A composition, preparation method and use for alleviating acute alcoholic liver damage

Abstract

The present invention relates to the field of medical technology, and in particular to a composition, a preparation method and a use for alleviating acute alcoholic liver injury. The present invention provides a composition consisting of ginseng, Poria cocos, Pueraria root, Lycium barbarum, Gardenia jasminoides, Prunus mume and oligomeric walnut peptides. The composition of the present invention is non-toxic and harmless, has high nutritional value, and does not cause severe stimulation and damage to the body. It has a good effect of alleviating liver injury, and is particularly suitable for people with long-term excessive drinking and physical weakness. At the same time, the composition for alleviating acute alcoholic liver injury provided by the present invention has been verified by animal experiments and clinical trials, and can effectively alleviate liver function, is one of the effective methods for alleviating symptoms after drinking, relieving inflammation, protecting the liver, and improving the quality of life, and can provide a clinically safe and good medicine and food homologous combination product with good liver protection. It has important social significance for alleviating liver inflammation and preventing and treating the occurrence and development of liver diseases.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a composition, a preparation method and a use thereof for alleviating acute alcoholic liver injury. Background Art

[0002] Alcoholic liver injury refers to a series of pathological changes such as liver damage caused by excessive alcohol intake. Alcoholic liver injury can be divided into acute alcoholic liver injury and chronic alcoholic liver injury. Acute alcoholic liver injury is caused by liver function damage due to excessive alcohol intake at one time, manifested by acute hepatitis-like symptoms such as loss of appetite, nausea, liver discomfort and jaundice. The main drugs for the treatment of alcoholic liver injury are: anti-endotoxin drugs, antioxidants, glucocorticoids, and drugs that counteract and improve ethanol metabolism. These drugs have certain therapeutic effects on acute alcoholic liver injury and the early stages of chronic alcoholic liver injury.

[0003] However, these drugs are all chemically synthesized and have serious toxic side effects. If taken for a long time, they will increase the burden on the liver to varying degrees and further damage the liver. At present, there are few products on the market that use medicinal and edible plants to regulate the body and reduce the harm of alcoholic liver damage, and there is a problem of poor effect. Finding safe and effective ingredients from natural products and developing new drugs and functional foods have become a hot topic and a scientific research difficulty. Summary of the invention

[0004] In order to overcome the shortcomings of the above-mentioned technical defects, the present invention develops the advantages of traditional Chinese medicine health care and provides a composition, such as a pharmaceutical composition or a functional food composition, which can effectively restore intestinal bacteria metabolism, alleviate metabolic disorders, reduce liver fat deposition, and alleviate liver inflammatory response, thereby alleviating acute alcoholic liver damage.

[0005] Traditional Chinese medicine for both food and medicine refers to animals, plants, minerals and their processed products that can be used as both food and medicine, with the characteristics of wide dosage range and small toxic and side effects. The inventor uses the basic theory of traditional Chinese medicine as a guide, and combines modern pharmacological research to select ginseng, Poria cocos, Pueraria root, Lycium barbarum, Gardenia jasminoides, and Plum for reasonable compatibility. Among them, Poria cocos and Pueraria root are wine-removing and dampness-removing medicine pairs. Poria cocos is flat, sweet, and light, and belongs to the heart, lung, spleen, and kidney meridians. First, it can help ginseng replenish qi and strengthen the spleen, regulate the middle jiao, and help the movement of qi; second, it can nourish the heart and calm the mind, and relieve symptoms such as irritability, palpitations and anxiety after drinking; third, it can strengthen the spleen and penetrate dampness, and lead the wine dampness to be eliminated from the urine, restricting the excessive supplementation of ginseng and wolfberry, so that there is elimination in the supplementation, and the supplementation is not stagnant. Pueraria root is sweet, spicy, and cool, and belongs to the spleen and stomach meridians. First, it can raise yang and disperse, so that the wine dampness is resolved from the surface; second, it can relieve the bitter heat of alcohol, protect the yin fluid, and relieve headaches and dry mouth after drinking. Ginseng and wolfberry are a pair of medicines for regulating qi and strengthening the spleen. Ginseng is warm, sweet and bitter. It enters the heart meridian, lung meridian, spleen meridian, and kidney meridian. It is sweet and slightly cold, and it nourishes the five internal organs, especially the qi of the middle burner, and does not cause heat to be generated by the nourishment, which will cause qi to surge and blood to overflow. Wolfberry is flat in nature, sweet in taste, and enters the liver meridian and kidney meridian. It nourishes the liver and kidney, and can prevent liver and kidney yin deficiency caused by alcohol toxicity and damp heat. Gardenia and black plum are a pair of medicines for clearing away alcohol heat. Gardenia is cold and bitter, and enters the heart, lung, and triple burner meridians. It can purge fire and relieve restlessness. First, it can be used to make ginseng and Poria cocos, and it can be used for both elimination and tonic; second, it can treat heart yin deficiency caused by alcohol heat damaging yin, and relieve symptoms such as virtual heat and thirst after drinking. Black plum is flat, sour and astringent, and enters the liver meridian, spleen meridian, lung meridian, and large intestine meridian. Its sour taste can adjust the taste of various medicines and make people drink, and can relieve symptoms of drunkenness, thirst, vomiting and anorexia. This prescription contains six herbs, which have the same origin as food and medicine, and are moderate and peaceful. Together, they can achieve the effect of "transforming alcohol and removing dampness, regulating qi and strengthening the spleen". It has a good effect in relieving liver damage, and is especially suitable for people who are weak due to long-term excessive drinking. Assisted by oligowalnut peptides, the combined effect of the two is better than using them alone. It is suitable for people with weak constitution and prone to external infection; those who are addicted to smoking and drinking, have cough, asthma, and excessive sputum, liver-intestinal disharmony, and loose and irregular stools; those who are under great pressure, often stay up late, have chronic fatigue syndrome, are in sub-healthy conditions, and often suffer from insomnia, forgetfulness, palpitations, etc.

[0006] One of the purposes of the present invention is to provide a composition, such as a pharmaceutical composition, a health care composition or a food composition, which is composed of ginseng, Poria cocos, Pueraria root, wolfberry, gardenia and ebony.

[0007] The present invention is based on a clinically effective prescription for treating alcoholic liver disease by a famous Chinese medicine doctor in Yunnan Province. After long-term practice, the efficacy is definite. The prescription is composed of six herbs: ginseng, tuckahoe, kudzu root, wolfberry, gardenia, and black plum. The six herbs are combined, the food and medicine are of the same origin, and the medicine is moderate and peaceful, which can achieve the effect of "transforming alcohol and removing dampness, regulating qi and strengthening the spleen". When this prescription is used clinically, the medicine is used dialectically and added or subtracted according to the symptoms. It is mainly used for patients with weak constitutions and prone to external infection; those who are addicted to smoking and drinking, coughing, wheezing, and sputum, gastrointestinal disharmony, loose stools, and patients with obvious spleen and stomach qi deficiency such as those under great pressure, often staying up late, chronic fatigue syndrome, and sub-healthy state.

[0008] Among them, Poria cocos and Pueraria root are a pair of drugs for dispelling alcohol and removing dampness. Poria cocos is flat, sweet, and light, and it belongs to the heart, lung, spleen, and kidney meridians. First, it can help ginseng to replenish qi and strengthen the spleen, regulate the middle jiao, and help the qi to move and transform; second, it can nourish the heart and calm the mind, and relieve the symptoms of irritability, palpitations, and anxiety after drinking; third, it can strengthen the spleen and penetrate dampness, and lead the alcohol dampness to be eliminated through urination, restricting the excessive supplementation of ginseng and wolfberry, so that the supplementation can be eliminated, and the supplementation is not stagnant. Pueraria root is sweet, pungent, and cool, and it belongs to the spleen and stomach meridians. First, it can raise yang and disperse, so that the alcohol dampness can be eliminated from the surface; second, it can relieve the bitter heat of alcohol, protect the yin fluid, and relieve headaches and dry mouth after drinking.

[0009] Ginseng and wolfberry are a pair of medicines for regulating qi and strengthening the spleen. Ginseng is warm, sweet and bitter. It enters the heart meridian, lung meridian, spleen meridian and kidney meridian. It is sweet and slightly cold, nourishing the five internal organs, especially the qi of the middle burner, without causing heat and blood to surge. Wolfberry is flat in nature, sweet in taste, enters the liver meridian and kidney meridian, nourishes the liver and kidney, and can prevent liver and kidney yin deficiency caused by alcohol poisoning and damp heat.

[0010] Gardenia and Plum Blossom are a pair of medicines for clearing away alcohol heat. Gardenia is cold and bitter, and it enters the heart, lung, and triple burner meridians. It can clear away heat and relieve restlessness. It can be used to make ginseng and Poria cocos, which can be used to both eliminate and replenish. It can also treat the heart yin deficiency caused by alcohol heat damaging yin, and relieve symptoms such as deficiency heat and thirst after drinking. Plum Blossom is flat, sour, and astringent, and it enters the liver meridian, spleen meridian, lung meridian, and large intestine meridian. Its sour taste can adjust the taste of various medicines and make people drink, and can relieve symptoms of drunkenness, thirst, vomiting, and anorexia.

[0011] In some embodiments, the amount of ginseng in the composition of the present invention can be 1-20 parts by weight of ginseng, such as 1-18 parts by weight, or 1-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight, or 1-9 parts by weight, or 1-5 parts by weight, such as 3 parts by weight; and

[0012] 1-50 parts by weight of Poria cocos, for example 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight, or 10-20 parts by weight, or 12-18 parts by weight, such as 15 parts by weight; and

[0013] 1-50 parts by weight of Pueraria root, for example 1-40 parts by weight, or 1-30 parts by weight, or 5-30 parts by weight, or 10-30 parts by weight, or 15-30 parts by weight, or 15-25 parts by weight, such as 20 parts by weight; and

[0014] 1-50 parts by weight of wolfberry, for example 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight, or 10-20 parts by weight, or 12-18 parts by weight, such as 15 parts by weight; and

[0015] 1-30 parts by weight of Gardenia, for example 1-25 parts by weight, or 1-20 parts by weight, or 1-15 parts by weight, or 1-10 parts by weight, or 3-10 parts by weight, or 5-10 parts by weight, such as 8 parts by weight; and

[0016] 1-20 parts by weight of dark plum, for example 1-18 parts by weight, or 1-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight, or 1-9 parts by weight, or 3-5 parts by weight, such as 5 parts by weight.

[0017] The second object of the present invention is to provide a composition, such as a pharmaceutical composition, a health care composition or a food composition, which is composed of ginseng, Poria cocos, Pueraria root, wolfberry, gardenia, ebony, and oligomeric walnut peptides.

[0018] In some embodiments, the amount of oligo walnut peptide in a single dose formulation of the composition of the present invention can be 100-1000 mg / kg, such as 100-800 mg / kg, or 100-600 mg / kg, 200-600 mg / kg, 400-600 mg / kg, such as 440 mg / kg.

[0019] In some embodiments, the ginseng comprises ginseng powder, ginseng extract, ginseng extract or a combination thereof; and / or

[0020] The Poria cocos comprises one or a combination of Poria cocos powder, Poria cocos extract, and Poria cocos extract; and / or

[0021] The kudzu root comprises kudzu root powder, kudzu root extract, kudzu root extract or a combination thereof; and / or

[0022] The wolfberry includes wolfberry powder, wolfberry extract, wolfberry extract or a combination thereof; and / or

[0023] The gardenia comprises gardenia powder, gardenia extract, gardenia extract or a combination thereof; and / or

[0024] The black plum includes black plum powder, black plum extract, black plum extract or a combination thereof.

[0025] The third object of the present invention is to provide a method for preparing the composition, wherein the drug raw materials are measured according to the formula, crushed, decocted and cooled; the obtained drug liquid is concentrated until a viscous, nearly paste-like liquid is obtained, and then dried to form an extract powder.

[0026] In some embodiments, the drug solution is concentrated by a reduced pressure concentration method, and the concentration temperature is 40-42°C, preferably 42°C.

[0027] The third object of the present invention is to provide the use of the above-mentioned composition in a drug, health product, or food for alleviating acute alcoholic liver injury, preferably the drug, health product, or food is in a dosage form for administration through the gastrointestinal tract.

[0028] Gastrointestinal dosage forms refer to dosage forms that enter the gastrointestinal tract after oral administration and exert local or systemic effects through absorption, such as powders, tablets, granules, capsules, solutions, emulsions, and suspensions.

[0029] Furthermore, the dosage form for administration through the gastrointestinal tract includes any one of tablets, pastes, powders, decoctions, granules, capsules or pills.

[0030] Furthermore, the dosage form for administration through the gastrointestinal tract uses the composition as an active ingredient and is prepared with pharmaceutically acceptable excipients.

[0031] The composition, medicine, health product, or food of the present invention may further include auxiliary materials, such as medicinal

[0032] Excipients. Excipients (e.g., pharmaceutical excipients) may be selected from one or more of the following: solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesive agents, integrities, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, foaming agents, defoamers, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and deflocculating agents, filter aids, and release retardants.

[0033] The composition of the present invention is non-toxic and harmless, has high nutritional value, and will not cause severe stimulation and damage to the body. It has a good effect of alleviating liver damage, and is particularly suitable for people who are physically weak due to long-term excessive drinking. At the same time, the composition for alleviating acute alcoholic liver damage provided by the present invention has been verified by animal experiments and clinical trials, and can effectively alleviate liver function, is one of the effective methods for alleviating symptoms after drinking, relieving inflammation, protecting the liver, and improving the quality of life, and can provide a clinically safe and good medicine and food combination product with good liver protection effect. It has important social significance for alleviating liver inflammation and preventing and treating the occurrence and development of liver diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is the HE staining result of mouse liver tissue in the present invention;

[0035] Figure 2 This is a diagram showing the HE staining results of mouse intestinal tissue according to the present invention. DETAILED DESCRIPTION

[0036] In order to make those skilled in the art better understand the technical solution of the present invention, the present invention is described in detail below in conjunction with specific embodiments. The experimental methods in the following examples that do not specify specific conditions are usually based on conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, percentages and parts are calculated by weight. Unless otherwise defined, all professional and scientific terms used in the text have the same meanings as those familiar to those skilled in the art. In addition, any method and material similar or equivalent to the recorded content can be applied to the present invention. The preferred implementation methods and materials described in the text are for demonstration purposes only.

[0037] The endpoints of ranges and any values ​​disclosed herein are not limited to the precise range or value.

[0038] Ranges or values ​​should be understood to include values ​​close to these ranges or values.

[0039] The endpoint values ​​of the ranges, the endpoint values ​​of each range and the individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be regarded as specifically disclosed herein.

[0040] According to the present invention, on the one hand, it relates to a composition, such as a pharmaceutical composition, a health care composition or a food composition, comprising: ginseng, Poria cocos, Pueraria root, wolfberry, Gardenia jasminoides, and Ebony plum; optionally, oligomeric walnut peptides.

[0041] According to the present invention, one aspect relates to a first composition, such as a pharmaceutical composition, a health care composition or a food composition, comprising: ginseng, tuckahoe, kudzu root, wolfberry, gardenia, and ebony.

[0042] In some embodiments, the first composition consists only of ginseng, tuckahoe, kudzu root, wolfberry, gardenia, and ebony.

[0043] In some embodiments, the ginseng comprises ginseng powder, ginseng extract, ginseng extract or a combination thereof; and / or

[0044] The Poria cocos comprises one or a combination of Poria cocos powder, Poria cocos extract, and Poria cocos extract; and / or

[0045] The kudzu root comprises kudzu root powder, kudzu root extract, kudzu root extract or a combination thereof; and / or

[0046] The wolfberry includes wolfberry powder, wolfberry extract, wolfberry extract or a combination thereof; and / or

[0047] The gardenia comprises gardenia powder, gardenia extract, gardenia extract or a combination thereof; and / or

[0048] The black plum includes black plum powder, black plum extract, black plum extract or a combination thereof.

[0049] In some embodiments, the first composition consists of ginseng powder, tuckahoe powder, kudzu root powder, wolfberry powder, gardenia powder, and ebony powder.

[0050] In some embodiments, the first composition consists of ginseng extract, Poria cocos extract, Pueraria root extract, Lycium barbarum extract, Gardenia jasminoides extract, and Prunus mume extract.

[0051] In some embodiments, the first composition consists of ginseng extract, Poria cocos extract, Pueraria root extract, Lycium barbarum extract, Gardenia jasminoides extract, and Prunus mume extract.

[0052] In some embodiments, the first composition can be applied to patients with acute alcoholic liver injury.

[0053] In some embodiments, the first composition can be applied to patients with chronic fatigue syndrome or sub-health conditions.

[0054] According to the present invention, one aspect relates to a second composition, such as a pharmaceutical composition, a health care composition or a food composition, comprising: ginseng, tuckahoe, kudzu root, wolfberry, gardenia, ebony and oligomeric walnut peptide.

[0055] In some embodiments, the second composition consists of ginseng, Poria cocos, Pueraria root, wolfberry, gardenia, black plum, and oligomeric walnut peptide.

[0056] In some embodiments, the second composition consists of ginseng powder, tuckahoe powder, kudzu root powder, wolfberry powder, gardenia powder, ebony powder, and oligo-walnut peptide.

[0057] In some embodiments, the second composition consists of ginseng extract, Poria cocos extract, Pueraria root extract, wolfberry extract, Gardenia jasminoides extract, Prunus mume extract, and oligo-walnut peptides.

[0058] In some embodiments, the second composition consists of ginseng extract, Poria cocos extract, Pueraria root extract, wolfberry extract, Gardenia jasminoides extract, Prunus mume extract, and oligomeric walnut peptides.

[0059] In some embodiments, the second composition can be applied to patients with acute alcoholic liver injury.

[0060] In some embodiments, the second composition can be applied to patients with chronic fatigue syndrome or sub-health conditions.

[0061] According to the present invention, on the one hand, it relates to a composition for alleviating acute alcoholic liver injury, such as a pharmaceutical composition, a health care composition or a food composition, which is composed of ginseng, Poria cocos, Pueraria root, wolfberry, gardenia, ebony, and oligomeric walnut peptides.

[0062] In some embodiments, the present invention relates to a composition, such as a pharmaceutical composition, a health care composition or a food composition, comprising a ginseng extract, a Poria extract, a Pueraria extract,

[0063] It is composed of wolfberry extract, gardenia extract, ebony extract and oligo walnut peptide.

[0064] According to the present invention, on the one hand, it relates to a composition for alleviating chronic fatigue syndrome and sub-health, such as a pharmaceutical composition, a health care composition or a food composition, which is composed of ginseng, Poria cocos, Pueraria lobata, wolfberry, gardenia, ebony, and oligomeric walnut peptides.

[0065] In some embodiments, the present invention relates to a composition, such as a pharmaceutical composition, a health care composition or a food composition, which is composed of ginseng extract, Poria cocos extract, Pueraria lobata extract, wolfberry extract, Gardenia jasminoides extract, Eume extract and oligo-walnut peptides.

[0066] In some embodiments, the amount of ginseng in the composition of the present invention can be 1-20 parts by weight, such as 1-18 parts by weight, or 1-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight, or 1-9 parts by weight, or 1-5 parts by weight, such as 3 parts by weight.

[0067] In some embodiments, the amount of Poria cocos in the composition of the present invention can be 1-50 parts by weight, for example 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight, or 10-20 parts by weight, or 12-18 parts by weight, such as 15 parts by weight.

[0068] In some embodiments, the amount of Pueraria root in the composition of the present invention can be 1-50 parts by weight, for example 1-40 parts by weight, or 1-30 parts by weight, or 5-30 parts by weight, or 10-30 parts by weight, or 15-30 parts by weight, or 15-25 parts by weight, such as 20 parts by weight.

[0069] In some embodiments, the amount of wolfberry in the composition of the present invention can be 1-50 parts by weight, such as 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 5-20 parts by weight, or 10-20 parts by weight, or 12-18 parts by weight, such as 15 parts by weight; and

[0070] In some embodiments, the amount of Gardenia jasminoides in the composition of the present invention can be 1-30 parts by weight, for example 1-25 parts by weight, or 1-20 parts by weight, or 1-15 parts by weight, or 1-10 parts by weight, or 3-10 parts by weight, or 5-10 parts by weight, such as 8 parts by weight.

[0071] In some embodiments, the amount of ebony in the composition of the present invention can be 1-20 parts by weight, for example 1-18 parts by weight, or 1-15 parts by weight, or 1-12 parts by weight, or 1-10 parts by weight, or 1-9 parts by weight, or 3-5 parts by weight, such as 5 parts by weight.

[0072] For the second composition, the amount of oligo walnut peptide in the composition of the present invention may be 100-1000 mg / kg, such as 100-800 mg / kg, or 100-600 mg / kg, 200-600 mg / kg, 400-600 mg / kg, such as 440 mg / kg.

[0073] In the present invention, the unit "mg / kg" refers to the amount of oligo-walnut peptide added in mg per kg of the composition.

[0074] According to the present invention, another aspect relates to a method for preparing the composition, wherein the drug raw materials are measured according to the formula, crushed, decocted and cooled; the obtained drug liquid is concentrated until a viscous, nearly paste-like liquid is obtained, which is then dried to form an extract powder.

[0075] In some embodiments, the drug solution is concentrated by a reduced pressure concentration method, and the concentration temperature is 40-42°C, preferably 42°C.

[0076] In some embodiments, the reduced pressure concentration is performed by rotary evaporation under reduced pressure using a rotary evaporator.

[0077] Another aspect of the present invention relates to use of the composition of the present invention for alleviating acute alcoholic liver injury.

[0078] Another aspect of the present invention relates to a method for alleviating acute alcoholic liver injury, comprising administering to a subject an effective amount of the composition of the present invention.

[0079] Another aspect of the present invention relates to use of the composition of the present invention in preparing medicines, health products, or foods for alleviating acute alcoholic liver injury.

[0080] Another aspect of the present invention relates to use of the composition of the present invention for alleviating chronic fatigue syndrome and sub-health.

[0081] Another aspect of the present invention relates to the use of the composition of the present invention in preparing medicines, health products, or foods for alleviating chronic fatigue syndrome and sub-health.

[0082] Another aspect of the present invention relates to a method for alleviating chronic fatigue syndrome and sub-health, comprising administering an effective amount of the composition of the present invention to a subject.

[0083] The composition of the present invention can be a drug, health product, or food for alleviating acute alcoholic liver injury in the form of a gastrointestinal tract administration dosage form or a parenteral administration dosage form, such as an oral dosage form.

[0084] The dosage form for administration through the gastrointestinal tract refers to a dosage form in which the drug preparation enters the gastrointestinal tract after oral administration and exerts a local or systemic effect through absorption, such as tablets, ointments, powders, decoctions, granules, capsules or pills, etc. In some embodiments, the composition, drug, health product, or food of the present invention is a capsule.

[0085] The composition, medicine, health product, or food of the present invention may be administered in a dispersed form, including the following dosage forms:

[0086] Solution type: A uniform dispersion system formed by the drug being dispersed in a dispersion medium in a molecular or ionic state (for example, the diameter of a particle is less than 1 nm), also known as a low-molecular solution, such as aromatic water, solution, syrup, glycerin, spirit, injection, etc.

[0087] Colloidal solution type: a uniform dispersion system mainly formed by macromolecules (for example, the diameter of particles is 1 to 100 nm) dispersed in the dispersion medium, also known as polymer solution, such as glue, collodion, coating agent, etc.

[0088] Emulsion: Oily drugs or drug oil solutions are dispersed in the dispersion medium in the form of droplets.

[0089] Uniformly dispersed systems, such as oral emulsions, intravenous emulsions, some ointments, etc.

[0090] Suspension type: A non-uniform dispersion system formed by solid drugs dispersed in the dispersion medium in the form of particles, such as mixtures, lotions, suspensions, etc.

[0091] Gas dispersion type: a dispersion system formed by liquid or solid drugs being dispersed in a gas dispersion medium in the form of particles, such as an aerosol.

[0092] Microparticle dispersion type: The drug is dispersed in the form of particles of different sizes in liquid or solid state, such as microsphere preparations, microcapsule preparations, nanocapsule preparations, etc.

[0093] Solid dispersion type: a dispersion system in which solid drugs exist in the form of aggregates, such as tablets, powders, granules, capsules, pills, etc.

[0094] The composition, medicine, health product, or food such as new resource food of the present invention may further include an adjuvant, such as a pharmaceutical adjuvant. The adjuvant (such as a pharmaceutical adjuvant) may be selected from one or more of the following: solvent, propellant, solubilizer, cosolvent, emulsifier, colorant, adhesive, disintegrant, filler, lubricant, wetting agent, osmotic pressure regulator, stabilizer, glidant, flavoring agent, preservative, suspending agent, coating material, fragrance, anti-adhesive agent, integrator, penetration enhancer, pH regulator, buffer, plasticizer, surfactant, foaming agent, defoamer, thickener, inclusion agent, humectant, absorbent, diluent, flocculant and deflocculating agent, filter aid, and release retardant.

[0095] The technical solution of the present invention is further described in detail below in conjunction with specific embodiments and drawings. It should be understood that the following embodiments are only used to explain the present invention and are not used to limit the present invention.

[0096] Example 1

[0097] The composition is composed of the following medicinal raw materials in parts by weight: 3 parts of ginseng, 15 parts of tuckahoe, 20 parts of kudzu root, 15 parts of wolfberry, 8 parts of gardenia and 5 parts of ebony.

[0098] The preparation method is as follows:

[0099] Weigh the drug raw materials according to the above-mentioned mass fractions, grind them, and soak them in deionized water 10 to 15 times the volume of the drug raw materials for half an hour. Boil the water over high heat, then simmer for 30 minutes over low heat. After decocting, filter the drug residue with gauze, and pour the drug residue back into the pot and decoct again for 2 times. For the second decoction, add deionized water 10 times the volume of the drug residue, boil it over high heat, then simmer for 30 minutes over low heat, and take the filtrate. For the third decoction, add deionized water 8 times the volume of the drug residue, boil it over high heat, then simmer for 30 minutes over low heat, filter the filtrate, and combine the filtrates obtained after the three decoctions to obtain a drug solution, which is cooled to obtain a decoction.

[0100] Example 2

[0101] The composition is composed of the following medicinal raw materials in parts by mass: 3 parts of ginseng, 15 parts of Poria cocos, 20 parts of Pueraria root, 15 parts of wolfberry, 8 parts of Gardenia jasminoides, 5 parts of Prunus mume, and 440 mg / kg of oligo-walnut peptide.

[0102] The preparation method is as follows:

[0103] Weigh the drug raw materials according to the above mass fractions (except walnut peptide), crush them, soak them in deionized water 10 to 15 times the volume of the drug raw materials for half an hour, boil the water over high heat, then simmer for 30 minutes over low heat, filter the residue with gauze after decocting, pour the residue back into the pot and decoct again for 2 times, add deionized water 10 times the volume of the residue for the second decoction, boil over high heat, then simmer for 30 minutes over low heat, and take the filtrate; add deionized water 8 times the volume of the residue for the third decoction, boil over high heat, then simmer for 30 minutes over low heat, filter the filtrate, and combine the filtrates obtained after the three decoctions to obtain a medicinal solution, cool, and obtain a decoction; at the same time, dissolve the oligomeric walnut peptide in the medicinal solution at a dose of 440 mg / kg.

[0104] Example 3

[0105] The composition is composed of the following medicinal raw materials in parts by weight: 5 parts of ginseng, 18 parts of tuckahoe, 25 parts of kudzu root, 18 parts of wolfberry, 10 parts of gardenia and 3 parts of ebony.

[0106] The preparation method is as follows:

[0107] Weigh the drug raw materials according to the above mass fractions, crush them, soak them in 10-15 times the volume of deionized water for half an hour, boil the water over high heat, then simmer for 30 minutes over low heat, filter the drug residue with gauze after decocting, pour the drug residue back into the pot and decoct again for 2 times, add 10 times the volume of deionized water of the drug residue for the second decoction, boil over high heat, then simmer for 30 minutes, and take the filtrate; add 8 times the volume of deionized water of the drug residue for the third decoction, boil over high heat, then simmer for 30 minutes, filter and take the filtrate, and combine the filtrates obtained after the three decoctions to obtain a medicinal solution, cool, and obtain a decoction; at the same time, melt the oligo walnut peptide in the medicinal solution at a dose of 440 mg / kg to prepare a decoction;

[0108] The obtained decoction is further concentrated by using a rotary evaporator for reduced-pressure rotary evaporation. The specific operation is as follows: the cooled liquid is poured into the rotary evaporator in multiple times, and the liquid poured in each time cannot exceed one-third of the total volume of the rotary evaporator. The rotary evaporation temperature is controlled at 42°C, the rotation speed is adjusted to gear 4, the atmospheric pressure is first adjusted to 80 atmospheres, and after the rotary evaporation starts, the atmospheric pressure is reduced according to the situation until it is concentrated into a viscous, nearly paste-like liquid. The above-mentioned viscous, nearly paste-like liquid is poured into a glass container and dried in a drying oven to a paste, thereby obtaining the ointment.

[0109] Example 4

[0110] The composition is composed of the following medicinal raw materials in parts by mass: 5 parts of ginseng, 18 parts of tuckahoe, 25 parts of kudzu root, 18 parts of wolfberry, 10 parts of gardenia, 3 parts of ebony, and 400 mg / kg of oligo-walnut peptide.

[0111] The preparation method is as follows:

[0112] Weigh the drug raw materials according to the above mass fractions (except walnut peptide), crush them, soak them in 10-15 times the volume of deionized water for half an hour, boil the water over high heat, then simmer for 30 minutes over low heat, filter the drug residue with gauze after decocting, pour the drug residue back into the pot and decoct again for 2 times, add 10 times the volume of deionized water of the drug residue for the second decoction, boil over high heat, then simmer for 30 minutes, and take the filtrate; add 8 times the volume of deionized water of the drug residue for the third decoction, boil over high heat, then simmer for 30 minutes, filter and take the filtrate, and combine the filtrates obtained after the three decoctions to obtain a drug solution, cool, and obtain a decoction; at the same time, melt the oligomeric walnut peptide in the drug solution at a dose of 440 mg / kg to prepare a decoction;

[0113] The obtained decoction is further concentrated by using a rotary evaporator for reduced-pressure rotary evaporation. The specific operation is as follows: the cooled liquid is poured into the rotary evaporator in multiple times, and the liquid poured in each time cannot exceed one-third of the total volume of the rotary evaporator. The rotary evaporation temperature is controlled at 42°C, the rotation speed is adjusted to gear 4, the atmospheric pressure is first adjusted to 80 atmospheres, and after the rotary evaporation starts, the atmospheric pressure is reduced according to the situation until it is concentrated into a viscous, nearly paste-like liquid. The above-mentioned viscous, nearly paste-like liquid is poured into a glass container and dried in a drying oven to a paste, thereby obtaining the ointment.

[0114] Example 5

[0115] The composition is composed of the following medicinal raw materials in parts by weight: 10 parts of ginseng, 20 parts of tuckahoe, 30 parts of kudzu root, 20 parts of wolfberry, 25 parts of gardenia and 12 parts of ebony.

[0116] The preparation method is as follows:

[0117] The drug raw materials are weighed according to the above-mentioned mass fractions, and 50% ethanol is used as the extraction solvent for percolation extraction. Before the extraction, the drug raw materials are first soaked with 1 to 3 times the volume of the solvent, and then 8 to 9 times the volume of the solvent is used for extraction. The flow rate of the percolation extraction is controlled at 4 to 5 ml / min, and an extract is obtained after the extraction is completed; the obtained extract is further subjected to reduced-pressure rotary evaporation by a rotary evaporator to obtain a viscous, nearly paste-like liquid, and auxiliary materials including fillers and lubricants are added to the above-mentioned viscous, nearly paste-like liquid, and then prepared into tablets by wet granulation, wherein the above-mentioned fillers and lubricants can be selected from the existing technology.

[0118] Example 6

[0119] The composition is composed of the following medicinal raw materials in parts by mass: 10 parts of ginseng, 20 parts of tuckahoe, 30 parts of kudzu root, 20 parts of wolfberry, 25 parts of gardenia, 12 parts of ebony, and 500 mg / kg of oligo-walnut peptide.

[0120] The preparation method is as follows:

[0121] The drug raw materials are weighed according to the above-mentioned mass fractions, and 50% ethanol is used as the extraction solvent for percolation extraction. Before the extraction, the drug raw materials are first soaked with 1 to 3 times the volume of the solvent, and then 8 to 9 times the volume of the solvent is used for extraction. The flow rate of the percolation extraction is controlled at 4 to 5 ml / min, and an extract is obtained after the extraction is completed; the obtained extract is further subjected to reduced-pressure rotary evaporation by a rotary evaporator to obtain a viscous, nearly paste-like liquid, and auxiliary materials including fillers and lubricants are added to the above-mentioned viscous, nearly paste-like liquid, and then prepared into tablets by wet granulation, wherein the above-mentioned fillers and lubricants can be selected from the existing technology.

[0122] Example 7

[0123] The composition is composed of the following medicinal raw materials in parts by weight: 12 parts of ginseng, 30 parts of tuckahoe, 40 parts of kudzu root, 12 parts of wolfberry, 15 parts of gardenia, and 9 parts of ebony.

[0124] The preparation method is as follows:

[0125] The drug raw materials were weighed according to the above mass fractions, and 50% ethanol was used as the extraction solvent for percolation extraction.

[0126] Before extraction, soak the drug raw materials with 1 to 3 times the volume of solvent, and then use 8 to 9 times the volume of

[0127] The extraction is performed by accumulating solvent, and the flow rate of the percolation extraction is controlled at 4-5 ml / min, and an extract is obtained after the extraction is completed;

[0128] The obtained extract is further subjected to reduced pressure rotary evaporation by a rotary evaporator to obtain a viscous nearly paste-like liquid, and the viscous nearly paste-like liquid is used as a raw material, and gum base, flavoring agent, antioxidant, filler, etc. are added during the preparation process to prepare it into chewing gum. Among them, the gum base, flavoring agent, antioxidant, filler, etc. can be selected from the existing technology.

[0129] Example 8

[0130] The composition is composed of the following medicinal raw materials in parts by mass: 12 parts of ginseng, 30 parts of Poria cocos, 40 parts of Pueraria root, 12 parts of wolfberry, 15 parts of Gardenia jasminoides, 9 parts of Prunus mume, and 440 mg / kg of oligo-walnut peptide.

[0131] The preparation method is as follows:

[0132] The drug raw materials were weighed according to the above mass fractions, and 50% ethanol was used as the extraction solvent for percolation extraction.

[0133] Before extraction, soak the drug raw materials with 1 to 3 times the volume of solvent, and then use 8 to 9 times the volume of

[0134] The extraction is performed by accumulating solvent, and the flow rate of the percolation extraction is controlled at 4-5 ml / min, and an extract is obtained after the extraction is completed;

[0135] The obtained extract is further subjected to reduced pressure rotary evaporation by a rotary evaporator to obtain a viscous nearly paste-like liquid, and the viscous nearly paste-like liquid is used as a raw material, and gum base, flavoring agent, antioxidant, filler, etc. are added during the preparation process to prepare it into chewing gum. Among them, the gum base, flavoring agent, antioxidant, filler, etc. can be selected from the existing technology.

[0136] The composition of the present invention is tested for its efficacy.

[0137] Experimental methods and materials: 30 18-22g SPF male C57BL6 / J mice were selected and fed in an animal room with a temperature of about 25 degrees and a humidity of 50% to 60% for one week. They were randomly divided into 5 groups, each with 6 mice, marked as blank group, model group, Example 1, and Example 2. After the mice were adaptively fed, they were fasted but not watered for 24 hours. The model group and the example group were given 52° Red Star Erguotou by gavage at 10 mL / kg, and the blank group was given an equal amount of normal saline. The model group and the example group were gavaged with drugs or normal saline every morning (the daily dose for each rat was 8.58g / kg), and 52° Red Star Erguotou was given by gavage half an hour after gavage. The intervention lasted for 7 days, and the samples were collected on the 8th day.

[0138] (1) Investigate the effect of drug administration on the average body weight of mice

[0139] The above-mentioned drug-administered groups were administered drugs for 7 consecutive days. Samples were collected on the eighth day, and the weight changes of the mice were observed and recorded within 7 days. The experimental results are shown in Appendix 1.

[0140] Table 1

[0141]

[0142] As can be seen from the table above, the weight of the blank group mice was stable, and the weight of the model group mice and the drug administration group mice decreased. Compared with the blank group, the weight of the model group mice decreased significantly, and compared with the model group, the weight of the mice in each drug administration group increased significantly, and compared with the Example 1 group, the weight of the Example 2 group increased significantly. It can be seen that the composition of the present invention can improve the rapid weight loss caused by excessive alcohol and improve the quality of life of patients.

[0143] (2) Investigating the effects of drug administration on serum inflammatory factors in mice

[0144] The serum of mice was taken and the serum inflammatory factors IL-10 and TNF-α were detected by enzyme-linked immunosorbent assay. The specific method is as follows: 40 μL of sample diluent, 10 μL of sample, and 100 μL of enzyme-labeled reagent were added to each sample well; 50 μL of each standard solution and 100 μL of enzyme-labeled reagent were added to the standard well; 40 μL of sample diluent was added to the blank well; the plate was sealed with a sealing film and placed in a 37°C constant temperature incubator for 1 h in the dark; the plate was quickly washed 5 times with a spray gun, and the plate was cleaned after each wash; then 50 μL of color developer A and 50 μL of color developer B were added respectively, and the plate was incubated at a constant temperature and in the dark for 15 min; the absorbance of each well was detected at a wavelength of 450 nm; the standard curve was drawn, the concentration was calculated, and statistical analysis was performed. The experimental results are shown in Appendix 2.

[0145] Table 2

[0146]

[0147] As can be seen in the table above, compared with the blank group, the serum IL-4 and IL-10 levels of the model group mice were significantly decreased, and the TNF-α level was significantly increased. Compared with the model group, the serum IL-4 and IL-10 expression of the mice in the example group was significantly increased, and the TNF-α expression was significantly decreased. This indicates that administration can alleviate the systemic inflammatory response of mice caused by alcohol.

[0148] (3) Investigate the effects of drug administration on the blood ethanol concentration and the activities of alcohol dehydrogenase and acetaldehyde dehydrogenase in mice

[0149] Mouse serum was collected and the ethanol concentration in the mouse serum was detected using a chemical kit, and the activities of alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) were detected using the ELISA method. The experimental results are shown in Appendix 3.

[0150] Table 3

[0151]

[0152] As can be seen in the table above, the ethanol concentration in the serum of the mice in the model group was significantly higher than that in the blank control group. It was significantly reduced after administration, indicating that the administration promoted the alcohol metabolism rate in the blood of mice to a certain extent. Compared with the model group, the activities of alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) in the example group were significantly increased. It can be seen that the administration can effectively increase the expression of ADH and ALDH in mice, regulate the ethanol metabolism enzyme system, and thus improve its damage.

[0153] (4) Investigate the effect of drug administration on mouse liver function (AST, ALT, AKP)

[0154] After blood was collected from the eyeball, it was centrifuged at 2500r for 15 minutes to obtain serum, and the changes of mouse liver function indicators in the serum were detected.

[0155] Mouse serum ALT and AST were detected by microplate method.

[0156] Engineering Research Institute, Nanjing, China) was equilibrated at room temperature for 20 min, and the matrix solution was preheated at 37℃ for 20 min; 5 μL of sample and 20 μL of reagent 1 were added to the measurement well, and the mixture was mixed repeatedly and reacted at 37℃ for 30 min. After the reaction, 20 μL of reagent 2 was added to the measurement well and the control well, and 5 μL of the sample to be tested was added to the control well. After mixing, the reaction continued for 20 min. Finally, 200 μL of the prepared sodium hydroxide solution was added and placed at room temperature for 15 min. The absorbance was measured at a wavelength of 510 nm. The standard curve was used for calculation to obtain the result. Mouse liver tissue AKP was detected using a chemical kit. The method was as follows: 30 mg of mouse liver tissue was accurately weighed, and physiological saline was added at a ratio of weight (g): volume (mL) = 1:9 for homogenization. The supernatant was taken for determination after centrifugation at 3000 r for 15 min. The kit was equilibrated at room temperature for 20 min, 5 μL of double distilled water was added to the blank well, 5 μL of 0.1 mg / mL phenol standard application solution was added to the standard well, and 5 μL of the sample to be tested was added to the measurement well. Add 50 μL of buffer and matrix solution to the above wells, mix thoroughly and incubate at 37℃ for 15 min, then add 150 μL of color developer, shake the plate gently to mix, and measure the absorbance at a wavelength of 520 nm. Substitute into the standard curve for calculation. The experimental results are shown in Appendix 4.

[0157] Table 4

[0158]

[0159] As can be seen in the table above, the levels of serum ALT, AST, and AKP in each model group of alcoholic liver injury in this study were significantly higher than those in the blank control group, indicating that the model was successfully established. And they all showed a downward trend after administration, indicating that the drug is effective. As shown in the table, the total cholesterol values ​​ALT, AST, and AKP in the serum of mice in the model group increased, and there was a significant downward trend after administration, so it was proved that the Shen Ge prescription and the combined walnut peptide can improve the liver function damage of mice with alcoholic liver injury.

[0160] (5) Investigate the effect of drug administration on mouse tissue pathology

[0161] Observe the pathological changes of tissues under HE staining microscope: After the tissues are collected, they are fixed with tissue fixative for 42 hours, and then the dehydrated tissues are embedded in the paraffin embedding machine, and then the wax blocks are fixed on the slicer for slicing. The slices are placed in dewaxing solution, anhydrous ethanol, 75% alcohol, and deionized water in turn for dewaxing. Perform hematoxylin staining: The slices are immersed in hematoxylin staining solution, deionized water, differentiation solution, deionized water, and blueing solution in turn, and then rinsed with running water. Perform eosin staining: After the slices are dehydrated with alcohol, they are immersed in eosin staining solution. Then dehydrate and seal the slices: The slices are immersed in anhydrous ethanol, xylene in turn, and then sealed with neutral gum to collect image information. The experimental results of mouse liver and intestinal tissues are shown in Figures 1-2, respectively.

[0162] like Figure 1 As shown in the figure, the central vein was selected because the liver lobule lesions near the central vein were more obvious. Compared with the blank group, a large number of lipid droplets were formed in the liver cells of the mice in the model group, the boundaries of the liver cords were blurred, the liver cells were arranged irregularly, and there was a small amount of inflammatory cell infiltration. In contrast, the number of lipid droplets in the tissues of the mice in the example group decreased and the morphology became smaller, the cells were arranged neatly, and the inflammatory cell infiltration decreased.

[0163] like Figure 2 As shown, HE staining observed that the intestinal mucosal epithelium of the blank group mice was continuous and complete, the glands were arranged regularly, the crypts were evenly distributed, the submucosal blood vessels were clearly visible, and there was little inflammatory cell infiltration and muscle thickening. The mice in the model group had destruction of the mucosal epithelial structure, disordered glands, missing crypts, edema, congestion, and ulcers in the mucosa, a large number of inflammatory cell infiltrations in the mucosa and submucosal layers, a decrease in goblet cells, and varying degrees of thickening of the mucosal muscularis. The intestinal mucosal epithelial cells of the mice in the embodiment group were improved compared with those in the model group, and the inflammatory infiltration was alleviated compared with the model group.

[0164] (6) Investigate the effect of drug administration on the expression of inflammatory factors in liver and intestinal tissues

[0165] The ELISA method was used to detect inflammatory factors in mouse liver tissue and intestinal tissue. The experimental results are shown in Table 5.

[0166] Table 5

[0167]

[0168] As can be seen from the table above, compared with the blank group, the IL-10 content in the liver tissue of the model group mice was significantly decreased, and the IL-6 and TNF-α contents were significantly increased; the IL-10 content in the colon tissue was significantly decreased, and the IL-6 and TNF-α contents were significantly increased; compared with the model group, the IL-10 content in the liver tissue of the mice in each example group was significantly increased, and the IL-6 and TNF-α contents were significantly decreased; the IL-10 content in the colon tissue of the mice administered with Example 2 was significantly increased, and the IL-6 and TNF-α contents were significantly decreased. This shows that administration can reduce the inflammatory response of the hepatointestinal tissue and alleviate the damage of the hepatointestinal tissue.

[0169] (7) Investigate the effect of drug administration on SIgA, an intestinal barrier indicator in mice

[0170] The intestinal barrier indicator SIgA was detected in the intestinal tissue of mice using the ELISA method. The experimental results are shown in Table 6.

[0171] Table 6

[0172]

[0173] As can be seen in the table above, SIgA in the colon tissue of mice was significantly downregulated after modeling, indicating that excessive alcohol leads to decreased local mucosal immune function in the intestines of mice. It was significantly upregulated after administration, indicating that administration can upregulate SIgA, protect the intestinal immune barrier, and alleviate the decreased intestinal barrier function caused by excessive alcohol.

[0174] (8) Investigate the effect of drug administration on the intestinal flora of mice

[0175] The results of the experiment on detecting the flora and its metabolites in the intestinal contents of mice using 16S rDNA high-throughput sequencing and GC-MS technology are shown in Appendix 7.

[0176] Table 7

[0177]

[0178] As can be seen in the table above, after administration, the abundance of bacteria (such as Lactobacillus) that can produce short-chain fatty acids in the mouse intestine increased significantly. And their short-chain fatty acids, such as propionic acid, acetic acid, and butyric acid, all increased. This shows that administration can regulate intestinal flora, promote the production of short-chain fatty acids, and prevent and treat alcoholic liver damage.

[0179] Finally, it should be noted that the above description is only a preferred embodiment of the present invention. Under the guidance of the present invention, those skilled in the art can make a variety of similar expressions without violating the purpose and claims of the present invention, and such changes all fall within the protection scope of the present invention.

Claims

1. A composition, characterized in that The invention is composed of the following raw materials: 1-20 parts by weight of ginseng, 1-50 parts by weight of tuckahoe, 1-50 parts by weight of kudzu root, 1-50 parts by weight of wolfberry, 1-30 parts by weight of gardenia, 1-20 parts by weight of ebony and 100-1000 mg / kg of oligo-walnut peptide.

2. The composition according to claim 1, characterized in that The ginseng is ginseng powder, ginseng extract or a combination thereof; and / or The Poria cocos is one or a combination of Poria cocos powder and Poria cocos extract; and / or The kudzu root is kudzu root powder, kudzu root extract or a combination thereof; and / or The wolfberry is wolfberry powder, wolfberry extract or a combination thereof; and / or The gardenia is gardenia powder, gardenia extract or a combination thereof; and / or The black plum is black plum powder, black plum extract or a combination thereof.

3. The method for preparing the composition according to claim 1 or 2, characterized in that: The drug raw materials are measured according to the formula, crushed, boiled and cooled; the obtained drug solution is concentrated until a viscous, nearly paste-like liquid is obtained, which is then dried to form an extract powder.

4. The preparation method according to claim 3, wherein The drug solution is concentrated by a reduced pressure concentration method, and the concentration temperature is 40-42°C.

5. Use of the composition according to claim 1 or 2 in the preparation of a drug for alleviating acute alcoholic liver injury.

6. Use of the composition prepared by the method according to claim 3 or 4 in the preparation of a drug for alleviating acute alcoholic liver injury.

7. The application according to claim 5 or 6, characterized in that, The medicine is in the form of a gastrointestinal tract administration form.

8. The application according to claim 7, wherein: The dosage form for administration through the gastrointestinal tract includes any one of tablets, pastes, powders, decoctions, granules, capsules or pills.

9. The application according to claim 8, wherein: The dosage form for administration through the gastrointestinal tract has the composition as an active ingredient and is prepared with pharmaceutically acceptable auxiliary materials.

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