appetite, severe cold, or中气下陷) with the above-mentioned symptoms, the lower abdomen is dull and often watery stools, prolapse, uterine prolapse, etc. is used. Chronic wasting disease including tuberculosis disease, visceral sewage including gastritis, summer riding, chronic colitis, umbilical cord (

), a series of bleeding, etc. can be used. You can take the above medicine by decocting it in water or making powdered pills with honey, 8~12g at a time, 3 times a day.

② Ginseng, Saengjihwang (生地黃), Hwanggi (黃耆), Angelica (當歸), Cheongung (Stream), Shiho (柴胡), Dermal (陳皮), Ganghwa (羌活), Baekchul (白朮), Windbreak Consists of 2.8g each, finestain (細辛), licorice (甘草) 2g each, ginger (生薑) 3 cloves, and contrasting (大棗) 2 pieces (Donguibogam), qi blood血) is not enough, I have a cold, a fever, a headache, a cold sweat, it's cold, I'm very tired and I don't have energy. Take 1 tablet of the above medicine, decocted in water. It is also called Dosibojungikgitang (陶氏補中益气湯).

③ Ginseng (人參), Hwanggi (黃耆) 12g each, Baekchul (白朮), Angelica (當歸), ginseng (陳皮), licorice (甘草) 4g each, Perilla leaves, Kwakhyang 2g each (Sasang Medical Clinic), as a prescription for soeumin (少陰人), in the early days of mangyang for sun-disease, and the body is very tired and low in energy, but the body is weak. It is used for fever, chest tightness, and cold sweats while doing this. Take 1 tablet of the above medicine, decocted in water.

In addition, Korean Patent No. 10-1332829 discloses a composition for treating lung cancer containing Bojungikgi-tang, and Korean Patent Registration No. 10-1740021 discloses a composition for enhancing the therapeutic effect of thyroid dysfunction including Bojungikgi-tang. and Korean Patent No. 10-1866553 discloses a composition for treating dementia comprising Bojungikgi-tang, and Korean Patent Publication No. 10-2004-0103984 discloses a composition containing an extract of Bojungikgi-tang or an extract of Gagam-Bojungikgi-tang. Disclosed is a pharmaceutical composition for the treatment of inflammation. However, there is no disclosure of a composition for preventing, improving or treating type 2 diabetes comprising the Bojungikgi-tang extract of the present invention as an active ingredient.

Korean Patent Registration No. 10-1332829 (2013.11.27. Announcement) Korean Patent Registration No. 10-1740021 (2017.05.25. Announcement) Korean Patent Registration No. 10-1866553 (2018.07.17. Announcement) Korean Patent Publication No. 10-2004-0103984 (published on Dec. 10, 2004)

One object of the present invention is to provide a pharmaceutical composition for the prevention or treatment of type 2 diabetes comprising the extract of Bojungikgi-tang 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 comprising the extract of Bojungikgi-tang as an active ingredient.

In order to achieve the above object, the present invention is a pharmaceutical for the prevention or treatment of type 2 diabetes comprising a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube as an active ingredient. Provides an enemy composition.

In addition, the present invention provides a food composition for preventing or improving type 2 diabetes, comprising, as an active ingredient, a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube.

The composition comprising the Bojungikgi-tang extract of the present invention, more specifically, the Bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube, as an active ingredient, can be used in an animal model of type 2 diabetes. Since it reduces blood sugar and increases insulin consumption when applied, it can be usefully used in medicines and foods for the prevention, improvement or treatment of type 2 diabetes.

1 is a road showing the effect of the Bojungikgi-tang water extract of the present invention on fasting blood sugar in an animal model of type 2 diabetes, and is a graph showing the measurement of fasting blood glucose levels using a blood glucose meter.
2 is a road showing the effect of the Bojungikgi-tang water extract of the present invention on the reduction of blood insulin in an animal model of type 2 diabetes, which is a graph showing the insulin level measured at a wavelength of 450 nm.

As a result of the present inventors' diligent efforts to find natural products with fewer side effects while exhibiting the prevention, improvement or treatment effect of type 2 diabetes, the Bojungikgi-tang extract reduces blood sugar and increases insulin consumption when applied to an animal model of type 2 diabetes. By confirming the improvement or therapeutic effect of type 2 diabetes, the present invention was completed.

As an aspect, the present invention provides a pharmaceutical composition for preventing or treating type 2 diabetes, comprising, as an active ingredient, a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube. A composition is provided.

As used herein, the term "Bojungikgi-tang (防防通性散)" is an oriental medicine prescription for decoction of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube.

The term "diabetes (diabetes mellitus)" is 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 divided 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 function of insulin 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 "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 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 dilutions of the results, their concentrates, their preparations, and their purified products.

In the present invention, the extract means a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube.

The bojungikgi-tang extract is not limited thereto, but 22 to 26% by weight of astragalus, 15 to 18% by weight of ginseng, 15 to 18% by weight of baekchul, 15 to 18% by weight of licorice, 7 to 9% by weight of angelicasis, 7 to 9% by weight of dermis It may be a mixed extract of 4 to 5.5% by weight of horseback riding, 4 to 5.5% by weight of Shiho, 2 to 4 pages of health, and 1 to 3 jujubes.

The bojungikgi-tang extract is preferably 23 to 26% by weight of Astragalus, 15.5 to 17% by weight of ginseng, 15.5 to 17% by weight of baekchul, 15.5 to 17% by weight of licorice, 7.5 to 8.5% by weight of Angelica Root, 7.5 to 8.5% by weight of dermis, It may be a mixed extract of 4.5 to 5.5% by weight of horseback riding, 4.5 to 5.5% by weight of Shiho, 2 to 4 pages of health, and 1 to 3 jujubes.

The Bojungikgi-tang extract is more preferably 24 to 25% by weight of astragalus, 16 to 17% by weight of ginseng, 16 to 17% by weight of baekchul, 16 to 17% by weight of licorice, 8 to 8.5% by weight of angelicasis, 8 to 8.5% by weight of dermis It may be a mixed extract of 3% by weight, 4.6 to 5.2% by weight of horseback riding, 4.6 to 5.2% by weight of Shiho, 3 pyeonyi and 2 jujubes.

The bojungikgi-tang extract is more preferably astragalus 24.6% by weight, ginseng 16.4% by weight, baekchul 16.4% by weight, licorice 16.4% by weight, Angelica 8.2% by weight, dermis 8.2% by weight, horseback riding 4.9% by weight, Shiho 4.9% by weight It may be a mixed extract of 3 p. , health and 2 jujubes.

The Bojungikgi-tang extract can be obtained by extraction with water or various organic solvents. In this case, the organic solvent used is not particularly limited as long as an extract having a preventive or therapeutic effect for type 2 diabetes can be obtained, but preferably water, a polar solvent or a non-polar solvent, and more preferably may be water, a lower alcohol having 1 to 4 carbon atoms (methanol, ethanol, propanol or butanol, etc.), a mixed solvent thereof, etc., 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 can be obtained, but preferably the astragalus, ginseng, baekchul, licorice, angelica, dermis , horseback riding, shiho, health and jujube, immersed in the solvent, that is, water, and heated to 90 to 110 ℃, preferably 105 ℃ heat extraction method can be used for extraction. 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 Bojungikgi-tang hot water extract 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 means any action that inhibits or delays the onset of type 2 diabetes by administration of the pharmaceutical composition according to the present invention, and "treatment" refers to any action that is prevented by administration of the pharmaceutical composition. It refers to any action that improves or beneficially changes the symptoms of an individual suspected of or having type 2 diabetes.

In the present invention, the prevention or treatment of type 2 diabetes may be achieved by showing the effect of reducing blood sugar and increasing insulin consumption in an animal model of type 2 diabetes by the extract.

As described above, the Bojungikgi-tang extract provided in the present invention can prevent and treat type 2 diabetes mellitus by reducing blood sugar and reducing insulin.

In one embodiment of the present invention, in order to confirm the improvement or therapeutic effect of the Bojungikgi-tang water extract for type 2 diabetes, the results of analyzing fasting blood glucose and blood insulin concentration in an animal model of type 2 diabetes, It was found that the Bojungikgi-tang water extract significantly reduced blood insulin concentration by reducing blood sugar ( FIGS. 1 and 2 ).

In addition to the Bojungikgi-tang extract, which is the active ingredient of the composition of the present invention, it can be formulated and administered in the form of a complex formulation mixed with other useful therapeutic drugs for type 2 diabetes, for example, a hypoglycemic agent.

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.

The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient and diluent. As used herein, the term “pharmaceutically acceptable” refers to 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, pain relievers, 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 and 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 commonly used diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

Solid preparations for oral administration include tablets, pills, powders, granules, capsules, etc., and such solid preparations include at least one excipient in the Bojungikgi-tang extract, for example, starch, calcium carbonate, sucrose It is prepared by mixing sucrose or lactose, gelatin, etc. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid formulations for oral use include various excipients such as wetting agents, sweeteners, fragrances, preservatives, etc. in addition to simple diluents such as water and liquid paraffin, which are commonly used for suspensions, solutions, emulsions, syrups, etc. . Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried 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. As a 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" means introducing a predetermined substance to 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, mice, mice, and livestock. Preferably, it may be a mammal including a human.

The term "pharmaceutically effective amount" means an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and not to cause side effects, and the effective dose level is determined by the patient's gender, age, and weight. , health condition, type of disease, severity, activity of drug, sensitivity to drug, administration method, time of administration, route of administration, and rate of excretion, duration of treatment, 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 may be administered in several divided doses.

Meanwhile, the Bojungikgi-tang extract in the composition may be included in an amount of 100 to 2000 mg/kg, 120 to 1500 mg/kg, or 150 to 1500 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 food for preventing or improving type 2 diabetes, comprising a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube as an active ingredient A composition is provided.

The bojungikgi-tang extract is not limited thereto, but 22 to 26% by weight of astragalus, 15 to 18% by weight of ginseng, 15 to 18% by weight of baekchul, 15 to 18% by weight of licorice, 7 to 9% by weight of angelicasis, 7 to 9% by weight of dermis It may be a mixed extract of 4 to 5.5% by weight of horseback riding, 4 to 5.5% by weight of Shiho, 2 to 4 pages of health, and 1 to 3 jujubes.

The bojungikgi-tang extract is preferably 23 to 26% by weight of Astragalus, 15.5 to 17% by weight of ginseng, 15.5 to 17% by weight of baekchul, 15.5 to 17% by weight of licorice, 7.5 to 8.5% by weight of Angelica Root, 7.5 to 8.5% by weight of dermis, It may be a mixed extract of 4.5 to 5.5% by weight of horseback riding, 4.5 to 5.5% by weight of Shiho, 2 to 4 pages of health, and 1 to 3 jujubes.

The Bojungikgi-tang extract is more preferably 24 to 25% by weight of astragalus, 16 to 17% by weight of ginseng, 16 to 17% by weight of baekchul, 16 to 17% by weight of licorice, 8 to 8.5% by weight of angelicasis, 8 to 8.5% by weight of dermis It may be a mixed extract of 3% by weight, 4.6 to 5.2% by weight of horseback riding, 4.6 to 5.2% by weight of Shiho, 3 pyeonyi and 2 jujubes.

The bojungikgi-tang extract is more preferably astragalus 24.6% by weight, ginseng 16.4% by weight, baekchul 16.4% by weight, licorice 16.4% by weight, Angelica 8.2% by weight, dermis 8.2% by weight, horseback riding 4.9% by weight, Shiho 4.9% by weight It may be a mixed extract of 3 p. , health and 2 jujubes.

The improvement effect of type 2 diabetes by the Bojungikgi-tang extract is as described above, and when the composition of the present invention is used as a food additive, the Bojungikgi-tang extract can be added as it is or used with other foods or food ingredients, It can be used suitably according to a conventional method. The mixing amount of the active ingredient may be suitably determined according to the purpose of use (prevention, 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 great 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.

As used herein, the term "functional food" refers to 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 means 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 in the present invention refers to a food manufactured and processed using a specific ingredient as a raw material or by extracting, concentrating, refining, or mixing a specific ingredient contained in the food raw material for the purpose of health supplementation, It refers to a 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 Bojungikgi-tang extract of the present invention as an active ingredient can be prepared by mixing other suitable auxiliary ingredients that may be contained in food and known additives 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 as a main component 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 sweetening agents, 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 Bojungikgi-tang extract of the present invention 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 used.

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 Bojungikgi-tang 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 at the content (wt%) shown in Table 1 below, water 10 times the sample weight (513.1 g) was added, and then using the reflux cooling extraction method at 105 ° C. for 5 hours, twice. Repeatedly, hot water extraction was performed. 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 Bojungikgi-tang extract (BPS) was dried using a freeze dryer.

Components and content ratio (wt%) constituting the Bojungikgi-tang extract ingredient scientific name content (g) weight Astragalus Astragalus membranaceus Bunge 5.62 24.6 Ginseng Panax ginseng C. A. Meyer 3.75 16.4 Baekchul Atractylodis Rhizoma Alba 3.75 16.4 licorice Glycyrrhizae Radix et Rhizoma 3.75 16.4 donkey Angelicae Gigantis Radix 1.875 8,2 dermis Fraxini Cortex 1.875 8.2 riding Cimicifugae Rhizoma 1.12 4.9 Shiho Bupleuri Radix 1.12 4.9 health Zingiber officinale Roscoe page 3 jujube Zizyphi Fructus 2 Sum 22.86 100

163 g of the test material was obtained, confirming a yield of about 31.8%, and the dried powder was dissolved in 0.5% carboxymethyl cellulose (CMC, Sigma, St. Louis, MO, USA) 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 BJL 150mg/kg Bojungikgi-tang water extract administration 5 BJM 500mg/kg Bojungikgi-tang water extract administration 5 BJH 1000mg/kg Bojungikgi-tang water extract administration 5

The composition of Bojungikgi-tang 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 for the concentration of one 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 combined 10 mg/kg sitagliptin and 20 mg/kg metformin with reference to other research results related to type 2 diabetes. During oral administration (Hayes J. et al ., Drug Design, Development and Therapy , 10:2263-2270, 2016). The Bojungikgi-tang water extract administration group was orally administered at a concentration of 150 mg/kg, 500 mg/kg, or 1000 mg/kg, respectively. After the end of the experiment, all experimental animals were euthanized by hyperventilation of _{CO 2} according to the laboratory animal management standards of the Institutional Animal Care and Use Committee (IACUC).

Example 1-3: Final fasting blood glucose measurement

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: blood insulin measurement

On the day of the end of the test, whole blood was collected from the blood of the test animals, and 5 μl of blood was analyzed using an Ultra sensitive mouse insulin ELISA kit (Crystal Chem, IL, USA). After diluting 5 μl of blood 20-fold with diluent buffer, aliquot it on a plate, incubate at 4° C. for 2 hours, wash with wash buffer, and then add 100 μl conjugate solution. After addition, incubated at room temperature for 30 minutes. After washing again with a wash buffer, 100 μl of a substrate solution was added and incubated for 10 to 40 minutes. Thereafter, 100 μl of a stop solution was added, and the insulin (insulin) value was measured and calculated at a wavelength of 450 nm using a ^{microplate reader Infinite ® 200 PRO (TECAN, Mannedorf, Switzerland).}

Example 1-5: 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 Bojungikgi-tang on fasting blood sugar in an animal model of type 2 diabetes

The db/db mouse is a strain with a mutation in the 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). ., 1017: 8,503,754, 2017). An experiment was conducted to find out how the Bojungikgi-tang water extract affects blood sugar and glycated hemoglobin in an animal model of type 2 diabetes.

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 185.4±35.3 mg/dL, which was decreased compared to the negative control group, and the 100 mg/kg, 500 mg/kg, or 1000 mg/kg Bojungikgi-tang water extract group received 242.3±34.0 mg/dL and 327.0±55.9 mg/dL, respectively. dL and 386.4±30.1 mg/dL. Interestingly, the 100 mg/kg Bojungikgi-tang administration group (BPL) had a high effect on reducing fasting blood sugar ( FIG. 1 ).

Example 3: Analysis of the effect of Bojungikgi-tang on insulin consumption in an animal model of type 2 diabetes

Insulin is one of the hormones that play an important role in our body's metabolic system. It is secreted from beta cells in the islets of Langerhans in the pancreas and plays a role in maintaining a constant blood glucose level, which is the level of glucose in the blood. Improving insulin resistance is very important for treatment (Wilcox G. Insulin and insulin resistance. Clin Biochem Rev. 26:19-39. 2015.).

Accordingly, as a result of analyzing the effect of Bojungikgi-tang on insulin consumption, the blood insulin level of the normal control group (NOR) was 0.9±0.1 ng/ml, the negative control group (CON) was 9.8±1.7 ng/ml, and the positive control group (POS) was It was measured to be 1.9±0.2 ng/ml, and the 100 mg/kg, 500 mg/kg, or 1000 mg/kg Bojungikgi-tang treatment group had 3.8±0.8 ng/ml, 2.8±0.7 ng/ml and 1.7±04 ng/ml, respectively. ml and was found to increase insulin consumption in a concentration-dependent manner (FIG. 2).

Preparation Example 1: Preparation of a pharmaceutical composition for preventing or treating type 2 diabetes containing the extract of Bojungikgi-tang as an active ingredient

Preparation Example 1-1: Preparation of powder

1 g of lactose was mixed with 2 g of the Bojungikgi-tang water extract of the present invention, and the powder was prepared by filling in an airtight bag.

Preparation Example 1-2: Preparation of tablets

100 mg of the Bojungikgi-tang water extract of the present invention, 100 mg of corn starch, 100 mg of lactose, and 2 mg of magnesium stearate were mixed, and then tableted according to a conventional tablet manufacturing method to prepare tablets.

Preparation Example 1-3: Preparation of capsules

100 mg of Bojungikgi-tang water extract of the present invention, 100 mg of corn starch, 100 mg of lactose and 2 mg of magnesium stearate were mixed, and then filled into gelatin capsules according to a conventional capsule preparation method to prepare capsules.

Preparation Example 1-4: Preparation of a ring

After mixing 1 g of the Bojungikgi-tang 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 Bojungikgi-tang water extract 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. .

Preparation Example 2: Preparation of food for preventing or improving type 2 diabetes containing Bojungikgi-tang extract 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 Bojungikgi-tang of the present invention was added to wheat flour, and breads, 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 Bojungikgi-tang of the present invention to soup and broth, processed meat products for health promotion, soup and broth of noodles were prepared.

Preparation 2-3: Preparation of ground beef

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

Preparation Example 2-4: Preparation of dairy products

5-10 parts by weight of the water extract of Bojungikgi-tang 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 into powder having a particle size of 60 mesh with a grinder.

The water extract of Bojungikgi-tang of the present invention was concentrated under reduced pressure in a vacuum concentrator, and the dried product obtained by drying with a spray and 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 proportions:

Grains (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), Bojungikgi-tang 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 Bojungikgi-tang 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%). After this, it was manufactured 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 Bojungikgi-tang water extract 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 Bojungikgi-tang water extract of the present invention to 1,000 ml of apple or grape juice.

Claims (5)

A pharmaceutical composition for the prevention or treatment of type 2 diabetes, comprising, as an active ingredient, a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube.
The method of claim 1, wherein the bojungikgi-tang extract is 22 to 26% by weight of astragalus, 15 to 18% by weight of ginseng, 15 to 18% by weight of baekchul, 15 to 18% by weight of licorice, 7 to 9% by weight of angelicasis, 7 to 9% by weight of dermis Weight%, horseback riding 4 to 5.5% by weight, Shiho 4 to 5.5% by weight, health 2 to 4, and a mixed extract of 1 to 3 jujubes, a pharmaceutical composition for the prevention or treatment of type 2 diabetes.
The pharmaceutical composition for preventing or treating type 2 diabetes according to claim 1, wherein the extraction solvent of the Bojungikgi-tang extract is water, C ₁ to C _{4 lower alcohol or a mixture thereof.}
A food composition for preventing or improving type 2 diabetes, comprising, as an active ingredient, a bojungikgi-tang extract consisting of astragalus, ginseng, baekchul, licorice, angelica, dermis, horseback riding, shiho, health and jujube.
According to claim 4, wherein the bojungikgi-tang extract is 22 to 26% by weight of astragalus, 15 to 18% by weight of ginseng, 15 to 18% by weight of baekchul, 15 to 18% by weight of licorice, 7 to 9% by weight of angelicasis, 7 to 9% by weight of dermis Weight%, horseback riding 4 to 5.5% by weight, Shiho 4 to 5.5% by weight, health 2 to 4 pages, and a mixed extract of 1 to 3 jujubes, a food composition for preventing or improving type 2 diabetes.

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