KR20050116007A - Pharmaceutical composition comprising the crude drug extract for preventing and treating liver disease - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for the prevention and treatment of liver diseases containing herbal extracts, and more particularly to a pharmaceutical composition for the prevention and treatment of liver diseases, which essentially contain phosphorus, baekchul, fingering, seungsong and nyo extract. . Since the composition of the present invention exhibits excellent liver protection and is stable to the human body, the composition of the present invention can be usefully used for medicines and health functional foods for protecting liver cells and preventing or treating liver damage.

Description

Pharmaceutical composition comprising the crude drug extract for preventing and treating liver disease}

The present invention relates to a pharmaceutical composition and health functional food for preventing and treating liver disease, which essentially contain phosphorus, baekchul, fingering, seungsong and nyol extract.

The liver is an organ that has been known to be involved in blood storage and circulation, blood volume control and detoxification, and is also closely related to mental activity. Since our bodies are always exposed to various pollutants and toxic substances due to industrialization, the liver is also constantly suffering from detoxification. Furthermore, hepatic damage caused by mental stress is a serious problem. Damaged hepatocytes can be repaired in the event of mental rest, but in a busy modern society, they cannot afford to rest. Because of the body's defense and detoxification effect due to the immune system may cause other diseases. The liver is a large buffering organ that does not appear well in the early stages of the disease and is found only when it is significantly weakened.

Hepatotoxic agents include carbon tetrachloride and D-galactosamine. Aliphatic halogen hydrocarbons, carbon tetrachloride, are xenobiotics that cause biofilm damage and cause toxic effects on the liver and kidneys (Bruckner, JV, Fund. Appl. Toxicology , 6 , pp 16-34; Butler, TC, J. Pharmacol.Exp. Ther. , 134 , pp 311-319).

Recently, a lot of experiments have been reported on the action of inhibiting free radical generation through natural products such as edible and medicinal plants for the prevention or treatment of liver toxicity (Caragy, AB, Food Technology , 46 , pp65-68, 1992; Liang jun, Y., et al., Biochem. And Biophy.Res. Com. , 212 , pp360-366, 1995; Kim, HK, et al., Korean J. Food Sci.Technol., 27 , pp80 -85, 1995; Middleton, E., Int. J. Pharmacognosy , 34 , pp344-348, 1996). In particular, silymarin (SLM) is a substance isolated from the fruit of Silybum marianum (Carduus marianus) belonging to the Asteraceae family, and BDD (biphenyl dimethyl dicarboxylate (BDD) is similar to Schizandrin, a component of Schizandra chinensis. As an artificial synthetic material, it has been developed and used as a therapeutic agent for liver diseases derived from natural products.

Therefore, the present invention was intended to evaluate the possibility of development as a drug for improving liver function or hepatotoxicity by observing the effect of improving the liver function of herbal combinations that are expected to be effective in the prevention or treatment of liver toxicity clinically.

Injinho (茵 蔯 蒿, Artemisiae Capillaris Herba) is an asteraceae plant of Asteraceae, which has a bluish heat moistness, Baekseok Idam, shingling fever, and small liver wool. Has the effect of the upper limit (급성), acute hepatitis (急性 肝炎), cholecystitis (膽囊炎), ulcers (濕 瘡 瘙痒), jaundice (黄疸), urine bulge (小便 不利) has been used. Injinho's medicinal effects have been shown to be effective in the treatment and prevention of circulatory diseases such as hypertension, obesity and stroke, and the protective effect of liver function is known (Nam, SM, et al., J. Kor. soc.food Sci. 27 (2), 338 (1998); Nam, SM, J. Kor. soc.food Sci. 28 (1), 199 (1999)), Injinsuk's methanol extract increased the GOT and GPT. (Klimura, et al., Chem. Pharm. Bull., 33, 2028 (1995)), and studies have reported that the ethanol aqueous layer of water extracts inhibits liver damage and lipid peroxidation (Park, EJ, et al. , Chem. Pharm. Bull., 33, 2028 (1985).

Baekchul (Atractylodis Rhizoma Alba) is an asteraceae plant with dry weight, warmth, humidity, turbidity, flower, flower, branch, antae Angu, Saengjin, Sogok, Bo-seul, Long-term Meat, Livestock Dam Water, Iso-stool, Jeji-do It is a herbal medicine with the effects of, 복 服, 신 身, 신 身, 년 年, 不 기 (비), non-crisis medicine, taegigigi, hari (痢), mummies, water species, jaundice, each, urinate, Hyun-hun, Dohan, Taegi-anxiety, etc. It is the medicinal herb used. In folk medicine, it has been used for gastric ulcer, gastric ulcer prevention and bile secretion promotion, especially in China as tonic (Chen, ZL, et al., Planta.med., 53, 493 (1987); Chen, ZL, Phytochemistry , 45 (4), 765 (1997).

Coriolus versicolor belongs to polyporaceae, which grows in hardwood or coniferous bases in the eastern regions of China, Korea, and Japan. In recent years, there is a lot of research on anticancer activity with Ganoderma lucidum mushrooms. There are reports that the mechanism of action of the fingerlings inhibits the growth of cancer indirectly by activating the immune mechanism in vivo rather than direct cytotoxic action (Kim, BK, et al. ., Sing.Arch.pharm.Res. 2, 153 (1979).

Orostachydis Herba is a perennial herbaceous plant of stone trees. It has been used in Chinese medicine for hepatitis, hepatitis, malaria, fever, and otmus pain.

Polyporus is a fungus that has a potency of Isu, samsui, detoxification and iso-stool. Used for the treatment of upper limit, warm zone, diarrhea, urinary deficiency, turbidity, dying, dysentery, and lobster do. Recently, there have been reports of renal function improving and anti-cancer antimicrobial activity (Ha, Y.D., et al., Journal of Agricultural Products Distribution 8 (4) 481, 2001).

As mentioned above, many researches have been conducted on the effects and toxicity of humans, whitenings, fingerings, wasong, ghosts, etc., which have been used for a long time in the oriental medicine and civilian without special toxicity or side effects. However, as for the composition for preventing and treating liver disease containing the herbal extract, there is no research literature or other data as well as the study itself.

Accordingly, the present inventors focused on research on improving liver function derived from natural products, and found that a composition containing phosphorus, white roe, fingering, turmeric, and aging mixed extracts as an essential active ingredient has an excellent liver disease treatment effect. The invention was completed.

It is an object of the present invention to provide a pharmaceutical composition and health functional food for preventing and treating liver disease, which essentially contain a mixed extract of jinjin, baekchul, fingering, seungsong and nyul.

In order to achieve the above object, the present invention is a pharmaceutical composition for the prevention or treatment of liver disease, including jinjin, baekchul, fingering, seungsong and ghost mixed extract as an essential active ingredient and a pharmaceutically acceptable carrier, excipient or diluent To provide.

In addition, the present invention provides a pharmaceutical composition further comprising one or more herbal extracts selected from the group consisting of Myeongilyeop, Taxa, Takbak, Baekbokyeong, Licorice, Agaricus, and Ginger in the essential active ingredient.

The extract includes a polar solvent selected from water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof, preferably an extract available in water.

Hereinafter, the present invention will be described in detail.

The extract is characterized in that it is included in the form of a pulverized product, extract or powder extract thereof. At this time, the composition according to the present invention includes a mixed extract comprising a single extract of each herbal medicine, or a complex extract prepared by extracting a plant containing two or more of each herbal medicine.

The extract according to the present invention may be a crude extract prepared by applying a solvent extraction method using a conventional water extract, alcohol, etc. as a solvent, and may also be a fraction extract purified using column chromatography. Extraction method according to the invention can be applied to all extraction methods known to those of ordinary skill in the art, for example, extraction with water, alcohol or mixed solvents, extraction method using a bath or room temperature, etc. Including but not limited to.

In a preferred embodiment of the present invention, dried herbal medicines may be washed to remove foreign substances, etc. present on the surface of the material, and then dried in a dryer, mixed in an appropriate blending ratio, and ground to obtain the herbal powders.

In addition, 5 to 20 times, preferably 10 to 15 times the volume / weight of distilled water, lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof, preferably distilled water alone or 10 to 50% of the powdered complex herbal medicines. A mixed solvent of water and ethanol is added and cold-pressed at a temperature of 0 ° C to room temperature, preferably 4 to 6 ° C for 12 hours to 48 hours, preferably 20 to 24 hours, or 80 to 110 ° C, preferably 1 to 24 hours, preferably 2 to 5 hours at an extraction temperature of 90 ℃ or more by extracting 2 to 5 times with water of 20 to 50 times the total amount of extraction by a hydrothermal extraction method without pressure to the complex herbal extracts available in polar solvents Extracts can be obtained.

In addition, after filtering the extract obtained from the extraction step, it was concentrated under reduced pressure at 80 to 90 ℃ concentrated X 1 to 5 times azeotropically with water of 10 to 60 times the total amount of X, then hot air drying or vacuum drying Preferably, the hot air is dried to obtain a powder extract. By the same method as described above, the present invention may additionally contain Myeongilyeop, Taxa, Baekbak, Baekbokyeong, Licorice, Agaricus or Ginger extract in addition to the essential active ingredients including the jinjin, baekchul, fingering, seungsong and yeongseol extract.

Complex herbal extracts for preventing and treating liver disease of the present invention is not limited thereto, but is based on the dry weight of each herbal medicines 1-10: 1-10: 0.1-5: 0.5 -5: It is preferable to contain in ratio of 0.5-10. The herbal extracts have been used as food for a long time as the extract of the present invention extracted therefrom also has no problems such as toxicity and side effects.

In addition, as a result of examining the effect on the carbon tetrachloride-induced chronic liver disorder of the composition obtained by the above method, it was confirmed that the effect of improving the liver disorder, significantly inhibits the progression of fibrosis of liver tissue in cirrhosis.

In addition, the present invention provides a pharmaceutical composition for preventing and treating liver disease, which comprises the complex herbal extract and comprises a pharmaceutically acceptable carrier, excipient or diluent.

The pharmaceutical dosage forms of the extracts 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.

Pharmaceutical compositions comprising extracts according to the invention, in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral preparations, suppositories and sterile injectable solutions, respectively, according to conventional methods. Can be formulated and used. Carriers, excipients and diluents that may be included in the composition comprising the extract 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 such solid preparations may include at least one excipient such as starch, calcium carbonate and 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 extract of the present invention is preferably administered at 0.0001 to 100 mg / kg, preferably 0.001 to 100 mg / kg per day. 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.

Complex herbal extract of the present invention is a drug that can be used with confidence even when taken for a long time for the purpose of prevention because there is little toxicity and side effects.

In addition, the present invention provides a health functional food for improving liver function, including the complex herbal extract and food supplements acceptable food supplement.

In detail, the present invention provides a health functional food for preventing and treating liver disease, including a multi-medicinal herb extract containing foods of jinjin, baekchul, fingertips, turmeric, and ghost extract as an active ingredient and a food supplement acceptable additive. . The health functional food of the present invention includes the complex herbal extract in the form of a ground powder, extract or powder extract. At this time, the complex herbal extracts containing phosphorus, white extract, fingering, seungsong, nysing in the ratio of 1-10: 1-10: 0.1-5: 0.5-5: 0.5-10 based on the dry weight of each herbal medicine Preferably, the essential active ingredient may further contain one or more herbal extracts selected from the group consisting of Myeongilyeop, Taxa, Takbak, Baekbokyeong, Licorice, Agaricus and Ginger.

The composition containing the extract of the complex herbal medicine of the present invention can be used in a variety of drugs, food and beverages for the prevention and treatment of liver disease. Foods to which the complex herbal extract of the present invention may be added include various foods, for example, beverages, gums, teas, vitamin complexes, health supplements, and the like, pills, powders, granules, acupuncture tablets, capsules, or the like. It can be used in the form of a drink. 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 1g based on 100 ml. have.

The health functional beverage composition of the present invention is not particularly limited to other ingredients except for having the extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates, etc. as additional ingredients, as in general beverages. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those mentioned above, natural flavoring agents (tauumatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of said natural carbohydrates is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.

In addition to the above, the extract of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the extracts of the present invention may contain flesh for the production of natural fruit juices and 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 detail by the following Examples and Experimental Examples.

However, the following Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following Examples and Experimental Examples.

Example 1 Preparation of Complex Herbal Extract 1

After washing the phosphorus, baekrye, fingering, wasong, and deceased purchased from Kyungdong market cleanly, 10g of phosphorus 2g, baekrye 1.7g, 1g of fingering, 0.7g, yeongsong and 10g of ethanol are extracted into the extractor (medicinal weight ± 10 ) Was immersed for 12 hours or more, and the mixture was extracted under reflux at a primary pressure for 2 hours at 105 ° C. After that, the extract was filtered again and the residue was extracted under reflux with a secondary volume of water at a secondary pressure. The extract was filtered with a filter (filtration seive NO .: 140 (106 µm)), and each filtrate was collected and concentrated under reduced pressure at 80-90 ° C. The total concentrate was about 1 L (concentration of the concentrate was about 1.2-1.3, Brix: 60). Or more). The extract concentrated under reduced pressure was dried in a hot air dryer at 60 ° C. so as to have a water content of 5% or less, and the sample was pulverized. The powder was obtained through 50 (phi 300 micrometer) sieve.

Example 2. Preparation of Complex Herbal Extract 2

Injin, Baekchul, Cloudy, Wasong, Ghost, Myeong Il-Yop, Taxi, Hubak, Baekbokyeong, Licorice, Agaricus and Ginger purchased from Kyungdong Market, 2g, Baek 1.7g, 1g, Finger Song 0.7g, Dry powder was obtained using the same method as in Example 1, 1 g, 0.7 g of fresh day leaves, 1.7 g of tack, 0.7 g of thick, 0.7 g of Baekbokyeong, 0.7 g of licorice, 1.3 g of agaricus, and 0.3 g of ginger.

Experimental Example 1. Effect on carbon tetrachloride-induced chronic liver disorder

In order to confirm the improvement effect on the liver damage of the composition according to the present invention with the extract prepared in Examples 1 and 2 was examined the improvement effect on carbon tetrachloride-induced rat liver damage using the following experimental method .

1-1. Preparation of Reagents and Laboratory Animals

Reagents were purchased with CCl ₄ (carbon tetrachloride Sigma Co.), olive oil (Sigma Co.), alanine amino trasperase (ALT, GPT, Stanbio Co.) and aspartate amino transferase (AST, GOT, Stanbio Co.). Used.

The experimental animals were SD rats (Sparague-Dawley) rats weighing about 200 g in weight, and feed (Harlan, teklan. USA) and drinking water were freely ingested. The temperature of the kennel was 21-24 ℃ and the relative humidity was 60%. Maintained inside and outside. In addition, the light in the kennel was adjusted to repeat day and night every 12 hours.

1-2. Effects on carbon tetrachloride-induced chronic liver failure

Normal group received saline only for 4 days. In the control group, a mixture of olive oil and carbon tetrachloride 1: 1 (v / v) was intraperitoneally administered to each rat at 1.0 mg / kg for 3 days to induce acute hepatotoxicity, followed by saline. Was administered. In experimental group MC, a mixture of olive oil and carbon tetrachloride 1: 1 (v / v) was intraperitoneally administered to each rat at 1.0 mg / kg / kg for 3 days to induce acute hepatotoxicity, and in Example 1 The prepared extract was suspended in 1% carboxymethyl cellulose, and 6 mg / kg, 30 mg / kg, and 60 mg / kg were orally administered for 4 days after the administration of the carbon tetrachloride solution. Meanwhile, the experimental group AC was intraperitoneally administered with a solution of olive oil and carbon tetrachloride 1: 1 (v / v) in a dose of 1.0 mg / kg per weight (kg) for 3 days to induce acute hepatotoxicity. The extract prepared in 2 was suspended in 1% carboxymethyl cellulose, and 6 mg / kg, 30 mg / kg, and 60 mg / kg were orally administered for 4 days after administration of the carbon tetrachloride solution for 1 hour. On the last day of the test, the animals were anesthetized, and 1.5 ml of blood was collected and perfused. The collected blood was centrifuged at 3000 rpm for 20 minutes, and GOT and GPT were measured using CH100 ⁺ (SEAC Co.). Experimental group settings and experimental schedules are listed in Table 1.

group Dosage group (days) One 2 3 4 Normal Saline + Saline Saline Control CCl ₄ -olive oil (1: 1) + saline Saline HA MC ^*  x 1 CCl ₄ -olive oil (1: 1) + HA MC HA MC x 5 x 10 HA AC ** x 1 CCl ₄ -olive oil (1: 1) + HA AC HA AC x 5 x 10

* MC: Combination extract consisting of five main medicines

** AC: Combination extract of 12 kinds of main medicine and auxiliary herbal medicine

In liver-induced model of carbon tetrachloride, the GOT and GPT activities of serum-derived hepatocytes were measured, and the five medicinal herbs that make up HA decreased in a dose-dependent manner and were treated with 30 mg / kg dose. There was a significant difference in the test group administered at the mg / kg dose (P <0.05 ^* , P <0.01 ^** ) (FIGS. 1A and 1B). In addition, the extract of the 12 combinations in the carbon tetrachloride-induced liver disease model animals lowered the activity of GOT and GPT in a dose-dependent manner, showing a significant difference in all 12 mg, 60 mg, 120 mg compared to the control group (P <0.05 ^* , P <0.01 ^** ) (FIGS. 2A and 2B). Therefore, it was confirmed that the composition of the present invention has an excellent effect on improving liver function.

Experimental Example 2. Collagen distribution of liver tissue and improvement effect of GOT and GPT

In order to confirm the improvement effect on the cirrhosis of the composition according to the present invention with the extract prepared in Examples 1 and 2 was examined the improvement effect on rat cirrhosis using the following experimental method.

2-1. Preparation of Reagents and Laboratory Animals

The reagent is DMN (Dimethylnitrosamine, Sigma co.), Alanine amino trasperase (ALT, GPT, Stanbio Co.) and aspartate anino transferase (AST, GOT, Stanbio Co.) were used and purchased.

The test animals were Wister rats weighing about 270g, and the feed (Harlan, teklan USA) and drinking water were freely ingested. The temperature of the kennel was maintained at 21 ~ 24 ℃ and the relative humidity was about 60%. It was. In addition, the light in the kennel was adjusted to repeat day and night every 12 hours.

2-2. Collagen distribution of liver tissue and improvement of GOT and GPT in liver cirrhosis

In the normal group, saline was administered orally for 4 weeks for 3 days a week. Meanwhile, in the control group, 1% DMN was administered intraperitoneally at a dose of 10 μl / kg / day to induce cirrhosis, followed by saline, and experimental group MC was prepared in Example 1 instead of saline instead of 30 mg / kg / day. The extract was orally administered for 4 weeks, and the experimental group AC was orally administered with the extract of 60 mg / kg / day prepared in Example 2 for 4 weeks. On the last day of the test, the animals were anesthetized, 1.5 ml of blood was collected, perfusion fixed, and liver tissues were separated. After the blood was centrifuged at 3000 rpm for 20 minutes, GOT and GPT were measured using CH100 ⁺ (SEAC Co.) (see FIGS. 3A and 3B).

On the other hand, in order to determine the distribution of collagen fibers on isolated liver tissue, Masson trichrome staining was performed to stain only collagen fibers. The separated liver tissue was paraffin embedded using an automatic tissue processor (Citadel 2000, Shandon Co.) and cut into 4 μm thicknesses using a tissue cutter (LEICA RM2145), followed by an image analysis system. Five parts of each tissue were selected to measure the fibrin ratio and the average value thereof was calculated and expressed as the amount of collagen fibers (see FIG. 4).

As a result, the extracts of the five main liquid extracts as well as the extracts of the 12 complexes in DMN-induced cirrhosis model animals lowered the activities of GOT and GPT as compared to the control group. In addition, the collagen fiber showed no significant change in the normal range of about 0.53 in the normal group, and the control group was 2.93, but 1.21 in the HA MC (about 5 species) administration group and 1.05 in the HA-AC (all 12 species) group. In comparison, it was confirmed that hepatic fibrosis was inhibited.

Experimental Example 3. Toxicity Test

In order to investigate the presence of toxicity by oral administration to the rats of the composition of Example 1, male and female rats of the SD line were respectively administered 1 g / kg, 2 g / kg and 5 g / kg in three doses of 5 The animals were orally administered once and observed for 14 days of death, general symptoms, weight change and autopsy findings. The result of this test is as follows.

(1) There were no deaths observed during the entire test period in all administration groups of the composition of the present invention during the test period, and there was no change in general symptoms specifically observed compared to the control group.

(2) Body weight change showed significant weight loss on day 3 after administration in 5 g / kg dose group, but was not different from control group in all other administration groups.

As a result, no clinical symptoms were observed in all the test substance-treated groups compared to the death and control groups, and there were almost no specific symptoms in the anatomical changes at the time of body weight and autopsy. In addition, since the composition did not show a clear toxicity at the dose of 5 g / kg or less, LD ₅₀ (lethal dose) in rats by oral administration is determined to be more than 5 g / kg.

Extract of the present invention can be administered in the following formulations, the formulation examples below are merely to illustrate the invention, whereby the content of the invention is not limited.

Formulation Example 1 Preparation of Powder

20 mg of extract of Example 1

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

10 mg of extract of Example 1

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

10 mg of extract of Example 1

3 mg of crystalline cellulose

Lactose 14.8 mg

Magnesium Stearate 0.2 mg

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

10 mg of extract of Example 1

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

Na ₂ HPO _4, 12H ₂ O 26 mg

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

20 mg of extract of Example 1

10 g of isomerized sugar

5 g of mannitol

Purified water

According to the conventional method of preparing a liquid solution, each component is added to the purified water to dissolve it, the lemon flavor is added appropriately, the above components are mixed, purified water is added, the whole is adjusted to 100 ml by the addition of purified water, and then filled in a brown bottle. The solution is prepared by sterilization.

Formulation Example 6 Preparation of Healthy Food

1000 mg of the composition of the present invention

Zinc oxide 1.5 mg

Magnesium oxide 12 mg

Magnesium stearate 1.5 mg

PA Color Collar I 9 mg

Hydroxypropylmethylcellulose 6.8 mg

Glycerin Fatty Acid Ester 0.35 mg

Vitamin B 30 mg

Vitamin C 12 mg

Vitamin E 23 mg

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

Formulation Example 7 Preparation of Healthy Drink

1000 mg of extract of Example 1

Citric acid 1000 mg

100 g oligosaccharides

Plum concentrate 2 g

1 g of taurine

Add 900 ml of purified water

After mixing the above components in accordance with the conventional healthy beverage manufacturing method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed sterilization and refrigerated Used to prepare the healthy beverage composition of the invention.

 Although the composition ratio is a composition 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, use purpose.

As mentioned above, the composition of the present invention exhibits excellent liver function protection in carbon tetrachloride-induced liver failure, and is also stable in the human body while significantly lowering GOT and GPT levels in liver cirrhosis, thereby preventing liver cell protection and preventing liver damage or It can be usefully used for therapeutic medicines and dietary supplements.

1 is a diagram showing the effect according to the concentration-specific administration of the composite herbal extract of Example 1 of the present invention to carbon tetrachloride-induced rats, Figure 1a is a serum GOT results, Figure 1b is a diagram showing the serum GPT results,

Figure 2 shows the effect of the administration according to the concentration of the complex herbal extract of Example 2 of the present invention in carbon tetrachloride-induced rats, Figure 2a is a serum GOT results, Figure 2b is a diagram showing the serum GPT results,

Figure 3 shows the effect of the administration of the complex herbal extract of the present invention to cirrhosis-induced rats, Figure 3a is a serum GOT results, Figure 3b is a diagram showing the serum GPT results,

4 is a diagram illustrating the collagen distribution of liver tissue after administration of the complex herbal extract of the present invention to liver cirrhosis-induced rats.

Claims (8)

A pharmaceutical composition for preventing or treating liver disease, which comprises jinjin, baekrye, fingering, seungsong, and age extract as an essential active ingredient and a pharmaceutically acceptable carrier, excipient or diluent. The extract of claim 1, wherein the extract contains phosphorus, baekrye, fingering, wasong, mortality in a ratio of 1-10: 1-10: 0.1-5: 0.5-5: 0.5-10 based on the dry weight of each herbal medicine Pharmaceutical composition, characterized in that. The pharmaceutical composition according to claim 1, wherein the essential active ingredient further comprises at least one herbal extract selected from the group consisting of Myeongil, Taksa, Takbak, Baekbokyeong, Licorice, Agaricus, and Ginger. The pharmaceutical composition according to any one of claims 1 to 3, wherein the herbal extract is soluble in a polar solvent selected from water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof. A dietary supplement comprising phosphorus, baekrye, fingering, turmeric, and medicinal extracts, which have an effect of preventing or treating liver disease, as an essential active ingredient, and a food supplement that is acceptable as a food. 6. The extract of claim 5, wherein the extract contains phosphorus, baekrye, fingering, wasong, and ferment in a ratio of 1-10: 1-10: 0.1-5: 0.5-5: 0.5-10 based on the dry weight of each herbal medicine Health functional food characterized in that. The health functional food according to claim 5, wherein the essential active ingredient further comprises one or more herbal extracts selected from the group consisting of Myeong Il-Yeop, Taxa, Takbak, Baekbokyeong, Licorice, Agaricus, and Ginger. The health functional food of claim 5, wherein the food is a dietary supplement.