KR20100096565A - Composition comprising the peel extract of allium cepa l. for preventing and treating hepatic disease - Google Patents

Abstract

PURPOSE: A composition containing onion peel extract is provided to improve GOT(glutamic-oxaloacetic transaminase), GPT(glutamic-pyruvic transaminase) and LDH(lactate dehydrogenase) activation. CONSTITUTION: A pharmaceutical composition for preventing and treating liver diseases contains onion peel extract as an active ingredient. The onion peel extract is isolated using water, spirit, low alcohol of C1-C4, or mixture solvent thereof. A health food for preventing and treating liver diseases contains the onion peel extract as an active ingredient. The health food is manufactured in the form of powder, granule, tablet, capsule, or beverage.

Description

Composition for the peel extract of Allium cepa L. for preventing and treating hepatic disease}

The present invention relates to a composition for the prevention and treatment of liver disease containing onion peel extract as an active ingredient.

1 Moody et al., Proc. Natl. Acsd. SCI., 79 , pp . 2855-2859, 1982

Junqueira, et al., Toxicology , 41 , pp. 193-204, 1986

[Reference 3] Dong Joon Kim. et al., The Korean Journal of Hepatology, 14 , p.126, 2008

[4] Taejeon Kangsan and All Small and Medium, Diagnosis and Treatment, 65 , p.991, 1977

Recknagel et al., Life Sciences , 33 , pp. 401-408, 1983

[Document 6] Korean Patent Application, 10-06-0028689, Application for March 30, 2006

[Document 7] Son Jong-yeon et al., Korean Journal of Culinary Science, 1998

[Ref. 8] Na, Kyung-Soo et al., Korean Society of Food Science and Technology, 1997

[9] Cho Jung-soon et al., Journal of the Korean Nutrition Society, 1998

Reitman, S, Frankel, S., Am. J. Clin. Pathol ., 28 , pp. 56-63, 1957

[11] King, F. Clin. Chem ., 18 , p. 1443, 1972

The cause of tissue damage in vivo, including hepatocytes, is the production of lipid peroxidation by free radicals (O _2- , H ₂ O ₂ , OH), resulting in cell death and cell necrosis such as protein destruction, chromosomal aberration and red blood cell destruction. (Moody et al., Proc. Natl. Acsd. SCI., 79 , pp . 2855-2859, 1982; Junqueira, et al., Toxicology , 41 , pp. 193-204, 1986).

The prevalence and chronic mortality of chronic liver disease in Korea is high. According to statistics from the National Statistical Office, the mortality rate from liver disease in 2004 was 19.1 per 100,000 population, ranking 6th among men and 5th among men. In men in their 40s and 50s, liver disease is the second largest cause of death after cancer. In addition, chronic liver disease is the cause of liver cancer, and liver cancer is the third cancer registered in the country after stomach cancer and lung cancer, with about 10,000 new cases a year occurring in Korea. After all, chronic liver disease causes liver cancer as well as liver disease itself, so liver cancer and chronic liver disease should be identified as one category, but the current statistical data classification system separates the effect of chronic liver disease than it actually is. It is easy to grasp. Moreover, complications such as cirrhosis and liver cancer are prone to occur in the 40s and 50s with active economic activity, and problems caused by chronic liver disease are not limited to individuals but affect the existence of an entire family and ultimately reduce social productivity. It becomes a factor.

There is no large epidemiologic study of the cause of chronic liver disease in the entire population, but chronic liver disease caused by hepatitis B virus is the most common (~ 70%), and alcoholic or hepatitis C virus ranks next. do. In other words, hepatitis B is the most important cause in Korea (Dong Joon Kim. Et al., The Korean Journal of Hepatology, 14 , p.126, 2008).

Methods for screening liver function improving agents include lactate dehydrogenase (lactate dehydrogenase), which is secreted from damaged liver by treating carbon tetrachloride, which is a liver damage substance, and a sample material with respect to hepatocytes or plasma collected from a test animal itself or a test animal; LDH), glutamine oxaloacetic transaminase (GOT), glutamine pyruvic transaminase (GPT) and other methods to compare the inhibitory effect of the enzyme mainly adopted (Taejeon Kangsan and All Small and Medium, Diagnosis and Treatment, 65 , p. 991, 1977).

Carbon tetrachloride is a drug that causes experimental liver failure.CCl ₃ free radicals produced by the mixed function (cytochrome P ₄₅₀ ) oxidase system in the body are strongly covalently bonded to the membrane protein thiol of the liver microsomes, resulting in membrane lipid peroxidation. Facilitates the reaction and causes disorders, resulting in inhibition of protein synthesis in the liver, decrease in glycogen levels, release of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) into the blood, and histologically, necrosis and fibrosis of hepatocytes (Recknagel et al., Life Sciences , 33 , pp. 401-408, 1983).

Onion of the present invention (Allium cepa L.) is a perennial plant belonging to the genus Liliaceae, the flowers bloom in September in white, forming a stalk in the end of the flower stems between the leaves and rounded like a ball. The stalk is cylindrical, reaches 50 ~ 100cm high, the bottom is swollen, and 2 ~ 3 leaves hang under it. The shell is divided into 6 pieces, and the split pieces are shaped like an upside down egg and spread horizontally. There are six stamens, three of which have small bumps on both sides under the operating table, with one pistil. The varieties are divided into round shape, flat round shape, and red, yellow and white scales of the scales. It is also divided into sweet onions and spicy onions. The varieties cultivated in Korea include the yellow, yellow, horticultural 1, horticultural 2, aegean and shellfish. Harvesting is usually done when the leaves fall and have a little green color in June ~ July, and the leaves are edible before the scales grow. Onions are mainly edible, and the peculiar smell of scales is due to compounds such as propyl disulfide and allyl sulfide. It promotes the secretion of digestive juices physiologically and has an effect such as excitement, sweating and diuresis. In addition, the scales contain minerals such as calcium and phosphate together with various vitamins to remove harmful substances in the blood. Scales are often used in salads, soups, and meat dishes, and are used as spices in various dishes. The leaves contain vitamin I 5,000 IU, vitamin C 45 mg, calcium 80 mg, magnesium 24 mg and potassium 220 mg in 100 g.

Studies related to onion peels include the present invention's prevention and treatment of diabetes with onion peel extract (Korean patent application, 10-06-0028689, filed on March 30, 2006), antioxidant and synergistic effect of onion peel extract (Song Jong-yeon et al., Korean Culinary Research Division) Journal, 1998), Antioxidant Effect of Solvent Extracts Isolated from Onion Peel (Na Kyung et al., Korean Journal of Food Science and Technology, 1997), Antioxidant Effects of Solvent Extracts of Onion Peel and Onion Peel (Jung Soon et al., Korean Journal of Nutritionists, 1998) There is no disclosure or teaching about the effect of preventing and treating liver peel liver disease in any of the above documents.

Therefore, the present inventors conducted the pharmacological effect of onion peel extract to find an excellent substance that is effective in the prevention and treatment of liver disease without side effects in the living body, and the onion peel extract improves GOT, GPT and LDH activity of plasma. The present invention was completed by confirming the effect.

In order to accomplish the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of liver disease containing onion (Allium cepa L.) peel extract as an active ingredient.

In addition, the present invention provides a health functional food for the prevention and improvement of liver disease containing onion peel extract as an active ingredient.

The extract as defined herein includes an extract selected from water, spirits, lower alcohols of C ₁ to C ₄ or mixed solvents thereof, preferably alcohols, including purified water.

Liver diseases as defined herein are specifically acute and chronic hepatitis, cirrhosis, fatty liver or hepatic fibrosis, preferably acute and chronic hepatitis.

Hereinafter, a method of obtaining the onion peel extract of the present invention will be described in detail.

First, the dried onion skin is pulverized, and then about 0.1 to 100 times (v / w), preferably about 1 to 50 times (v / w), more preferably 10 to 30 times (v) of the dried sample weight. / w) a solvent selected from water, alcohol, C ₁ to C ₄ lower alcohols or a mixed solvent thereof, preferably alcohol, about 1 to 48 hours at room temperature, preferably 20 to 28 After extracting using an extraction method such as hot water extraction, cold needle extraction, reflux cooling extraction or ultrasonic extraction for a time, the onion peel extract of the present invention can be obtained through a manufacturing process of filtration under reduced pressure.

The present invention provides a pharmaceutical composition for the prevention and treatment of liver disease containing the onion peel extract obtained by the above method as an active ingredient.

The pharmaceutical composition containing the extract of the present invention contains the extract in an amount of 0.1 to 50% by weight based on the total weight of the composition.

However, the composition as described above is not necessarily limited thereto, and may vary according to the condition of the patient and the type and extent of the disease.

The 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.

The compositions of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions.

The compositions of the present invention can be used in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral formulations, external preparations, suppositories, and sterile injectable solutions, respectively, according to conventional methods. 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 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 styrate talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters 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.

The preferred dosage of the composition of the present invention varies depending on the condition and the weight of the patient, the degree of disease, the type of drug, the route of administration and the period of time, but can be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 0.5 g / kg to 5 g / kg, preferably 1 g / kg to 3 g / kg per day. The administration may be carried out once a day or divided into several doses. Therefore, the above dosage does not limit the scope of the present invention in any aspect.

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

In addition, the present invention provides a health functional food for the prevention and improvement of liver disease containing onion peel extract obtained by the above method as an active ingredient.

The composition comprising the extract of the present invention can be used in various ways, such as drugs, foods and drinks for the prevention and improvement of liver disease. Foods to which the extract of the present invention may be added include, for example, various foods, beverages, gums, teas, vitamin complexes, health supplements, and the like, and may be used in the form of powders, granules, tablets, capsules, or beverages. Can be.

Extracts of the present invention may be added to food or beverages for the purpose of preventing and improving liver disease. At this time, the amount of the extract in the food or beverage is generally the health food composition of the present invention can be added to 1 to 5% by weight of the total food weight, the health beverage composition is 0.02 to 10 g, preferably based on 100 ml Can be added in a ratio of 0.3 to 1 g.

In addition to containing the extract as an essential ingredient in the indicated ratio, the health beverage composition of the present invention is not particularly limited in the liquid component and may contain various flavors or natural carbohydrates as additional ingredients, as in general beverages. Examples of the above-mentioned natural carbohydrates include monosaccharides such as disaccharides such as glucose and fructose such as maltose, sucrose and the like and polysaccharides such as dextrin, cyclodextrin and the like Sugar, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those described above, natural flavoring agents (tauumatin, stevia extract (e.g., 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 composition 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 adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks, and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and vegetable beverages. These components can be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

Onion peel extract of the present invention, the onion peel extract of the present invention exhibits the effect of improving the GOT, GPT and LDH activity of plasma, can be used in pharmaceutical compositions and health functional foods useful for the prevention and treatment of liver disease.

Hereinafter, the present invention will be described in detail by reference examples, examples and experimental examples.

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

Example 1 Preparation of Onion Peel Extract

Peeled onion (Allium cepa L.) purchased from Changnyeong, Gyeongnam, lyophilized and 100 g of onion skin pulverized by crushing with a crusher was added 1.5 liter of alcohol and extracted for 24 hours at room temperature. After filtration under reduced pressure with), the filtrate was concentrated under reduced pressure with an idling concentrator (Tokyo Rikakikai Co. Ltd., EYELA) at 37 ° C. to obtain 10.2 g of onion peel alcohol extract, which was used as a sample of the following experimental example. ACE ").

Reference Example 1. Animal Model Preparation and Statistical Processing

1-1. Animal model preparation

Sprague-Dawley male rats (n = 21) with an average body weight of 120-150g were purchased from Hyochang Science (Daegu) and bred for 7 days before experiment at Inje University Animal Resource Center. It was.

In order to measure the effect of improving the in vivo liver function of the onion peel extract prepared in Example 1 divided the animals into three groups, normal control group, carbon tetrachloride Control and Carbon Tetrachloride Divided into onion peel group. The control group and the carbon tetrachloride control group were provided with a control diet, and the carbon tetrachloride onion shell group was provided with a diet containing 1% of the onion peel extract for 3 weeks. On the 21st day of the diet, the carbon tetrachloride control group and the carbon tetrachloride onion shell group were intraperitoneally injected with 1 ml / kg BW of carbon tetrachloride (carbon tetrachloride: corn oil = 1: 1 (v / v)) to induce hepatotoxicity. In addition, the normal control group was intraperitoneally injected with the same amount of corn oil.

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 twice a week.

1-2. Statistical analysis

All results were expressed as mean ± standard deviation. The significance test of each group was performed using ANOVA and Tukey's test was used as a follow test (α = 0.05).

Experimental Example 1. Measurement of dietary intake and weight gain

All experimental animals received the AIN-93G basic diet shown in Table 1 for three weeks.

Furtherance Control Diet (%) Onion Peel Extract Diet (%) Cornstarch ¹⁾ 39.7 38.7 Casein ²⁾ 20.0 20.0 Luxury starch 13.2 13.2 Sucrose ³⁾ 10.0 10.0 α-cellulose ⁴⁾ 5.0 5.0 Mineral mixtures ⁵⁾ 3.5 3.5 Vitamin mixtures ⁵⁾ 1.0 1.0 L-cystine ⁵⁾ 0.3 0.3 Choline bitartrate ³⁾ 0.25 0.25 4-butylhydroquinone 0.0014 0.0014 Soybean oil ⁶⁾ 7.0 7.0 Onion Peel Extract (ACE) - 1.0 ¹⁾ Target company, Korea
²⁾ Murry goulburn Co., Australia
³⁾ Samyangsa, Korea
⁴⁾ Sigma, USA
⁵⁾ ICN Biochemical, USA
⁶⁾ CheilJedang, Korea

As shown in Table 2 below, the weights of the normal control group, carbon tetrachloride control group, and carbon tetrachloride onion shell group were 200.6 ± 21.26 g, 187.4 ± 19.2 g, and 191.4 ± 19.6 g, respectively. The dietary intakes of the normal control group, carbon tetrachloride control group, and carbon tetrachloride onion shell group were not significantly different from 5.0 ± 1.3 g / day, 19.8 ± 1.9 g / day, 20.4 ± 2.3 g / day, and 20.9 ± 2.83 g / day, respectively.

Weight (g) Dietary Intake (g / day) Normal control 200.6 ± 21.2 19.87 ± 1.9 Carbon tetrachloride control 187.4 ± 19.2 20.4 ± 2.3 Carbon tetrachloride onion peel group 191.4 ± 19.6 20.9 ± 2.8 Mean ± S.D.

Experimental Example 2 Plasma GOT, GPT and LDH Measurement

2-1. Sampling

The experimental animals of Reference Example 1-1 were sacrificed 24 hours after administration of carbon tetrachloride or corn oil. The animals using the choke by a carbon dioxide gas after 14 hours fasting prior to sacrifice into a EDTA (t e hylene diamine tetra acetic acid) by 10 ㎎ syringe. A blood sample was collected from the heart. Blood was centrifuged at 3,000 rpm for 15 minutes to collect plasma and stored at -70 ° C.

2-2. Plasma GOT Activity Measurement

Plasma GOT (glutamic-oxaloacetic transaminase) activity was measured using the assay kit (Asan Pharmaceutical Co., Ltd., Korea), using only RATEMAN method (Reitman, S, Frankel, S., Am. J. Clin. Pathol ., 28 , pp.56- 63, 1957).

Aspartic acid and alpha-ketoglutaric acid are converted into oxaloacetic acid and glutamic acid by GOT. The produced oxaloacetic acid is converted to malic acid by the action of MDH in the presence of coenzyme NADH. In this reaction, the absorbance decrease rate of NADH was measured to determine the activity of GOT.

After 1.0 mL of GOT substrate solution was warmed for 2 minutes in a 37 ℃ water bath, 0.2 mL of the plasma collected in Experimental Example 2-1 was added and reacted for 60 minutes in a 37 ℃ water bath. After 60 minutes, 1.0 mL of the coloring solution was added and left at room temperature for 20 minutes. Then, 10.0 mL of 0.4 N NaOH was added thereto, and the absorbance was measured at 505 nm. GOT standard solution (2 mM pyruvate) was developed for each concentration in the same manner as described above to measure the absorbance and extrapolated to the standard curve to calculate the concentration of the sample.

Experimental results, as shown in Figure 1, carbon tetrachloride Plasma GOT activity (402.0 ± 45.2 IU / L) of the control group was significantly higher than that of the normal control group (72.4 ± 16.4 IU / L). It was confirmed that liver damage occurred by administration (p <0.01). In addition, the plasma GOT activity of the carbon tetrachloride onion shell group was 200.7 ± 38.3 IU / L significantly decreased compared to the carbon tetrachloride control group (p <0.01).

2-3. Measurement of Plasma GPT Activity

Plasma GPT (glutamic-pyruvic transaminase) activity was measured using the assay kit (Asan Pharmaceutical Co., Ltd., Korea), using only RATEMAN method (Reitman, S, Frankel, S., Am. J. Clin. Pathol ., 28 , pp.56- 63, 1957).

Alanine and alpha-ketoglutaric acid are converted to pyruvic acid and glutamic acid by GPT. The pyruvic acid produced was converted to lactic acid by the action of LDH in the presence of coenzyme NADH. In this reaction, the rate of absorbance decrease of NADH was measured to determine the activity of GPT.

After 1.0 mL of GPT substrate solution was warmed in a 37 ° C. water bath for 2 minutes, 0.2 mL of the plasma obtained in Experimental Example 2-1 was added and reacted in a 37 ° C. water bath for 30 minutes. After 60 minutes, 1.0 mL of the coloring solution was added and left at room temperature for 20 minutes. Then, 10.0 mL of 0.4 N NaOH was added thereto, and the absorbance was measured at 505 nm. GPT standard solution (2 mM pyruvate) was developed for each concentration in the same manner as described above to measure the absorbance and extrapolated to a standard curve to calculate the concentration of the sample.

As shown in FIG. 2, the plasma GPT activity (316.7 ± 34.8 IU / L) of the carbon tetrachloride control group was significantly higher than that of the normal control group (57.9 ± 14.7 IU / L) (p <0.01). Plasma GPT activity of the carbon tetrachloride onion shell group was 179.0 ± 31.8 IU / L, which was significantly decreased compared to the carbon tetrachloride control group (p <0.01).

2-4. Measurement of Plasma LDH Activity

Plasma lactate dehydrogenase (LDH) activity was measured by King's method (King, F. Clin. Chem ., 18 , p. 1443, 1972) using an assay kit (Asan Pharmaceutical, Korea).

LDH results in the oxidation of NADH to NAD ⁺ , which catalyzes the conversion of pyruvic acid to lactic acid. The oxidation rate and the activity of LDH are shown proportionally. In this reaction, the rate of absorbance decrease of NADH was measured to obtain LDH activity.

0.05 ml of the plasma collected in Experimental Example 2-1 was taken and added to 1 ml of a mixture of lactate and NAD previously heated to 37 ° C., and the change in absorbance at 340 nm was measured for 1 minute.

Experimental results, as shown in Figure 3, carbon tetrachloride The plasma LDH activity (516.0 ± 48.1 IU / L) of the control group was significantly higher than that of the normal control group (195.4 ± 24.0 IU / L) (p <0.01). The plasma LDH activity of the carbon tetrachloride onion shell group was 387.1 ± 36.3 IU / L showed a significant decrease compared to the carbon tetrachloride control (p <0.01). Therefore, onion peel extract is thought to inhibit liver damage induced by carbon tetrachloride.

Experimental Example 3. Acute Toxicity Test

Acute toxicity test was performed using 6-week-old specific pathogen-free (SPF) SD rats. Two animals in each group were orally administered with onion peel extract of the present invention at a dose of 100 mg / kg. After administration of the test substance, mortality, clinical symptoms, and changes in body weight were observed. Hematological and hematological examinations were performed. Necropsy was performed to visually observe abnormalities in the tonic and thoracic organs.

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. As a result, the onion peel extract of the present invention does not show a toxic change even in rats up to 100 mg / kg, respectively, oral administration minimum dose (LD ₅₀ ) was determined to be a safe substance more than 100 mg / kg.

Hereinafter, the preparation examples of the composition including the onion peel extract of the present invention, but the present invention is not intended to limit it, but is intended to explain in detail only.

Formulation Example 1 Preparation of Powder

Onion Peel Extract (ACE) 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

Onion Peel Extract (ACE) 10 mg

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

Onion Peel Extract (ACE) 10 mg

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

Onion Peel Extract (ACE) 10 mg

180 mg mannitol

Sterile sterilized water for injection 2974 mg

Na2HPO4,12H2O 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

Onion Peel Extract (ACE) 20 mg

10 g of isomerized sugar

5 g of mannitol

Purified water

After dissolving each component in purified water according to the usual method of preparing a liquid solution, adding lemon flavor appropriately, mixing the above components, adding purified water, adjusting the whole to 100 ml by adding purified water, and then filling into a brown bottle. The solution is prepared by sterilization.

Formulation Example 6 Preparation of Healthy Food

Onion Peel Extract (ACE) 1000 mg

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 1.7 mg

Folate 50 ㎍

Calcium Pantothenate 0.5mg

Mineral mixture

Ferrous Sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

Potassium monophosphate 15 mg

Dibasic calcium phosphate 55 mg

Potassium Citrate 90 mg

Calcium Carbonate 100 mg

Magnesium chloride 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.

Formulation Example 7 Preparation of Healthy Drink

Onion Peel Extract (ACE) 1000 mg

Citric acid 1000 mg

100 g of oligosaccharide

Plum concentrate 2 g

Taurine 1 g

Purified water was added to a total of 900 ml

The above components were mixed according to a conventional health drink manufacturing method, and the mixture was heated at 85 DEG C for about 1 hour with stirring, and the solution thus prepared was filtered to obtain a sterilized 2-liter container, which was sealed and sterilized, &Lt; / RTI &gt;

Although the composition ratio is a mixture of the components suitable for the preferred beverage as a preferred embodiment, the blending ratio may be arbitrarily varied according to the regional and national preferences such as the demand level, the demanding country, and the intended use.

1 is a diagram showing the effect of improving the plasma GOT activity of onion peel extract in carbon tetrachloride-induced liver damage animal model,

Figure 2 is a diagram showing the effect of improving the plasma GPT activity of onion peel extract in carbon tetrachloride-induced liver damage animal model,

Figure 3 is a diagram showing the effect of improving the plasma LDH activity of onion peel extract in carbon tetrachloride-induced liver damage animal model.

Claims (6)

A pharmaceutical composition for the prevention and treatment of liver disease, which contains onion (Allium cepa L.) bark extract as an active ingredient. The pharmaceutical composition according to claim 1, wherein the extract is an extract available in a solvent selected from water, spirits, C ₁ to C ₄ lower alcohols, or a mixed solvent thereof, including purified water. The pharmaceutical composition according to claim 1, wherein the liver disease is acute chronic chronic hepatitis, cirrhosis, fatty liver or liver fibrosis. The pharmaceutical composition according to claim 1, comprising 0.1 to 50% by weight of the onion peel extract based on the total weight of the composition. Health functional food for the prevention and improvement of liver disease containing onion peel extract as an active ingredient. A dietary supplement according to claim 5 which is a powder, granule, tablet, capsule or beverage.

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