KR20070118754A - Pharmaceutical composition for treating or preventing diabetes mellitus containing an extract of chinese herb as an effective ingredient - Google Patents

Abstract

A pharmaceutical composition comprising the extracts of Chinese herbs is provided to inhibit activity of alpha-glucosidase and suppress rapid increase of glucose concentration in blood after digestion by reducing digestion speed of carbohydrates, thereby treating or preventing diabetes mellitus. A pharmaceutical composition for treating or preventing diabetes mellitus comprises 0.1-50 wt.% of the extracts of Chinese herbs including Panax ginseng C. A. Meyer, Astragalus membranaceus, Glycyrrhiza uralensis, Lycium chinense, Morus, Pueraria thunbergiana, Prunella vulgaris var. lilacina, Acanthopanax sessiliflorus, Schizandra chinensis, Scutellaria baicalensis, Dioscorea batatas, Polygonatum odoratum var. pluriflorum, Paeonia lactiflora and Rehmannia glutinosa in a mixing ratio of 1 : 0.7 : 0.4 : 0.7 : 0.4 : 0.7 : 1.1 : 0.9 : 0.4 : 0.4 : 0.7 : 0.7 : 0.9 : 0.9(w/w), which are prepared by extracting Chinese herbs with water, C1-4 lower alcohol or a mixed solvent thereof.

Description

Pharmaceutical Composition for Treating or Preventing Diabetes Mellitus Containing an Extract of Chinese Herb as an Effective Ingredient}

Figure 1 shows the effect of inhibiting the activity of α-glucosidase (α-glucosidase).

Field of invention

The present invention relates to a pharmaceutical composition for the prevention or treatment of diabetes mellitus containing the herbal medicine extract having a hypoglycemic effect as an active ingredient.

Background

Diabetes is a metabolic disorder caused by dysfunction and lack of action of insulin secreted by pancreatic cells, which leads to overproduction of glucose, breakdown of body fat, and waste of protein, and abnormal glands of glucagon, causing metabolic confusion. (Abrams, JJ, Ginsberg, H. et . Al ., Diabetes , 31: 903, 1982).

Diabetes mellitus is divided into two types. Type 1 diabetes mellitus is caused by a deficiency of insulin, a glucose-regulating hormone in the blood, mainly in young people in their teens to 20s. It is also called juvenile diabetes because it develops. Type 2 diabetes mellitus mainly occurs after the age of 40, and occupies most of the diabetic patients in Korea. Unlike type 1, it is called adult-type diabetes and the cause of the disease is not clear yet, but it is known to be caused by genetic factors and environmental factors. As a etiology of type 2 diabetes, both pancreatic beta cells secrete insulin secretion and target cells have a deficiency of insulin action (insulin resistance).

The most important goal in the treatment of diabetes is to control blood glucose levels as close to normal as possible, and postprandial blood sugar control, together with fasting blood glucose, is important in improving diabetes and preventing or treating complications (Jenkins, DJ, Wolever, A. et. . al., Starchy foods and glycemic index , Diabetes Care , 11: 149, 1988; Menendez, CM, Stoecker, BJ, The role of diet in improving glycemic control in Nutrition and Diabetes , Javanovic, L., Peterson, CM (ed.), Alan, R. Liss Inc., 15, 1995), treatments include pharmacotherapy, diet and exercise.

Oral hypoglycemic agents currently used in patients with type 1 and type 2 diabetes include α-glucosidase inhibitors, sulfonylureas, and biguanides. Glucosidase inhibitors have a therapeutic effect on diabetes by delaying the digestion and absorption of carbohydrates in the ingested diet, thereby reducing the elevation of postprandial blood sugar and blood insulin. α-glucosidase inhibitors promote the secretion of glucagon-like peptide-1 in the small intestine that promotes insulin secretion and inhibits glucagon secretion without causing hyperinsulinemia or hypoglycemia Has advantages (Mooradian, AD, Thurman, JE, Drugs , 57:19, 1999; Baron, AD Diabetes Research and Clinical Practice , 40: S 54, 1998).

The current clinical use includes acarbose, avoglibose and miglitol, but long-term use of α-glycosidase inhibitors may cause abdominal bloating, vomiting and diarrhea in some patients. May have adverse effects and may limit their use (Hanefeld, M., Journal of Diabetes and its Complications, 12: 228, 1998).

Although there are various studies on the blood glucose lowering effect of medicinal herbs, studies on disease prevention of medicinal medicinal compositions prepared by mixing specific medicinal herbs are inadequate. Star liquor composition and its manufacturing method are all.

The main herbal medicine constituting the herbal composition is white ginseng ( Panax ginseng C. A. Meyer ), Astragalus membranaceus ), licorice ( Glycyrrhiza uralensis ), wolfberry ( Lycium) chinense ), Morus leaves, Pueraria thunbergiana ), and second ( Prunella vulgaris var . lilacina ), Acanthopanax sessiliflorus ), Schizandra chinensis ), golden ( Scutellaria baicalensis ), medicinal herb ( Dioscorea batatas ), citrine ( Polygonatum odoratum var . pluriflorum ), peony ( Paeonia lactiflora ), dough ( Rehmannia glutinosa ).

White ginseng ( Panax ginseng C. A. Meyer ) is a grade of red ginseng belonging to ginseng. The root is medicinal and its shape is called human ginseng. Ginseng is said to be the old medicine of Buddha, Jangsaeng, Ikgi, and Shinshin. The root of ginseng cultivated in Korea is Geun-geun root (肥大 根), which consists of one root and two to five roots (支 根) and is pale yellow white. The number of roots is different depending on soil quality, transplantation method, fertilizer, water, etc., but it is a strong branching plant, and the shape of root varies according to age. Six years old is used as a raw material for red ginseng, a Korean monopoly. The six-year-old fuselage has a length of 7-10 cm, a diameter of 2.5 cm, and a root length of 34 cm and a weight of 80 g. Ginseng shoots come out from the underground stem every year, and in the fall, stems and leaves die, leaving traces of dead stems.

Astragalus membranaceus ( Astragalus membranaceus ) is a legume, diuretic, small-species, such as the effects of physical weakness, fatigue boredom, deprivation of blood, prolapse, uterine deprivation, visceral sewage, cold sweat, peripheral nerves. It is cultivated as an herb, and it is harvested in the fall of Korea to remove outcrops and roots, and dried in sunlight.

Licorice ( Glycyrrhiza The pod of uralensis ) is thin and long like a line, curved like a bow, and contains 6 to 8 seeds. The roots are sweet and are used as sweeteners and herbal medicines. Siberian acid ( G. glabra var . glandulifera ) and G. glabra ( G. glabra ), and similar species is G. pallidiflora . It has little sweetness and is not used for medicinal purpose unlike licorice. It has little hair, fruit is oval, sharp in tip, and is distributed in northeastern China, Siberia and Mongolia.

Wolfberry ( Lycium chinense ) is the fruit of Goji berry, which contains protein, fat, sugar, calcium, phosphorus, iron, betaine, rutin, and vitamins (A, B1, B2, C). In oriental medicine, it is used as a tonic and antipyretic. It is known to improve eyesight, prevent adult diseases such as diabetes, improve the function of lungs and kidneys, and mix it with perilla oil, and then apply it to the hair to prevent the formation of gray hair and to burn. After the surgery or in the recovery period, put powder or juice, boil porridge, and soak alcohol. It is known as a tonic to weaken the constitution. A little alcohol is mixed with sugar to make jam.

Morus is a generic name for deciduous trees or shrubs belonging to the dicotyledonous nettle mulberry and mulberry, and its origin is temperate and subtropical, and there are about 30 species in the world. In Korea, M. bombycis and Baeksang (白)桑: M. alba), street (魯桑: 3 and paper cultivation of M. lhou), among Whites is grown most. Leaves are used to raise silkworms, and the fruit is called audi, which is dipped or eaten raw. Root bark is used for antipyretic, Jinhae, diuretic and sowing in oriental medicine, and wood is used for furniture.

Brown root ( Pueraria thunbergiana ) is peeled and finely chopped root roots, soaked in brine or white rice and dried. The outer surface is grayish white and tastes bitter. The starch is starch and herbal medicine for sweating, fever, and laxatives (緩 下 劑) as a high fever, headache, high blood pressure, heart failure, diarrhea, when the shoulder is prescribed. Galguntang is famous as a cold medicine.

Prunella vulgaris var . lilacina ) is yellowish brown with a length of 1.6 mm. The fruit is a branch (divided in each branch) and edible young shoots in spring. The herbal medicinal herbs are dried flowers, and in Chinese medicine, gonorrhea, tuberculosis, boils, systemic edema, playing window and as anti-inflammatory and diuretic. It is distributed in temperate regions of Korea, Japan, China, Taiwan, Sakhalin, and southeastern Siberia. White Lamiaceae that a similar kind of blooming white flowers (For. Albiflora), red flower red Lamiaceae the blood (For. Lilacina), stems standing upright from the bottom there is no group stem dume that short sprouts running under the stem Lamiaceae (For aleutica ).

Acanthopanax sessiliflorus ) Flowers bloom in August-September, purplish, small flower stems are short, and flowers grow in inflorescences. The petals are five and the style is combined to the end. Fruits are nucleus, somewhat flat oval, ripening in October. Root bark is called Ogalpi, and it is used as a tonic and painkiller in oriental medicine, and bark is an aromatic plant used to make Ogalpisul. It is distributed in Korea, China, Ussuri, and Amur.

Schizandra chinensis ) contains ingredients such as xanthrin, gomisin, citric acid, malic acid, citric acid, etc., which strengthen the heart, lower blood pressure, and increase immunity, which is used as a tonic. Strong lung function and antitussive, expectorant action to help treat coughs and thirst. Soak dried fruit in cold water, add honey and sugar to reddish water, drink it as a drink, or make a flower or starch. Boil chestnuts, jujube, and miso together to make tea or to soak alcohol.

Golden ( Scutellaria baicalensis ) is a perennial herb of dicotyledon and calliflora nectar . Two of four stamens are long, one has pistil, and the ovary is deeply divided into four. Fruits are fruiting in September, rounded in calyx. The cone is conical and the flesh is yellow. In oriental medicine, roots are used as antipyretic, diuretic, branch, yedam and anti-inflammatory drugs. It is grown as a medicinal plant and is distributed in Korea, China, Mongolia, and eastern Siberia.

Yam (Dioscorea batatas) is magwa (科: Disocoreaceae) vine yam belongs to (Disocorea japonica ) or hemp ( Disocorea It is a tube root of batatas ), which is collected between autumn and winter seasons, and dried in winter. The outer surface is white or yellowish brown, and the inside is solid or powdered keratin. Ingredients contain starch, mucus, protein, fat, arginine choline and diastases, and act on the meridians, lungs, kidneys, stomach and liver. When the appetite is reduced and energy is insufficient, it is taken monthly with Baekchul, white rice, ginseng and so on. When the body is dry and lacking in energy, ginseng, femo, bokyeong, passersby, etc., is known to be a good combination. Even if you take diabetes every month for a long time instead of tea, it is known to be effective, but when you have inflammatory diarrhea or stool harden, stop taking it.

Hwangjeong (Polygonatum odoratum var . pluriflorum) is greater that the projections Polygonatum such a piece of glass and there are many mountains that the length of the flower 2~2.5 ㎝ Polygonatum (Var. thunbergii), turning over the leaves cup the back of the Mac running Flowers 1-4 on the back of each leaf (Var . maximowiczii), leaf length is 16 ㎝, butterfly about 5 ㎝ and are hairy on McDonagh Polygonatum (P. koreanum), the entire back of the leaves large flower that is run by one fourth king that Polygonatum each flower 2-5 run (P. robustum ). Eat young leaves and rhizomes in the spring. The crude oil of the herbal medicine is the dried root stem, and in oriental medicine, it is used for the treatment of alternating root stem, diabetes, and heart failure, and is distributed in Korea, Japan, and China.

Peeonia lactiflora ) is beautiful for flowers and is used for gardening. Root is used as a medicine such as pain, abdominal pain, dysmenorrhea, amenorrhea, hemostasis, anemia, bruises. In China, it was already cultivated for ornamental purposes during the Qin and Ming times, and its cultivation history is older than that of peonies. Dozens of varieties are recorded in the Qing Dynasty after the Song. It is known to be distributed in Korea, Mongolia and East Siberia.

Dough ( Rehmannia glutinosa ) is native to China and is grown as a medicinal plant. In Chinese medicine, raw raw sulfur of raw roots, dried dried guernsey yellow, steamed dried sujijihwang is called. Sukjihwang is used as a blood donor, menstrual disorders, weak constitution, children's developmental insufficiency, dementia, premature ejaculation, erectile dysfunction, raw jizohwang is used for weak constitution, bleeding, nosebleed, uterine bleeding, menstrual irregularity, constipation It is effective for thirst and internal heat thirst and is known to stop hemorrhage and nosebleeds (Brittanicer Online Encyclopedia).

In fact, however, the therapeutic effects of the herbal medicines on diabetes have not been reported in the above-mentioned documents and research reports.

Republic of Korea Patent Registration 10-0052207 in the roots, yangbuja, Sangbaekpi, Mcmundong, astronomical dong, rhubarb, gardenia, golden, peppermint, bamboo leaf, talc, gypsum, rhubarb, yellow white, halved, white ginseng, licorice, broiler, walnut, dermis, jimo , Hansuseok, Sansa, Singok, Jisil, Angelica, Earl, Baekjihwang, Baekchul, Astragalus, Baekbokryeong, Yeonjak, Sanctuary, Breeding, Schisandra chinensis, Forget-me-not, Zhigolpi, Yeongwa, Hakja, Wooseol, Rosewood incense, Casualties, Compared to Gugijagi, Bokbunja, Malt Medicinal acceptable dietary fiber and pharmaceutically acceptable, containing cornus, bark, nutmeg, cattle white, ripe, wooden, white porcelain, stone, celestial, passerby, throat, green skin, sterling silver, yellow, earthenware, stone spear and longan It describes a therapeutic agent for diabetes characterized in that it comprises a carrier. In addition, Republic of Korea Patent No. 10-0189513 discloses a diabetic treatment containing Macmundong, Jimo, Sukjihwang, Bokryeong, White ginseng, licorice, gypsum and sine, and in the Republic of Korea Patent No. 10-0486963, deep water, organic germanium and tongs, Loquat leaf, fruit tree, fruit and vegetable, two books, pedestrian, twin, righteous, chajeoncho, talc, pesticide, raw material, hair growth, raw money, rooting, natural flower, cornus, stone carving, hair growth, samsam, pulsation, taxa, Schisandra chinensis, ginseng, gypsum Includes herbal extracts such as Bokyeong, Cheonnyeon, Golden, Astronomical dong, Toe Chung, Gyeenggeum, Dongnae, Deck, Earthenware, Wonsam, Creation, Ginseng, Roof Tile, Shouo, Baekjuk, Itinerary, Gugija, Jigolpi, Licorice, Chondong, Heungmae, etc. It is described as a dietary supplement that is effective in the treatment and prevention of diabetes mellitus, but it is only described that it is effective in lowering blood sugar, it is described that exhibits a hypoglycemic effect by inhibiting the activity of α-glucosidase Uh no.

Therefore, the present inventors have made efforts to develop a natural extract effective in the prevention or treatment of diabetes, white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, haechocho, Ogalpi, Schisandra chinensis, golden, medicinal herbs, yellow peony, peony And it was confirmed that the herbal medicine extract consisting of dough is effective in the prevention or treatment of diabetes mellitus due to metabolic disturbances and completed the present invention.

The main object of the present invention is the prevention of diabetes containing herbal extracts consisting of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, red pepper, ogalpi, Schisandra chinensis, golden herb, yellow herb, yellow cherries, peony and dough as an active ingredient To provide a pharmaceutical composition for treatment.

Another object of the present invention is a herbal medicine extract for the prevention or treatment of diabetes consisting of white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, vinegar, ogalpi, Schisandra chinensis, golden, mountain, yellow, peony and dough. A dietary supplement comprising an acceptable food supplement additive is provided.

In order to achieve the above object, the present invention contains a Chinese herbal medicine extract consisting of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, haechocho, ogalpi, Schisandra chinensis, golden, medicinal herb, yellow flower, peony and raw materials as an active ingredient It provides a pharmaceutical composition for the prevention or treatment of diabetes.

In the present invention, the herbal extract may be characterized in that extracted with water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof, the pharmaceutical composition is white ginseng, Astragalus, licorice, wolfberry, mulberry leaves, brown root, The composition ratios of Gochucho, Ogalpi, Schisandra chinensis, Golden, Potion, Yellow Crown, Peony and Dough are 1: 0.7: 0.4: 0.7: 0.4: 0.7: 1.1: 0.9: 0.4: 0.4: 0.7: 0.7: 0.9: 0.9 (w / w It may be characterized in that), it may be characterized in that it comprises 0.1 to 50% by weight of the herbal extracts relative to the total weight of the composition.

In the present invention, the herbal extract may be characterized by reducing blood sugar by inhibiting the activity of α-glucosidase (α-glucosidase).

The present invention is also a herbal medicine extract for preventing or treating diabetes consisting of white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, hyacinth, ogalpi, Schisandra chinensis, golden herb, yellow pepper, peony and peony and foodstuffs. It provides a dietary supplement comprising possible food supplement additives.

In the present invention, the health supplement may be characterized in that the powder, granules, tablets, capsules or beverages.

Hereinafter, the present invention will be described in detail.

Herbal medicine composition of the present invention, white ginseng, Astragalus, licorice, gojija, mulberry leaf, brown root, gojicho, ogalpi, Schisandra chinensis, golden, cayenne, yellow, peony and dough to freeze-dried and milled, the weight of the dried sample weight 2 to 15 times, preferably about 5 to 10 times the volume of water, C ₁ to C ₄ lower alcohols such as methanol, ethanol, butanol and the like or a mixed solvent having a mixing ratio of about 1: 0.1 to 1:10, Preferably hot water extraction, cold extraction, reflux cooling extraction or ultrasonic extraction, preferably hot water extraction with methanol for about 1 hour to 1 day, preferably 6 hours to 12 hours at room temperature with methanol, and extract and residue After separating, the obtained residues of C ₁ to C ₄ such as about 2 to 10 times, preferably about 3 to 5 times the volume of water, methanol, ethanol, butanol, etc. A low egg Hot water extraction, cold extraction, reflux cooling extraction or sonication for 1 to 10 hours, more preferably 1 to 5 hours with kohl or a mixed solvent thereof having a mixing ratio of about 1: 0.1 to 1:10, preferably methanol After extraction, preferably hot water extraction, filtration and concentration under reduced pressure may be used to obtain a herbal extract.

Pharmaceutical compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the manufacture of pharmaceutical compositions.

Pharmaceutical dosage forms of the extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, or may be used alone or in combination with other pharmaceutically active compounds, as well as in any suitable collection.

The pharmaceutical compositions according to the invention can be used in the form of oral dosage forms, external preparations, suppositories, and sterile injectable solutions, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, etc., respectively, according to conventional methods. Can be. Carriers, excipients and diluents that may be included in the composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, Methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

When formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, and surfactants are usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and the solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose in the extract. ) Or lactose, gelatin and the like are mixed. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. . Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate and the like can be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.

Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the preferred effect, the extract of the present invention is preferably administered at 0.0001 to 100 mg / kg, preferably at 0.001 to 100 mg / kg. Administration may be administered once a day or may be divided several times. The dosage does not limit the scope of the invention in any aspect.

The extract of the present invention can be administered to mammals such as mice, mice, livestock, humans, etc. by various routes. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.

The present invention provides a dietary supplement comprising the herb extract and a foodstuff acceptable food supplement additive exhibiting a prophylactic or therapeutic effect of diabetes. Examples of foods to which the medicinal herb extract can be added include various foods, beverages, gums, teas, vitamin complexes, health functional foods, powders, granules, tablets, capsules and beverages.

It may also be added to foods or beverages for the purpose of preventing or treating diabetes. At this time, the amount of the extract in the food or beverage may be added in 0.01 to 15% by weight of the total food weight, the health beverage composition may be added in a ratio of 0.02 to 5 g, preferably 0.3 to 1 g based on 100 ml. have.

The health functional beverage composition of the present invention is not particularly limited to other ingredients except for containing the extract as an essential ingredient in the indicated ratios, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. Examples of the above-mentioned natural carbohydrates include conventional sugars such as monosaccharides, disaccharides such as glucose and fructose, polysaccharides such as maltose and sucrose, dextrins and cyclodextrins, and sugar alcohols such as xylitol, sorbitol and erythritol. to be. As flavoring agents other than those mentioned above, natural flavoring agents (stevia extracts such as taumartin, rebaudioside A, glycyrgin) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used. The proportion of such natural carbohydrates is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention.

In addition to the above, the herbal extracts of the present invention are various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic and natural flavors, coloring and neutralizing agents (such as cheese, chocolate), pectic acid and salts thereof, alginic acid and Salts, organic acids, protective colloid thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks, and the like. In addition, the extract of the present invention may contain natural fruit juice and fruit flesh for the production of fruit juice beverages and vegetable beverages. These components can be used independently or in combination. The proportion of such additives is not so critical but is usually selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the extract of the present invention.

Hereinafter, the present invention will be described in more detail with reference to Examples. These examples are only for illustrating the present invention, it will be apparent to those skilled in the art that the scope of the present invention is not to be construed as limited by these examples.

Example 1. Preparation of Herbal Extracts

Commercially purchased white ginseng, Astragalus, licorice, wolfberry, mulberry leaf, brown root, haechocho, ogalpi, schisandra chinensis, golden pepper, yellow pepper, yellow flower, peony and dough, respectively 10 g, 7 g , 4 g, 7 g, 4 g, 7 g, 11 g, 9 g, 4 g, 4 g, 7 g, 7 g, 9 g, 9 g each, lyophilized and ground to use as a sample of the following example . The herbal composition was extracted using a magnetic stirrer for 12 hours by adding 100% methanol corresponding to 10 times the sample weight. After filtering under reduced pressure to separate the extract and the residue, 100% methanol corresponding to 5 times the weight of the herbal composition at the start of extraction was added to the obtained residue, and extracted using a magnetic stirrer for 6 hours. After filtration under reduced pressure again, 100% methanol corresponding to three times the weight of the herbal composition at the start of extraction was added to the obtained residue, followed by extraction using a magnetic stirrer for 3 hours, followed by filtration under reduced pressure and concentration to obtain an extract.

Example 2. Determination of inhibition of α-glucosidase activity of herbal extracts

Yeast α-glucosidase was purchased from Sigma, Louis, MO, USA, and the enzyme substrate was para-nitrophenyl-alpha-D-glucopyranoside. As a positive control, acarbose (acarbose, Bayer-Korea), which is used clinically, is used as a blood glucose increase inhibitor. After drying the medicinal herb extract obtained in Example 1, dissolved in dimethylsulfoxide (dimethylsulfoxide) at a concentration of 0.5 mg / ㎖, and put it in the enzyme reaction solution containing yeast α-glucosidase α-glucose The degree of inhibition of sidase was measured.

As a result, the enzymatic activity inhibitory effect of the herbal extract and acarbose was 25.2%, 20.7%, respectively, it was confirmed that significantly inhibited α-glucosidase (Fig. 1).

Example 3 Measurement of Dietary Intake and Weight Gain in Type 2 Diabetic Animal Models

In vitro ( In Example 2) vitro) in vivo (In the medicinal herb extracts shown to let the α- glucosidase inhibiting activity superior to measure vivo) diabetes improving effect, and the second type separated by on experimental method the diabetic animal model, the db / db mice of 4 weeks of age to be similar to the mean blood glucose of the groups, the base diet for the control group, fed groups for basic diet A diet containing 10% of the medicinal herb extract lyophilized was taken for 6 weeks (Table 1). Diet and drinking water freely ( ad libitum ), the temperature and humidity of the breeding room were maintained at 20 ~ 25 ℃, 50 ~ 60%, respectively, the contrast was turned on and off every 12 hours. Animal weight and dietary intake were measured three times a week.

Dietary composition Basic diet Herbal Medicine Extract Diet Corn starch ^{1 )} 39.7 39.7 Luxury starch 13.2 13.2 Casein ^{2 )} 20.0 18.9 Soybean oil ^{3 )} 7.0 6.9 α-cellulose ^{4 )} 5.0 1.7 Sucrose ^{5 )} 10.0 6.6 Mineral mixtures ^{6 )} 3.5 3.5 Vitamin mixtures ^{6 )} One One L-cystine6) 0.3 0.3 Choline bitartrate6) 0.25 0.25 4-butylhydroquinone 0.0014 0.0014 Herbal Medicine Extract 0 10 ¹⁾ Daesang, Korea ²⁾ Murry goulburn Co., Australia ³⁾ Cheil Jedang, Korea ⁴⁾ Sigma, Korea ⁵⁾ Samyang, Korea ⁶⁾ ICN Biochemical, Korea

Animals were sacrificed at 6 weeks of diet. The animals were fasted for 14 hours before sacrifice, suffocated with carbon dioxide gas, and blood was collected from the heart with a syringe containing 10 mg of ethylene diamine tetra acetic acid (EDTA). Blood was collected by centrifugation at 3,000 rpm for 15 minutes to collect plasma and stored at -70 ° C. Liver tissue was extracted and stored at -70 ° C.

All results were expressed as mean ± standard deviation, and the significance test between the control group and the herbal extract administration group was carried out using the Student's t-test (α = 0.05).

Body weight and dietary intake were measured to be 40.4 ± 2.6 g and 39.5 ± 1.6 g for the control group and the medicinal herb extract for 6 weeks. The dietary intake was 4.47 ± 0.62 g / Day, 4.30 ± 0.60 g / day showed no significant difference (Table 2).

Body weight and dietary intake of control group and medicinal herb extract in diabetic animal model Control Chinese Herb Extract Intake Group Weight (g) 40.4 ± 2.6 39.5 ± 1.6 Dietary Intake (g / day) 4.47 ± 0.62 4.30 ± 0.60 ^* Mean ± SD

Example 4. Determination of the Effect of Herbal Medicine Extracts on Blood Glucose Levels

Glucose content in fasting plasma was measured by glucose oxidase enzyme assay (Raabo, E., Terkildsen, TC, On the enzymatic determination of blood glucose, Scand J using an assay kit (Sigma, USA). Clin lab Invest 12: 402, 1960).

As a result, the concentration of fasting plasma glucose was 442.5 ± 36.0 mg / dL in the herbal extract intake group, which was significantly lower than the control group (489.8 ± 34.6 mg / dL) ( p <0.05, Table 3). This indicates that long-term intake of the herbal extract of the present invention is effective in improving or treating diabetes by significantly reducing fasting blood glucose.

Plasma Glucose Concentrations in Control and Intake Groups in Diabetic Animal Models Control Chinese Herb Extract Intake Group Glucose concentration (mg / dL) 489.8 ± 34.6 442.5 ± 36.0 ^{* *} Mean ± SD

Example 5. Acute Toxicity Test

Acute toxicity experiments were performed using 6-week-old specific pathogen-free (SPF) SD rats. Two animals in each group were orally administered with the herbal extract at a dose of 100 mg / kg. After administration of the medicinal herb extract, the mortality, clinical symptoms, and weight changes of the animals were observed. Hematological and hematological examinations were performed.

As a result, no significant clinical symptoms or dead animals were noted in all the animals to which the medicinal herb extract was administered, and no toxic changes were observed in weight changes, blood tests, blood biochemical tests, and autopsy findings. In addition, the herbal extract of the present invention did not show a toxic change even in rats up to 100 mg / kg, respectively, and the minimum lethal dose (LD50) was determined to be a safe substance of 100 mg / kg or more.

Hereinafter, the formulation of the pharmaceutical composition comprising the herbal extract of the present invention will be described, but the present invention is not intended to limit it, but is intended to explain in detail only.

Formulation Example 1 Preparation of Powder

Herbal Medicine Extract 20 mg

Lactose 100 mg

Talc 10 mg

The above ingredients are mixed and filled in an airtight cloth to prepare a powder.

Formulation Example 2 Preparation of Tablet

Herbal Medicine Extract 10mg

Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.

Formulation Example 3 Preparation of Capsule

Herbal Medicine Extract 10mg

3 mg of crystalline cellulose

Lactose 14.8 mg

Magnesium Stearate 0.2mg

According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.

Formulation Example 4 Preparation of Injection

Herbal Medicine Extract 10mg

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

_{Na 2 HPO 4 · 12H 2 O} 26 ㎎

According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule (2 ml).

Formulation Example 5 Preparation of Liquid

Herbal Medicine Extract 20 mg

10 g of isomerized sugar

5 g of mannitol

Purified water

By dissolving each component in purified water according to a conventional liquid preparation method, and adding a proper amount of lemon aroma, and then mixing the above components and adding purified water to adjust the total volume to 100 ㎖ by filling in a brown bottle and sterilizing Prepare a liquid formulation.

Formulation Example 6 Preparation of Healthy Food

Chinese Herb Extract 1000mg

Vitamin mixture proper amount

70 μg of Vitamin A Acetate

Vitamin E 1.0 mg

Vitamin B1 0.13 mg

Vitamin B2 0.15 mg

Vitamin B6 0.5 mg

0.2 μg of vitamin B12

Vitamin C 10 mg

10 μg biotin

Nicotinic acid amide 1.7 mg

50 μg folic acid

Pantothenic acid calcium 0.5 mg

Mineral mixture

Ferrous sulfate 1.75 mg

Zinc oxide 0.82 mg

Magnesium carbonate 25.3 mg

Potassium phosphate monobasic 15 mg

Dicalcium phosphate 55 mg

Potassium citrate 90 mg

Calcium carbonate 100 mg

Magnesium chloride 24.8 mg

The composition ratio of the vitamin and mineral mixtures is a composition suitable for health foods in a preferred embodiment, but the composition ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health food manufacturing method, and then granulated. It can be prepared and used in the manufacture of health foods according to conventional methods.

Formulation Example 7 Preparation of Healthy Drink

Medicinal Herb Extract 100mg

15 g of vitamin C

100 g of vitamin E (powder)

Iron lactate 19.75 g

3.5 g of zinc oxide

Nicotinamide 3.5 g

0.2 g of vitamin A

0.25 g of vitamin B1

0.3 g of vitamin B2

Water quantity

After mixing the above components according to the conventional healthy beverage production method, and then stirred and heated at 85 ℃ for about 1 hour, filtered and obtained in a sterilized 2 L container, sealed sterilization and then refrigerated and stored in the health beverage of the present invention Used to prepare the composition.

Although the composition ratio is a composition suitable for the preferred beverage in the preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, and usage.

As described in detail above, in the present invention, the herbal medicine extract composed of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, red pepper, ogalpi, Schisandra chinensis, golden, medicinal herb, yellow cherries, peony and dough is α-glucosidase In addition to showing inhibitory activity, it has been found to reduce fasting blood sugar, and has an effect of providing a pharmaceutical composition and health supplement for preventing or treating diabetes containing the herbal extract as an active ingredient.

The herbal extract according to the present invention exhibits α-glucosidase inhibitory activity and slows down the digestion rate of carbohydrates after meals, thereby suppressing a rapid rise in blood glucose levels, and thus can be used as a preventive or therapeutic drug for diabetes or as a dietary supplement.

The specific parts of the present invention have been described in detail above, and it is apparent to those skilled in the art that such specific descriptions are merely preferred embodiments, and thus the scope of the present invention is not limited thereto. something to do. Thus, the substantial scope of the present invention will be defined by the appended claims and their equivalents.

Claims (7)

Herbal extracts, food supplements, and food supplements for the prevention or treatment of diabetes consisting of white ginseng, Astragalus, licorice, wolfberry, mulberry leaf, brown root, vinegar, ogalpi, schisandra chinensis, golden herb, yellow tablet, peony and dough Health supplements that contain. The dietary supplement of claim 2, wherein the dietary supplement is a powder, granule, tablet, capsule or beverage. A pharmaceutical composition for the prevention or treatment of diabetes, comprising a Chinese herbal extract consisting of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, goji vinegar, Ogalpi, Schisandra chinensis, golden, wild herb, yellow tablet, peony and raw dough. The pharmaceutical composition of claim 3, wherein the herbal extract is extracted with water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof. The pharmaceutical composition of claim 3, wherein the composition of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, hyacinth, Ogalpi, Schisandra chinensis, golden, medicinal herb, yellow cherries, peony and dough is 1: 0.7: 0.4: 0.7 : 0.4: 0.7: 1.1: 0.9: 0.4: 0.4: 0.7: 0.7: 0.9: 0.9 (w / w). According to claim 3, wherein the pharmaceutical composition is a pharmaceutical composition comprising 0.1 to 50% by weight of the herbal extract based on the total weight of the composition. The pharmaceutical composition of claim 3, wherein the herbal extract lowers blood sugar by inhibiting the activity of α-glucosidase.

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