KR20070111624A - Pharmaceutical composition for improving lipid metabolism containing an extract of chinese herb as an effective ingredient - Google Patents

Abstract

A composition containing the extracts of medicinal herbs is provided to diminish concentrations of total cholesterol and neutral fat in blood plasma without side effects, thereby improving lipid metabolism commonly occurring in type II diabetes patients. A composition for improving lipid metabolism contains 0.1-50 wt.% of the extracts of medicinal 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 weight 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, wherein the medicinal herb extracts are prepared by extracting them with water, C1-C4 lower alcohol or a mixed solvent thereof; the lipid metabolism is the blood neutral fat, blood total cholesterol and blood HDL(high density lipoprotein)-cholesterol metabolism; and the composition is a pharmaceutical or health food composition having a formulation selected from powder, granule, tablet, capsule and beverage.

Description

Pharmaceutical Composition for Improving Lipid Metabolism Containing an Extract of Chinese Herb as an Effective Ingredient}

Figure 1 shows the plasma cholesterol concentration of the diabetic animal model in the control group and the herbal medicine intake group.

Figure 2 shows the plasma triglyceride concentration of the diabetic animal model in the control group and the herbal composition intake group.

Field of invention

The present invention relates to a pharmaceutical composition for improving lipid metabolism, which contains the herb extract as an active ingredient having an effect of reducing the concentration of total cholesterol and triglycerides in plasma.

Background

Diabetes mellitus is a disease in which hyperglycemia occurs because cells in the body cannot use sugar due to reduced insulin secretion or reduced insulin function. In diabetes, hormone imbalance, including insulin, is characteristic of hyperglycemia due to abnormal physiological metabolic control functions such as carbohydrate, protein, lipid and electrolyte metabolism (Gonuth, SM, Ann . Intern. Med . , 79, 812-822, 1973 If these hyperglycemic symptoms persist, serious chronic complications such as blood circulation disorders, retinal damage, nerve cell damage, renal insufficiency and vascular complications may occur (Kannel, WB, et. al ., JAMA , 241, 2035-2038, 1979).

In particular, diabetics have a higher incidence of cardiovascular diseases such as atherosclerosis, cerebral infarction, cerebral thrombosis, and myocardial infarction (Fuller, JH, Lancet , 1, 1373-1376, 1980). Diabetes patients have a high risk of death from coronary artery disease or cerebrovascular disease, which is often caused by hypertension, hyperlipidemia, obesity, etc. (Ho, Bum-beom, The Korean Journal of Nutrition, 15-18, 1984).

Type 2 diabetics have increased lipid metabolism with increased triglyceride and cholesterol levels and decreased HDL-cholesterol (Goldberg, RB, Diabetes). Care , 4, 561-572, 1981), which causes coronary artery disease, a complication of diabetes (Reaven, JW, Am. J. Med ., 83, 31-40, 1987). 67% of people with type 2 diabetes reported one or more types of lipid metabolism (Harris, MI, Diabetes) Care , 23, 754-758, 2000).

In diabetic patients, the incidence of vascular diseases such as coronary heart disease and atherosclerosis is known to be two to six times higher than that of non-diabetic patients, and cardiovascular complications are the leading cause of death for diabetic patients. In addition, diabetic eyes, like other organs, are susceptible to metabolic disorders caused by diabetes, including increased non-enzymatic glycosylation, oxidation of proteins and lipids, and reduced glutathione. Decreases the skin's resistance to harmful substances and leads to clouding of the lens and cataracts (Yarat A., et al ., Free Rad . Biol . Med ., 31 (9), 1038-1042, 2001).

The results of studies on the lowering of lipid metabolism of herbal medicines are diverse, but the results of disease prevention related studies of herbal medicines prepared by mixing specific Chinese herbal medicines are inadequate. Constitutional alcohol composition by the constitution and methods for producing the same are all. Accordingly, the present inventors confirmed that the extracts of brown root, golden and hard bones and herbal compositions containing them are effective in improving lipid metabolism.

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 ), Prunella vulgaris var . lilacina ), Acanthopanax sessiliflorus ), Schizandra chinensis ), golden ( Scutellaria baicalensis ), mountain drugs ( Dioscorea batatas ), Hwangjeong (Polygonatum odoratum var . pluriflorum ), Peony (Paeonia lactiflora ) and dough ( Rehmannia glutinosa ).

White ginseng ( Panax ginseng C. A. Meyer ) is a grade of red ginseng and its root is medicinal and its form 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 hypertrophy, consisting of one root and two to five roots, and 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. The ginseng shoots from the underground stem every year, and the stems and leaves die in autumn, but the dead stems remain.

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 root is sweet, so use it as a sweetener or herbal medicine. Siberian acid ( G. glabra var . glandulifera ) and G. glabra ( G. glabra ) and similar species include G. pallidiflora . It has little sweetness and is not used for medicinal purpose unlike licorice. It has less hair, fruit is oval, pointed and 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 operation or recovery period, put powder or juice to 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 fever, Jinhae, diuretic, and small species 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 ingredient is starch and herbal medicine is a sweating, antipyretic, laxative (緩 下 劑) and is prescribed for high fever, headache, high blood pressure, heart failure, diarrhea and shoulder stiffness. Galguntang is famous as a cold medicine.

Prunella vulgaris var . lilacina ) is yellowish brown, about 1.6mm long, and fruit is branched. Eat young shoots in the spring. Herbal Hagocho (夏枯草) is dried flower ear, and in oriental medicine, gonorrhea, tuberculosis, boil, systemic species, playing window, and writes 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 samsam together to make tea or make 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 cultivated 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 tuber of batatas , collected between autumn and winter seasons, and dried. 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 other 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. If your body is dry and lacking in energy, ginseng, famo, 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 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, poor development of children, dementia, premature ejaculation, erectile dysfunction. It is effective for heat thirst and internal organs and is known to stop hemorrhage and nosebleeds (Brittanicer Online Encyclopedia).

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

Republic of Korea Patent No. 10-0516180 discloses a drug for treating hyperlipidemia containing the upper leaf, Astragalus, mountain breeding, ultra-determination, brown root, Dansam, Shouao, Yellow Jung, Dae Haeop, Gugija, Baekbongryeong, Baekchul, Uiin and Injinho, 10-2006-0007105 describes hyperlipidemia treatments containing sewage, taxa, Schizandrae, absentia, perilla, cornus, hawthorn, turmeric, whiskers, halved, raw, steat, aerated and konjac, but the concentrations of cholesterol and triglycerides It is only used as a hyperlipidemic agent to reduce the effect of improving lipid metabolism.

Therefore, the present inventors have made efforts to develop a natural extract that is effective in improving lipid metabolism, white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, haechocho, Ogalpi, Schisandra chinensis, golden, medicinal herbs, yellow peony, peony and dough It was confirmed that the herbal extract consisting of has an excellent effect on improving lipid metabolism and completed the present invention.

The main purpose of the present invention is to improve the lipid metabolism containing the herb extract, consisting of white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, hyacinth, ogalpi, Schisandra chinensis, golden, wild herb, yellow flower, peony and dough It is to provide a pharmaceutical composition.

Another object of the present invention is herbal medicine extract for improving lipid metabolism consisting of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, red pepper, ogalpi, Schisandra chinensis, golden, wild herb, yellow flower, peony and dough. It is to provide a dietary supplement comprising a possible food supplement additive.

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 improving lipid metabolism.

In the present invention, the herbal medicine extract may be characterized in that extracted with water, 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 lipid metabolism may be selected from the group consisting of blood triglycerides, blood total cholesterol, and blood HDL-cholesterol metabolism.

The present invention also, herbal medicine extract for improving the lipid metabolism consisting of white ginseng, Astragalus, licorice, wolfberry, mulberry leaf, brown root, hyacinth, ogalpi, Schisandra chinensis, golden, wild herb, yellow flower, peony and dough It provides a dietary supplement comprising a food supplement additive.

Hereinafter, the present invention will be described in detail.

Herbal extract of the present invention is white ginseng, Astragalus, licorice, gojija, mulberry leaves, brown root, gojicho, ogalpi, Schisandra chinensis, golden, medicinal herb, yellow, peony and dough after lyophilization and grinding, the weight of the dried sample About 1 to 20 times, preferably about 5 to 15 times the amount of water, C ₁ to C ₄ lower alcohols such as ethanol, methanol or the like or about 1: 0.1 to 1:10, preferably 1: 0.2 to 1: As a mixed solvent having a mixing ratio (kg / L) of 5, an extraction method such as hot water extraction, cold needle extraction, reflux cooling extraction, or ultrasonic extraction for about 1 to 24 hours, preferably 5 to 15 hours at room temperature is used. In this case, the crude extract which is a soluble extract of the present invention can be preferably obtained by cold extraction followed by concentration under reduced pressure.

       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.

The pharmaceutical dosage forms of the compositions of the present invention may be used in the form of their pharmaceutically acceptable salts, and may be used alone or in combination with other pharmaceutically active compounds as well as in a 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 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 compositions 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 desired effect, the composition 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 composition of the present invention can be administered to mammals such as rats, 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 a herb extract and a pharmaceutically acceptable food supplement additive exhibiting a lipid metabolism improving effect. Examples of the food to which the 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 improving lipid metabolism. 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 ratio, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. . Examples of the natural carbohydrates described above 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 Medicine Composition and Analysis of General Ingredients

Commercially purchased white ginseng, Astragalus, licorice, wolfberry, mulberry leaf, brown root, red pepper, ogalpi, schisandra, golden, cod, yellow, 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 was lyophilized and ground and then used as a sample of the following example.

The general composition of the herbal composition was analyzed by AOAC method (Association of Official Analytical Chemists, Association of Official Analytical Chemists, 15th ed., 1990). Moisture was analyzed by atmospheric heating and drying, crude fat by Soxhlet extraction, crude protein by semi-micro Kjeldhal method, and crude ash by ingestion method (Food Code (2005) General Ingredient Test Law, Korea Food Research Institute) and total dietary fiber content was measured by the modified AOAC method developed by Prosky et al . (Prosky, L., et al ., Journal - Association of Official Analytical Chemists , 71, 1017-1023, 1988). The content of common ingredients was 6.9 g of water, 1.3 g of fat, 10.8 g of protein, 14.6 g of ash, and 32.8 g of dietary fiber per 100 g.

Example  2. Preparation of Diabetic Animal Model and Preparation of Herbal Medicine Experimental Diet

In vivo of the herbal extract prepared in Example 1 ( In vivo) to measure the lipid metabolism improving effect, the type 2 diabetes animal model, the db / db mice of 4 weeks of age (n = 12) the average blood glucose to a similar method to separate on experimental divided into two groups. The diet and drinking water were freely ingested. The temperature and humidity of the feeding room were maintained at 20 ~ 25 ℃ and 50 ~ 60%, respectively, and the contrast was turned on and off every 12 hours. Animal weight and dietary intake were measured three times a week.

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

The control group was ingested for 6 weeks the basic diet shown in Table 1, the ingestion group for 6 weeks containing the 10% lyophilized herbal composition of Example 1 in the basic diet.

Dietary composition Basic diet Herbal medicine composition 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-cystine ^{6 )} 0.3 0.3 Choline Bitartrate ^{6 )} 0.25 0.25 4-butylhydroquinone 0.0014 0.0014 Herbal Medicine Composition 0 10 ¹⁾ Target company, Korea ²⁾ Murry goulburn Co., Australia ³⁾ CheilJedang, Korea ⁴⁾ Sigma, USA ⁵⁾ Samyang, Korea ⁶⁾ ICN Biochemical, USA

Example  3. Measuring Dietary Intake and Weight Gain

As a result of measuring the weight and dietary intake, as shown in Table 2, the weight of the intake group fed the control group and the medicinal herb composition extract diet for 6 weeks was 40.4 ± 2.6 g and 39.5 ± 1.6 g, respectively. 4.47 ± 0.62 g / day and 4.30 ± 0.60 g / day, respectively, showed no significant difference.

Body weight and dietary intake of control and intake groups in diabetic animal models Control Chinese herbal composition intake group Body weight (g) 40.4 ± 2.6 39.5 ± 1.6 Dietary Intake (g / day) 4.47 ± 0.62 4.30 ± 0.60 Average ± S.D.

Example  4. Determination of plasma total cholesterol and triglyceride levels

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 EDTA (ehylene diamine tetra acetic acid). Blood was collected by centrifugation at 3,000 rpm for 15 minutes to collect plasma and stored at -70 ° C, and liver tissue was extracted and stored at -70 ° C.

Plasma total cholesterol is the method of sale (Sale, FO, et. al ., Anal . Biochem. , 142, 347-348, 1984).

Saleh's method refers to the presence of free and ester cholesterol in serum. When cholesterol ester hydrolase reacts with ester cholesterol, it breaks down into free and fatty acids. ₂ O ₂ and δ-cholesterone are produced. When the peroxidase, 4-aminoantipyrine and phenol are reacted simultaneously with the produced H ₂ O ₂ , quinone is produced by oxidative condensation reaction. How to quantify. The plasma collected above was reacted for 5 minutes at 37 ° C., and then absorbance was measured and measured at 500 nm using a sample and a standard.

As a result, the total cholesterol concentration was 185.4 ± 13.7 mg / dL in the control group, 159.2 ± 18.4 mg / dL in the intake group (Fig. 1). From this, it was confirmed that long-term intake of the active ingredient of the herbal composition significantly decreased plasma cholesterol concentration in diabetic animals (p <0.05).

Plasma triglycerides were measured by Buoccole's method (Buoccole, G., David, H., Clin . Chem ., 19, 476, 1973).

In the method of bucolol, triglyceride is decomposed into glycerol and fatty acid by lipase, glycerol is converted into glycerol-1-phosphate, and glycerol-1-phosphate is decomposed by GPO to produce H ₂ O ₂ . The produced H ₂ O ₂ reacts with aminoatiphyrin and TOOS (N-ethyl-N- (2-hydroxy-3-sulfopropyl) -3-methylaniline) to produce red quinone by oxidative condensation reaction It is a method of quantifying triglycerides. The plasma collected above was reacted at 37 ° C. for 5 minutes, and then absorbance was measured and measured at 546 nm using a sample and a standard.

As a result, the plasma triglyceride concentration was found to be 108.8 ± 11.0 mg / dL in the control group, 99.4 ± 15.0 mg / dL in the intake group (Fig. 2). From this, the long-term intake of the active ingredient of the herbal composition did not have a significant difference in the concentration of triglycerides in diabetic animals, but it was confirmed that the tendency to decrease.

Example  5. Acute Toxicity Test

Acute toxicity experiments were performed using 6-week-old specific pathogen-free (SPF) SD rats. Two animals of each group were orally administered with the above-mentioned 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 and biochemical tests were performed.

As a result, no significant clinical symptoms or dead animals were noted in all animals treated with the test substance, 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 was determined to be a safe substance having a minimum lethal dose (LD50) of 100 mg / kg or more.

Hereinafter, the preparation of the pharmaceutical composition containing 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  One. Powder  Produce

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 Tablets

Herbal Medicine Extract 10mg

Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components and tableting according to the conventional tablet manufacturing method to prepare a tablet.

Formulation example  3. Manufacture 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 Injectables

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. Liquid  Produce

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. Manufacture 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

Dibasic calcium phosphate (potassium phosphate dibasic) 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. Manufacture of health drinks

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 and filtered. It is obtained in a sterile 2 L container, sealed, sterilized and stored in a refrigerated state before use in the manufacture of a healthy beverage composition of the present invention.

Although the composition ratio is mixed with a component suitable for a preferred beverage in a 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 total cholesterol concentration of plasma is composed of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, hyacinth, ogalpi, Schisandra chinensis, golden, medicinal herb, yellow cherries, peony and dough. And found to reduce the concentration of triglycerides, there is an effect of providing a pharmaceutical composition and dietary supplement for improving lipid metabolism containing the herbal extract as an active ingredient.

According to the present invention, the herbal medicine extract can be used in medicines and health supplements for improving lipid metabolism by reducing the concentration of total cholesterol and triglycerides in plasma.

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)

A pharmaceutical composition for improving lipid metabolism, which contains a herb extract consisting of white ginseng, Astragalus, licorice, goji berry, mulberry leaf, brown root, hyacinth, ogalpi, schisandra chinensis, golden herb, yellow jungja, peony and dough. The pharmaceutical composition of claim 1, 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 1, 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 1, 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 1, wherein the lipid metabolism is selected from the group consisting of triglyceride in blood, total cholesterol in blood and HDL-cholesterol metabolism in blood. Herbal extracts for improving lipid metabolism consisting of white ginseng, Astragalus, licorice, wolfberry, mulberry leaf, brown root, vinegar, Ogalpi, Schisandra chinensis, golden, medicinal herb, yellow flower, peony and raw materials, and a food acceptable additive Health supplements. The dietary supplement of claim 6, wherein the dietary supplement is a powder, granule, tablet, capsule or beverage.

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