Traditional chinese medicine composition and use thereof

Abstract

A traditional Chinese medicine composition which is composed of Salvia miltiorrhiza total phenolic acids and Crataegus pinnatifida total triterpene acids, and is used for preparing drugs for preventing or treating non-alcoholic steatohepatitis and liver fibrosis.

Description

Traditional Chinese medicine compositions and their applications Technical Field

[0001] This application belongs to the field of pharmaceutical technology, specifically relating to a traditional Chinese medicine composition and its application. Background Technology

[0002] Non-alcoholic steatohepatitis (NASH, also known as metabolic-associated steatohepatitis) is a serious liver disease characterized by inflammatory cell infiltration and necrosis. It represents an important transitional stage from non-alcoholic fatty liver disease to more severe liver conditions. It is characterized by ballooning degeneration and inflammation of hepatocellular carcinoma and can progress to fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. Due to improved economic conditions and lifestyle changes, the prevalence of NASH in the population is increasing year by year, and NASH is considered a major cause of liver cancer.

[0003] Currently, the main treatment modalities for NASH are weight loss, dietary adjustments, lifestyle modifications, and drug intervention. Traditional Chinese medicine plays a crucial role in disease treatment, and developing effective TCM treatments for non-alcoholic steatohepatitis remains a complex and challenging task.

[0004] On the other hand, liver fibrosis is a common pathological stage in the development of many chronic liver diseases. It is a pathological process in which the abnormal growth of connective tissue in the liver and excessive accumulation of diffuse extracellular matrix (ECM) in the liver are caused by a variety of pathogenic factors. If timely and effective treatment is not taken, it will lead to cirrhosis and liver cancer.

[0005] CN02112488.4 discloses a pharmaceutical composition containing total phenolic acids from tanshinone and total triterpenic acids from hawthorn, said pharmaceutical composition being used for the prevention or treatment of hyperlipidemia. The literature "Journal of Integrated Traditional and Western Medicine on Cardiovascular and Cerebrovascular Diseases, 2015, 13(11):3" discloses a study on the prevention of hyperlipidemia in rats using tanshinone and hawthorn extracts. After rats were administered a fat emulsion for 14 days, hyperlipidemia and hepatic steatosis developed. Administration of tanshinone and hawthorn extracts inhibited the formation of hyperlipidemia and hepatic steatosis.

[0006] Currently, there are no studies on the therapeutic effects of pharmaceutical compositions containing total phenolic acids from tanshinone and total triterpenic acids from hawthorn on non-alcoholic steatohepatitis, nor have there been any reports that traditional Chinese medicine compositions containing total phenolic acids from tanshinone and total triterpenic acids from hawthorn can be used to prevent or treat liver fibrosis. Summary of the Invention

[0007] The following is an overview of the subject matter described in detail herein. This overview is not intended to limit the scope of the claims.

[0008] In view of the above-mentioned problems existing in the prior art, the purpose of this application is to provide a traditional Chinese medicine composition and its application.

[0009] To achieve the above objectives, this application adopts the following technical solution:

[0010] In a first aspect, this application provides a traditional Chinese medicine composition containing total phenolic acids from tanshinone and total triterpenoid acids from hawthorn, the traditional Chinese medicine composition being used for the prevention or treatment of non-alcoholic steatohepatitis.

[0011] In the traditional Chinese medicine composition described in this application, the content of total phenolic acids of tanshinone accounts for 80-20% of the total weight of the traditional Chinese medicine composition, and the content of total triterpenic acids of hawthorn accounts for 20-80% of the total weight of the traditional Chinese medicine composition.

[0012] The traditional Chinese medicine composition described in this application improves non-alcoholic steatohepatitis by reducing AST and / or ALT levels.

[0013] The traditional Chinese medicine composition described in this application can reduce the NAS score of non-alcoholic steatohepatitis.

[0014] The traditional Chinese medicine composition described in this application can reduce the content of triglycerides and cholesterol in the liver, and reduce the accumulation of lipids, fatty degeneration and inflammatory infiltration in the liver.

[0015] The traditional Chinese medicine composition described in this application can reduce the area of ​​liver tissue fibrosis.

[0016] The traditional Chinese medicine composition described in this application also contains one or more pharmaceutically acceptable excipients.

[0017] In one embodiment, the pharmaceutically acceptable excipients include one or more of the following: diluents, antioxidants, preservatives, solubilizers, disintegrants, lubricants, pH adjusters, colorants, dispersants, osmotic pressure regulators, or surfactants.

[0018] In one embodiment, the diluent is selected from one or more of sucrose, lactose, galactose, glucose, starch, dextrin, gelatin, microcrystalline cellulose, carboxymethyl cellulose, ethyl cellulose, etc.

[0019] In one embodiment, the antioxidant is selected from one or more of ascorbic acid or butylated hydroxytoluene (BHT).

[0020] In one embodiment, the preservative is selected from one or more of benzoic acid, sodium benzoate, p-hydroxybenzoate, trisorbate, or glycerol.

[0021] In one embodiment, the lubricant is selected from one or more of magnesium stearate, calcium stearate, or talc.

[0022] The traditional Chinese medicine composition described in this application is selected from capsules, tablets, granules, pills, powders, granules, solutions, emulsions, or suspensions.

[0023] In one embodiment, the traditional Chinese medicine composition is selected from capsules or tablets.

[0024] The dosage of the traditional Chinese medicine composition described in this application is 0.1-1000 mg / kg / day, or optionally 1-1000 mg / kg / day, and further optionally 1-500 mg / kg / day.

[0025] The dosage of the traditional Chinese medicine composition described in this application is 250-5000 mg / day, or optionally 500-3750 mg / day, and further optionally 750-2500 mg / day.

[0026] The traditional Chinese medicine composition described in this application is a blood-activating and lipid-lowering capsule.

[0027] In one embodiment, the blood-activating and lipid-lowering capsules are used to prevent or treat non-alcoholic steatohepatitis.

[0028] Secondly, this application provides the use of the traditional Chinese medicine composition as described in the first aspect in the preparation of a medicament for the prevention or treatment of non-alcoholic steatohepatitis.

[0029] Thirdly, this application provides a traditional Chinese medicine composition containing total phenolic acids from tanshinone and total triterpenoid acids from hawthorn, which is used to prevent or treat liver fibrosis.

[0030] In the traditional Chinese medicine composition described in this application, the content of total phenolic acids of tanshinone accounts for 80-20% of the total weight of the traditional Chinese medicine composition, and the content of total triterpenic acids of hawthorn accounts for 20-80% of the total weight of the traditional Chinese medicine composition.

[0031] The traditional Chinese medicine composition described in this application improves liver fibrosis by reducing the content of hydroxyproline in the liver.

[0032] The traditional Chinese medicine composition described in this application also contains one or more pharmaceutically acceptable excipients.

[0033] In one embodiment, the pharmaceutically acceptable excipients include one or more of the following: diluents, antioxidants, preservatives, solubilizers, disintegrants, lubricants, pH adjusters, colorants, dispersants, osmotic pressure regulators, or surfactants.

[0034] In one embodiment, the diluent is selected from one or more of sucrose, lactose, galactose, glucose, starch, dextrin, gelatin, microcrystalline cellulose, carboxymethyl cellulose, ethyl cellulose, etc.

[0035] In one embodiment, the antioxidant is selected from one or more of ascorbic acid or butylated hydroxytoluene (BHT).

[0036] In one embodiment, the preservative is selected from one or more of benzoic acid, sodium benzoate, p-hydroxybenzoate, trisorbate, or glycerol.

[0037] In one embodiment, the lubricant is selected from one or more of magnesium stearate, calcium stearate, or talc.

[0038] The traditional Chinese medicine composition described in this application is selected from capsules, tablets, granules, pills, powders, granules, solutions, emulsions, or suspensions.

[0039] In one embodiment, the traditional Chinese medicine composition is selected from capsules or tablets.

[0040] The dosage of the traditional Chinese medicine composition described in this application is 0.1-1000 mg / kg / day, or optionally 1-1000 mg / kg / day, and further optionally 1-500 mg / kg / day.

[0041] The dosage of the traditional Chinese medicine composition described in this application is 250-5000 mg / day, or optionally 500-3750 mg / day, and further optionally 750-2500 mg / day.

[0042] The traditional Chinese medicine composition described in this application is a blood-activating and lipid-lowering capsule.

[0043] In one embodiment, the blood-activating and lipid-lowering capsules are used to prevent or treat liver fibrosis.

[0044] Fourthly, this application provides the use of the traditional Chinese medicine composition as described in the third aspect in the preparation of a medicament for the prevention or treatment of liver fibrosis.

[0045] Compared with the prior art, this application has the following beneficial effects:

[0046] 1. The traditional Chinese medicine composition described in this application is used to treat non-alcoholic steatohepatitis. After treatment, there is no change in body weight and food intake, but the levels of plasma AST and ALT decrease, the NAS score improves, the levels of liver triglycerides and cholesterol decrease, the accumulation of lipids, steatosis and inflammatory infiltration in the liver decrease, and the area of ​​liver tissue fibrosis decreases.

[0047] 2. The traditional Chinese medicine composition described in this application can reduce the area of ​​liver fibrosis and improve the pathological score of liver fibrosis in the prevention or treatment of liver fibrosis. The traditional Chinese medicine composition can also improve liver fibrosis by reducing the content of hydroxyproline in the liver.

[0048] 3. The new pharmaceutical uses of the pharmaceutical composition described in this application have broad clinical application prospects.

[0049] After reading and understanding the accompanying diagrams and detailed descriptions, the other aspects can be understood. Attached Figure Description

[0050] The accompanying drawings are used to provide a further understanding of the technical solutions in this paper and form part of the specification. They are used together with the embodiments of this application to explain the technical solutions in this paper and do not constitute a limitation on the technical solutions in this paper.

[0051] Figure 1 shows the effect of long-term administration of the traditional Chinese medicine composition XYJZ on Sirius red staining in the liver tissue of C57BL / 6J mice.

[0052] Figure 2 shows the effect of long-term administration of the traditional Chinese medicine composition XYJZ on liver fibrosis in C57BL / 6J mice (Note: *, P<0.05 compared with Vehicle; ***, P<0.001 compared with Vehicle). Detailed Implementation

[0053] The technical solution of this application will be further described below through specific embodiments. Those skilled in the art should understand that the embodiments described are only to help understand this application and should not be regarded as specific limitations on this application.

[0054] The reagent kits (such as AST kit, ALT kit, etc.), reagents, syringes, blood collection tubes, etc. used in this application are all commercially available.

[0055] Example 1

[0056] Preparation of Traditional Chinese Medicine Compositions

[0057] The traditional Chinese medicine composition described in this application was prepared with reference to patent CN 02112488.4, hereinafter referred to as XYJZ.

[0058] Establishment of an animal model (diet-induced non-alcoholic steatohepatitis model in mice)

[0059] Male C57BL / 6J mice aged 8-10 weeks were purchased from Beijing Huafukang Biotechnology Co., Ltd. After approximately 6 weeks of acclimatization, the experiment began. All C57BL / 6J mice were deprived of food and starved for 12-16 hours (water was not restricted) one afternoon before modeling, and then fed a high-fat, high-sugar, high-cholesterol diet (D09100310 Research Diet) to initiate modeling. Ten mice in the normal diet control group (NC) were fed a standard diet. At 14 weeks of modeling, C57BL / 6J mice were selected based on average body weight and plasma AST / ALT levels, and divided into groups of 10 mice each: a model control group (Vehicle), a positive control drug group (MGL-3196), and an XYJZ group. The C57BL / 6J mice fed a standard diet concurrently served as the normal diet control group (NC). Specific grouping and drug administration details are shown in Table 1. The XYJZ group was given the traditional Chinese medicine composition XYJZ, the MGL-3196 group was given the positive control drug MGL-3196, and the model control group (Vehicle) and the normal control group (NC) were given an equal volume of triple-distilled water.

[0060] Table 1. Grouping and Dosing of Experimental Substances

[0061] detection indicators

[0062] Random body weight: The random body weight of mice in each group was measured twice a week on the morning of the day of administration.

[0063] Food intake: The food intake of mice in each group was measured twice a week on the morning of the day of drug administration.

[0064] Determination of liver enzyme activity: Blood was collected from the posterior ocular venous plexus of animals under isoflurane anesthesia at weeks 4, 6 and 12 of drug administration. Plasma was collected by centrifugation and the plasma AST / ALT activity level was measured.

[0065] Dissection: On the day of dissection, blood was collected from the retroorbital venous plexus of each group of animals under isoflurane anesthesia. The plasma was collected by centrifugation, frozen at -80°C, and plasma biochemical indicators were tested. The animals were then euthanized by cervical dislocation, and the organs and tissues were separated, weighed, and the ratio of organ weight to body weight was calculated. At the same time, the liver tissue was fixed with 4% paraformaldehyde, and some tissues were frozen in liquid nitrogen.

[0066] Determination of liver lipid content: After dissection, liver tissue was taken to detect the content of triglycerides and total cholesterol.

[0067] Liver tissue pathological analysis: After animal dissection, liver tissue was fixed with 4% paraformaldehyde solution. Paraffin or frozen sections were prepared from the largest surface of the tissue, stained with hematoxylin and eosin (HE), and statistical analysis was performed.

[0068] Liver NAS score scoring criteria: The NAS scoring criteria adopt the scoring criteria of the diagnosis and treatment guidelines for non-alcoholic fatty liver disease formulated by the Chinese Society of Hepatology. The scoring is conducted by pathology experts from Wuhan Saiwei Biotechnology Co., Ltd. on HE-stained pathology slides. The scoring criteria are as follows:

[0069] Data processing and statistical analysis

[0070] Data expressed as mean ± standard error The data were analyzed using the Student-t test, with p < 0.05 considered statistically significant. The T-test was a one-tailed statistical method. All data are presented in tables, with some data also presented in graphs.

[0071] The test results are as follows:

[0072] Regarding body weight, the body weight of mice in the normal diet group remained relatively stable throughout the administration process, and was significantly lower than that in the model group. XYJZ had no significant effect on mouse body weight.

[0073] Regarding food intake, the traditional Chinese medicine composition XYJZ was administered once a day for 12 weeks. Compared with the model control group, long-term administration of XYJZ had no significant effect on the food intake of high-fat mice.

[0074] Effects of long-term administration of the traditional Chinese medicine composition XYJZ on plasma liver enzyme levels in C57BL / 6J mice

[0075] Table 2. Effects of long-term administration of the traditional Chinese medicine composition XYJZ on plasma AST levels (U / L) in C57BL / 6J mice. Note: *, P<0.05 compared to Vehicle; **, P<0.01 compared to Vehicle; ***, P<0.001 compared to Vehicle.

[0076] Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are key indicators for evaluating liver function. Compared with the blank control group, the plasma ALT and AST levels of C57BL / 6J mice in the model group were significantly increased due to the accumulation of large amounts of fat in the liver. The traditional Chinese medicine composition XYJZ, administered once daily for 12 weeks, significantly reduced plasma ALT and AST levels in C57BL / 6J mice.

[0077] Effects of long-term administration of the traditional Chinese medicine composition XYJZ on lipid accumulation in liver tissue of C57BL / 6J mice

[0078] Table 4. Effects of long-term administration of the traditional Chinese medicine composition XYJZ on hepatic lipid accumulation in C57BL / 6J mice.

[0079] Regarding liver lipid accumulation, triglyceride and cholesterol levels were measured in liver tissues of each group after drug administration. Results showed that, compared to the control group, the model group experienced a significant increase in liver cholesterol and triglyceride levels due to a high-fat, high-sugar, and high-cholesterol diet. Regarding triglycerides: The traditional Chinese medicine composition XYJZ, administered once daily for 12 weeks, significantly reduced triglyceride levels in the liver tissue of C57BL / 6J mice. Regarding cholesterol: The traditional Chinese medicine composition XYJZ, administered once daily for 12 weeks, significantly reduced cholesterol levels in the liver tissue of C57BL / 6J mice.

[0080] Evaluation of the ameliorative effect of long-term administration of the traditional Chinese medicine composition XYJZ on non-alcoholic steatohepatitis in C57BL / 6J mice

[0081] Lipid accumulation analysis was performed using HE and Oil Red staining: Compared with the normal control group, the NASH model mice showed severe lipid accumulation in their livers. Long-term administration of XYJZ reduced lipid accumulation, steatosis, and inflammatory infiltration in the livers of C57BL / 6JNASH model mice, and significantly lowered the NAS score. Evaluation using Sirius Red staining: Compared with the normal control group, the Sirius Red staining area in the livers of NASH model mice was significantly increased; compared with the Vehicle group, the Sirius Red staining area was significantly reduced, indicating a significant reduction in the area of ​​liver fibrosis. The results are shown in Figure 1 and Table 5.

[0082] Table 5. Effects of long-term administration of the traditional Chinese medicine composition XYJZ on pathological changes in liver tissue and NAS scores in C57BL / 6J mice.

[0083] Example 2: The effect of long-term administration of the traditional Chinese medicine composition (XYJZ) on improving carbon tetrachloride-induced liver fibrosis in C57BL / 6J mice.

[0084] Preparation of Traditional Chinese Medicine Compositions

[0085] The traditional Chinese medicine composition described in this application was prepared with reference to patent CN 02112488.4, hereinafter referred to as XYJZ.

[0086] Animal modeling

[0087] Using a carbon tetrachloride (CCl4)-induced liver fibrosis model in C57BL / 6J mice, the effect of daily, long-term oral administration of a traditional Chinese medicine composition (XYJZ) on improving CCl4-induced liver fibrosis in mice was observed.

[0088] Seventy-two male C57BL / 6J mice, 6-7 weeks old, were used for the experiment after approximately two weeks of acclimatization. All C57BL / 6J mice were randomly weighed on the morning of the modeling day and injected intraperitoneally with either 10% CCl4 or solvent-based olive oil according to body weight (40 μL for 17.5g-22.5g, 50 μL for 22.5g-27.5g, and 60 μL for 27.5g-32.5g). Modeling was performed three times a week. Mice were randomly divided into six groups of 12 mice each: a model control group (Vehicle), a positive control drug group (OCA, obeticholic acid), and three doses of the XYJZ group. The C57BL / 6J mice in the intraperitoneal olive oil group served as the normal control group (NC). Drug administration began the day after grouping. Specific grouping details are shown in Table 6.

[0089] Dosing regimen

[0090] Preparation method:

[0091] XYJZ Preparation: Accurately weigh the Chinese herbal medicine composition, add the corresponding volume of sterile water, and sonicate until completely dissolved into a clear solution. Administer once daily, and prepare the medicine once daily.

[0092] OCA preparation: Accurately weigh the drug into a mortar and grind it thoroughly. First, add 0.5% CMC-Na solution, grind it thoroughly until dissolved, and then bring the volume up to the appropriate level. Prepare the drug once a week.

[0093] The medication is administered orally at a volume of 10 mL / kg, once daily, on the morning of the day of administration.

[0094] Table 6 Grouping of Experimental Animals

[0095] detection indicators

[0096] 1. Random body weight: The body weight of mice in each group was measured three times a week on the morning of the day of modeling.

[0097] 2. Feeding: The food intake of mice in each group was measured three times a week on the morning of the day of modeling.

[0098] 3. Determination of plasma liver markers AST and ALT: Blood was collected from the retro-orbital venous plexus of animals in each group at weeks 4 and 7 after administration of isoflurane anesthesia. The plasma was collected by centrifugation and stored at -80℃ for determination of plasma AST and ALT levels.

[0099] 4. Dissection: On the day of dissection, blood was collected from the retro-orbital venous plexus of each group of animals under isoflurane anesthesia. The plasma was collected by centrifugation, frozen at -80℃, and tested for plasma biochemical indicators. The animals were then euthanized by cervical dislocation, and the liver tissue was separated, weighed, and its ratio to body weight was calculated. At the same time, the liver tissue was fixed with 4% paraformaldehyde, and some tissue was frozen in liquid nitrogen.

[0100] 5. Fibrosis area statistics: After dissection of the animals in each group, liver tissue sections fixed with 4% paraformaldehyde were stained with Sirius red, photographed, and the proportion of fibrosis area was counted.

[0101] 6. Detection of hydroxyproline content in liver tissue.

[0102] (1) Tissue hydrolysis: Weigh about 100 mg of frozen liver tissue into a 10 mL centrifuge tube, add 1 mL of hydrolysis solution, and hydrolyze in a 95 °C water bath for 20 minutes; then adjust the pH to about 6.0 to 6.8.

[0103] (2) Sample detection: Add an appropriate amount of activated carbon (about 20-30 mg, the supernatant should be clear and colorless after centrifugation), centrifuge at 3500 rpm for 10 minutes, take 1 mL of supernatant and perform the detection according to the instructions of the commercially available product (Nanjing Jiancheng Bioengineering Institute). Calculate the hydroxyproline content based on the absorbance value of each well at 550 nm wavelength measured by the microplate reader.

[0104] 7. Fibrosis scoring criteria: The ISHAK scoring criteria were used to score Sirius red-stained pathological slides. The scoring criteria are as follows:

[0105] (1) 0 points, no fibrosis;

[0106] (2) 1 part of the port area is fibrotic, with or without short fiber septa;

[0107] (3) 2 points: most of the portal area is enlarged with fibrosis, with or without short fibrous septa;

[0108] (4) 3 points: most of the manifolds are enlarged by fiberization, and occasionally manifold-manifold bridging fiberization is seen;

[0109] (5) Enlarged fibrosis in the 4th portal area, with obvious bridging fibrosis (including portal area-portal area; portal area-central vein);

[0110] (6) 5 points: Significant bridging fibrosis (including portal area-portal area; portal area-central vein), with occasional regenerative nodules (incomplete cirrhosis);

[0111] (7) 6 points indicates possible or confirmed cirrhosis.

[0112] Data processing and statistical analysis

[0113] Data expressed as mean ± standard error The data were analyzed using the Student-t test, with p < 0.05 considered statistically significant. The T-test was a one-tailed statistical method. All data are presented in tables, with some data also presented in graphs.

[0114] Experimental results

[0115] 1. Effects of long-term administration of the traditional Chinese medicine composition XYJZ on liver fibrosis in C57BL / 6J mice

[0116] According to the Ishak scoring criteria, pathological scoring of Sirius red staining results revealed that, compared with the normal control group, the pathological score of the CCl4-induced model group was 4 points, indicating significant liver fibrosis in mice. The pathological score of the low-dose group of the traditional Chinese medicine composition XYJZ was close to 4 points, showing no significant difference from the model control group. After long-term administration of the medium-dose and high-dose groups of XYJZ, the fibrosis scores significantly decreased, indicating that the fibrosis in these dose groups was effectively improved (Table 7). Further, we performed statistical analysis on Sirius red staining. The results showed that although there was no significant difference in the pathological score of the low-dose group of the traditional Chinese medicine composition XYJZ, the collagen area stained by Sirius red staining had significantly decreased. The medium-dose and high-dose groups of XYJZ, as well as the positive OCA dose group, significantly reduced the area of ​​liver fibrosis (Table 7, Figure 2). These results indicate that XYJZ administration can significantly improve CCl4-induced liver fibrosis in mice.

[0117] Table 7. Effects of the traditional Chinese medicine composition XYJZ on liver fibrosis in C57BL / 6J mice.

[0118] 2. Effects of long-term administration of the traditional Chinese medicine composition XYJZ on the hydroxyproline content in the liver of C57BL / 6J mice

[0119] Hydroxyproline is an amino acid specific to collagen. To further directly reflect the reduction of collagen fibers, we further examined the hydroxyproline content in the liver of mice in each group. The results showed that, compared with the model control group, the XYJZ 1000 mg / kg and positive OCA dose groups significantly reduced the liver hydroxyproline content, and the XYJZ dose groups showed a certain dose-dependent effect, as shown in Table 8.

[0120] Table 8. Effects of the traditional Chinese medicine composition XYJZ on the hydroxyproline content in the liver of C57BL / 6J mice.

Claims

1. A traditional Chinese medicine composition, wherein, The traditional Chinese medicine composition contains total phenolic acids from tanshinone and total triterpenoid acids from hawthorn. The traditional Chinese medicine composition is used to prevent or treat non-alcoholic fatty liver disease.

2. The traditional Chinese medicine composition according to claim 1, wherein, The total phenolic acid content of tanshinone accounts for 80-20% of the total weight of the traditional Chinese medicine composition, and the total triterpenic acid content of hawthorn accounts for 20-80% of the total weight of the traditional Chinese medicine composition.

3. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition improves non-alcoholic steatohepatitis by reducing AST and / or ALT levels.

4. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition can reduce NAS scores.

5. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition can reduce the levels of triglycerides and cholesterol in the liver, and reduce lipid accumulation, fatty degeneration, and inflammatory infiltration in the liver.

6. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition can reduce the area of ​​liver tissue fibrosis.

7. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition also contains one or more pharmaceutically acceptable excipients.

8. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition is selected from capsules, tablets, granules, pills, powders, granules, solutions, emulsions, or suspensions; The traditional Chinese medicine composition may further be in the form of capsules or tablets.

9. [Amended according to Rule 26, 10.02.2025] According to claim 1, the traditional Chinese medicine composition, wherein, The dosage of the traditional Chinese medicine composition is 0.1-1000 mg / kg / day, optionally 1-1000 mg / kg / day, and further optionally 1-500 mg / kg / day.

10. The traditional Chinese medicine composition according to claim 1, wherein, The dosage of the traditional Chinese medicine composition is 250-5000 mg / day, optionally 500-3750 mg / day, and further optionally 750-2500 mg / day.

11. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition is a blood-activating and lipid-lowering capsule.

12. Use of a traditional Chinese medicine composition according to any one of claims 1-11 in the preparation of a medicament for the prevention or treatment of non-alcoholic steatohepatitis.

13. A traditional Chinese medicine composition, wherein, The traditional Chinese medicine composition contains total phenolic acids from tanshinone and total triterpenoid acids from hawthorn, and is used to prevent or treat liver fibrosis.

14. The traditional Chinese medicine composition according to claim 13, wherein, The total phenolic acid content of tanshinone accounts for 80-20% of the total weight of the traditional Chinese medicine composition, and the total triterpenic acid content of hawthorn accounts for 20-80% of the total weight of the traditional Chinese medicine composition.

15. The traditional Chinese medicine composition according to claim 13, wherein, The traditional Chinese medicine composition improves liver fibrosis by reducing the hydroxyproline content in the liver.

16. The traditional Chinese medicine composition according to claim 13, wherein, The traditional Chinese medicine composition also contains one or more pharmaceutically acceptable excipients.

17. The traditional Chinese medicine composition according to claim 13, wherein, The traditional Chinese medicine composition is selected from capsules, tablets, granules, pills, powders, granules, solutions, emulsions, or suspensions; The traditional Chinese medicine composition may further be in the form of capsules or tablets.

18. [Amended according to Rule 26, 10.02.2025] The traditional Chinese medicine composition according to claim 13, wherein, The dosage of the traditional Chinese medicine composition is 0.1-1000 mg / kg / day, optionally 1-1000 mg / kg / day, and further optionally 1-500 mg / kg / day.

19. The traditional Chinese medicine composition according to claim 13, wherein, The dosage of the traditional Chinese medicine composition is 250-5000 mg / day, optionally 500-3750 mg / day, and further optionally 750-2500 mg / day.

20. The traditional Chinese medicine composition according to claim 13, wherein, The traditional Chinese medicine composition is a blood-activating and lipid-lowering capsule.

21. Use of the traditional Chinese medicine composition according to any one of claims 13-20 in the preparation of a medicament for the prevention or treatment of liver fibrosis.

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