A traditional Chinese medicine composition for treating alcoholic fatty liver and its application

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating alcoholic fatty liver and its application. It comprises the following components: 6-150 parts of kudzu flower, 6-150 parts of chrysanthemum flower, 6-150 parts of rose flower, 6-150 parts of cordyceps flower, 3-75 parts of notoginseng flower, 6-150 parts of mulberry leaf, 3-75 parts of hawthorn fruit, 3-75 parts of tangerine peel, 6-150 parts of Japanese raisin tree fruit, 6-150 parts of Imperata cylindrica root, 6-150 parts of wolfberry fruit, 3-75 parts of Ganoderma lucidum, 3-75 parts of Schisandra chinensis fruit, 6-150 parts of coix seed, 3-75 parts of Poria cocos, and 3-75 parts of licorice root. This invention treats alcoholic fatty liver using traditional Chinese medicine principles, namely, strengthening the spleen and resolving dampness, clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and harmonizing the liver and spleen. Experiments have shown that it can significantly inhibit hepatocyte steatosis, regulate the content of cytokines in serum, and improve the immune function of animals, thereby achieving the effect of treating alcoholic fatty liver.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating alcoholic fatty liver and its application. Background Technology

[0002] The information disclosed in the background section is intended only to enhance understanding of the overall background of the invention and is not to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] The liver is the primary site of alcohol oxidation and metabolism, and long-term alcohol abuse can lead to a range of liver diseases. Alcoholic liver disease (ALD) is a common condition, often manifesting in its early stages as alcoholic fatty liver disease (AFLD). While AFLD is reversible, without timely intervention, it can progress to more serious liver conditions such as alcoholic hepatitis, liver fibrosis, cirrhosis, and even liver cancer. Currently, treatment for AFLD primarily includes abstinence from alcohol, nutritional support, and medication. At present, abstinence from alcohol is the most effective treatment for AFLD; more specific drug treatments have not yet been fully explored or established. Therefore, new therapies are urgently needed to prevent the progression of AFLD, especially for patients who cannot stop drinking. Summary of the Invention

[0004] To address the problems existing in the prior art, this invention provides a traditional Chinese medicine composition for treating alcoholic fatty liver and its application. This invention treats alcoholic fatty liver using traditional Chinese medicine principles, namely, strengthening the spleen and resolving dampness, clearing heat and cooling the blood, promoting blood circulation and removing blood stasis, and harmonizing the liver and spleen. This invention is based on the above research findings.

[0005] To achieve the above-mentioned objectives, the present invention discloses the following technical solutions:

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating alcoholic fatty liver, comprising the following components in parts by weight:

[0007] Kudzu flower 6-150 parts, chrysanthemum 6-150 parts, rose 6-150 parts, cordyceps flower 6-150 parts, Panax notoginseng flower 3-75 parts, mulberry leaf 6-150 parts, hawthorn 3-75 parts, tangerine peel 3-75 parts, Japanese raisin tree fruit 6-150 parts, Imperata cylindrica root 6-150 parts, wolfberry 6-150 parts, Ganoderma lucidum 3-75 parts, Schisandra chinensis 3-75 parts, coix seed 6-150 parts, Poria cocos 3-75 parts, licorice root 3-75 parts.

[0008] It should be noted that, in this invention, the above-mentioned traditional Chinese medicine composition for treating alcoholic fatty liver is named Wuhua Jiejiu Fang (Five-Flower Relief Formula).

[0009] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, wherein the method includes, but is not limited to, water decoction, water extraction and alcohol precipitation, enzymatic hydrolysis, acid-base extraction and ultrasonic extraction, and preferably water decoction.

[0010] A third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating alcoholic fatty liver.

[0011] In a fourth aspect, the present invention provides a pharmaceutical preparation for treating alcoholic fatty liver disease, the pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0012] Compared with existing technologies, one or more of the above technical solutions have achieved the following beneficial effects:

[0013] 1) The above technical solution provides the application of the Five-Flower Alcohol-Relieving Formula in alcoholic fatty liver. The Five-Flower Alcohol-Relieving Formula uses kudzu flower and Japanese raisin tree fruit as the principal ingredients. Kudzu flower is effective in detoxifying alcohol and invigorating the spleen and stomach; Japanese raisin tree fruit clears heat, promotes urination, relieves irritability, and quenches thirst. The two ingredients work synergistically to achieve the effect of relieving alcohol and protecting the liver, directly addressing the core pathogenesis of alcoholic fatty liver—internal accumulation of alcohol toxins and damp-heat trapping the spleen. Chrysanthemum, rose, cordyceps flower, Panax notoginseng flower, and mulberry leaf are used as assistant ingredients, all of which have the effects of soothing the liver, clearing heat, relieving depression, and promoting blood circulation; they are commonly used essential herbs in alcohol-relieving medications. Chrysanthemum enters the liver meridian, clearing the liver and improving eyesight, and calming liver yang; rose can soothe the liver and relieve depression, and promote blood circulation and remove blood stasis; cordyceps flower nourishes the lungs and kidneys, protects the liver and lowers enzymes; Panax notoginseng flower can clear heat and calm the liver, and promote blood circulation and unblock collaterals; mulberry leaf can clear the lungs and moisten dryness, and calm the liver and cool the blood; with hawthorn, tangerine peel, Imperata cylindrica root, coix seed, and Poria cocos as adjuvants, it can strengthen the spleen, remove dampness, resolve phlegm and reduce fat; with wolfberry, Ganoderma lucidum, Schisandra chinensis, and licorice as guiding herbs, the whole formula has a good long-term effect of nourishing the liver and kidneys and anti-oxidation, and is a commonly used empirical medicine for relieving hangovers. It is particularly effective against inflammatory changes around the liver. Licorice can clear heat and detoxify, and harmonize the medicines, and is a commonly used guiding herb. Among them, wolfberry nourishes the liver and kidneys, benefits essence and improves eyesight; Ganoderma lucidum replenishes qi and calms the mind, and strengthens the body; Schisandra chinensis astringes and consolidates, and replenishes qi and generates fluids. Overall, the treatment prioritizes detoxification from alcohol, while also focusing on soothing the liver and strengthening the spleen, clearing heat and promoting diuresis, and simultaneously supporting the body's resistance and eliminating pathogens.

[0014] 2) The traditional Chinese medicine compound of this 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, thus having good practical application value. Attached Figure Description

[0015] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0016] Figure 1The image shows the in vitro antioxidant activity of the Five-Flower Hangover Relief Formula in Example 1 of this invention. A represents the ABTS scavenging activity, B represents the DPPH scavenging activity, and C represents the total antioxidant activity.

[0017] Figure 2 This is a graph showing the change in mouse body weight in Example 2 of the present invention;

[0018] Figure 3 The following is a diagram showing the effects of mouse liver tissue pathology in Example 2 of this invention; in order, the groups are the positive control group, high-dose group, medium-dose group, low-dose group, model group, and blank group of the Five-Flower Detoxification Formula.

[0019] Figure 4 The graph shows the effects of liver function indicators and oxidative stress on mice in Example 2 of this invention. A represents liver function indicators, B represents serum ALT level, and C represents serum AST level.

[0020] Figure 5 This is a graph showing the effect of oxidative stress on mice in Example 2 of the present invention. A represents MDA content, and B represents CAT content.

[0021] Figure 6 This is a graph showing the influence of mouse liver inflammatory factor levels in Example 2 of the present invention. A represents IL-10, and B represents IL-1β. Detailed Implementation

[0022] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0023] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0024] The present invention will be further illustrated with specific examples. These examples are for illustrative purposes only and do not limit the scope of the invention. Experimental conditions not specifically specified in the examples are generally performed under conventional conditions or as recommended by the selling company; unless otherwise specified in the present invention, these conditions are commercially available.

[0025] In a typical embodiment of the present invention, a traditional Chinese medicine composition for treating alcoholic fatty liver is provided, comprising the following components by weight:

[0026] Kudzu flower 6-150 parts, chrysanthemum 6-150 parts, rose 6-150 parts, cordyceps flower 6-150 parts, Panax notoginseng flower 3-75 parts, mulberry leaf 6-150 parts, hawthorn 3-75 parts, tangerine peel 3-75 parts, Japanese raisin tree fruit 6-150 parts, Imperata cylindrica root 6-150 parts, wolfberry 6-150 parts, Ganoderma lucidum 3-75 parts, Schisandra chinensis 3-75 parts, coix seed 6-150 parts, Poria cocos 3-75 parts, licorice root 3-75 parts.

[0027] Specifically, the ingredients are: 6-20 parts kudzu flower, 6-20 parts chrysanthemum flower, 6-20 parts rose flower, 6-20 parts cordyceps flower, 3-10 parts Panax notoginseng flower, 6-20 parts mulberry leaf, 3-10 parts hawthorn, 3-10 parts Citrus reticulata peel, 9-30 parts Japanese raisin tree fruit, 9-30 parts Imperata cylindrica root, 6-20 parts wolfberry, 3-10 parts Ganoderma lucidum, 3-10 parts Schisandra chinensis, 9-30 parts coix seed, 3-10 parts Poria cocos, and 3-10 parts licorice.

[0028] Specifically, the ingredients are: 9 parts kudzu flower, 9 parts chrysanthemum, 9 parts rose, 9 parts cordyceps flower, 6 parts Panax notoginseng flower, 9 parts mulberry leaf, 6 parts hawthorn, 6 parts tangerine peel, 12 parts Japanese raisin tree fruit, 12 parts Imperata cylindrica root, 9 parts wolfberry, 6 parts Ganoderma lucidum, 6 parts Schisandra chinensis, 15 parts coix seed, 6 parts Poria cocos, and 6 parts licorice.

[0029] The formulation characteristics of the traditional Chinese medicine composition of the present invention are as follows:

[0030] The aforementioned Five-Flower Hangover Relief Formula uses kudzu flower and Japanese raisin tree fruit as its principal ingredients. Kudzu flower specifically enters the spleen and stomach meridians, excelling at detoxifying alcohol, invigorating the spleen and stomach, accelerating the decomposition and metabolism of ethanol, and relieving nausea and epigastric fullness after drinking. Japanese raisin tree fruit enters the liver and spleen meridians, clearing heat and promoting diuresis, relieving irritability and quenching thirst, promoting acetaldehyde excretion, and improving thirst and headache after drinking. The two ingredients work synergistically: kudzu flower primarily detoxifies alcohol in the middle jiao (middle burner), while Japanese raisin tree fruit clears damp heat in the lower jiao (lower burner), creating a "clearing the upper and draining the lower" effect, directly targeting alcohol metabolism. The underlying cause of the disorder is addressed with a formula consisting of chrysanthemum, rose, cordyceps flower, notoginseng flower, and mulberry leaf. Chrysanthemum clears the liver and improves vision, calms liver yang, and relieves red eyes and headaches after drinking alcohol. Rose soothes the liver and relieves depression, promotes blood circulation and removes blood stasis, and improves hypochondriac pain caused by liver qi stagnation. Cordyceps flower nourishes the lungs and kidneys, lowers enzymes and protects the liver, and repairs alcoholic liver damage. Notoginseng flower clears heat and calms the liver, invigorates blood circulation and unblocks collaterals, and inhibits the progression of liver fibrosis. Mulberry leaf clears the lungs and moistens dryness, cools the blood and calms the liver, and regulates lipid peroxidation. These five herbs work together to soothe liver heat and clear liver collaterals, forming a comprehensive intervention of "clearing, soothing, invigorating, and nourishing." The formula uses hawthorn, tangerine peel, Imperata cylindrica root, coix seed, and Poria cocos as adjuvants. Hawthorn helps digestion, eliminates food stagnation, disperses qi stagnation and blood stasis, and promotes lipid decomposition. Tangerine peel dries dampness and resolves phlegm, regulates qi and relieves abdominal distension and loss of appetite. Imperata cylindrica root cools the blood and promotes urination. Coix seed drains dampness and strengthens the spleen. Poria cocos promotes urination and calms the mind. The three ingredients work together to eliminate edema, heaviness, and other signs of damp-heat. By using the three methods of "eliminating, resolving, and draining," the pathological chain of "spleen deficiency generating dampness, dampness accumulating into phlegm" is broken. The formula also includes wolfberry, Ganoderma lucidum, Schisandra chinensis, and licorice. Wolfberry nourishes the liver and kidneys, replenishes essence and blood, and repairs the yin fluids depleted by alcohol. Ganoderma lucidum replenishes qi and calms the mind, strengthens the body's resistance, and enhances the liver's antioxidant capacity. Schisandra chinensis astringes and consolidates, replenishes qi and generates fluids, and regulates the stability of liver cell membranes. Licorice clears heat and detoxifies, harmonizes the other herbs, and moderates the harshness of other drugs. This allows the medicinal group to both assist the principal, assistant, and adjuvant medicines in eliminating pathogens and prevent attacks from harming the body's vital energy, thus achieving the goal of "eliminating pathogens without harming the body's vital energy, and supporting the body's vital energy without leaving behind pathogens."

[0031] Experiments have verified that the above-mentioned five-flower hangover remedy is effective in treating alcoholic fatty liver as follows:

[0032] a) Recovery of liver function;

[0033] b) Improve liver metabolic function;

[0034] c) Reduce inflammatory response, thereby enhancing the body's immune function.

[0035] The preparation methods of the above-mentioned traditional Chinese medicine composition include, but are not limited to, water decoction, water extraction and alcohol precipitation, enzymatic hydrolysis, acid-base extraction, and ultrasonic extraction. In another specific embodiment of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition is provided, wherein the preparation method is water decoction.

[0036] Specifically, the above-mentioned medicinal materials are soaked in water, and the decoction is obtained by water decoction. After freeze-drying, the five-flower hangover relief freeze-dried powder is obtained.

[0037] Specifically, the steps of the decoction method are as follows: after soaking all components except rose petals, heat to a boil and maintain boiling for one decoction, then pour out the supernatant and filter; after the first decoction, add rose petals to the remaining dregs and continue to add water until it covers the herbs, heat to a boil and maintain boiling for a second decoction, then pour out the supernatant and filter; after the second decoction, add water to the remaining dregs until it covers the herbs, heat to a boil and maintain boiling for a third decoction.

[0038] More specifically, the decoctions from the three decoctions are combined, concentrated, and freeze-dried to obtain the final product.

[0039] In another specific embodiment of the present invention, the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating alcoholic fatty liver is provided. Experiments using a mouse model of alcoholic fatty liver have demonstrated that this drug can significantly inhibit hepatocyte steatosis, improve the disordered lipid metabolism within hepatocytes, and also reduce liver inflammation by inhibiting the expression of inflammatory factors, slowing the progression of liver fibrosis, activating the activity of immune cells, regulating the balance of the immune cytokine network, and thus enhancing the body's immune function, exerting a comprehensive liver protective and immunomodulatory effect. That is, the drug has at least one of the following effects: a) restoring liver function; b) improving liver metabolic function; c) reducing inflammatory response, thereby enhancing the body's immune function.

[0040] In another specific embodiment of the present invention, a pharmaceutical preparation for treating alcoholic fatty liver is provided, the pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0041] Specifically, the pharmaceutical preparation can be formulated into various dosage forms, preferably oral liquids, decoctions, pills, capsules, tablets, powders or granules, etc., which are suitable for practical applications.

[0042] Specifically, pharmaceutically acceptable excipients in the pharmaceutical formulation include, but are not limited to, one or more of the following: diluents, fillers, disintegrants, lubricants, binders, flow agents, complexing agents, plasticizers, colorants, sweeteners, viscosity enhancers, preservatives, or antioxidants.

[0043] 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.

[0044] The fillers include, but are not limited to, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatinized starch, etc.

[0045] The disintegrants include, but are not limited to, dry starch, crospovidone, crospovidone sodium carboxymethyl cellulose, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose.

[0046] The lubricant includes, but is not limited to, magnesium stearate, sodium dodecyl sulfate, or micronized silica gel.

[0047] In another specific embodiment of the present invention, a method for treating alcoholic fatty liver is provided, the method comprising: administering to a subject a therapeutically effective dose of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation.

[0048] The subject refers to an animal or human that is already the subject of treatment, observation or experimentation, wherein the animal can be a mouse, rat, monkey, chimpanzee, dog, etc.

[0049] The term "therapeutic effective amount" refers to an amount including the traditional Chinese medicine composition or pharmaceutical preparation of the present invention that can elicit a biological or medical response in an organ system or animal as sought by researchers, veterinarians, doctors or other medical personnel, including the reduction or partial reduction of symptoms of the treated disease, syndrome, symptom or disorder.

[0050] It must be recognized that the optimal dosage and interval of the active ingredient of the present invention are determined by its properties and external conditions such as the form, route and site of administration and the specific mammal being treated, and this optimal dosage can be determined using conventional techniques.

[0051] To enable those skilled in the art to better 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.

[0052] Example 1

[0053] The specific preparation and extraction steps of a traditional Chinese medicine composition for treating alcoholic fatty liver are as follows:

[0054] Soaking: 9 parts kudzu flower, 9 parts chrysanthemum, 9 parts cordyceps flower, 6 parts notoginseng flower, 9 parts mulberry leaf, 6 parts hawthorn, 6 parts tangerine peel, 12 parts Japanese raisin tree fruit, 12 parts imperata root, 9 parts wolfberry, 6 parts ganoderma, 6 parts schisandra, 15 parts coix seed, 6 parts poria cocos, and 6 parts licorice. Mix and crush the ingredients, then pour them into a decoction vessel. Add 10 times the amount of drinking water and soak for 60 minutes to open the capillaries of the herbs and facilitate the extraction of active ingredients.

[0055] Extraction of alcoholic fatty liver: Soak all ingredients except rose petals for 1 hour; bring to a 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 petals, bring to a boil over high heat, and simmer over low heat for 30 minutes; add 6 times the amount of water for the third time, bring to a boil over high heat, and simmer over low heat for 20 minutes. After each decoction, filter through 4 layers of gauze.

[0056] Concentration: Combine the decoctions from the three decoctions and concentrate them using a rotary evaporator.

[0057] Freeze-drying: The medicinal liquid is cooled and then placed in a freezer at -80℃ for 48 hours, and then freeze-dried for 48 hours to obtain the freeze-dried powder of the Five-Flower Hangover Relief Formula.

[0058] Example 2

[0059] The application scope includes the following:

[0060] Direction 1: Determination of the antioxidant capacity of the freeze-dried powder of the Five-Flower Hangover Relief Formula in Example 1;

[0061] Direction 2: The protective effect of the freeze-dried powder of the Five-Flower Hangover Relief Formula in Example 1 on the liver.

[0062] 1. Pharmacodynamic experiments

[0063] The five-flower hangover remedy freeze-dried powder in direction 1 was formulated into low (130mg•kg) solutions. -1 ), medium (260mg•kg) -1 High (520 mg•kg) -1 The dosage was administered to mice via gavage.

[0064] The five-flower hangover remedy freeze-dried powder in direction 2 is prepared to an appropriate concentration.

[0065] 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 kit, tissue fixative, hematoxylin staining solution, eosin staining solution, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and malondialdehyde (MDA) ELISA kit.

[0066] Establishment of a mouse model of alcoholic fatty liver disease

[0067] Healthy adult male C57BL / 6 mice, 8 weeks old and weighing 20±2g, were purchased from Yunnan University and acclimatized for one week before the experiment. The mice were housed in an environment with a temperature of 23±2℃, a relative humidity of 50±10%, and a photoperiod of 12 hours, under free access to food and water.

[0068] Grouping and processing of laboratory animals

[0069] Seventy-two 8-week-old C57BL / 6 mice were acclimatized for one week and then randomly divided into six groups: normal control group, positive control group, model control group, high-dose group of Wuhua Jiejiu Fang (a traditional Chinese medicine formula), medium-dose group of Wuhua Jiejiu Fang, and low-dose group of Wuhua Jiejiu Fang, with n=6 in each group. Except for the normal control group, which was administered physiological saline by gavage, the other groups were administered 52% baijiu (a type of Chinese liquor) by gavage for 7 consecutive days. Starting on the 8th day, the positive control group (Haiwang Jinzun) and the model group continued to be administered Erguotou (another type of Chinese liquor) by gavage, while the drug groups were administered different concentrations of Wuhua Jiejiu Fang decoction by gavage for 14 consecutive days. Twelve hours after the last administration, the mice were anesthetized with ether, sacrificed, and samples were collected.

[0070] 2. Experimental Methods

[0071] Direction 1: Determination of the antioxidant capacity of the Five-Flower Hangover Relief Formula;

[0072] Direction 2: The protective effect of the Five-Flower Hangover Relief Formula in Example 1 on the liver (see Table 1 for specific experimental steps and operations).

[0073] Table 1 Experimental Design Table

[0074]

[0075] 3. Results and Analysis

[0076] 3.1 Data Analysis Methods

[0077] All experimental data are expressed as Means ± SD. Data were initially processed and calculated using Excel. GraphPad Prism 6.0 software was used for plotting and analysis, and SPSS 18.0 software was used for multiple comparisons of variance analysis. P <0.05 indicates a statistically significant difference.

[0078] 3.1 In vitro antioxidant effects of the Five-Flower Hangover Relief Formula

[0079] like Figure 1As shown in Figures A, B, and C, the ABTS free radical scavenging activity rapidly increased with increasing concentration of the lyophilized powder of the Five-Flower Hangover Relief Formula from 0.00 mg / mL. At approximately 0.05 mg / mL, the scavenging activity reached about 80% and then stabilized. Further increases in concentration did not significantly alter the scavenging activity, indicating that it exhibits good ABTS free radical scavenging ability even at lower concentrations, and that the scavenging ability no longer significantly increases after a certain concentration. The DPPH free radical scavenging activity increased with increasing concentration of the hangover relief compound, showing a significant increase in the 0.00-0.05 mg / mL range. At 0.05 mg / mL, the scavenging activity approached 80%, and when the concentration was further increased to 0.20 mg / mL, the scavenging activity remained around 100%, indicating a good scavenging effect on DPPH free radicals, and that the activity stabilized after reaching a certain concentration. The total antioxidant capacity of the Five-Flower Hangover Relief Formula continuously increased with the concentration of its lyophilized powder (from 0 mg / mL to 15 mg / mL). A significant increase in antioxidant capacity was observed at a concentration of 10 mg / mL, rising from approximately 3 μmol / L to 4 μmol / L, and reaching approximately 5 μmol / L at 15 mg / mL, demonstrating a trend of increasing total antioxidant capacity with increasing concentration. In summary, the Five-Flower Hangover Relief Formula exhibits good scavenging ability against ABTS and DPPH free radicals in vitro, and its total antioxidant capacity increases with increasing concentration, demonstrating good in vitro antioxidant activity within a certain concentration range. Overall, the Five-Flower Hangover Relief Formula possesses high antioxidant activity.

[0080] 3.2 Effects of the Five-Flower Alcohol-Eliminating Method on Mouse Body Weight

[0081] like Figure 2 As shown, during the treatment period, the body weight of mice in the normal control group showed a steady upward trend, while the body weight of mice in the positive control group, high-, medium- and low-dose drug groups showed different degrees of initial decrease followed by increase. The body weight of mice in the model group showed a downward trend, and the differences were statistically significant (P<0.05). This indicates that the Five-Flower Detoxification Formula has an ameliorative effect on the weight loss in mice caused by alcohol-induced fatty liver.

[0082] 3.3 Protective effect of Five-Flower Hangover Relief Formula on Mice with Alcoholic Fatty Liver

[0083] 3.3.1 Effects of Five-Flower Hangover Relief Formula on the Liver of Mice with Alcoholic Fatty Liver

[0084] like Figure 3As shown, in hematoxylin-eosin (HE) staining, in the normal control group mice, hepatocytes were neatly arranged, liver lobules were clearly defined, cell morphology was normal, and there were no obvious pathological changes. However, in the model group mice, hepatocytes showed obvious abnormalities, disordered cell structure, and possible signs of inflammatory cell infiltration and partial cell necrosis. This indicates that the modeling successfully induced liver damage, reflecting the adverse effects of alcohol or related factors on liver tissue. The pathological state of liver tissue in the positive control group was improved; compared to the model group, the cell structure was relatively orderly, and inflammation was reduced. Different dosage groups of the Five-Flower Relief Formula showed varying degrees of improvement. Although the low-dose group showed some improvement, some abnormal cell structure and mild inflammation were still observed, suggesting that the low-dose Five-Flower Relief Formula had limited repair effect on liver damage. The medium-dose group showed more orderly hepatocyte arrangement, reduced inflammatory cell infiltration, and cell morphology tended to be normal, indicating that the medium-dose Five-Flower Relief Formula could effectively reduce liver tissue damage and had a positive effect on the recovery of liver structure. The high-dose group showed liver tissue with near-normal structure, good cell morphology, and no obvious inflammatory response, indicating that the high-dose Five-Flower Relief Formula has a significant repair effect on liver damage. This suggests that the Five-Flower Relief Formula can effectively improve alcohol-induced liver damage.

[0085] 3.3.2 Effects of Five-Flower Hangover Relief Formula on Liver Function Indicators in Mice with Alcoholic Fatty Liver

[0086] like Figure 4 As shown in Figures A, B, and C, the liver index of mice in each group was calculated. The liver index of mice administered alcohol by gavage was significantly higher than that of the normal control group, indicating that the livers of the model group mice had edema. The liver index of mice treated with different doses of the Five-Flower Detoxification Formula was lower than that of the model group, indicating that the Five-Flower Detoxification Formula could alleviate alcohol-induced liver edema in mice. To further evaluate the effect of the Five-Flower Detoxification Formula on the liver of mice with alcoholic fatty liver, the levels of aspartate aminotransferase (ALT) and alanine aminotransferase (AST) in the serum of mice in each group were measured. The data showed that the levels in the model group mice were significantly higher than those in the normal mice, while in the Five-Flower Detoxification Formula group, the levels of ALT and AST in mice were significantly lower than those in the model group, with statistically significant differences (P<0.05), indicating that the Five-Flower Detoxification Formula could alleviate the increase in ALT and AST levels in the serum of mice induced by alcohol.

[0087] 3.3.3 Effects of Five-Flower Hangover Relief Formula on Hepatic Oxidative Stress in Mice with Alcoholic Fatty Liver

[0088] like Figure 5As shown in Figures A and B, the levels of malondialdehyde (MDA) and catalase (CAT) in mouse liver tissue were analyzed. Compared with the blank control group, the CAT level in the model group decreased, while the CAT level in the positive drug control group and the drug group increased. The CAT level in the low-dose drug group was slightly lower than that in the positive drug control group. 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. This indicates that the Five-Flower Detoxification Formula can effectively improve the trend of increased MDA level and decreased CAT level.

[0089] 3.3.4 Effects of Five-Flower Hangover Relief Formula on Liver Inflammatory Factor Levels in Mice with Alcoholic Fatty Liver

[0090] like Figure 6 As shown in Figures A and B, the levels of IL-10 and IL-1β in the liver homogenate of mice in each group were analyzed. The data show that mice fed an alcohol-based diet had higher levels of IL-10 and lower levels of IL-1β in their liver homogenate, while different doses of the Five-Flower Detoxification Formula inhibited the production of alcohol-induced liver inflammatory factors to varying degrees. Specifically, the high-dose group showed a significant decrease in IL-1β compared to the model group.

[0091] 4. Discussion

[0092] Alcohol-induced liver damage is a difficult-to-detect and easily overlooked disease. When the liver is stimulated by damage, it will counteract the damage by regulating corresponding signaling pathways, and the levels of various cytokines released by hepatocytes will be affected. 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 a large amount of reactive oxygen species, which can damage membrane lipids, proteins, and DNA, impair hepatocyte function, and trigger inflammatory responses. In this embodiment, a mouse model of alcoholic fatty liver was successfully constructed, and the weight changes of mice were monitored during treatment to evaluate the effect of drugs on alcoholic fatty liver. When recording the weight of mice, it was found that at the time of modeling, the weight of mice in the normal group remained stable and increased, while the weight of mice in the other groups decreased. After drug administration, the weight of mice in the model group decreased, while the weight of mice in the other groups decreased to varying degrees. This may be because alcohol produces toxic substances such as acetaldehyde from alcohol metabolism in mice, which can cause hepatocyte damage, inflammatory responses, and lipid metabolism disorders, leading to impaired liver function. Liver dysfunction affects fat, protein, and carbohydrate metabolism, preventing the body from effectively utilizing and storing energy. Mice are forced to consume their stored fat and protein to maintain bodily functions, leading to weight loss. Furthermore, alcohol-induced liver inflammation triggers systemic inflammation, disrupting hormonal balance and affecting the appetite regulation center, resulting in decreased appetite and food intake – another significant cause of weight loss. After administration, except for the model group, the weight of mice in all other groups returned to normal, indicating that the Five-Flower Detoxifying Formula can alleviate alcohol-induced liver damage in mice.

[0093] This embodiment visually reveals the protective effect of the Five-Flower Relief Formula on the liver tissue of mice with alcoholic fatty liver disease through HE staining results. The model group mice exhibited significant hepatocyte abnormalities, disordered cell structure, and pathological features such as possible inflammatory cell infiltration and partial cell necrosis, highly consistent with the typical pathological process of alcoholic fatty liver disease (AFLD), suggesting that long-term alcohol exposure leads to disordered lipid metabolism in hepatocytes and induces inflammatory responses. Notably, after high-dose intervention with the Five-Flower Relief Formula, the liver tissue structure tended to normalize, and inflammatory infiltration was significantly reduced. The drug group showed a clear dose-response relationship, suggesting that its active ingredients may have concentration-dependent bioavailability.

[0094] This embodiment reveals the protective effect of the Five-Flower Relief Formula on alcoholic fatty liver disease (AFLD) in mice through multi-dimensional experimental data. The model group mice exhibited typical pathological features in their livers, including significant hepatocyte abnormalities, disordered cell structure, possible inflammatory cell infiltration, and signs of partial cell necrosis. This was accompanied by elevated liver indices, abnormal serum transaminase / AST levels, oxidative stress imbalance (elevated MDA, decreased CAT), and dysregulation of inflammatory factors (elevated IL-1β). These results comprehensively reflect the widespread damage to liver metabolism, antioxidant capacity, and inflammatory regulation caused by alcohol exposure. After intervention with the Five-Flower Relief Formula, all of the above pathological features were significantly improved, especially in the high-dose group, suggesting that its effect is dose-dependent. From a liver morphological perspective, high-dose Five-Flower Relief Formula significantly reduced lipid droplet deposition and repaired hepatocyte structure, possibly related to its direct protective effect of regulating lipid metabolism and reducing hepatocyte damage. The decrease in liver indices and serum ALT and AST levels further confirms the efficacy of this formula in alleviating liver function damage, suggesting that it may maintain normal liver function by improving hepatocyte membrane stability or promoting damage repair. Furthermore, the improvement in liver oxidative stress indicators (decreased MDA levels and restored CAT activity) indicates that this formula may reduce alcohol-induced lipid peroxidation damage by enhancing the antioxidant defense system. Notably, the significant inhibitory effect of the drug 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.

[0095] In summary, this embodiment systematically verified the protective effect of the Five-Flower Hangover Relief Formula on alcoholic fatty liver from four aspects: histopathology, liver function, oxidative stress, and inflammation regulation. It provides experimental evidence for its clinical application and also lays a theoretical foundation for the modernization of traditional hangover relief formulas.

[0096] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to the given examples, those skilled in the art can modify or make equivalent substitutions to the technical solutions of the present invention as needed without departing from the spirit and scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating alcoholic fatty liver, characterized in that, According to the weight parts, it is composed of the following components: Gegen 6-150 parts, chrysanthemum 6-150 parts, rose 6-150 parts, cordyceps 6-150 parts, sanchi 3-75 parts, mulberry leaf 6-150 parts, cloud hawthorn 3-75 parts, dried tangerine peel 3-75 parts, jujube 6-150 parts, white lily 6-150 parts, medlar 6-150 parts, ganoderma 3-75 parts, schisandra 3-75 parts, yiyi 6-150 parts, cloud fuling 3-75 parts and licorice 3-75 parts.

2. The traditional Chinese medicine composition of claim 1, wherein, According to the weight parts, it is composed of the following components: Gegen 6-20 parts, chrysanthemum 6-20 parts, rose 6-20 parts, cordyceps 6-20 parts, sanchi 3-10 parts, mulberry leaf 6-20 parts, cloud hawthorn 3-10 parts, dried tangerine peel 3-10 parts, jujube 9-30 parts, white lily 9-30 parts, medlar 6-20 parts, ganoderma 3-10 parts, schisandra 3-10 parts, yiyi 9-30 parts, cloud fuling 3-10 parts and licorice 3-10 parts.

3. The traditional Chinese medicine composition of claim 1, wherein, According to the weight parts, it is composed of the following components: Gegen 6-20 parts, chrysanthemum 6-20 parts, rose 6-20 parts, cordyceps 6-20 parts, sanchi 3-10 parts, mulberry leaf 6-20 parts, cloud hawthorn 3-10 parts, dried tangerine peel 3-10 parts, jujube 9-30 parts, white lily 9-30 parts, medlar 6-20 parts, ganoderma 3-10 parts, schisandra 3-10 parts, yiyi 9-30 parts, cloud fuling 3-10 parts and licorice 3-10 parts.

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

5. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, Each medicinal material is soaked in water, and the medicinal liquid is obtained by water decoction method. After freeze-drying, the freeze-dried powder of Wuhua Jiujiu is obtained.

6. The preparation method of the traditional Chinese medicine composition according to claim 4, characterized in that, The specific steps of the water decoction method are as follows: after the other components except rose are mixed and soaked, they are boiled, and the first decoction is carried out by keeping boiling. The supernatant is poured out and filtered. The remaining residue after the first decoction is added with rose and water is added to cover the medicinal materials. After boiling, the second decoction is carried out by keeping boiling. The supernatant is poured out and filtered. The remaining residue after the second decoction is added with water to cover the medicinal materials. After boiling, the third decoction is carried out by keeping boiling. The medicinal liquids of the three decoctions are combined, concentrated, and freeze-dried to obtain the freeze-dried powder.

7. The application of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a medicine for treating alcoholic fatty liver.

8. The use according to claim 7, characterized in that, The medicine has at least one of the following effects: a) liver function recovery; b) improving liver metabolic function; c) reducing inflammatory response and thereby enhancing immune function of the body.

9. A pharmaceutical preparation for treating alcoholic fatty liver, characterized by, The medicine preparation comprises the traditional Chinese medicine composition of any one of claims 1-3 and pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that The pharmaceutically acceptable excipients in the medicine 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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