Pharmaceutical composition for treating alcoholic liver disease and preparation method thereof

Abstract

The invention discloses a pharmaceutical composition for treating alcoholic liver diseases and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The pharmaceutical composition is prepared from radix puerariae, hovenia dulcis thunb, fructus amomi, fructus amomi rotundus, orange peel, semen coicis, fried semen coicis, semen phaseoli, poria cocos, ginseng, fresh ginger and mung beans according to specific parts by weight. The preparation method comprises the following steps: carrying out reflux extraction twice by using an ethanol solution, combining filtrates, and concentrating to obtain an extract. The pharmaceutical composition disclosed by the invention has the effects of dispelling the effects of alcohol, protecting the liver, invigorating the spleen and inducing diuresis, achieves an exact curative effect in clinical use, can effectively promote alcohol metabolism, improve lipid metabolism disorder and oxidative stress, remarkably relieve discomfort caused by drunkenness and relieve symptoms of alcoholic liver diseases, is high in safety and free of toxic and side effects, and achieves the purpose of treating both symptoms and root causes.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a drug for treating alcoholic liver disease, namely a traditional Chinese medicine composition for treatment and a method of application thereof. Background Technology

[0002] Alcoholic liver disease (ALD) seriously endangers human health and is one of the most common types of liver disease worldwide, leading to a significant disease burden and mortality risk. ALD is a liver damage disease caused by excessive alcohol consumption exceeding the body's metabolic capacity. Its spectrum includes alcoholic fatty liver, hepatitis, liver fibrosis, cirrhosis, and liver cancer, ultimately leading to death. The core pathogenesis of ALD mainly involves two aspects: impaired alcohol metabolism and lipid metabolism disorders. Excessive alcohol consumption prevents the liver from metabolizing alcohol in a timely manner, leading to the accumulation of hepatotoxic acetaldehyde in the liver, which in turn triggers oxidative stress and causes liver damage. Alcohol also interferes with lipid metabolism, causing fat accumulation in the liver and forming alcoholic fatty liver. In addition, iron overload, endotoxin leakage into the gut, and inflammatory responses are also closely related to the pathogenesis of ALD. Currently, there are no specific drugs for the clinical treatment of ALD. Common clinical treatments for ALD include silymarin and S-adenosylmethionine, but these usually have drawbacks such as hepatotoxicity, limited efficacy, and numerous side effects. Furthermore, common clinical treatments for alcoholic liver disease (ALD) include abstinence from alcohol, nutritional support, drug therapy, and liver transplantation, but each has limitations such as severe withdrawal symptoms, limited efficacy, and high relapse rates. Therefore, finding safe and effective new methods to prevent and treat ALD is of great significance. Summary of the Invention

[0003] To address the problems existing in the prior art, this invention provides a pharmaceutical composition for treating alcoholic liver disease and its preparation method. This invention provides a method for treating alcoholic liver disease using a traditional Chinese medicine composition. The method involves extracting 12 herbs—kudzu root, Japanese raisin tree fruit, amomum villosum, cardamom, tangerine peel, coix seed, roasted coix seed, red adzuki bean, poria cocos, ginseng, ginger, and mung bean—twice with reflux using 2000 mL of 75% ethanol, for 2 hours and 1.5 hours respectively. The two filtrates are combined and concentrated to obtain an extract. This invention is easy to take and absorb, has stable efficacy, quickly and effectively relieves patient symptoms, and has a detoxifying and liver-protecting effect. Furthermore, the drug has high safety and no obvious toxic side effects.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solutions.

[0005] This invention discloses a pharmaceutical composition for treating alcoholic liver disease, characterized in that, by weight, the traditional Chinese medicine composition comprises: kudzu root, Japanese raisin tree fruit, amomum villosum, cardamom, tangerine peel, coix seed, stir-fried coix seed, red adzuki bean, poria cocos, ginseng, ginger, and mung bean.

[0006] Furthermore, by weight, the raw materials of the traditional Chinese medicine composition are: 15 parts of kudzu root, 15 parts of Japanese raisin tree fruit, 15 parts of amomum villosum, 6 parts of cardamom, 6 parts of tangerine peel, 6 parts of coix seed, 6 parts of stir-fried coix seed, 6 parts of red adzuki bean, 6 parts of poria cocos, 6 parts of ginseng, 6 parts of ginger, and 6 parts of mung bean.

[0007] The present invention also discloses a method for preparing the above-mentioned pharmaceutical composition, comprising the following steps: extracting the raw material twice by reflux with an ethanol solution of 75% by volume, the first extraction for 2 hours and the second extraction for 1.5 hours, combining the two extracts, filtering, and concentrating to obtain an extract.

[0008] Furthermore, according to the preparation method described above, the concentrated extract has a yield of 11.5%.

[0009] The present invention also discloses a pharmaceutical preparation prepared from the above-described pharmaceutical composition and pharmaceutically acceptable excipients.

[0010] Furthermore, the pharmaceutically acceptable excipients include ethanol, polyethylene glycol 400, Tween 80, and glucose.

[0011] Furthermore, the mass ratio of ethanol, polyethylene glycol 400, Tween 80 and 5% glucose is 3:6:1:20.

[0012] Furthermore, any of the above-mentioned pharmaceutical preparations is an oral liquid.

[0013] The present invention also discloses the use of the pharmaceutical composition described in any one of the above claims, the pharmaceutical composition prepared by any one of the above claims, or the pharmaceutical preparation described in any one of the above claims in the preparation of a drug having a hangover-relieving effect.

[0014] The present invention also discloses the use of the pharmaceutical composition described in any one of the above claims, the pharmaceutical composition prepared by any one of the above claims, or the pharmaceutical preparation described in any one of the above claims in the preparation of a medicament for treating alcoholic liver disease.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0016] 1. Compared with commonly used small molecule chemical drugs in clinical practice, the significant effect of the drug of this invention is as follows.

[0017] (1) This invention overcomes the shortcomings of clinical treatment drugs for alcoholic liver disease, such as limited efficacy, inability to cure the disease, and easy recurrence. This invention addresses the root cause of the disease and, under the guidance of the traditional Chinese medicine concept of syndrome differentiation and treatment, can quickly relieve discomfort symptoms such as dizziness, nausea, facial flushing, and rapid heart rate caused by ethanol. It can both excrete alcohol toxins and protect organs, and achieve the goal of "treating both the symptoms and the root cause".

[0018] (2) The pathogenesis of alcoholic liver disease is complex. This invention overcomes the difficulty of single target of common clinical chemical drugs and gives full play to the advantages of multiple components and multiple targets of traditional Chinese medicine. It has multiple effects such as promoting alcohol metabolism, relieving oxidative stress damage and improving lipid metabolism disorders, and effectively improving the symptoms of patients with alcoholic liver disease.

[0019] (3) Commonly used drugs for alcoholic liver disease have disadvantages such as many adverse reactions and significant hepatotoxicity. The entire formula of this invention consists of food and medicine products, using pure natural plant roots, rhizomes, fruits, peels and seeds, which have advantages such as good safety, low toxicity and side effects and no harmful residues.

[0020] 2. Compared with existing traditional Chinese medicine composition inventions, the significant advantages of this invention are as follows: In this invention, the medicinal materials used include kudzu root, which relieves muscle tension and promotes the production of body fluids; it can both guide the dampness and stagnation caused by alcohol to dissipate from the skin surface and generate qi in the spleen and stomach to produce body fluids; and jujube fruit, which promotes urination, allowing the dampness and stagnation caused by alcohol to be expelled through urination. Together, these two herbs serve as the principal herbs, their dispersing and permeating effects helping to expel the dampness and stagnation caused by alcohol from the body. Amomum villosum strengthens the spleen, regulates qi, harmonizes the middle jiao, and resolves dampness; cardamom warms the spleen, promotes qi circulation, resolves dampness, and stops vomiting; and tangerine peel strengthens the spleen, dries dampness, regulates qi, and relieves stagnation. These three pungent and dispersing herbs facilitate the ascending, descending, entering, and exiting of qi, assisting the principal herbs in removing stagnation and fullness, and are therefore used as the assistant herbs. Job's tears promote diuresis and reduce swelling; stir-fried Job's tears strengthen the spleen and eliminate dampness; Poria cocos is sweet and bland, promoting diuresis. The three herbs combined promote diuresis without harming Yin. Red adzuki beans drain dampness and clear heart fire; ginseng is added to tonify the spleen and stomach, replenishing those damaged by alcohol-induced dampness. The five herbs together promote Qi circulation, diuresis, and spleen function, assisting the principal and assistant herbs in eliminating alcohol-induced dampness, thus serving as adjuvant herbs. Ginger and mung beans harmonize the other herbs. These twelve herbs work synergistically to "relieve alcohol-induced dampness, strengthen the spleen, and promote diuresis," effectively alleviating damp-heat stagnation, phlegm formation, and spleen dysfunction caused by alcohol poisoning. They also have the effect of relieving alcohol-induced liver damage, with excellent therapeutic effects.

[0021] The pharmaceutical composition provided by this invention can effectively relieve the symptoms of alcoholic liver disease, alleviate post-drinking symptoms, shorten sobering time, and also regulate chronic liver disease caused by drinking, improve liver function and tissue morphology, and has a liver-protective effect. Attached Figure Description

[0022] Figure 1 Modeling process.

[0023] Figure 2 The effect of Feijiu Formula on the detoxification of alcohol in mice with alcoholic liver disease. A: Intoxication rate; B: Intoxication latency period; C: Duration of intoxication; D: Aldehyde dehydrogenase (ALDH) level. Compared with NC group: *** P<0.001; Compared withVeh group: # P<0.05, ##P<0.01, ### P<0.001.

[0024] Figure 3 Effects of Feijiu Formula on General Indicators in Mice with Alcoholic Liver Disease. A: Body weight of mice in each group; B: Liver index; C: Representative liver tissue morphology and HE-stained sections (×200); D: Liver tissue pathological score. Compared with NC group, *** P<0.001; Compared with Veh group, # P<0.05, ### P<0.001.

[0025] Figure 4 Effects of the "Feijiu Formula" on biochemical indicators in mice with alcoholic liver disease. A: Serum alanine aminotransferase (ALT) level; B: Serum aspartate aminotransferase (AST) level; C: Serum alkaline phosphatase (AKP) level; D: Hepatic superoxide dismutase (SOD) level; E: Serum total cholesterol (TC) level; F: Serum triglyceride (TG) level. Compared with the NC group, *** P<0.001; Compared with Veh group, ### P<0.001. Detailed Implementation

[0026] The present invention will be further described in detail below with reference to specific embodiments. However, this should not be construed as limiting the scope of the above-described subject matter of the present invention to the following embodiments; all technologies implemented based on the content of the present invention fall within the scope of the present invention.

[0027] Unless otherwise specified, all reagents and materials used in this invention are commercially available.

[0028] The drug of this invention has shown significant therapeutic effects through relevant pharmacological experiments conducted in animals. The specific details of the experiments are as follows.

[0029] I. Experimental Materials.

[0030] 1. Laboratory animals.

[0031] Thirty-two 6-8 week old, SPF-grade male C57BL / 6J mice, weighing (20±2) g, were provided by Liaoning Changsheng Biotechnology Co., Ltd. (License No.: SYXK(Liaoning) 2020-0001) and housed in the SPF animal laboratory of the Experimental Animal Center of Liaoning University of Traditional Chinese Medicine. The environment was maintained at 22±1℃, 50±5% humidity, under natural light, with free access to food and water. Adaptation feeding was implemented for one week, with bedding changed every other day to maintain a clean environment. The experiments conducted in this study adhered to ethical guidelines and were approved by the Animal Ethics Committee of Liaoning University of Traditional Chinese Medicine (Approval No.: 21000042024021).

[0032] 2. Experimental reagents and their preparation.

[0033] The formula for treating alcohol poisoning consists of 15g of kudzu root, 15g of Japanese raisin tree fruit, 15g of amomum villosum, 6g of cardamom, 6g of tangerine peel, 6g of coix seed, 6g of stir-fried coix seed, 6g of red adzuki bean, 6g of poria cocos, 6g of ginseng, 6g of ginger, and 6g of mung bean, totaling 99g per dose, provided by the Pharmacy of Liaoning University of Traditional Chinese Medicine. The herbs are soaked overnight in 2000mL of 75% ethanol at 8 times the prescribed volume, then extracted by reflux for 2 hours, filtered, and extracted again for 1.5 hours. The two filtrates are combined and concentrated to obtain an extract with a yield of 11.5%. Excipients are added to dilute the extract into high-dose (30mg / mouse) and low-dose (10mg / mouse) solutions. The excipient ratio is ethanol (E), PEG400 (P), Tween 80 (T), and 5% glucose (G) in a ratio of 3:6:1:20.

[0034] 3. Main reagents.

[0035] (1) Anhydrous ethanol (Sinopharm Chemical Reagent Co., Ltd., batch number: 20231026).

[0036] (2) Hematoxylin-eosin (HE) staining kit (Beijing Solarbio Science & Technology Co., Ltd., batch number: G1120).

[0037] (3) Biochemical reagent kits: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AKP), total cholesterol (TC), and triglyceride (TG) were purchased from Nanjing Jiancheng Company (batch numbers: A059-2-2, A111-1-1, A110-1-1, C009-1-1, C010-2-1, respectively); Superoxide dismutase (SOD) and acetaldehyde dehydrogenase (ALDH) biochemical activity kits were purchased from Beijing Solarbio Company (batch numbers: BC5165, BC0755, respectively).

[0038] 4. Major instruments and equipment.

[0039] High-speed low-temperature centrifuge (Hitachi, Japan, model: CR-GII); -80℃ ultra-low temperature freezer (Zhongke Meiling); fully automatic dehydrator (Heotion, model: ATP 700ST); biological tissue embedding machine (Jinhua Yidi Medical Equipment Co., Ltd., model: YD-6D); pathological slide machine (Leica, model: RM2245); biological tissue freezing stage (Jinhua Yidi Medical Equipment Co., Ltd., model: YD-6L); biological tissue spreader (Jinhua Yidi Medical Equipment Co., Ltd., model: YD-A); biological tissue drying machine (Jinhua Yidi Medical Equipment Co., Ltd., model: YD-B); upright microscope (Olympus, model: CX41); multi-functional full-wavelength microplate reader (Thermo Fisher, model: MultiskanFC).

[0040] II. Experimental Methods.

[0041] 1. The raising of laboratory animals.

[0042] 1.1 Grouping and modeling.

[0043] Thirty-two male C57BL / 6J mice were randomly divided into four groups (n=8 per group) after one week of acclimatization: a normal control group (NC), a model control group (Veh), a low-dose group (10 mg / mouse) of the drug, and a high-dose group (30 mg / mouse). From day 1 to day 15, mice in the low-dose and high-dose groups were administered the corresponding drug solution by gavage (0.2 mL per mouse); mice in the normal control and model control groups were administered the same amount of excipient by gavage. On day 15, 30 minutes after gavage, except for the normal control group, each mouse in the other groups was administered 0.1 mL of 50% ethanol solution by gavage to induce the drug model. The normal control group received an equal amount of physiological saline instead. The mice's state of intoxication was observed, and the latency period (from the time of alcohol administration to the onset of the righting reflex) and duration of intoxication (from the onset of the righting reflex to its disappearance) were recorded.

[0044] 1.2 Feeding.

[0045] The experimental animals were housed at the Experimental Animal Center of Liaoning University of Traditional Chinese Medicine. The environment was maintained at a temperature of 22±1℃, humidity of 50±5%, natural light, and free access to food and water. The bedding was changed every other day to keep the environment clean.

[0046] 1.3 Administration method and dosage.

[0047] The drugs were administered by gavage from day 1 to day 15 of the experiment. The dosages for each group were calculated based on the human-mouse equivalent dose formula and with reference to the previous experimental data of the research group.

[0048] (1) Blank control group (NC) mice: equal volume excipient.

[0049] (2) Model control group (Veh) mice: equal volume excipient.

[0050] (3) Low-dose group of Feijiufang (L-FJF) mice: The drug concentration was 10 mg / mouse and the dose was 0.2 mL.

[0051] (4) High-dose group of Feijiufang (H-FJF) mice: The drug concentration was 30 mg / mouse and the dose was 0.2 mL.

[0052] 1.4 Collection of materials.

[0053] After gavage with 50% ethanol, the mice were fasted but allowed free access to water for 12 hours. Immediately afterward, tissue samples were collected. Blood from the orbital venous plexus was collected by removing the mouse eyeballs and allowed to stand at room temperature for 2 hours. Next, the liver was removed, and the hepatic lobes were fixed in 4% formaldehyde. A portion of the liver tissue was homogenized using a liver tissue:physiological saline ratio of 1:9 (g / mL). The plasma and liver tissue homogenate were centrifuged at 3500 r / min for 10 min at 4°C. The supernatant was collected and stored in EP tubes at -80°C for later use.

[0054] 2. Observation of intoxication behavior in mice.

[0055] Mice were observed immediately after being administered 50% ethanol by gavage. Intoxication in mice was defined as the loss of the righting reflex: a mouse was considered intoxicated if it remained in a back-down position for more than 30 seconds. The latency period of intoxication (time from gavage administration of 50% ethanol to the loss of the righting reflex) and the duration of intoxication were recorded for each group, and the intoxication rate for each group was calculated.

[0056] 3. Calculate the liver index.

[0057] After harvesting the mouse liver, it was rinsed in physiological saline, dried with filter paper, and weighed on a precision electronic scale to calculate the liver index. The liver index was calculated using the formula: Liver Index = Liver Weight / Body Weight × 100%.

[0058] 4. Tissue dehydration, embedding, and sectioning.

[0059] (1) Sample collection: The liver lobe tissue of mice was removed from paraformaldehyde, trimmed with a scalpel, placed in the corresponding embedded box, and rinsed under running water for several minutes.

[0060] (2) Dehydration: The embedding box is placed in a basket and dehydrated in a fully automatic dehydrator according to a gradient. The specific process is as follows: 50% ethanol, 2h → 75% ethanol, overnight → 85% ethanol, 2h → 95% ethanol, 2h → 100% ethanol I, 40min → 100% ethanol II, 40min → xylene I, 5min → xylene II, 5min → xylene III, 2min → paraffin I, 40min → paraffin II, 40min → paraffin III, 40min, to complete dehydration, clearing and wax impregnation.

[0061] (3) Embedding: Take out the tissue that has been soaked in wax and embed it on a tissue embedding machine. First, place a small amount of 65°C wax liquid in the embedding frame. Before the wax liquid solidifies, quickly immerse the tissue with the cut side down in the wax and place it in the corresponding embedding frame. Cool it on a -20°C freezing stage. After solidification, demold it.

[0062] (4) Sectioning: Place the wax block on a biological tissue slicer, trim the wax block to a thickness of 30 μm, and then slice it to a thickness of 5 μm. Place the slices into a biological tissue spreader at a water temperature of 42℃ to flatten them, pick them up with an adhesive slide, absorb excess water with filter paper, and then place the slices on a biological tissue baking machine at 60℃ to bake for 2 hours. After the water is dried and the paraffin is melted, take them out and store them in a slide box at room temperature.

[0063] 5. HE staining of liver tissue.

[0064] (1) Dewaxing the slide to water: Place the slide containing the sample in a dehydration basket and immerse it in xylene I, 10 min → xylene II, 10 min → 100% ethanol I, 1 min → 100% ethanol II, 1 min → 95% ethanol, 1 min → 85% ethanol, 1 min → 75% ethanol, and 1 min to dewax to water.

[0065] (2) Hematoxylin staining of cell nuclei: Place the slices in hematoxylin staining solution for 5 min, wash with tap water, differentiate with 1% hydrochloric acid alcohol for a few seconds, rinse with running water for 3 min to return to blue.

[0066] (3) Eosin staining of cytoplasm: Place the slide in eosin staining solution for 5 min.

[0067] (4) Dehydration and mounting: The slides are dipped in tap water, then in 75% ethanol, then in 95% ethanol for 30 seconds, then in 100% ethanol for 3 minutes, then in xylene I for 10 minutes, then in xylene II for 10 minutes to dehydrate and clear the slides. The slides are then removed, slightly dried, and mounted with a coverslip using neutral resin. The slides are left to stand for several days to dry.

[0068] 6. Determination of biochemical indicators in serum and liver tissue.

[0069] Two hours in advance, remove the serum samples and liver tissue homogenate supernatant from the -80℃ freezer and allow them to fully equilibrate to room temperature. Measure the OD values ​​of ALT, AST, AKP, TC, TG, SOD, and ALDH using an ELISA reader, following the kit instructions.

[0070] III. Experimental Results.

[0071] 1. The Feijiu formula has a significant alcohol-relieving effect on ALD mice.

[0072] Intoxication is defined as the loss of the righting reflex and other signs of intoxication. For example... Figure 2As shown in Figure A, all mice in the model group (Veh) successfully developed an alcoholic state. Compared with the Veh group, the intoxication rates of mice in the low-dose (L-FJF, 10 mg / mouse) and high-dose (H-FJF, 30 mg / mouse) groups decreased to 75% and 62.5%, respectively. The time from alcohol administration to the disappearance of the righting reflex in mice is called the intoxication latency period. The intoxication latency period of the model group mice was 21.75 ± 6.18 minutes. The low- and high-dose groups of the alcoholic formula significantly prolonged the intoxication latency period of mice, which were 33.50 ± 10.1 minutes and 50.80 ± 15.02 minutes, respectively. Figure 2 B). The time from the disappearance of the righting reflex to its recovery is called the duration of intoxication. See [link to article]. Figure 2 The duration of intoxication in mice in the C, Veh group was 5.90±0.85 hours. In contrast, the durations in the low- and high-dose Feijiufang groups were 4.33±0.69 hours and 3.83±0.96 hours, respectively, showing a significant reduction in intoxication duration. Furthermore, the ALDH content in the liver tissue of the model group mice was significantly decreased (P<0.001), indicating that excessive alcohol consumption inhibits normal alcohol metabolism in the liver. Compared to the model group, the ALDH content was significantly increased after Feijiufang intervention (P<0.001), indicating that Feijiufang can significantly increase the acetaldehyde metabolism rate, accelerate alcohol metabolism, and reduce liver damage. Figure 2 D). The above results indicate that the formula has a significant alcohol-relieving effect on ALD mice.

[0073] 2. The Feijiu formula can significantly improve liver damage in ALD mice and has a hepatoprotective effect.

[0074] In the experiment, the body weight of mice in each group increased naturally without significant differences, indicating that the drug was safe. Figure 3 A). When liver injury occurs, the liver swells. Compared with the control group, the liver index in the model group was significantly increased, while the liver index decreased after the intervention of Feijiufang (a traditional Chinese medicine formula), indicating that Feijiufang can alleviate liver hypertrophy caused by alcohol consumption. Figure 3 B). Observe the pathological morphology of mouse liver tissue under a light microscope and score it pathologically. In the blank control group, the hepatocytes of mice were arranged in an orderly manner, radially centered on the central vein, without lipid vacuoles or necrosis; compared with the blank control group, the hepatocytes of mice in the model control group were disordered, with obvious cell swelling, narrowing of the hepatic sinusoids, and a large number of lipid vacuoles and inflammatory cell infiltration; compared with the model group, the hepatocytes of mice in the low-dose Feijiufang group were relatively orderly, with a small number of lipid vacuoles visible; the liver tissue structure of mice in the high-dose Feijiufang group was basically normal, with no lipid vacuoles observed. Figure 3 C. Liver score results as follows Figure 3 As shown in Figure D. These results indicate that the alcohol-inducing formula significantly improved alcohol-induced liver damage in ALD mice.

[0075] 3. Feijiu formula improves liver damage in ALD mice, inhibits oxidative stress, and promotes lipid metabolism.

[0076] Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (AKP) are commonly used indicators of liver damage. Figure 4 As shown in AC, compared with the blank group, the serum levels of ALT, AST, and AKP in the model group mice were increased (P<0.001), indicating that the mice had acute alcoholic liver injury. Compared with the model group, the serum levels of ALT, AST, and AKP in the mice were decreased after the intervention of Feijiufang, with statistical differences (P<0.001) and a dose-dependent effect, indicating that Feijiufang has an ameliorative effect on liver injury in ALD mice.

[0077] Superoxide dismutase (SOD), total cholesterol (TC), and triglycerides (TG) are important indicators for evaluating oxidative stress and lipid metabolism in the body. Figure 4 As shown in the DF diagram, compared with the control group, the SOD level in the liver tissue of mice in the model group was significantly decreased (P<0.001). Compared with the model group, the SOD level in mice in the low- and high-dose Feijiufang groups was significantly increased (P<0.001), indicating that Feijiufang can alleviate liver damage by increasing the level of antioxidant stress in mice. Compared with the control group, the serum TC and TG levels in mice in the model group were significantly increased (P<0.001), indicating that alcohol consumption disrupts lipid metabolism in the liver of mice, leading to lipid accumulation. Compared with the model group, the TC and TG levels in the low- and high-dose Feijiufang groups were both decreased (P<0.001), indicating that Feijiufang can effectively promote lipid metabolism in the liver.

[0078] This study analyzed the effects of Feijiufang on mice with alcoholic liver injury (ALD) by measuring body weight, liver index, various biochemical indicators in serum and liver homogenate, and liver tissue pathological sections. The results showed that Feijiufang could promote alcohol metabolism, improve lipid metabolism disorders, and alleviate oxidative stress damage. Furthermore, it showed no significant drug toxicity, indicating its safety. This study demonstrates that Feijiufang can effectively improve alcohol intoxication symptoms and alleviate liver damage in mice, providing new insights into the potential mechanism of Feijiufang in preventing ALD.

[0079] The above description is merely a preferred embodiment of the present invention and is not intended to limit the patent scope of the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating alcoholic liver disease, characterized in that, The traditional Chinese medicine composition, by weight, comprises: kudzu root, Japanese raisin tree fruit, amomum villosum, cardamom, tangerine peel, coix seed, stir-fried coix seed, red adzuki bean, poria cocos, ginseng, ginger, and mung bean.

2. The pharmaceutical composition according to claim 1, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of kudzu root, 15 parts of Japanese raisin tree fruit, 15 parts of amomum villosum, 6 parts of cardamom, 6 parts of tangerine peel, 6 parts of coix seed, 6 parts of stir-fried coix seed, 6 parts of red adzuki bean, 6 parts of poria cocos, 6 parts of ginseng, 6 parts of ginger, and 6 parts of mung bean.

3. The method for preparing the pharmaceutical composition according to claim 1, characterized in that, Includes the following steps: The raw material was extracted twice by reflux with a 75% ethanol solution. The first extraction lasted 2 hours and the second extraction lasted 1.5 hours. The two extracts were combined, filtered, and concentrated to obtain an extract.

4. The preparation method according to claim 3, characterized in that, The yield of the concentrated extract was 11.5%.

5. A pharmaceutical preparation, prepared from the pharmaceutical composition of claim 1 and pharmaceutically acceptable excipients.

6. The pharmaceutical preparation according to claim 5, characterized in that, The pharmaceutically acceptable excipients include ethanol, polyethylene glycol 400, Tween 80, and glucose.

7. The pharmaceutical preparation according to claim 6, characterized in that, The mass ratio of ethanol, polyethylene glycol 400, Tween 80 and 5% glucose is 3:6:1:

20.

8. The pharmaceutical preparation according to any one of claims 5-7, characterized in that, The dosage form of the pharmaceutical preparation is an oral liquid.

9. The use of the pharmaceutical composition according to claims 1-2, the pharmaceutical composition prepared by the preparation method according to any one of claims 3-4, or the pharmaceutical preparation according to any one of claims 5-8 in the preparation of a drug having an anti-hangover effect.

10. The use of the pharmaceutical composition of claims 1-2, the pharmaceutical composition prepared by the preparation method of any one of claims 3-4, or the pharmaceutical preparation of any one of claims 5-8 in the preparation of a medicament for treating alcoholic liver disease.

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