Traditional Chinese medicine composition with effects of dispelling effects of alcohol and protecting liver as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with effects of dispelling effects of alcohol and protecting liver as well as a preparation method and application of the traditional Chinese medicine composition, and belongs to the technical field of medicines. The technical problem to be solved is to provide a safe and low-toxicity traditional Chinese medicine composition with the effects of dispelling the effects of alcohol and protecting the liver, the drunkenness state of a mouse can be effectively improved within the dosage range of each component, and meanwhile, the traditional Chinese medicine composition has similar drug effects compared with a clinical application drug metadoxine. The composition can remarkably prolong the drunkenness time of mice, shorten the sleep and sobering time and increase the food intake of the mice; the ethanol mass concentration and AST and ALT levels in serum of drunken mice are remarkably reduced, the activity of ADH, ALDH and SOD is remarkably improved, and the pathological state of the liver of the mice is improved. According to the technical scheme, the traditional Chinese medicine composition is prepared from the following raw materials: flos puerariae, semen hoveniae, pericarpium citri reticulatae viride, white poria, pericarpium citri reticulatae, fructus mume, fructus lycii and radix glycyrrhizae.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medicine, in particular to a traditional Chinese medicine composition with the effects of dispelling alcohol, protecting liver and hepatoprotective, a preparation method and application. BACKGROUND

[0002] For understanding the technical content of the present application: Wine has obvious damage to the human liver, excessive drinking is harmful to human health, and can also cause diseases. Alcohol can cause more than 200 diseases and injuries, including alcohol dependence, cirrhosis, tumors and cardiovascular diseases, mental illness, and injuries caused by violence, traffic accidents and collisions.

[0003] Alcoholism is commonly known as drunkenness. After alcohol enters the human body, 30% is absorbed by the stomach, and 70% is absorbed in the upper part of the small intestine. It is transported to the liver and other organs by the blood. More than 90% of the alcohol entering the human body is metabolized by the liver. After alcohol enters the liver cells, it is first converted into acetaldehyde, then into acetic acid, and finally decomposed into carbon dioxide and water and excreted from the body. Drunkenness is a series of manifestations of abnormal function of the body organs caused by the liver's inability to metabolize excessive alcohol. The symptoms that appear after excessive drinking mainly involve the following aspects: 1. Nervous system: abnormal mental state, dizziness, headache, drowsiness, ataxia, etc. 2. Circulatory system: rapid heart rate, flushed or pale face, etc. 3. Digestive system: nausea, vomiting, upper abdominal discomfort or pain, diarrhea, etc. In addition, some people experience fever, conjunctival hyperemia, blurred vision, decreased hearing, liver discomfort or pain, and severe cases can experience respiratory failure, shock, coma and other complications. Therefore, the prevention and treatment of drunkenness should focus on protecting the liver, improving the liver's metabolic rate of alcohol, and protecting and repairing the nervous system, cardiovascular system and digestive system. Reduce damage to other systems of the human body while reducing damage to the liver, and improve the symptoms of drunkenness.

[0004] At present, there are many alcoholism products on the market, but the effect is not good, the alcoholism speed is slow, and the protection of the liver and other systems of the human body is weak, and the improvement of the symptoms of drunkenness is not obvious.

[0005] The relevant patent documents searched: CN102657834A, published on September 12, 2012, discloses a traditional Chinese medicine for treating alcoholism and its preparation process. The medicine is made from medicinal materials including 6-40 parts of Hovenia dulcis Thunb, 6-50 parts of Pueraria lobata Ohwi, 6-30 parts of Citrus reticulata Blanco, 7-40 parts of Crataegus pinnatifida Bunge, 1-18 parts of Glycyrrhiza uralensis Fisch, 3-18 parts of Poria cocos, 1-18 parts of Zingiber officinale Roscoe, 1-18 parts of Stevia rebaudiana Bertoni, 3-18 parts of Polyporus umbellatus and 1-18 parts of Alisma orientale Sam. The Hovenia dulcis Thunb, Pueraria lobata Ohwi, Citrus reticulata Blanco, Crataegus pinnatifida Bunge, Glycyrrhiza uralensis Fisch, Zingiber officinale Roscoe and Stevia rebaudiana Bertoni are first crushed into coarse powder, then extracted with a polar solvent, and concentrated into traditional Chinese medicine extract. The Poria cocos, Polyporus umbellatus and Alisma orientale Sam are crushed into fine powder, then mixed with the traditional Chinese medicine extract to prepare the medicine.

[0006] The relevant non-patent literature searched is as follows: The Journal of Pharmacy Practice, "Study on the effect of Puerariae radix, Puerariae flos and Hoveniae fructus mixture on the acute alcoholism of mice", Vol. 35, Chapter 5, published on September 25, 2017, discloses the effect of Puerariae radix, Puerariae flos and Hoveniae fructus mixture on the acute alcoholism of mice. The acute alcoholism model of mice is established by alcohol gavage, the effect of different proportions of the mixture on the mice is observed, and the optimal proportion is selected. The mice are divided into a low-dose group and a high-dose group according to the optimal proportion, and the effect of the Puerariae radix, Puerariae flos and Hoveniae fructus mixture on the mice is observed by measuring the tolerance time, drunken time, ethanol concentration in blood and activity of ethanol dehydrogenase in liver of the mice. The results prove that the Puerariae radix, Puerariae flos and Hoveniae fructus mixture can increase the tolerance time of the mice to alcohol, shorten the drunken time of the mice, reduce the ethanol concentration in blood and improve the activity of ethanol dehydrogenase in liver.

[0007] Modern pharmacological studies show that natural medicine research and development driven by traditional Chinese medicine theory is a feasible method for treating alcoholism, protecting liver and preventing liver damage. Therefore, a new composition developed from plant medicinal materials can relieve the state of drunkenness, prevent the damage of alcohol to liver and gastric mucosa, and aims to more safely and effectively prevent and treat liver-related diseases caused by drinking and improve the life quality of long-term drinkers. SUMMARY

[0008] The purpose of the present application is to provide: A traditional Chinese medicine composition with the effects of treating alcoholism, protecting liver and preventing liver damage and a preparation method thereof, and related technologies, to solve the technical problems of providing a new traditional Chinese medicine composition with the effects of treating alcoholism, protecting liver and preventing liver damage and the like or a combination thereof.

[0009] Term explanation: Unless defined otherwise, all technical and scientific terms used herein have the same meaning as those commonly understood by one of ordinary skill in the art to which this subject matter belongs. All patents, patent applications, publications, and other documents referred to in this text are hereby incorporated by reference in their entirety unless otherwise indicated. If this document incorporates one or more open-ended claims with terms such as "comprising," "including," "containing," "consisting of," and the like, it will be understood by those skilled in the art that when a combination is sought, the combination can include additional one or more elements or steps even though the claim is drafted to the particular combination.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the subject matter claimed. In this application, the use of the singular includes the plural unless specifically stated otherwise. It should also be noted that, unless otherwise indicated, the use of "or" in this text is used in the "and / or" sense unless otherwise indicated. Furthermore, the use of the term "including" as well as other forms such as "include", "includes," and "included" is not limiting.

[0011] Definitions of standard chemical terminology can be found in the reference "Pharmacopoeia of the People's Republic of China (2020 Edition)" China Medical Science and Technology Press: May 2020, 1st edition.

[0012] Unless otherwise specified, conventional methods used in the art of synthetic organic chemistry, such as those for mixing, separating, concentrating, drying, and the like, are employed.

[0013] Unless specifically defined otherwise, the use of each of the terms "a", "an", and "the" in this text is intended to include both singular and plural referents unless the context clearly dictates otherwise. The terms "comprising", "including", "containing", and "having" are used interchangeably in this text to mean inclusion of a recited item or group of items in a process, method, article, or apparatus that are useful in connection with the subject matter disclosed in this text. Further, the terms "comprise", "comprising", "include", "including", and "comprises" are not intended to be limiting in the sense of "consist only of". The terms "exemplary" and "for example" are used herein to mean "an example of" and are not intended to convey an indication of a recommended or preferred implementation. The term "or" is used in the "and / or" sense in this text unless otherwise indicated. The term "about" means "approximately" or "around", and is intended to convey that the value is within a reasonable range of the value being described, for example, within 10% of the value being described. The term "consisting essentially of" means that the composition, method or process can include additional steps, components, ingredients, compounds or elements, but only if no additional steps, components, ingredients, compounds or elements affect the basic and novel characteristics of the composition, method or process.

[0014] The term "pharmaceutically acceptable carrier", as used herein, refers to a pharmaceutically acceptable material, such as a liquid or solid filler, stabilizer, dispersing agent, suspending agent, diluent, excipient, thickening agent, solvent, or encapsulating material, involved in carrying or transporting any pharmaceutical composition from one organ, or portion of the body, to another organ, or portion of the body. Each carrier must be "acceptable" in the sense of being compatible with the other ingredients of the pharmaceutical composition and not injurious to the patient.

[0015] The term "mixing", as used herein, refers to the process of uniformly combining two or more substances through mechanical force or other means, with the core purpose of ensuring uniformity of ingredient distribution, thereby affecting the stability, effectiveness, and safety of the drug.

[0016] The term "separation", as used herein, refers to the process of separating different components in a mixture through physical or chemical means, with the core being to extract or purify the target substance by taking advantage of the differences in properties between components (such as solubility, density, boiling point, etc.).

[0017] The term "concentration" as used herein refers to a process of reducing solvent or carrier by physical or chemical methods to increase the concentration or relative content of the target component. The core is to realize solute enrichment by using the property difference (such as volatility, solubility, etc.) between components.

[0018] The term "drying" as used herein refers to a process of removing water or solvent from the material by physical or chemical methods to reduce the moisture content to the target range.

[0019] In a first aspect, the present application provides a traditional Chinese medicine composition with the effects of dispelling alcohol, protecting liver and hepatoprotective, which is composed of the following raw materials in parts by mass: Gegen 18-32 parts, Hovenia acerba 12-28 parts, green peel 8-18 parts, white Poria 5-18 parts, dried tangerine or orange peel 5-15 parts, dark plum 8-15 parts, medlar 3-10 parts and licorice 1-8 parts.

[0020] Among them, the technical features include the mass fraction of raw materials.

[0021] Any value or range in the above-mentioned numerical range can achieve the technical effect of the present application, for example: Gegen 18-32 parts, indicating that the mass fraction of Gegen can be selected from 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 31 parts, 32 parts or any range of two.

[0022] Hovenia acerba 12-28 parts, indicating that the mass fraction of Hovenia acerba can be selected from 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts or any range of two.

[0023] Green peel 8-18 parts, indicating that the mass fraction of green peel can be selected from 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts or any range of two.

[0024] White Poria 5-18 parts, indicating that the mass fraction of white Poria can be selected from 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts or any range of two.

[0025] Dried tangerine or orange peel 5-15 parts, indicating that the mass fraction of dried tangerine or orange peel can be selected from 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts or any range of two.

[0026] Wumei 8-15 parts, indicating that the mass fraction of Wumei can be selected from 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts or any range of two.

[0027] Gouqi 3-10 parts, indicating that the mass fraction of Gouqi can be selected from 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts or any range of two.

[0028] Gancao 1-8 parts, indicating that the mass fraction of Gancao can be selected from 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or any range of two.

[0029] Among them, the mass fraction of the technical feature raw material is preferably: Gufa 20-30 parts, Zhidouzi 15-25 parts, Qingpi 10-15 parts, Baifuling 8-15 parts, Chenpi 8-12 parts, Wumei 10-12 parts, Gouqi 5-8 parts and Gancao 3-5 parts.

[0030] Any value or range in the above-mentioned numerical range can achieve the technical effect of the present application, such as the examples in the foregoing, which will not be repeated here.

[0031] Among them, the mass fraction of the technical feature raw material is further preferably: Gufa 30 parts, Zhidouzi 25 parts, Qingpi 15 parts, Baifuling 15 parts, Chenpi 10 parts, Wumei 10 parts, Gouqi 8 parts and Gancao 5 parts.

[0032] The efficacy activity of each raw material in the present application is as follows: According to the compatibility rules of traditional Chinese medicine, the formula is simple and reasonable, and through scientific collocation, the ingredients interact with each other, the function is more complete, the nature is more mild, at the same time, the raw material source is extensive, the cost is lower, the safety and side effect are small, the production process is simple, and it is suitable for industrialization.

[0033] The pharmacological effects of the compatible traditional Chinese medicines in each group are described as follows: Gufa, alias Gufa flower, is the dried flower of wild kudzu or kudzu vine. Gufa is cool in nature and sweet in taste, and belongs to the spleen and stomach channel. It was first recorded in "Famous Doctors". As a traditional alcoholism special medicine, its "alcoholism detoxification, liver and stomach" effect is clearly recorded in "Shennong Bencao Jing Shu". In modern patents, Gufa is listed as the core component of alcoholism tea, which confirms its traditional application value of alcoholism detoxification. It contains isoflavone components such as puerarin, soybean glycoside, saponin such as sophora flower saponin, and volatile oil components. It can reduce the absorption rate of ethanol, speed up the metabolism of acetaldehyde, relieve dizziness and vomiting, promote the absorption of vitamin D, and reduce alcohol-induced gastritis.

[0034] Hovenia dulcis Thunb. seed or fruit stalk. It is neutral in nature and sweet and sour in taste. It belongs to the heart and spleen channels. It is recorded in Bencao Zhijia that it can stop thirst, relieve restlessness, detoxify alcohol, and benefit urination and defecation. The chemical components include loline, quercetin, kaempferol, glucose, and potassium malate. Hovenia dulcis has significant diuretic, antihypertensive, alcohol detoxification, liver protection, and anti-inflammatory effects. Hovenia dulcis homogenate has anti-lipid peroxidation, cold tolerance, and heat tolerance.

[0035] Pericarpium Citri Reticulatae Viride, also known as green orange peel, is the dried immature fruit or pericarp of the Rutaceae plant. It is warm in nature and bitter and acrid in taste, and belongs to the liver, gallbladder, and stomach channels. It is said in Bencao Gangmu that it can "dissipate liver and gallbladder, and expel lung qi". It contains volatile oil components such as limonene and linalool, as well as flavonoid components such as hesperidin and naringin. It has the effects of soothing the liver and clearing heat, resolving food accumulation and abdominal pain, relieving depression and opening the orifices, and anti-inflammatory White Poria cocos, also known as Poria cocos, Yunling, and Anling, is the dried sclerotium of the Polyporaceae fungus Poria cocos. The white one is the best. It is neutral in nature and sweet and bitter in taste, and belongs to the heart, lung, spleen, and kidney channels. It is recorded in Bencaoping Huizhengyao that it can "benefit water and remove dampness, and invigorate the spleen and calm the heart". It contains polysaccharide components such as β-pachyman (>60%), triterpenoid components such as pachymic acid and dehydro-pachymic acid, and minerals such as zinc and selenium. It has the effects of benefiting water and removing dampness, whitening and lightening spots, spleen deficiency and dampness, edema, cough and sputum, anti-inflammatory and immune.

[0036] Pericarpium Citri Reticulatae, also known as orange peel and Guangchenpi, is the dried mature fruit of the Rutaceae plant. It is warm in nature and bitter and acrid in taste, and belongs to the lung and spleen channels. It is called in Bencaojing that it can "mainly invigorate the spleen, and reverse vomiting". It contains flavonoids including nobiletin, hesperidin, and volatile oil. It has the effects of regulating qi and invigorating the spleen, drying dampness and resolving phlegm, and is used for chest and abdominal distension, food and vomiting, cough and sputum, and anti-ulcerative colitis, and reducing rheumatoid arthritis.

[0037] Prunus mume, also known as Meishi and Suamei, is the dried nearly mature fruit of the Rosaceae plant Prunus mume. It is neutral in nature and sour and astringent in taste, and belongs to the liver, spleen, lung, and large intestine channels. It contains citric acid and tannins, and has the effects of astringing the intestines and stopping diarrhea, antibacterial, treating chronic cough, and treating chronic cough, and treating chronic cough.

[0038] Medlar, also known as Medlar Fruit, Xigouqi, and Jinqi Medlar, is the dried mature fruit of the Solanaceae plant Ningxia Medlar. It is neutral in nature and sweet in taste, and belongs to the liver and kidney channels. It contains betaine, polysaccharides, crude fat, crude protein, thiamine, riboflavin, nicotinic acid, carotene, ascorbic acid, nicotinic acid, β-sitosterol, linoleic acid, trace elements, and amino acids. It has the effects of improving immune regulation, removing free radicals, and protecting tissues. It is suitable for deficiency and loss of essence, and low immunity.

[0039] Licorice, also known as Guo Lao, Fencao, and Tiancaogen, is the dried root and rhizome of Glycyrrhiza uralensis Fisch, G. inflate Batal. or G. glabra L. It is flat in nature and sweet in flavor. It belongs to the heart, lung, spleen and stomach channels. Licorice contains many chemical components, but mainly glycyrrhizin and glycyrrhetic acid. It can tonify the spleen and replenish qi, clear heat and resolve toxicity, expel phlegm and relieve cough, relieve acute and chronic pain, and harmonize various drugs. It is used for spleen and stomach weakness, fatigue, palpitation, shortness of breath, cough with much phlegm, abdominal and limb pain, and can relieve drug toxicity and virulence. It has the functions of tonifying qi, moistening the lungs, relieving cough, clearing heat and resolving toxicity, relieving acute and chronic pain, and harmonizing the properties of drugs.

[0040] The above-mentioned 8 natural plant materials have the effects of antioxidant, anti-inflammatory, promoting lipid metabolism, dispelling and sobering up, protecting liver and stomach mucosa, and can significantly improve the state of drunkenness, shorten the time of drunkenness, promote the metabolism of alcohol in the body, reduce the damage to the gastrointestinal tract and liver caused by alcohol, and have the effects of clearing heat and resolving toxicity, warming the center to stop vomiting, dispelling and sobering up, protecting the liver, gastrointestinal tract and cardiovascular system, and reducing the medical costs caused by excessive alcohol intake. After taking it, there are basically no side effects, and it is suitable for long-term use.

[0041] Based on the further solution or simultaneous solution of multiple technical problems of the technical problem of the present application, in the technical solution provided in the first aspect of the present application, the preferred scheme comprises: The first preferred scheme: according to the mass fraction, the following raw materials are used: 20-30 parts of Flos Puerariae, 15-25 parts of Hovenia dulcis Thunb, 10-15 parts of Pericarpium Citri Reticulatae Viride, 8-15 parts of Poria cocos, 8-12 parts of Pericarpium Citri Reticulatae, 10-12 parts of Prunus mume, 5-8 parts of Lycium barbarum and 3-5 parts of Glycyrrhiza uralensis. This technical solution further solves the technical problem of "significantly prolonging the time of drunkenness, shortening the sleep and sobering-up time caused by drunkenness; significantly reducing the ethanol concentration, AST and ALT levels in the serum of drunken mice; significantly increasing the activities of ADH, ALDH and SOD in liver tissue; and significantly reducing liver tissue lesions" on the basis of solving the technical problem of "prolonging the time of drunkenness, shortening the sleep and sobering-up time caused by drunkenness; reducing the ethanol concentration, AST and ALT levels in the serum of drunken mice; increasing the activities of ADH, ALDH and SOD in liver tissue; and reducing liver tissue lesions".

[0042] The second priority scheme: according to the quality parts, the raw materials are composed of: Gegen 30 parts, Hovenia dulcis Thunb. 25 parts, green skin 15 parts, white Poria cocos 15 parts, dried tangerine or orange peel 10 parts, dark plum 10 parts, medlar 8 parts and licorice 5 parts. The technical scheme solves the technical problems of "prolonging the drunk time, shortening the sleep and sober-up time caused by drunkenness; reducing the ethanol concentration, AST and ALT levels in the serum of drunken mice; increasing the ADH, ALDH and SOD activities in the liver tissue; and reducing the liver tissue lesions", and further solves the technical problems of "more significantly prolonging the drunk time, shortening the sleep and sober-up time caused by drunkenness; more significantly reducing the ethanol concentration, AST and ALT levels in the serum of drunken mice; more significantly increasing the ADH, ALDH and SOD activities in the liver tissue; and more significantly reducing the liver tissue lesions".

[0043] In the second aspect, the application provides a preparation method of the traditional Chinese medicine composition, including the following steps: S1: mixing raw materials, water extraction 2-4 times, combining, to obtain water extract; S2: concentrating the water extract, alcohol precipitation, separation, obtaining supernatant, concentrating, drying, to obtain the traditional Chinese medicine composition.

[0044] In step S1, the technical feature of water extraction is that the raw materials are mixed with 8-10 times the mass of water, decocted for 0.5-1.5 h each time, and the decocted liquids are combined to obtain the water extract.

[0045] Any value or range within the above-mentioned numerical range can achieve the technical effects of the application. As examples in the foregoing, they will not be repeated here.

[0046] In step S1, the technical feature of water extraction is preferably that the raw materials are mixed with 10 times the mass of water, decocted for 1.5 h at a time, 8 times the mass of water is added after the decocted liquid is collected, decocted for 1 h, 8 times the mass of water is added after the decocted liquid is collected, decocted for 0.5 h, the decocted liquids are combined, and the water extract is obtained.

[0047] In step S2, the technical feature of alcohol precipitation is that the water extract is concentrated to 1.1-1.3 g crude drug / mL, ethanol is added to reach an alcohol content of 70-80 wt%, and the mixture is allowed to stand for 20-24 h, filtered, the supernatant is taken, and the ethanol is recovered.

[0048] Any value or range within the above-mentioned numerical range can achieve the technical effects of the application. As examples in the foregoing, they will not be repeated here.

[0049] Based on the further solving or simultaneous solving of multiple technical problems of the technical problems of the application, in the technical scheme provided in the second aspect of the application, the preferred scheme includes: The first priority scheme: in step S1, the water extraction is that the raw material is mixed with 8-10 times the mass of water, decocted for 2-4 times, each time for 0.5-1.5 h, and the decocted liquid is collected to obtain the water extract. This technical scheme solves the technical problems of prolonging the drunken time, shortening the sleep and sober-up time caused by drunkenness, reducing the ethanol mass concentration, AST and ALT levels in the serum of drunken mice, increasing the ADH, ALDH and SOD activities in the liver tissue, and reducing the liver tissue lesions.

[0050] The second priority scheme: in step S1, the water extraction is that the raw material is mixed with 10 times the mass of water, decocted for 1.5 h, 8 times the mass of water is added after the decocted liquid is collected, decocted for 1 h, 8 times the mass of water is added after the decocted liquid is collected, decocted for 0.5 h, the decocted liquid is collected, and the decocted liquid is combined to obtain the water extract. On the basis of solving the technical problems of prolonging the drunken time, shortening the sleep and sober-up time caused by drunkenness, reducing the ethanol mass concentration, AST and ALT levels in the serum of drunken mice, increasing the ADH, ALDH and SOD activities in the liver tissue, and reducing the liver tissue lesions, the technical scheme further solves the technical problems of significantly prolonging the drunken time, shortening the sleep and sober-up time caused by drunkenness, significantly reducing the ethanol mass concentration, AST and ALT levels in the serum of drunken mice, significantly increasing the ADH, ALDH and SOD activities in the liver tissue, and significantly reducing the liver tissue lesions.

[0051] The third priority scheme: in step S2, the alcohol precipitation is that the water extract is concentrated to 1.1-1.3 g crude drug / mL, ethanol is added to reach 70-80 wt%, and then the mixture is statically placed for 20-24 h, filtered, the supernatant is taken, and the ethanol is recovered. On the basis of solving the technical problems of prolonging the drunken time, shortening the sleep and sober-up time caused by drunkenness, reducing the ethanol mass concentration, AST and ALT levels in the serum of drunken mice, increasing the ADH, ALDH and SOD activities in the liver tissue, and reducing the liver tissue lesions, the technical scheme further solves the technical problems of significantly prolonging the drunken time, shortening the sleep and sober-up time caused by drunkenness, significantly reducing the ethanol mass concentration, AST and ALT levels in the serum of drunken mice, significantly increasing the ADH, ALDH and SOD activities in the liver tissue, and significantly reducing the liver tissue lesions.

[0052] In a third aspect, the application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine with the effects of sobering up, protecting and repairing the liver.

[0053] Preferably, the dosage form of the medicine is granules, tablets, capsules, decoctions, pills, powders, or oral liquids.

[0054] Preferably, the medicament further comprises a pharmaceutically acceptable excipient.

[0055] The pharmaceutically acceptable excipient includes, but is not limited to, an excipient, a buffer, an emulsifier, a stabilizer, a diluent, a binder, a preservative, a lubricant, a pH adjuster, a cryoprotectant, a flavoring agent, a filler, and an antioxidant.

[0056] Preferably, the excipient is at least one selected from microcrystalline cellulose, lactose, pregelatinized starch, cyclodextrin, carboxymethyl cellulose, mannitol, magnesium stearate, starch, calcium phosphate, ethyl cellulose, methyl cellulose, alginic acid, gelatin, acacia, glyceryl monostearate, sodium starch glycolate, guar gum, glycerol, and propylene glycol.

[0057] Preferably, the buffer is at least one selected from sodium phosphate monobasic, sodium bicarbonate, ammonium bicarbonate, sodium acetate, citrate, histidine, succinate.

[0058] Preferably, the emulsifier is at least one selected from magnesium stearate, zinc stearate, calcium stearate, glyceryl stearate, sorbitan isostearate, sorbitan oleate, polyglyceryl-3 polyricinoleate.

[0059] Preferably, the stabilizer is at least one selected from acacia, agar, alginic acid, cellulose ether, carboxymethyl chitin.

[0060] Preferably, the diluent is at least one selected from erythritol, mannitol, sorbitol, xylitol, lactose, sucrose, corn starch, potato starch, calcium phosphate, calcium citrate, crystalline cellulose.

[0061] Preferably, the binder is at least one selected from ethanol, starch paste, pregelatinized starch, dextrin, sugar syrup, hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyethylene glycol, sodium alginate, polyvinylpyrrolidone, acacia, gelatin, alginic acid.

[0062] Preferably, the preservative is at least one selected from methylparaben, propylparaben, nipagin, nipasol, nipasate, chlorobutanol, thiomersal, merfen, phenoxyethanol, chlorhexidine, benzoic acid, sodium benzoate, chlorocresol, benzalkonium bromide, benzalkonium chloride, hydroxyphenyl ethyl ester.

[0063] Preferably, the lubricant is at least one selected from magnesium stearate, zinc stearate, glyceryl monostearate, polyethylene glycol, stearic acid, talc, sodium chloride, sodium oleate, sodium lauryl sulfate, magnesium lauryl sulfate, sodium stearyl fumarate, poloxamer.

[0064] Preferably, the pH adjusting agent is selected from at least one of citric acid, fumaric acid, succinic acid, tartaric acid, malic acid and ascorbic acid.

[0065] Preferably, the flavoring agent is selected from at least one of sweet orange flavor, vanilla flavor, strawberry flavor, milk flavor, banana flavor, cherry flavor.

[0066] Preferably, the filler is selected from at least one of mannitol, xylitol, sorbitol, maltose, microcrystalline cellulose, glucose, lactose, sucrose, dextrin, starch, sodium alginate, sodium bicarbonate.

[0067] Preferably, the antioxidant can be selected from at least one of L-cysteine hydrochloride, L-cysteine base, tocopherol-rich extract (natural vitamin E), a-tocopherol (synthetic vitamin E), β-tocopherol, δ-tocopherol, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, octyl gallate, dodecyl gallate, tertiary butylhydroquinone (TBHQ), fumaric acid, malic acid, ascorbic acid (vitamin C), sodium ascorbate, calcium ascorbate, potassium ascorbate, ascorbic acid palmitate, ascorbic acid stearate.

[0068] The present application has at least the following beneficial effects: 1. As a traditional Chinese medicine composition, the present application can effectively reduce the AST and ALT ethanol content in the acute drunkenness model, significantly prolong the drunkenness time of mice, shorten the sleep and sober-up time, reduce the activity of ADH, ALD and SOD in the liver tissue of mice, significantly improve the pathological characteristics of the liver, and play a role in alcohol detoxification, liver protection and liver protection. Long-term or large-scale application of modern Western medicine using wake-promoting and metabolism-promoting drugs can stimulate the central nervous system, leading to dizziness, headache, insomnia, poor sleep quality, and other symptoms, and may also cause mania and other mental symptoms. Long-term or large-scale use is prone to ion disorder, such as potassium, sodium and other electrolyte imbalance. In comparison, the raw materials of the present composition are widely available, low in cost, safe and non-toxic; the formula is simple and reasonable, the production process is simple, and it is suitable for industrialization. Long-term use does not cause the patient's tolerance to decrease, the effect is mild and long-lasting, and it is more safe and suitable for daily use, providing a new idea for further development of drugs, special medical foods, functional food beverages or health products with alcohol detoxification, liver protection and liver protection.

[0069] 2, The combination principle of the application: combine Gegen, Huzhangzi, Qingpi, Baizhu, Chenpi, Wumei, Gouqi, and Gancao, and get the treatment of drunkenness model combination according to the traditional alcoholism, liver protection, TCM theory, and verify by modern biochemistry means, further confirm the effect of the traditional Chinese medicine composition in the application on alcoholism, liver protection. The various drug components in the application synergistically act, and have the effects of resolving alcoholism, waking up the spleen and stomach, clearing heat and diuresis, soothing the liver and regulating qi, invigorating the spleen and diuresis, promoting saliva and preventing dryness, nourishing the liver and kidney, thereby maintaining the normal function of the liver. Gegen in the traditional Chinese medicine composition in the application is the main drug for resolving alcoholism and waking up the spleen, and plays a leading role in view of the core pathogenesis of alcoholism. It has the largest dosage, and embodies the position of the monarch drug.

[0070] Huzhangzi can significantly reduce the alcohol concentration in the blood, accelerate alcohol metabolism, and protect the liver. It synergistically acts with Gegen, and is the monarch drug together with Gegen, and has the effects of resolving alcoholism and waking up the spleen. Qingpi soothes the liver and breaks qi, and eliminates accumulation and stagnation. Alcoholism is easy to stagnate liver qi, leading to distending pain in the lateral costal region and abdominal fullness. Qingpi soothes the liver and regulates qi, and helps the monarch drug to relieve liver stagnation caused by alcoholism, and embodies the liver-soothing effect of the liver protection and liver-soothing effect. Baizhu diureses and removes dampness, and invigorates the spleen and calms the heart. Alcohol wetness is an important pathological factor. Baizhu invigorates the spleen and removes dampness, promotes the excretion of water and dampness (including alcohol metabolism waste), reduces post-alcohol edema and heavy head and body, and invigorates the spleen to support the healthy qi, and helps the monarch drug to remove alcohol wetness. It embodies the spleen-invigorating effect of the liver protection and liver-soothing effect. Chenpi regulates qi and invigorates the spleen, and dries dampness and resolves phlegm. It assists Qingpi in soothing the liver and regulating qi, and more focuses on regulating qi and invigorating the spleen and stomach, relieving post-alcohol nausea, vomiting, and abdominal fullness. It assists Baizhu in invigorating the spleen and removing dampness. Wumei promotes saliva and stops thirst, and astringes the lung and intestines. Alcohol is hot and dry, and is easy to hurt the body fluid and consume qi. Wumei is sour and sweet, and has the effects of promoting saliva and stopping thirst, relieving post-alcohol dry mouth and thirst, preventing the monarch drug from being too scattered and consuming qi, and playing the role of mutual restriction. Gouqi nourishes the liver and kidney, and benefits the essence and eyes. Alcoholism is easy to hurt the yin of the liver and kidney. Gouqi nourishes the essence and blood of the liver and kidney, and aims at the root of the liver protection, enhances the self-repair and resistance of the liver, and embodies the liver-nourishing effect of the liver protection and liver-soothing effect. It assists the monarch drug, and supports the healthy qi and the root. Gancao invigorates the spleen and benefits qi, clears heat and resolves toxins, relieves phlegm and cough, relieves acute and chronic pain, and regulates the properties of various drugs. In the formula, it mainly plays the roles of regulating the properties of various drugs (especially relieving the partial properties of Gegen and Qingpi), protecting the stomach qi, and enhancing the detoxification (alcoholism) effect. It has the smallest dosage, and embodies the roles of regulation and guidance. BRIEF DESCRIPTION OF DRAWINGS

[0071] Figure 1 The effects of the composition of the application on the food intake and drunkenness latency time of mice.

[0072] Figure 2 The effects of the composition of the application on the alcoholism waking-up time and sleep time of mice.

[0073] Figure 3 The effects of the composition of the application on the serum alcohol concentration of mice.

[0074] Figure 4Effects of the composition of the present application on the levels of serum transaminase aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of mice.

[0075] Figure 5 Effects of the composition of the present application on the activities of ethanol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) in liver tissues of mice.

[0076] Figure 6 Effects of the composition of the present application on the activity of superoxide dismutase (SOD) in liver tissues of mice.

[0077] Figure 7 Effects of the composition of the present application on the morphology of liver tissues of mice.

[0078] Figure 8 Effects of Example 1 of the present application on the food intake and drunkenness latency of mice.

[0079] Figure 9 Effects of Example 1 of the present application on the sober-up time and sleep time of mice.

[0080] Figure 10 Effects of Example 1 of the present application on the serum ethanol concentration of mice.

[0081] Figure 11 Effects of Example 1 of the present application on the levels of serum transaminase aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of mice.

[0082] Figure 12 Effects of Example 1 of the present application on the activities of ethanol dehydrogenase (ADH), acetaldehyde dehydrogenase (ALDH) and superoxide dismutase (SOD) in liver tissues of mice.

[0083] Figure 13 Effects of Example 1 of the present application on the morphology of liver tissues of mice.

[0084] (Note: in the above figures: P <0.05, P <0.01, P <0.001, P <0.0001, compared with the blank group; P <0.05, P <0.01, P <0.001, P <0.0001, compared with the model group.) DETAILED DESCRIPTION The following non-limiting examples can provide a more complete understanding of the application to one of ordinary skill in the art, but are not intended to limit the application in any way. The following description merely is illustrative of the application and should not be construed as limiting the scope of the application in any way. Those skilled in the art can make many changes and modifications to the application described and illustrated herein without departing from its spirit and scope, which should be defined only by the appended claims.

[0085] The application is further described in the following specific examples. The various instruments, devices, equipment, reagents, products, etc. used in the examples of the application are obtained through conventional commercial sources unless otherwise specified.

[0086] Example 1 A traditional Chinese medicine composition having the effects of sobering up, protecting liver and hepatoprotective effect, which is composed of the following raw materials in parts by mass: Gegen 30 parts, Jijinzi 25 parts, Qingpi 15 parts, Bai Fuling 15 parts, Chenpi 10 parts, Wumei 10 parts, Gouqi 8 parts, Gancao 5 parts.

[0087] The traditional Chinese medicine composition of Example 1 is prepared according to the following method: S1. The Gegen, Jijinzi, Qingpi, Bai Fuling, Chenpi, Wumei, Gouqi and Gancao are cleaned, impurities and non-medicinal parts are removed, and then dried for standby use.

[0088] S2. The cleaned Gegen, Jijinzi, Qingpi, Bai Fuling, Chenpi, Wumei, Gouqi and Gancao are mixed, and 10 times the weight of water of the total weight of the medicinal materials is added. After soaking for 0.5 hours, decocting is performed for a total of 3 times, 10 times the water for 1.5 hours, 8 times the water for 1 hour, and 8 times the water for 0.5 hour, and the decocting liquid is combined.

[0089] S3. The decocting liquid is concentrated to 1.2 g of crude drug / mL, and the relative density is 1.15. Ethanol is added to make the alcohol content reach 75%, and then it is left to stand for 24 hours. Filtration is performed, and the supernatant is taken and the ethanol is recovered.

[0090] S4. The obtained supernatant is concentrated, and the filtrate is concentrated to an extract at 60°C with a relative density of 1.10. Then, drying under reduced pressure at 60°C, crushing, and passing through a 120-mesh sieve are performed to obtain the traditional Chinese medicine composition of the application.

[0091] Example 2 A traditional Chinese medicine composition having the effects of sobering up, protecting liver and hepatoprotective effect, which is composed of the following raw materials in parts by mass: Gegen 20 parts, Jijinzi 20 parts, Qingpi 15 parts, Bai Fuling 8 parts, Chenpi 8 parts, Wumei 12 parts, Gouqi 5 parts, Gancao 5 parts. The traditional Chinese medicine composition of Example 2 is prepared according to the same preparation method as Example 1.

[0092] Example 3 A traditional Chinese medicine composition with the effects of sobering up, protecting liver and hepatoprotective, which is prepared according to the same preparation method of Example 1 and consists of the following raw materials in mass fraction: Gegen 15 parts, Huzhangzi 30 parts, Qingpi 20 parts, Bai Fuling 4 parts, Chenpi 4 parts, Wumei 16 parts, Gouqi 15 parts, and Gancao 14 parts.

[0093] Comparative Example 1 A traditional Chinese medicine composition with the effects of sobering up, protecting liver and hepatoprotective, which is prepared according to the same preparation method of Example 1 and consists of the following raw materials in mass fraction: Gegen 15 parts, Huzhangzi 30 parts, Qingpi 20 parts, Bai Fuling 4 parts, Chenpi 4 parts, Wumei 16 parts, Gouqi 15 parts, and Gancao 14 parts.

[0094] Comparative Example 2 Prepared according to the preparation method of Example 1 in Chinese Patent CN103861060A.

[0095] Comparative Example 3 A traditional Chinese medicine composition with the effects of sobering up, protecting liver and hepatoprotective, which is prepared according to the same preparation method of Example 1 and consists of the following raw materials in mass fraction: Gegen 15 parts, Huzhangzi 30 parts, Qingpi 20 parts, Bai Fuling 4 parts, Chenpi 4 parts, Wumei 16 parts, Gouqi 15 parts, and Gancao 14 parts.

[0096] Test Example 1 Establishment of acute drunkenness model of mice 1. Principle Based on the fact that mice can be made to ingest or absorb a high dose of alcohol (ethanol) in a short period of time through artificial means, which can cause significant physiological and behavioral changes, thereby simulating the state of acute alcohol poisoning (drunkenness) in humans. The core purpose is to study the acute effects of alcohol on the body, toxic mechanisms, metabolic pathways, and possible interventions.

[0097] 2. Experimental animals SPF male Kunming mice (18-22 grams), a total of 104.

[0098] 2.1 Experimental methods and steps 2.1.1 Establishment of acute drunkenness model test of mice Take 40 mice, set up 5 dose groups, 8 mice in each group, respectively with 0.05, 0.10, 0.15, 0.20, 0.25 mL / 10g of 56° Hongxing Erguotou Baijiu to gavage mice, with the disappearance of mouse "turning right reflex" as the judgment index of drunkenness, record the number of drunkenness and death mice and calculate the drunkenness rate and mortality rate, with the highest drunkenness rate and the lowest mortality rate as the best gavage dose of the acute drunkenness model of mice.

[0099] 2.1.2 Dose grouping and experimental procedure After adaptive feeding, 64 mice were randomly divided into 8 groups, including a blank group, a model group, an example 1 group, an example 2 group, an example 3 group, a comparative example 1 group, a comparative example 2 group, and a comparative example 3 group, 8 mice in each group. Except for the blank group and the model group, the mice in the remaining groups (example 1 group - example 3 group and comparative example 1 group - comparative example 3 group) were given corresponding liquid by gavage every day, with a dose of 0.3 g / kg, and the model group and the blank group were given the same volume of normal saline by gavage, once a day, 0.2 mL for every 10 g of mice, and the gavage was continued for 7 days. After 30 min of gavage on the last day, the mice were given red star baijiu with 56° by gavage once, (the specific gavage dose was confirmed by acute drunkenness model test), and the time for the disappearance and recovery of the righting reflex of the mice was recorded, and the drunkenness time, sleep time, and sober-up time were calculated. After the experiment, the serum was separated from the eyeball blood, and the liver tissue was placed in a 4% paraformaldehyde solution.

[0100] Data analysis All experimental data were analyzed by t-test using GraphPad Prism 5 software, and the data were represented by the average value ± standard deviation (SD) of three independent repeated experiments.

[0101] 2.2 Determination index General state observation of mice: The basic activity and health status of mice in each group were recorded and observed every day, and the gavage dose of mice was adjusted according to the quality, whether there was any abnormality in food intake and water intake.

[0102] Determination of drunkenness, sleep, and sober-up time of mice: The drunkenness time, sleep time, and sober-up time of mice were recorded according to the righting reflex. The mouse back was kept down for 30 s as the righting reflex disappeared; the mouse back was turned right within 30 s as the righting reflex recovered. Drunkenness time: the time from gavage to the disappearance of the righting reflex; sober-up time: the time from the disappearance of the righting reflex to the recovery of normal behavior ability (such as normal walking and no obvious ataxia); sleep time: the time from the disappearance of the righting reflex to the recovery of the righting reflex. After the experiment, the food intake of mice was counted.

[0103] Determination of liver function and ethanol concentration of mice: The separated serum after the experiment was determined to detect the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and ethanol concentration in the serum.

[0104] Determination of ADH (alcohol dehydrogenase), ALDH (acetaldehyde dehydrogenase), and SOD (superoxide dismutase) in liver tissue of mice: After the experiment, the levels of ADH, ALDH, and SOD in the liver tissue of mice were detected.

[0105] Pathological histological detection of liver: Fresh liver tissue was fixed in a 4% paraformaldehyde solution, and the tissue was embedded for HE staining.

[0106] 2.3 Experimental results 2.3.1 Screening of optimal Baijiu dosage for acute drunkenness model of mice After different doses of Baijiu were administered to mice, the results of the acute drunkenness model experiment of mice were as shown in Table 1. The drunkenness rate of mice increased with the increase of the Baijiu dosage, and when the Baijiu dosage reached 0.15 mL / 10g, the drunkenness rate reached 100% and the mortality rate was 0, while the mortality rate of mice continued to increase with the increase of the Baijiu dosage. Therefore, 0.15 mL / 10g was selected as the optimal Baijiu dosage for the acute drunkenness model of mice.

[0107] Table 1. Results of acute drunkenness model experiment of mice (n=8)

[0108] 2.3.2 Effect on food intake of mice The results of determination of food intake of mice in different groups were as shown in Table 2. Figure 1 Compared with the blank group, the food intake of mice in the model group decreased, indicating that the appetite of mice decreased after drunkenness; compared with the model group, the food intake of mice in Example 1, Example 2 and Example 3 increased, indicating that the drunkenness state of mice could be improved and the food intake of mice could be increased after administration. 2.3.3 Effect on drunkenness, sleep and sober-up time of mice The results of determination of drunkenness, sleep and sober-up time of mice in different groups were as shown in Table 2, Figure 1 and Figure 2 Compared with the model group, the drunkenness time of mice in the example group and the control example group could be significantly prolonged, and the sleep and sober-up time of mice could be shortened; among them, Example 1 had the most obvious improvement effect; the control example group had certain difference compared with the model group, but the effect was not as obvious as that of the example group. It was indicated that the example 1 was the optimal formula, and after changing the ratio of the ingredients of each raw material (control example 1), increasing a plurality of ingredients to re-formulate (control example 2) or replacing any one ingredient to re-formulate (control example 3), the effects of prolonging the drunkenness time of mice and shortening the sleep and sober-up time of mice were not as good as those of the formula of the example of the application, which confirmed the rationality and efficacy of the formula of the application.

[0109] Table 2. Effect on drunkenness, sleep and sober-up time of mice (n=8)

[0110] Note: #P<0.05, ##P<0.01, ###P<0.001, ####P<0.0001, ns indicates no statistical significance, compared with the model group.

[0111] ​2.3.4 Effects on the ethanol, AST and ALT of mice serum.

[0112] The results of ethanol, AST and ALT of mice in different groups were shown in Table 3, Figure 3 and Figure 4 Compared with the blank group, the ethanol concentration, AST and ALT levels of the model group were significantly increased, which indicated that the model caused damage to the liver; compared with the model group, the ethanol concentration, AST and ALT levels of the mice serum of the example group were reduced, and the example 1 was the most obvious; the comparative example group had certain difference compared with the model group, but the effect was not obvious. It was indicated that the example 1 was the optimal formula, and after changing the ratio of each raw material component (comparative example 1), increasing multiple components to re-formulate (comparative example 2) or replacing any component to re-formulate (comparative example 3), the effect of improving liver damage was not as good as the formula of the example of the application, which confirmed the rationality of the formula of the application and the technical effect of significantly protecting the liver.

[0113] Table 3. Effects on the ethanol, AST and ALT of mice serum of different groups (n = 8)

[0114] Note: P <0.0001, compared with the blank group; #P<0.05, ##P<0.01, and ####P<0.0001, compared with the model group.

[0115] 2.3.5 Effects on the ADH, ALDH and SOD of mice liver tissue.

[0116] The results of ADH, ALDH and SOD of mice in different groups were shown in Table 4, Figure 5 and Figure 6 Oxidative stress is one of the main reasons for the occurrence and deterioration of alcoholic liver injury, and alcoholic liver injury is caused by the destruction of the balance between oxidation and antioxidant systems. Compared with the blank group, the excessive drinking of the model group significantly reduced the activities of ADH, ALDH and SOD in the liver of mice, and compared with the model group, the activities of ADH, ALDH and SOD in the liver of mice of the example group were increased, and the example 1 was the most obvious; the comparative example group had certain difference compared with the model group, but the effect was not obvious. It was indicated that the example 1 was the optimal formula, and after changing the ratio of each raw material component (comparative example 1), increasing multiple components to re-formulate (comparative example 2) or replacing any component to re-formulate (comparative example 3), the activities of ADH, ALDH and SOD were not as good as the formula of the example of the application, which confirmed the rationality of the formula of the application and the efficacy.

[0117] Table 4. Effects of different groups on ADH, ALDH and SOD in mouse liver tissue ( (n=8)

[0118] Note: P <0.0001, compared with the blank group; #P<0.05, ##P<0.01, ###P<0.001, ####P<0.0001, ns: no statistically significant difference compared with the model group.

[0119] 2.3.6 Effects on liver histopathology in chemically induced liver injury.

[0120] The fixed liver tissue was removed and stained with hematoxylin and eosin (HE) to observe the effects of Examples 1-3 on the chemical liver injury model. The results are shown in […]. Figure 7 Observation of the entire tissue section under a 40x objective lens revealed that in the control group, hepatocytes in the liver tissue were arranged in cords, radiating around the central vein. The hepatocyte cords were branched and anastomosed to form a network, and the hepatocyte structure was normal. Compared with the control group, the model group mice showed extensive vacuolar degeneration of hepatocytes, with round vacuoles of varying sizes visible in the cytoplasm. Many hepatocytes had loose or vacuolated cytoplasm, localized focal necrosis of hepatocytes, nucleus fragmentation, increased eosinophilicity of the cytoplasm, accompanied by hemorrhage and a small amount of inflammatory cell infiltration. Compared with the model group, Examples 1-3 alleviated the above conditions, with Example 1 showing the most significant reduction in liver tissue lesions.

[0121] Test Example 2 The effects of different dosages of the optimal formulation (Example 1) were verified: I. Traditional Chinese Medicine Compositions The traditional Chinese medicine composition prepared in Example 1.

[0122] II. Animal Experiments Establishment of an acute alcohol intoxication model in mice 1. Principle This study simulates acute alcohol poisoning (drunkenness) in humans by artificially exposing mice to high doses of alcohol (ethanol) within a short period of time, which are sufficient to cause significant physiological and behavioral changes. The core objective is to investigate the acute effects of alcohol on the body, its toxic mechanisms, metabolic pathways, and possible interventions.

[0123] 2. Laboratory animals SPF-grade male Kunming mice (18-22 g) were divided into 6 groups of 8 mice each.

[0124] 2.1 Experimental methods and procedures 2.1.1 Dose grouping and experimental steps After adaptive feeding, the mice were grouped. The traditional Chinese medicine composition prepared in Example 1 of the present application was configured into a medium-dose group at 0.3 g / kg, and on this basis, a high-dose group (0.6 g / kg) twice the medium-dose group and a low-dose group (0.15 g / kg) half the medium-dose group were set up. A blank group, a model group and a positive drug (methadone) group (142.9 mg / kg) were also set up, a total of 6 groups, 8 mice in each group. Except for the blank group and the model group, the mice in the other groups were given the corresponding liquid by gavage every day. The model group and the blank group were given the same volume of normal saline. Once a day, 0.2 mL was given to each 10 g mouse, and gavage was performed continuously for 7 days. Thirty minutes after the last gavage, the mice were given red star baijiu with 56° once by gavage (0.15 mL / 10 g). The time for the mice to lose and recover the righting reflex was recorded, and the drunk time, sleep time and sober-up time were calculated. After the experiment, the serum was separated from the eyeball blood, and the liver tissue was placed in a 4% paraformaldehyde solution.

[0125] Data analysis All experimental data were analyzed by t-test using GraphPad Prism 5 software, and the data were represented by the mean ± standard deviation (SD) of three independent repeated experiments.

[0126] 2.2 Determination index General state observation of mice: The basic activity and health status of mice in each group were observed and recorded every day after gavage. Whether there were any abnormalities in food intake and water intake was observed, and the gavage dose of mice was adjusted according to the quality.

[0127] Determination of drunk time, sleep time and sober-up time of mice: The drunk time, sleep time and sober-up time of mice were recorded according to the righting reflex. The mouse back was kept down for 30 s as the righting reflex disappeared; the mouse back was turned right within 30 s as the righting reflex recovered. Drunk time: the time from gavage to the disappearance of the righting reflex; sober-up time: the time from the disappearance of the righting reflex to the recovery. After the experiment, the food intake of mice was counted.

[0128] Determination of liver function and ethanol concentration of mice: The separated serum after the experiment was determined to detect the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and ethanol concentration in the serum.

[0129] Determination of ADH, ALDH and SOD in liver tissue of mice: After the experiment, the levels of ADH, ALDH and SOD in the liver tissue of mice were detected.

[0130] Pathological histological detection of liver: Fresh liver tissue was fixed in a 4% paraformaldehyde solution, and the tissue was embedded for HE staining.

[0131] 2.3 Experimental results 2.3.1 Effect on food intake of mice The results of food intake of mice in different groups are shown in Table 2. Figure 8 Compared with the blank group, the food intake of mice in the model group decreased, suggesting that the appetite of mice decreased after drunkenness; compared with the model group, the food intake of mice in the low, medium, high dose and metadoxine groups increased, suggesting that the drunken state of mice could be improved after administration, and the food intake of mice increased.

[0132] 2.3.2 Effect on drunkenness, sleep and sober-up time of mice The results of drunkenness, sleep and sober-up time of mice in different groups are shown in Table 5, Figure 8 and Figure 9 Compared with the model group, the drunkenness time of mice in the low, medium, high dose and metadoxine groups was significantly prolonged, and the sleep and sober-up time was shortened; among them, the drunkenness time of mice in the medium dose and metadoxine groups was the longest, and the sleep and sober-up time was the shortest.

[0133] Table 5. Effect on drunkenness, sleep and sober-up time of mice (n=8)

[0134] Note: P <0.05, P <0.01, P <0.001, P <0.0001, compared with the model group.

[0135] 2.3.3 Effect on serum ethanol, AST and ALT of mice

[0136] The results of ethanol, AST and ALT of mice in different groups are shown in Table 6, Figure 10 and Figure 11 Compared with the blank group, the ethanol concentration, AST and ALT levels of mice in the model group were significantly increased; compared with the model group, the ethanol concentration, AST and ALT levels of mice in the low, medium, high dose and metadoxine groups were significantly reduced; among them, the improvement of the medium dose was the most obvious, and was equivalent to that of the metadoxine group.

[0137] Table 6. Effect of different groups on serum ethanol, AST and ALT of mice (n=8)

[0138] Note: P <0.0001, compared with the blank group; ##P<0.01, ####P<0.0001, compared with the model group.

[0139] 2.3.4 Effects on ADH, ALDH and SOD of mouse liver tissues.

[0140] The results of ADH, ALDH and SOD determination of different groups of mice are shown in Table 7 and Figure 12 Oxidative stress is one of the main causes of the occurrence and aggravation of alcoholic liver injury, which is caused by the destruction of the balance between oxidation and antioxidant systems. Compared with the blank group, the excessive drinking of the model group significantly reduced the activities of ADH, ALDH and SOD in the liver, and compared with the model group, the low, medium and high dose and metadoxine groups can significantly increase the activities of ADH, ALDH and SOD; among them, the medium dose is the most obvious, and is equivalent to the metadoxine group.

[0141] Table 7. Effects of different groups on ADH, ALDH and SOD of mouse liver tissues (n = 8)

[0142] Note: P <0.0001, compared with the blank group; #P<0.05, ##P<0.01, ###P<0.001, and ####P<0.0001, ns indicates no statistically significant difference, compared with the model group.

[0143] 2.3.5 Effects on the pathology of liver tissues of chemical liver injury.

[0144] The fixed liver tissues were taken out for HE staining to observe the effects of different groups on the chemical liver injury model, and the results are shown in Figure 13 ; by observing the whole tissue section with a 40x objective lens, it was found that the liver tissues of the blank group mice arranged the liver cells into cord-like, and arranged radially around the central vein. The liver cell cord had branches, and anastomosed into a network with normal liver cell structure. Compared with the blank group, the model group mice had a large number of liver cell vacuolar degeneration, and the size of the round vacuoles in the cytoplasm was different. The cytoplasm of many liver cells was loose or vacuolated, and local liver cell small focal necrosis, nuclear fragmentation, and cytoplasmic eosinophilia were observed, accompanied by bleeding and a small amount of inflammatory cell infiltration. Compared with the model group, the low, medium and high dose and metadoxine groups can alleviate the above conditions, among which the medium dose is the most obvious, and is equivalent to the metadoxine group.

[0145] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by ordinary skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition with the effects of sobering up, protecting and healing liver, characterized in that, The raw materials comprise, by mass fraction, Gegen 18-32 parts, Hujitengzi 12-28 parts, Qingpi 8-18 parts, Bai Fuling 5-18 parts, Chenpi 5-15 parts, Wumei 8-15 parts, Gouqi 3-10 parts and Gancao 1-8 parts. ​ 2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials comprise, by mass fraction, Gegen 20-30 parts, Hujitengzi 15-25 parts, Qingpi 10-15 parts, Bai Fuling 8-15 parts, Chenpi 8-12 parts, Wumei 10-12 parts, Gouqi 5-8 parts and Gancao 3-5 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The raw materials comprise, by mass fraction, Gegen 30 parts, Hujitengzi 25 parts, Qingpi 15 parts, Bai Fuling 15 parts, Chenpi 10 parts, Wumei 10 parts, Gouqi 8 parts and Gancao 5 parts.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The method comprises the following steps: S1: mixing the raw materials, water extraction 2-4 times, combining, to obtain a water extract; S2: concentrating the water extract, alcohol precipitation, separation, to obtain supernatant, concentration, drying, to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, In step S1, the water extraction is as follows: the raw materials are mixed with 8-10 times the mass of water, decocted 2-4 times, each time for 0.5-1.5 h, and the decocted liquid is combined to obtain the water extract.

6. The production method according to claim 5, wherein In step S1, the water extraction is as follows: the raw materials are mixed with 10 times the mass of water, decocted once for 1.5 h, then 8 times the mass of water is added and mixed, decocted twice for 1 h, then 8 times the mass of water is added and mixed, decocted thrice for 0.5 h, the decocted liquid is collected, and the decocted liquid is combined to obtain the water extract.

7. The preparation method according to claim 4, characterized in that, In step S2, the alcohol precipitation is as follows: the water extract is concentrated to 1.1-1.3 g crude drug / mL, ethanol is added to a content of 70-80 wt%, and the mixture is left to stand for 20-24 h, filtered, the supernatant is collected, and the ethanol is recovered.

8. Use of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a medicament having the effects of dispelling alcohol, protecting the liver and hepatoprotective effects.

9. Use according to claim 8, characterized in that, The dosage form of the medicament is granules, tablets, capsules, decoctions, pills, powders or oral liquids; the medicament further comprises a pharmaceutically acceptable excipient. The dosage form of the medicament is granules, tablets, capsules, decoctions, pills, powders or oral liquids; the medicament further comprises a pharmaceutically acceptable excipient.

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