Traditional Chinese medicine composition for treating alcoholic fatty liver and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating alcoholic fatty liver and application thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 6-150 parts of flos puerariae, 6-150 parts of flos chrysanthemi, 6-150 parts of flos rosae rugosae, 6-150 parts of cordyceps flowers, 3-75 parts of sanchi flowers, 6-150 parts of folium mori, 3-75 parts of hawthorn fruits in Yunnan, 3-75 parts of exocarpium citri grandis, 6-150 parts of semen hoveniae, 6-150 parts of lalang grass rhizome, 6-150 parts of fructus lycii, 3-75 parts of lucid ganoderma, 3-75 parts of fructus schisandrae chinensis, 6-150 parts of semen coicis, 3-75 parts of poria cocos in Yunnan and 3-75 parts of liquorice roots. The traditional Chinese medicine is used for treating alcoholic fatty liver by traditional Chinese medicine thinking, and has the effects of invigorating spleen to eliminate dampness, removing heat to cool blood, promoting blood circulation to remove blood stasis and harmonizing liver and spleen. Experiments prove that the traditional Chinese medicine composition can remarkably inhibit fatty degeneration of liver cells, regulate the content of cytokines in serum and improve the immune function of animals, so that the effect of treating the alcoholic fatty liver can be achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating alcoholic fatty liver and application thereof. Background Art

[0002] The information disclosed in the background technology section is only intended to enhance understanding of the overall background of the invention and is not to be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.

[0003] The liver is the primary site of alcohol oxidative metabolism, and long-term alcohol abuse can lead to a range of liver diseases. Alcoholic liver disease is a common condition, often manifesting in the early stages as alcoholic fatty liver disease (AFLD). While reversible, without timely intervention, AFLD can progress to more serious liver diseases such as alcoholic hepatitis, liver fibrosis, cirrhosis, and even liver cancer. Currently, treatment for AFLD primarily involves abstinence from alcohol, nutritional support, and medication. Currently, the most effective treatment for AFLD is abstinence from alcohol, and more specific drug therapies have yet to be fully explored or established. Therefore, new therapies are urgently needed to prevent the progression of AFLD, especially for patients who are unable to stop drinking. Summary of the Invention

[0004] To address the aforementioned problems with the existing technologies, the present invention provides a traditional Chinese medicine composition for treating alcoholic fatty liver disease and its use. This invention utilizes Traditional Chinese Medicine principles to treat alcoholic fatty liver disease, specifically by strengthening the spleen and eliminating dampness, clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and harmonizing the liver and spleen. This invention was developed based on the aforementioned research findings.

[0005] In order to achieve the above-mentioned object of the invention, the present invention discloses the following technical solutions: The first aspect of the present invention provides a traditional Chinese medicine composition for treating alcoholic fatty liver, which is composed of the following components in parts by weight: 6-150 parts of Pueraria flowers, 6-150 parts of chrysanthemum flowers, 6-150 parts of rose flowers, 6-150 parts of cordyceps flowers, 3-75 parts of Panax notoginseng flowers, 6-150 parts of mulberry leaves, 3-75 parts of Yunhawthorn, 3-75 parts of Citrus aurantium, 6-150 parts of Hovenia dulcis fruits, 6-150 parts of Imperata rhizome, 6-150 parts of Lycium barbarum fruits, 3-75 parts of Ganoderma lucidum, 3-75 parts of Schisandra chinensis, 6-150 parts of Coix seeds, 3-75 parts of Yun Poria, and 3-75 parts of Licorice.

[0006] It should be noted that, in the present invention, the above-mentioned traditional Chinese medicine composition for treating alcoholic fatty liver is named Wuhua Jiejiu Fang.

[0007] The second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, which includes but is not limited to water decoction, water extraction and alcohol precipitation, enzymatic hydrolysis, acid-base extraction and ultrasonic extraction, preferably water decoction.

[0008] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating alcoholic fatty liver.

[0009] A fourth aspect of the present invention provides a pharmaceutical preparation for treating alcoholic fatty liver disease, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] Compared with the existing technology, the above one or more technical solutions have achieved the following beneficial effects: 1) The above technical solution provides a method for treating alcoholic fatty liver disease using the Wuhua Jiehang Recipe. This Wuhua Jiehang Recipe utilizes kudzu flower and Hovenia dulcis fruit as its main ingredients. Kudzu flower detoxifies alcohol, invigorates the spleen and soothes the stomach; Hovenia dulcis fruit clears heat, promotes urination, relieves restlessness, and quenches thirst. These two ingredients complement each other, synergizing to achieve alcohol detoxification and liver protection, directly addressing the core pathogenesis of alcoholic fatty liver disease—internal alcohol toxicity and damp-heat trapped in the spleen. Chrysanthemum flower, rose flower, cordyceps flower, Panax notoginseng flower, and mulberry leaf as its auxiliary ingredients, all of which possess liver-clearing, heat-clearing, depression-relieving, and blood-activating properties, making them commonly used essential ingredients in alcohol detoxification remedies. Chrysanthemum enters the liver meridian, clearing the liver and improving eyesight, calming liver yang; rose flower soothes the liver, relieves depression, harmonizes blood, and disperses stasis; cordyceps flower nourishes the lungs and kidneys, protects the liver, and reduces enzyme levels; Panax notoginseng flower clears heat and calms the liver, promoting blood circulation and unblocking meridians; mulberry leaf clears the lungs, moistens dryness, calms the liver, and cools the blood; Yunshan Crataegus, Hua Tangerine Peel, Imperata Root, Coix Seed, and Yun Fuling are used as adjuvants to strengthen the spleen, dispel dampness, resolve phlegm, and reduce fat; With wolfberry, Ganoderma Lucidum, Schisandra Chinensis, and Licorice as auxiliaries, this formula has excellent long-lasting, liver-tonifying and anti-oxidative effects, making it a commonly used key ingredient in alcohol remedies, particularly effective against inflammatory changes around the liver. Licorice, which clears heat and detoxifies, harmonizes various herbs, and is a common adjuvant. Among them, wolfberry nourishes the liver and kidneys, improves essence and improves eyesight; Ganoderma Lucidum replenishes Qi and calms the mind, strengthening the body; and Schisandra Chinensis is astringent, invigorating Qi and promoting fluid production. Looking at the whole process, detoxification of alcohol is the first priority, while soothing the liver and strengthening the spleen are equally important, clearing away heat and dampness are also taken into consideration, and strengthening the body and eliminating evil are all taken into consideration.

[0011] 2) The Chinese herbal compound of the present application is simple and efficient, the raw materials are economical and affordable, and the preparation and extraction methods are simple, low-cost, universal, and easy to scale up for production, thus having good practical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0013] Figure 1 This is a graph showing the in vitro antioxidant activity of the Wuhua Jiehang Recipe in Example 1 of the present invention, where A represents the ABTS scavenging activity, B represents the DPPH scavenging activity, and C represents the total antioxidant activity; Figure 2 This is a graph showing changes in mouse body weight in Example 2 of the present invention; Figure 3 This is the effect diagram of the mouse liver histopathology in Example 2 of the present invention; it is the Wuhua Jiejiu Recipe positive control group, high-dose group, medium-dose group, low-dose group, model group and blank group in order; Figure 4 This is a graph showing the effect of mouse liver function indicators and mouse oxidative stress in Example 2 of the present invention, where A represents the liver function indicator, B represents the serum ALT level, and C represents the serum AST level; Figure 5 This is a graph showing the effects of oxidative stress on mice in Example 2 of the present invention, where A represents the MDA content and B represents the CAT content; Figure 6 This is a diagram showing the effects of inflammatory factor levels in mouse liver in Example 2 of the present invention, where A represents IL-10 and B represents IL-1β. DETAILED DESCRIPTION

[0014] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0015] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0016] The present invention will be further described with reference to specific examples. The following examples are intended only to illustrate the present invention and are not intended to limit its contents. If the specific experimental conditions are not specified in the examples, conventional conditions or conditions recommended by the sales company are generally followed; unless otherwise specified in the present invention, all can be purchased through commercial channels.

[0017] In a typical embodiment of the present invention, a traditional Chinese medicine composition for treating alcoholic fatty liver is provided, which is composed of the following components in parts by weight: 6-150 parts of Pueraria flowers, 6-150 parts of chrysanthemum flowers, 6-150 parts of rose flowers, 6-150 parts of cordyceps flowers, 3-75 parts of Panax notoginseng flowers, 6-150 parts of mulberry leaves, 3-75 parts of Yunhawthorn, 3-75 parts of Citrus aurantium, 6-150 parts of Hovenia dulcis fruits, 6-150 parts of Imperata rhizome, 6-150 parts of Lycium barbarum fruits, 3-75 parts of Ganoderma lucidum, 3-75 parts of Schisandra chinensis, 6-150 parts of Coix seeds, 3-75 parts of Yun Poria, and 3-75 parts of Licorice.

[0018] Specifically, 6-20 parts of kudzu flowers, 6-20 parts of chrysanthemums, 6-20 parts of roses, 6-20 parts of cordyceps flowers, 3-10 parts of Panax notoginseng flowers, 6-20 parts of mulberry leaves, 3-10 parts of Yun hawthorn, 3-10 parts of Huajuhong, 9-30 parts of Hovenia dulcis fruits, 9-30 parts of Imperata rhizomes, 6-20 parts of wolfberries, 3-10 parts of Ganoderma lucidum, 3-10 parts of Schisandra chinensis, 9-30 parts of Coix seeds, 3-10 parts of Yun Poria, and 3-10 parts of licorice.

[0019] Specifically, 9 parts of Pueraria lobata flowers, 9 parts of chrysanthemum flowers, 9 parts of rose flowers, 9 parts of cordyceps flowers, 6 parts of Panax notoginseng flowers, 9 parts of mulberry leaves, 6 parts of Yunhawthorn, 6 parts of Citrus aurantium, 12 parts of Hovenia dulcis fruits, 12 parts of Imperata cylindrica roots, 9 parts of wolfberry fruits, 6 parts of Ganoderma lucidum, 6 parts of Schisandra chinensis, 15 parts of Coix seeds, 6 parts of Yun Poria cocos, and 6 parts of Licorice.

[0020] The formula characteristics of the Chinese medicine composition of the present invention are as follows: The five-flower hangover-relieving prescription uses kudzu flower and Hovenia dulcis as the main ingredients. Kudzu flower specifically enters the spleen and stomach meridians, is good at detoxifying alcohol, invigorating the spleen and stomach, accelerating the decomposition and metabolism of ethanol, and relieving nausea and abdominal distension after drinking. Hovenia dulcis enters the liver and spleen meridians, clears away heat and promotes diuresis, relieves restlessness and thirst, promotes acetaldehyde excretion, and improves thirst and headache after drinking. The two are complementary to each other. Kudzu flower mainly detoxifies alcohol in the middle burner, while Hovenia dulcis clears dampness and heat in the lower burner, forming a "clearing the upper part and clearing the lower part" trend, directly attacking alcohol metabolism. The disorder is addressed with chrysanthemum, rose, cordyceps flower, Panax notoginseng flower, and mulberry leaf as the auxiliary ingredients. Chrysanthemum clears the liver and improves eyesight, calms liver yang, and relieves red eyes and headaches after drinking. Rose soothes the liver and relieves depression, harmonizes blood circulation, and disperses blood stasis, improving flank pain caused by liver depression and qi stagnation. Cordyceps flower nourishes the lungs and kidneys, reduces enzymes and protects the liver, repairing alcoholic liver damage. Panax notoginseng flower clears heat and calms the liver, activates blood circulation and dredges the meridians, inhibiting the progression of liver fibrosis. Mulberry leaf clears the lungs and moistens dryness, cools blood and calms the liver, and regulates lipid peroxidation. Together, these five herbs relieve liver meridian heat and unblock liver meridian stasis, forming a three-dimensional intervention of "clearing, soothing, activating, and replenishing." The formula is supplemented with Yunshan Hawthorn, Hua Tangerine Peel, Imperata Root, Coix Seed, and Yun Poria. Yunshan Hawthorn helps digestion and resolves stagnation, dissipates Qi and blood stasis, and promotes lipid breakdown. Tangerine Peel dries dampness and resolves phlegm, regulating Qi and alleviating fullness, alleviating abdominal distension and poor appetite. Imperata Root cools the blood and promotes urination, Coix Seed invigorates the spleen, and Poria promotes diuresis and calms the mind. These three ingredients work together to eliminate edema, fatigue, and other symptoms of damp-heat. By combining the three principles of digestion, transformation, and penetration, they disrupt the pathological chain of dampness caused by spleen deficiency, which in turn leads to phlegm. Wolfberry, Ganoderma Lucidum, Schisandra Chinensis, and Licorice Root are combined. Wolfberry nourishes the liver and kidneys, replenishes essence and blood, and restores the Yin fluids depleted by alcohol. Ganoderma Lucidum replenishes Qi and calms the mind, strengthening the body and enhancing the liver's antioxidant capacity. Schisandra Chinensis is astringent, replenishes Qi and promotes fluid production, regulating the stability of liver cell membranes. Licorice Root clears heat and detoxifies, harmonizing the various herbs and mitigating the harsh properties of other drugs. The medicinal group can not only help the monarch, ministerial and adjuvant drugs to eliminate evil, but also prevent the attack and damage to the body, so as to achieve "eliminating evil without damaging the body, and supporting the body without leaving evil".

[0021] The above-mentioned Wuhua Jiehang Recipe has been verified by experiments to be effective in treating alcoholic fatty liver disease: a) Recovery of liver function; b) Improve liver metabolic function; c) Reduce inflammatory response and thus enhance the body's immune function.

[0022] The preparation method of the above-mentioned traditional Chinese medicine composition includes, but is not limited to, water decoction, water extraction and alcohol precipitation, enzymatic hydrolysis, acid-base extraction, and ultrasonic extraction. In another embodiment of the present invention, a preparation method of the above-mentioned traditional Chinese medicine composition is provided, wherein the preparation method is water decoction.

[0023] Specifically, the above medicinal materials are soaked in water, and a water decoction method is adopted to obtain a medicinal liquid, and the medicinal liquid is freeze-dried to obtain the Wuhua hangover-relieving freeze-dried powder.

[0024] Specifically, the water decoction method comprises the following steps: mixing and soaking the other components except rose flowers, heating and boiling, maintaining boiling for a first decoction, pouring out the supernatant and filtering; adding rose flowers to the remaining medicinal residue after the first decoction, and continuously adding water until the mixture covers the medicinal materials, heating and boiling, maintaining boiling for a second decoction, pouring out the supernatant and filtering; continuously adding water to the remaining medicinal residue after the second decoction until the mixture covers the medicinal materials, heating and boiling, maintaining boiling for a third decoction.

[0025] More specifically, the three decoctions are combined, concentrated, and freeze-dried to obtain the product.

[0026] Another specific embodiment of the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating alcoholic fatty liver disease. Experiments in a mouse model of alcoholic fatty liver disease have demonstrated that the composition can significantly inhibit hepatocyte steatosis and improve the disordered lipid metabolism within hepatocytes. Furthermore, the composition can inhibit the expression of inflammatory factors, alleviate liver inflammation, slow the progression of liver fibrosis, activate immune cell activity, and regulate the balance of immune cytokine networks, thereby enhancing immune function and exerting comprehensive liver protection and immunomodulatory effects. Specifically, the composition has at least one of the following effects: a) restoring liver function; b) improving liver metabolic function; and c) alleviating inflammatory responses, thereby enhancing immune function.

[0027] In another specific embodiment of the present invention, a pharmaceutical preparation for treating alcoholic fatty liver is provided, which comprises the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0028] Specifically, the pharmaceutical preparation can be prepared into various pharmaceutical dosage forms, preferably oral liquids, decoctions, pills, capsules, tablets, powders or granules, and other oral preparation types suitable for practical applications.

[0029] Specifically, the pharmaceutically acceptable excipients in the pharmaceutical preparation include, but are not limited to, one or more of diluents, fillers, disintegrants, lubricants, binders, flow agents, complex forming agents, plasticizers, colorants, sweeteners, viscosity enhancers, preservatives or antioxidants.

[0030] In another specific embodiment of the present invention, the diluent includes but is not limited to sorbitol, mannitol, starch, lactose, powdered cellulose, microcrystalline cellulose, dicalcium phosphate, tricalcium phosphate, etc.

[0031] The fillers include, but are not limited to, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatinized starch, and the like.

[0032] The disintegrant includes but is not limited to dry starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, etc.

[0033] The lubricant includes but is not limited to magnesium stearate, sodium lauryl sulfate or micro powder silica gel.

[0034] In another specific embodiment of the present invention, a method for treating alcoholic fatty liver is provided, comprising: administering a therapeutically effective dose of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation to a subject.

[0035] The subject refers to an animal or human who has been the object of treatment, observation or experiment, wherein the animal can be a mouse, rat, monkey, gorilla, dog, etc.

[0036] The "therapeutically effective amount" refers to an amount of the Chinese medicine composition or pharmaceutical preparation of the present invention, which can induce the biological or medical response of the tissue system or animal sought by the researcher, veterinarian, doctor or other medical personnel, including alleviating or partially alleviating the symptoms of the disease, syndrome, condition or disorder being treated.

[0037] It must be recognized that the optimal dosage and interval of the active ingredient of the present invention is determined by its nature and external conditions such as the form, route and site of administration and the specific mammal to be treated, and this optimal dosage can be determined using conventional techniques.

[0038] In order to enable those skilled in the art to more clearly understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0039] Example 1 The specific preparation and extraction steps of a traditional Chinese medicine composition for treating alcoholic fatty liver are as follows: Soak: 9 parts kudzu flower, 9 parts chrysanthemum flower, 9 parts cordyceps flower, 6 parts Panax notoginseng flower, 9 parts mulberry leaf, 6 parts Yun hawthorn, 6 parts Huatanghong, 12 parts Hovenia dulcis fruit, 12 parts Imperata cylindrica root, 9 parts Lycium barbarum fruit, 6 parts Ganoderma lucidum, 6 parts Schisandra chinensis, 15 parts Coix seed, 6 parts Yun Poria, and 6 parts Licorice root. Mix and mash, pour into a decoction container, add 10 times the amount of drinking water, and soak for 60 minutes to unclog the capillaries of the herbs and facilitate the exudation of the active ingredients.

[0040] Extraction of alcoholic fatty liver: Soak all ingredients except rose for 1 hour; boil over high heat, then simmer over low heat for 40 minutes; add 8 times the amount of water for the second time, add 9 parts of rose, boil over high heat, and simmer over low heat for 30 minutes; add 6 times the amount of water for the third time, boil over high heat, and simmer over low heat for 20 minutes. Filter with 4 layers of gauze after each decoction.

[0041] Concentration: Combine the three decoctions and concentrate them using a rotary evaporator.

[0042] Freeze-drying: The medicinal solution was cooled and then placed in a -80°C refrigerator for 48 hours, and then freeze-dried in a freeze dryer for 48 hours to obtain the Wuhua Jiehang Recipe freeze-dried powder.

[0043] Example 2 Applications include: Direction 1, determination of the antioxidant capacity of the lyophilized powder of Wuhua Jiehang Recipe in Example 1; Direction 2, the protective effect of the freeze-dried powder of Wuhua Jiehang Recipe in Example 1 on the liver.

[0044] 1. Pharmacodynamics experiments The freeze-dried powder of the Wuhua Jiehang Recipe in direction 1 was prepared into low (130 mg·kg -1 ), medium (260mg•kg -1 ), high (520mg•kg -1 ) doses were used for oral gavage of mice.

[0045] The lyophilized powder of the Wuhua Jiehang Recipe in direction 2 is prepared into appropriate concentrations.

[0046] DPPH free radical scavenging ability test kit, ABTS free radical cation scavenging ability test kit and total antioxidant capacity (T-AOC) test kit, mouse IL-10, IL-1β ELISA kits, tissue fixative, hematoxylin stain, eosin stain, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and malondialdehyde (MDA) ELISA kits. Establishment of an alcoholic fatty liver model in mice Healthy adult male C57BL / 6 mice, 8 weeks old, weighing 20 ± 2 g, were purchased from Yunnan University and acclimated for one week before the experiment. Mice were housed at 23 ± 2°C, 50 ± 10% relative humidity, and a 12-h light cycle with free access to food and water.

[0047] Experimental animal grouping and treatment After one week of adaptive feeding, 72 8-week-old C57BL / 6 mice were randomly divided into six groups: normal control, positive control, model control, high-dose Wuhua Jiejiu Fang, medium-dose Wuhua Jiejiu Fang, and low-dose Wuhua Jiejiu Fang. Each group had n = 6 mice. Except for the normal control group, which received normal saline, all other groups were gavaged with 52% baijiu for 7 days. Starting on the 8th day, the positive control group received Neptune Jinzun, and the model group continued to receive Erguotou. The drug groups were gavaged with different concentrations of Wuhua Jiejiu Fang decoction for 14 consecutive days. Twelve hours after the last dose, the mice were anesthetized with ether, sacrificed, and samples collected.

[0048] 2. Experimental Methods Direction 1: Determination of the antioxidant capacity of Wuhua Jiejiu Recipe; Direction 2, the protective effect of the Wuhua Jiehang Recipe in Example 1 on the liver (see Table 1 for specific experimental steps and operations).

[0049] Table 1 Experimental design table

[0050] 3. Results and Analysis 3.1 Data Analysis Methods All experimental data were expressed as Mean ± SD, and the data were preliminarily sorted and calculated using Excel. The obtained data were analyzed using GraphPad Prism 6.0 software, and SPSS 18.0 software was used for data variance analysis and multiple comparison. P The difference was statistically significant when the value was less than 0.05.

[0051] 3.1 In vitro antioxidant effects of Wuhua Jiehang Recipe like Figure 1 As shown in Figures A, B, and C, as the concentration of the Wuhua Jiehang Recipe freeze-dried powder increases from 0.00 mg / mL, the ABTS free radical scavenging activity increases rapidly. At a concentration of approximately 0.05 mg / mL, the scavenging activity reaches approximately 80% and then levels off. Further increases in concentration do not significantly change the scavenging activity, indicating that good ABTS free radical scavenging ability is exhibited at relatively low concentrations, and that the scavenging ability ceases to increase significantly after a certain concentration increase. The DPPH free radical scavenging activity increases with increasing concentration of the alcohol-detoxifying compound, with a significant increase in the 0.00-0.05 mg / mL range, reaching nearly 80% at 0.05 mg / mL. When the concentration is subsequently increased to 0.20 mg / mL, the scavenging activity remains around 100%, indicating a good scavenging effect on DPPH free radicals, and that the activity levels off after reaching a certain concentration. The total antioxidant capacity of Wuhua Jiejiu Fang (Wuhua Jiejiu Fang) increased continuously with increasing concentration of the lyophilized powder (from 0 mg / mL to 15 mg / mL). At a concentration of 10 mg / mL, the antioxidant capacity significantly increased, from approximately 3 μmol / L to 4 μmol / L, and reached approximately 5 μmol / L at 15 mg / mL, demonstrating a trend of increasing total antioxidant capacity with increasing concentration. In summary, Wuhua Jiejiu Fang exhibits excellent scavenging capacity against ABTS and DPPH free radicals in vitro, and its total antioxidant capacity increases with increasing concentration, demonstrating robust in vitro antioxidant activity within a range of concentrations. Overall, Wuhua Jiejiu Fang exhibits high antioxidant activity.

[0052] 3.2 Effect of Wuhua hangover treatment on mouse body weight like Figure 2As shown in the data, during the treatment period, the body weight of mice in the normal control group showed a steady upward trend, the body weight of mice in the positive control group, high-, medium- and low-dose drug groups showed a trend of first decreasing and then increasing to varying degrees, and the body weight of mice in the model group showed a downward trend, and the difference was significant (P<0.05), indicating that Wuhua Jiejiu Recipe has an improving effect on the weight loss of mice caused by alcohol-induced fatty liver.

[0053] 3.3 Protective effect of Wuhua Jiejiu recipe on mice with alcoholic fatty liver disease 3.3.1 Effects of Wuhua Jiejiu Recipe on the Liver of Mice with Alcoholic Fatty Liver Disease like Figure 3 As shown, hematoxylin-eosin (HE) staining revealed that in the normal control group, hepatocytes were regularly arranged, with clear hepatic lobule structure and normal cellular morphology, without significant pathological changes. In the model group, however, hepatocytes showed significant abnormalities, with disorganized cellular structure, possible inflammatory cell infiltration, and some signs of necrosis. This indicates that the model successfully induced liver damage, reflecting the adverse effects of alcohol or related factors on liver tissue. The positive control group showed improved liver pathology, with relatively orderly cellular structure and reduced inflammation compared to the model group. The Wuhua Jiejiu Recipe showed varying degrees of improvement in each dose group. While the low-dose group showed some improvement, some cellular abnormalities and mild inflammation were still observed, suggesting that the low-dose Wuhua Jiejiu Recipe has limited repair effects on liver damage. In the medium-dose group, hepatocytes showed more orderly arrangement, reduced inflammatory cell infiltration, and more normal cellular morphology, demonstrating that the medium-dose Wuhua Jiejiu Recipe effectively alleviates liver tissue damage and has a positive effect on liver structural restoration. The liver tissue in the high-dose group had a close to normal structure, good cell morphology, and no obvious inflammatory response, indicating that the high-dose Wuhua Jiehang Recipe had a significant effect on repairing liver damage, which shows that Wuhua Jiehang Recipe can effectively improve alcohol-induced liver damage.

[0054] 3.3.2 Effects of Wuhua Jiejiu Recipe on Liver Function Indexes in Mice with Alcoholic Fatty Liver Disease like Figure 4As shown in Figures A, B, and C, the liver index of each group of mice was calculated. The liver index of mice gavaged with alcohol was significantly higher than that of mice in the normal control group, indicating that the model group mice had liver edema. The liver index of mice treated with different doses of Wuhua Jiejiu Recipe decreased compared with the model group, indicating that Wuhua Jiejiu Recipe can alleviate alcohol-induced liver edema in mice. To further evaluate the effect of Wuhua Jiejiu Recipe on the livers of mice with alcoholic fatty liver disease, serum levels of aspartate aminotransferase (ALT) and alanine aminotransferase (AST) were measured in each group of mice. The data showed that the levels in the model group were significantly higher than those in normal mice, while the levels of ALT and AST in the Wuhua Jiejiu Recipe group were significantly lower than those in the model group. The differences were statistically significant (P < 0.05), indicating that Wuhua Jiejiu Recipe can alleviate the alcohol-induced elevation of ALT and AST in mouse serum.

[0055] 3.3.3 Effect of Wuhua Jiejiu Recipe on Liver Oxidative Stress in Mice with Alcoholic Fatty Liver Disease like Figure 5 As shown in Figures A and B, the contents of malondialdehyde (MDA) and catalase (CAT) in the liver tissues of mice were analyzed. Compared with the blank control group, the CAT level in the model group decreased, while the CAT levels in the positive drug control group and the drug group increased, among which the CAT level in the low-dose drug group was slightly lower than that in the positive drug control group; and the MDA level was lower than that in the control group, while the MDA level in the model group was higher than that in the control group, indicating that the Wuhua Jiehang Recipe can effectively improve the trend of increased MDA levels and decreased CAT levels.

[0056] 3.3.4 Effect of Wuhua Jiejiu Recipe on the Levels of Inflammatory Factors in the Liver of Mice with Alcoholic Fatty Liver Disease like Figure 6 As shown in Figures A and B, IL-10 and IL-1β levels were analyzed in liver homogenates from each group of mice. The data showed that liver homogenates from mice fed an alcoholic diet had higher IL-10 levels and lower IL-1β levels. Different doses of the Wuhua Jiejiu Recipe inhibited alcohol-induced liver inflammatory cytokines to varying degrees. IL-1β levels in mice in the high-dose group were significantly lower than those in the model group.

[0057] 4. Discussion Alcohol-induced liver damage is a subtle and often overlooked condition. Once the liver is damaged and stimulated, it counteracts the damage by regulating corresponding signaling pathways, affecting the levels of various cytokines released by liver cells. When the damage reaches a certain level, it can develop into serious liver diseases such as liver fibrosis, cirrhosis, and even liver cancer. Alcohol metabolism produces large amounts of reactive oxygen species, which damage membrane lipids, proteins, and DNA, impair liver cell function, and trigger an inflammatory response. This example successfully established a mouse model of alcoholic fatty liver disease. The weight changes of the mice were monitored during treatment to evaluate the effects of drugs on alcoholic fatty liver disease. When recording the weights of the mice, it was found that during modeling, except for the normal group, which maintained a steady increase in weight, the weight of the mice in all other groups decreased. Following drug administration, except for the model group, the weight of the mice in all other groups decreased to varying degrees. This may be due to the toxic substances such as acetaldehyde produced by alcohol metabolism in the mice, which trigger liver cell damage, inflammatory responses, and lipid metabolism disorders, leading to impaired liver function. Liver dysfunction affects fat, protein, and sugar metabolism, making it impossible for the body to effectively utilize and store energy. Mice are forced to consume their own stored fat and protein to maintain life activities, which causes weight loss. In addition, the liver inflammation response caused by alcohol can also trigger a systemic inflammatory state, interfere with hormone balance, and affect the appetite regulation center, resulting in decreased appetite and reduced food intake in mice, which is also one of the important reasons for weight loss. After administration, the weight of mice in all groups except the model group returned to normal, indicating that the Wuhua Jiejiu Recipe can alleviate alcohol-induced liver damage in mice.

[0058] This example demonstrates the protective effect of Wuhua Jiejiu Recipe on the liver tissue of mice with alcoholic fatty liver disease, as demonstrated by HE staining. Model mice exhibited significant hepatocyte abnormalities, with disrupted cellular structure, possible inflammatory cell infiltration, and some cellular necrosis, pathological features consistent with the typical pathological progression of alcoholic fatty liver disease (AFLD). This suggests that long-term alcohol exposure disrupts hepatocyte lipid metabolism and induces an inflammatory response. Notably, high-dose Wuhua Jiejiu Recipe treatment normalized liver tissue structure and significantly reduced inflammatory infiltration. A clear dose-response relationship was observed in the drug group, suggesting that the active ingredient may have concentration-dependent bioavailability.

[0059] This example demonstrates the protective effects of Wuhua Jiejiu Recipe on mice with alcoholic fatty liver disease (AFLD) through multi-dimensional experimental data. Model mice exhibited typical liver pathological features, including significant abnormalities in hepatocytes, disorganized cellular structure, possible inflammatory cell infiltration, and some signs of necrosis. These findings were accompanied by elevated liver indices, abnormal serum transaminase (ALT / AST) levels, oxidative stress imbalance (elevated MDA, decreased CAT), and dysregulation of inflammatory factors (elevated IL-1β). These findings collectively reflect the extensive damage alcohol exposure causes to liver metabolism, antioxidant capacity, and inflammatory regulation. Treatment with Wuhua Jiejiu Recipe significantly improved these pathological features, with the highest effect observed in the high-dose group, suggesting a dose-dependent effect. Liver morphology revealed that a high-dose Wuhua Jiejiu Recipe significantly reduced lipid droplet deposition and repaired hepatocyte structure, potentially related to its direct protective effects by regulating lipid metabolism and alleviating hepatocyte damage. Reductions in liver indices and serum ALT and AST levels further confirmed the formula's ability to alleviate liver damage, suggesting that it may maintain normal liver function by improving liver cell membrane stability or promoting damage repair. Furthermore, improvements in liver oxidative stress markers (reduced MDA levels and restored CAT activity) suggest that the formula may mitigate alcohol-induced lipid peroxidation damage by enhancing the antioxidant defense system. Notably, the significant inhibitory effect of the drug group on the inflammatory factor IL-1β, combined with the regulatory trend of IL-10, suggests that it may alleviate the inflammatory microenvironment of alcoholic liver disease by balancing the expression of pro-inflammatory and anti-inflammatory factors.

[0060] In summary, this example systematically verifies the protective effect of Wuhua Jiehang Recipe on alcoholic fatty liver disease from four aspects: tissue pathology, liver function, oxidative stress, and inflammation regulation, providing an experimental basis for its clinical application and laying a theoretical foundation for the modern development of traditional Jiehang Recipes.

[0061] It should be noted that the above embodiments are intended only to illustrate the technical solutions of the present invention and are not intended to limit the same. Although the present invention has been described in detail with reference to the examples given, those skilled in the art may modify or replace the technical solutions of the present invention as needed without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A Chinese medicine composition for treating alcoholic fatty liver, characterized in that: According to parts by weight, it is composed of the following components: 6-150 parts of Pueraria flowers, 6-150 parts of chrysanthemum flowers, 6-150 parts of rose flowers, 6-150 parts of cordyceps flowers, 3-75 parts of Panax notoginseng flowers, 6-150 parts of mulberry leaves, 3-75 parts of Yunhawthorn, 3-75 parts of Citrus aurantium, 6-150 parts of Hovenia dulcis fruits, 6-150 parts of Imperata rhizome, 6-150 parts of Lycium barbarum fruits, 3-75 parts of Ganoderma lucidum, 3-75 parts of Schisandra chinensis, 6-150 parts of Coix seeds, 3-75 parts of Yun Poria, and 3-75 parts of Licorice.

2. The Chinese medicine composition according to claim 1, wherein 6-20 parts of Pueraria flowers, 6-20 parts of chrysanthemum flowers, 6-20 parts of rose flowers, 6-20 parts of cordyceps flowers, 3-10 parts of Panax notoginseng flowers, 6-20 parts of mulberry leaves, 3-10 parts of Yunhawthorn, 3-10 parts of Citrus aurantium, 9-30 parts of Hovenia dulcis fruits, 9-30 parts of Imperatae rhizome, 6-20 parts of Lycium barbarum fruits, 3-10 parts of Ganoderma lucidum, 3-10 parts of Schisandrae chinensis, 9-30 parts of Coix seeds, 3-10 parts of Yunfuling, and 3-10 parts of Licorice.

3. The Chinese medicine composition according to claim 1, wherein 9 parts of Pueraria lobata flowers, 9 parts of chrysanthemum flowers, 9 parts of rose flowers, 9 parts of cordyceps flowers, 6 parts of Panax notoginseng flowers, 9 parts of mulberry leaves, 6 parts of cloud crab, 6 parts of orange peel, 12 parts of Hovenia dulcis fruits, 12 parts of Imperata cylindrica roots, 9 parts of wolfberry fruits, 6 parts of Ganoderma lucidum, 6 parts of Schisandra chinensis fruits, 15 parts of coix seeds, 6 parts of cloud Poria cocos, and 6 parts of liquorice.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method is a water decoction method.

5. The method for preparing the Chinese medicine composition according to claim 3, wherein: The medicinal materials are soaked in water, and a water decoction method is adopted to obtain a medicinal liquid, and the medicinal liquid is freeze-dried to obtain the Wuhua hangover-relieving freeze-dried powder.

6. The method for preparing the Chinese medicine composition according to claim 4, wherein: The specific steps of the water decoction method are as follows: mixing and soaking the other components except the rose flower, heating and boiling, maintaining the boiling for a first decoction, pouring out the supernatant and filtering; adding the rose flower to the remaining medicinal residue after the first decoction, continuing to add water until it covers the medicinal material, heating and boiling, maintaining the boiling for a second decoction, pouring out the supernatant and filtering; continuing to add water to the remaining medicinal residue after the second decoction until it covers the medicinal material, heating and boiling, maintaining the boiling for a third decoction; combining the three decoctions, concentrating, and freeze-drying to obtain the medicinal liquid.

7. Use of the Chinese medicine composition according to claims 1-3 in the preparation of a medicament for treating alcoholic fatty liver.

8. The use according to claim 7, characterized in that The drug has at least one of the following effects: a) restoration of liver function; b) Improve liver metabolic function; c) Reduce inflammatory response and thus enhance the body's immune function.

9. A pharmaceutical preparation for treating alcoholic fatty liver, characterized in that: The invention comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that The pharmaceutically acceptable excipients in the pharmaceutical preparation include one or more of diluents, fillers, disintegrants, lubricants, binders, flow agents, complex forming agents, plasticizers, colorants, sweeteners, viscosity enhancers, preservatives or antioxidants.

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