Composition, and use thereof in preparing drugs for preventing and / or treating nonalcoholic steatohepatitis

Abstract

Provided in the present invention is a composition for preventing and / or treating nonalcoholic steatohepatitis, which comprises a radix scutellariae extract and a fructus schisandrae chinensis extract. The fructus schisandrae chinensis extract is prepared by the following method: mixing fructus schisandrae chinensis with water, performing extraction, and filtering same to obtain medicine dregs; then performing extraction on the medicine dregs by using an aqueous ethanol solution, and not performing silica gel column chromatography separation on the obtained oily precipitate, which is the fructus schisandrae chinensis extract. On the basis of crude drug raw materials radix scutellariae and fructus schisandrae chinensis, the mass ratio of the radix scutellariae extract to the fructus schisandrae chinensis extract is 1:0.5-3. The present invention extracts fructus schisandrae chinensis with water to remove impurities, and the extract of active ingredients which is obtained by ethanol precipitation of the dregs is not subjected to any treatment, especially not subjected to silica gel column chromatography separation, and is compounded with the radix scutellariae extract for use. The composition achieves a good treatment effect on MCD feed-induced nonalcoholic steatohepatitis.

Description

Composition and its use in preparing medicine for preventing and / or treating non-alcoholic steatohepatitis

[0001] This application claims priority to the Chinese patent application filed with the State Intellectual Property Office of China on September 19, 2023, with application number 202311214444.0, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of traditional Chinese medicine, and more particularly to a composition and its use in preparing a medicament for preventing and / or treating non-alcoholic steatohepatitis. Background Art

[0003] Nonalcoholic steatohepatitis (NASH) is a special stage of nonalcoholic fatty liver disease (NAFLD), characterized by steatosis of more than 5% of hepatocytes combined with intralobular inflammation and ballooning degeneration of hepatocytes, often accompanied by F0-F4 liver fibrosis, which can further develop into cirrhosis and hepatocellular carcinoma.

[0004] Currently, pharmaceutical companies and research institutes worldwide are conducting a series of new drug development studies targeting potential NASH targets. These include metabolic targets such as glucagon-like peptides, liraglutide, acetyl-CoA carboxylase inhibitors, SCD1 inhibitors, fibroblast growth factor analogs, the farnesoid X receptor agonist obeticholic acid, inhibitors of peroxisome proliferator-activated receptors, mitochondrial pyruvate transporters, and thyroid hormone receptor-β agonists. These candidate compounds primarily aim to reduce liver fat accumulation and lipid metabolic toxicity, thereby improving or reversing NASH. However, to date, these compounds have not yielded satisfactory clinical results.

[0005] Summary of the Invention

[0006] In view of this, the object of the present invention is to provide a composition and its use in the preparation of a medicament for preventing and / or treating non-alcoholic fatty liver disease. The composition of the present invention has a good preventive and therapeutic effect on non-alcoholic fatty liver disease.

[0007] The inventors' team's previous research found that the combination of Schisandra chinensis and Scutellaria baicalensis has a good effect in preventing and treating liver damage, and they applied for a patent (ZL200910059894.0). In subsequent studies, they further found that the combination has a good protective effect on simple fatty liver induced by high-fat emulsion (10% lard plus 5% cholesterol) combined with dexamethasone, and alcoholic fatty liver induced by tetracycline 100mg / kg combined with ethanol (CN202010718492.3). However, in recent studies, the inventors found that the effect of the combination on non-alcoholic steatohepatitis induced by MCD feed was not significant. Based on this, the inventors conducted further research and the prepared composition has good preventive and therapeutic effects on non-alcoholic steatohepatitis.

[0008] The present application provides a composition for preventing and / or treating non-alcoholic steatohepatitis, comprising a scutellaria baicalensis extract and a schisandra chinensis extract; wherein the schisandra chinensis extract is prepared according to the following method:

[0009] The schisandra chinensis is mixed with water for extraction, and the medicinal residue is obtained after filtering;

[0010] The drug residue is extracted with an ethanol aqueous solution, and the obtained oily precipitate is not subjected to silica gel column chromatography to obtain the Schisandra chinensis extract;

[0011] Calculated based on the raw medicinal materials scutellaria baicalensis and schisandra chinensis, the mass ratio of the scutellaria baicalensis extract to the schisandra chinensis extract is 1:0.5-3.

[0012] After research, the inventors found that for Schisandra chinensis extract, the higher the total lignan content, especially the higher the schisandrin content, the worse the effect of the extract on non-alcoholic fatty liver disease induced by MCD feed when combined with Scutellaria baicalensis extract. In fact, the combination of schisandrin alone with Scutellaria baicalensis extract or baicalin has no therapeutic effect on non-alcoholic fatty liver disease induced by MCD feed. However, when Schisandra chinensis is extracted with water to remove impurities and the effective ingredients obtained after alcohol precipitation are not subjected to any treatment, especially the extract obtained without silica gel column chromatography separation is used in combination with Scutellaria baicalensis extract, it has a good therapeutic effect on non-alcoholic fatty liver disease induced by MCD feed.

[0013] In some specific implementations, the Schisandra chinensis extract is prepared according to the following method:

[0014] The schisandra chinensis is mixed with water for extraction, and the medicinal residue is obtained after filtering;

[0015] The Schisandra chinensis extract is obtained by extracting the medicinal residue with an ethanol aqueous solution without performing silica gel column chromatography separation on the obtained oily precipitate.

[0016] Specifically, the present invention first decocts Schisandra chinensis and water, filters, and discards the filtrate to obtain medicinal residue. The mass ratio of Schisandra chinensis to water is 1:8-12, preferably 9-11. The decoction time is 1-1.5 hours, preferably 1.1-1.4 hours. After obtaining the medicinal residue, the obtained medicinal residue is dried, crushed, and extracted with an ethanol aqueous solution. The ethanol aqueous solution is preferably a 60%-80% ethanol aqueous solution, more preferably a 70% ethanol aqueous solution. The present application preferably uses an ethanol aqueous solution to reflux extract the medicinal residue, and more preferably performs two reflux extractions. During the first extraction, the mass ratio of the ethanol aqueous solution to the medicinal residue is 1:9-13, preferably 1:10-12, and the time for the first extraction is preferably 1-2 hours, more preferably 1 hour; during the second extraction, the mass ratio of the ethanol aqueous solution to the medicinal residue is 1:7-10, preferably 1:8-9, and the time for the second extraction is preferably 1-2 hours, more preferably 1 hour. After the extraction is completed, the product is filtered, the filtrate is combined, and the ethanol is recovered. The obtained product is concentrated to a volume-to-weight ratio of schisandra chinensis of 1 to 1.3:1, and the product is allowed to stand overnight. The upper aqueous solution is poured off, and the obtained oily precipitate is not subjected to any treatment, especially without silica gel column chromatography analysis, to obtain the schisandra chinensis extract.

[0017] In some specific implementations, the Schisandra chinensis extract has a Schisandra chinensis lignin content of 30 wt% to 50 wt%, wherein the Schisandra chinensis ester A content is 0.5 wt% to 10 wt%, and the Schisandrin A content is 0.5 wt% to 10 wt%. The present application has no particular limitation on the Schisandra chinensis, such as Schisandra chinensis chinensis or Schisandra chinensis chinensis.

[0018] In some specific implementations, the scutellaria baicalensis extract is prepared according to the following method:

[0019] The scutellaria baicalensis root is mixed with water for extraction, and a filtrate is obtained after filtering;

[0020] The pH value of the filtrate is adjusted to 1.0-2.0, and the filtrate is kept at 60-100° C. and allowed to stand. The obtained precipitate is washed with water, a low-concentration ethanol aqueous solution, and a high-concentration ethanol aqueous solution in sequence until the pH value is 5.0-6.0, thereby obtaining the Scutellaria baicalensis extract.

[0021] Specifically, the present invention first decocts Scutellaria baicalensis with water and filters to obtain a filtrate. The present invention preferably decocts Astragalus baicalensis and water twice. During the first decoction, the mass ratio of Scutellaria baicalensis to water is 1:8-14, preferably 1:9-12, and the first decoction time is 1-2 hours, preferably 1.5 hours. During the second decoction, the mass ratio of Scutellaria baicalensis to water is 1:8-12, preferably 1:9-10, and the second decoction time is 0.5-1 hour, preferably 1 hour. After decoction is completed, the filtrates are filtered, combined, and concentrated to a volume-to-weight ratio of 4-5:1 to Scutellaria baicalensis.

[0022] The pH of the resulting filtrate is adjusted to 1-2, and the mixture is kept at 60-100°C and allowed to stand. The resulting precipitate is washed sequentially with water, a low-concentration aqueous ethanol solution, and a high-concentration aqueous ethanol solution until the pH is 5.0-6.0, thereby obtaining the Scutellaria baicalensis extract. In some specific implementations, the pH of the filtrate is preferably adjusted with hydrochloric acid, and the mixture is kept at 70-90°C, more preferably 80°C, and allowed to stand. After the heat treatment, the mixture is filtered, and the resulting precipitate is preferably washed sequentially with water, 45-55% ethanol, and 95-100% ethanol until the pH is 5.0-6.0. The mixture is then decompressed, dried, and pulverized to obtain the Scutellaria baicalensis extract.

[0023] In some specific implementations, the scutellaria baicalensis extract has a scutellaria flavonoid content of 40 wt% to 80 wt%, wherein the baicalin content is 20 wt% to 60 wt%.

[0024] In some specific implementations, the mass ratio of the scutellaria baicalensis extract to the schisandra chinensis extract is preferably 1:0.5 to 2, more preferably 1:1, 1:2, or 2:1. The inventors have found in their research that the scutellaria baicalensis extract and the schisandra chinensis extract have a synergistic effect in treating non-alcoholic steatohepatitis in a ratio of 1:0.5 to 3, while the effect on the treatment of non-alcoholic steatohepatitis is not significant outside this ratio range.

[0025] Based on this, the present application also provides the use of the above-mentioned composition in the preparation of a medicament for preventing and / or treating non-alcoholic steatohepatitis. In some specific implementations, the non-alcoholic steatohepatitis is non-alcoholic steatohepatitis caused by MCD. In some specific implementations, the above-mentioned composition can reduce lipids, including reducing lipids in the liver, such as cholesterol, triglycerides, and hydroxyproline.

[0026] The present invention has no particular limitation on the form of use of the composition. During use, the composition can be made into pills, tablets, suspensions or capsules, preferably oral preparations.

[0027] In some specific implementations, the composition can be prepared as a capsule, specifically comprising:

[0028] The Schisandra chinensis extract and ethanol are mixed and stirred evenly, and a filler, including but not limited to calcium hydrogen phosphate, is added. After uniform dispersion, the Scutellaria baicalensis extract is added and mixed evenly. After drying and crushing, a lubricant, including but not limited to magnesium stearate, is added and mixed evenly, and then filled into capsules to obtain capsules.

[0029] In some specific implementations, the composition can be prepared as a drop pill, specifically comprising:

[0030] The scutellaria baicalensis extract and the schisandra chinensis extract are added to a matrix, including but not limited to polyethylene glycol, etc., and stirred evenly to prepare drop pills.

[0031] In some specific implementations, the composition can be prepared as a tablet, specifically comprising:

[0032] After the scutellaria baicalensis extract and the schisandra chinensis extract are mixed, a filler, including but not limited to starch, powdered sugar, etc., is added, mixed evenly, granulated and tableted to obtain tablets.

[0033] After research, the inventors found that for Schisandra chinensis extract, the higher the total lignan content, especially the higher the schisandrin content, the worse the effect of the extract on non-alcoholic fatty liver disease induced by MCD feed when combined with Scutellaria baicalensis extract. In fact, the combination of schisandrin alone with Scutellaria baicalensis extract or baicalin has no therapeutic effect on non-alcoholic fatty liver disease induced by MCD feed. However, when Schisandra chinensis is extracted with water to remove impurities and the effective ingredients obtained after alcohol precipitation are not subjected to any treatment, especially the extract obtained without silica gel column chromatography separation is used in combination with Scutellaria baicalensis extract, it has a good therapeutic effect on non-alcoholic fatty liver disease induced by MCD feed. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is the liver tissue pathology images of MCD-induced NASH in MSG mice in each group, where A: control group; B: NASH model; C: Example 4; D: Example 5; E: Example 6; F: Comparative Example 1; G: Comparative Example 2; H: Comparative Example 3. DETAILED DESCRIPTION

[0035] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0036] The raw materials used in the following examples of the present invention are all commercially available commodities.

[0037] Example 1

[0038] Scutellaria baicalensis root was crushed and decocted twice with water: the first time with 10 times the weight of water and decocted for 1.5 hours, and the second time with 10 times the weight of water and decocted for 50 minutes. The filtrates were filtered, combined, and concentrated to a ratio of solution volume to Scutellaria baicalensis weight of approximately 4.5:1. The pH was adjusted to 1.0-2.0 with hydrochloric acid at approximately 80°C, kept warm, and allowed to stand overnight. The precipitate was then filtered, and washed with appropriate amounts of water, 50% ethanol, and 95% ethanol until the pH reached 5.5. The precipitate was dried under reduced pressure and pulverized to obtain a Scutellaria baicalensis extract with a yield of 9.4%. The Scutellaria baicalensis extract contained 40% flavonoids and 20% baicalin.

[0039] Example 2

[0040] Take Schisandra chinensis, add 10 times the weight of water, boil for 1 hour, filter, discard the filtrate, dry the residue in the sun, crush it, add 10 times the weight of 70% ethanol and 8 times the weight of 70% ethanol, reflux extract twice, each time for 1 hour, filter, combine the two filtrates, recover the ethanol in the filtrates, and concentrate until the ratio of solution volume to Schisandra chinensis weight is approximately 1.2:1. Let it stand overnight, decant the upper aqueous layer, and remove the lower oily precipitate to obtain a Schisandra chinensis extract with a yield of 10.7%. The Schisandra chinensis extract contains 0.5% schisandrin A and 0.5% schisandrin A.

[0041] Example 3

[0042] Take southern Schisandra chinensis, add 12 times the weight of water, decoct for 1 hour, filter, discard the filtrate, dry the residue in the sun, crush it, add 10 times the weight of 70% ethanol and 10 times the weight of 70% ethanol, reflux extract twice, each for 1 hour, filter, combine the two filtrates, recover the ethanol in the filtrates, and concentrate until the ratio of solution volume to Schisandra chinensis weight is approximately 1.2:1. Let it stand overnight, decant the upper aqueous layer, and remove the lower oily precipitate to obtain the northern Schisandra chinensis extract with a yield of 11.9%. The Schisandra chinensis extract contains 0.5% schisandrin A and 0.5% schisandrin A.

[0043] Examples 4 to 6

[0044] According to the formula shown in Table 1, the Schisandra chinensis extract prepared in Example 2 or 3 and the Scutellaria baicalensis extract prepared in Example 1 were ground evenly with a small amount of gum arabic powder before use, and then an appropriate amount of 0.5% CMC-Na solution was added to prepare a suspension of appropriate concentration.

[0045] Table 1 Formulations of Examples 4 to 6

[0046] Comparative Example 1

[0047] The composition was prepared according to the method of Example 1 in the "Pharmaceutical Composition for Preventing and Treating Liver Injury" with reference to application number 200910059894.0:

[0048] Take 10 kg of Scutellaria baicalensis, add water and boil, combine the decoctions, concentrate to an appropriate amount, adjust the pH value to 1.5 with hydrochloric acid, keep warm at 80°C, let it stand, filter, add appropriate amount of water to the precipitate and stir evenly, adjust the pH value to 7.0 with 40% sodium hydroxide, add an equal amount of ethanol, stir to dissolve, filter, adjust the pH value of the filtrate to 1.5 with hydrochloric acid, keep warm at 60°C, let it stand, filter, wash the precipitate with appropriate amount of water and different concentrations of ethanol in turn to a pH value of 7.0, evaporate the ethanol, and dry under reduced pressure to obtain Scutellaria baicalensis flavonoids with a yield of 1.2%, of which the content of baicalin is ≥90.0%.

[0049] Take 10 kg of Schisandra chinensis, add water and boil for 1 hour, filter, discard the filtrate, dry the residue, crush it, and extract it with 70% ethanol reflux twice, each time for 1.5 hours, filter, combine the filtrate, recover the ethanol until there is no alcohol taste, add appropriate amount of water, stir well, let it stand overnight, pour out the supernatant, separate the lower oily precipitate by silica gel column chromatography, first elute with petroleum ether-ethyl acetate (10:1) to remove impurities, then elute with petroleum ether-ethyl acetate (10:4), check by thin layer chromatography, combine the lignan-containing parts, remove the solvent, and obtain Schisandra chinensis lignans with a yield of 1.4%, of which the total lignan content is ≥95.0%.

[0050] Take the above extracts, mix them with the original medicinal materials in a 1:1 ratio, add a small amount of gum arabic powder and grind them evenly before use, then add an appropriate amount of 0.5% CMC-Na solution to prepare a suspension of appropriate concentration for use.

[0051] Comparative Example 2

[0052] The difference from Example 4 is that Scutellaria baicalensis and Schisandra chinensis are mixed at a raw drug weight ratio of 1:5.

[0053] Comparative Example 3

[0054] The difference from Example 4 is that Scutellaria baicalensis and Schisandra chinensis are mixed in a ratio of 4:1 based on the mass of the original medicinal materials.

[0055] Test example

[0056] The following experiments were carried out using the compositions prepared in the above examples and comparative examples as active pharmaceutical ingredients and as test drugs.

[0057] 1. Experimental Materials

[0058] 1.1 Experimental Reagents

[0059] MCD feed: code: TP3005G, batch number: 22041420, stored at 4°C, produced by Nantong Trophy Feed Technology Co., Ltd.

[0060] Sodium carboxymethyl cellulose (CMC-Na): AR, batch number: 2014102701, produced by Chengdu Kelong Chemical Reagent Factory. Prepare a 0.5% concentration solution with ultrapure water before use and set aside for later use.

[0061] 1.2 Biochemical detection kits

[0062] Hydroxyproline content detection kit (alkaline hydrolysis method): batch number: 20220727, produced by Nanjing Jiancheng Bioengineering Research Institute.

[0063] Triglyceride (TG) determination kit, batch number: 0122011; cholesterol (TC) determination kit, batch number: 1021031. Both the TG and TC kits are produced by Sichuan New Health Bio Co., Ltd.

[0064] 1.3 Main experimental instruments

[0065] Multifunctional microplate reader (Varioskan Flash, produced by Thermo, USA);

[0066] Automatic biochemical analyzer (Hitachi 7180 type, produced by Hitachi High-Technologies Corporation, Japan).

[0067] 1.4 Animals and environment

[0068] SPF-grade Kunming mice, provided by the Experimental Animal Center of Sichuan Academy of Traditional Chinese Medicine, with the production license number SCXK (Sichuan) - 2018 - 19. The animals were housed in the barrier system of the Experimental Animal Center of Sichuan Academy of Traditional Chinese Medicine, with the certificate number SYXK (Sichuan) - 2018 - 100. The room temperature was 22 - 25°C, the humidity was 50 ± 5%, and the light and dark periods were each 12 hours. During the experiment, the mice were allowed to freely eat and drink.

[0069] 2 Experimental methods

[0070] Select male monosodium glutamate-induced obese mice weighing 22 - 25 g, randomly divided into the NASH model, Examples 4 - 6, Comparative Examples 1 - 3, and a control group was also set up. Administer the drug by gavage once a day at the doses shown in Table 2 for 4 consecutive weeks. During this period, except for the animals in the control group fed with normal feed, the other animals were fed with MCD feed. Weigh the animals once a week and adjust the drug dosage accordingly. 24 hours after the last drug administration, fast the animals for 12 hours without water deprivation, bleed and sacrifice the animals, weigh the liver and calculate its organ index. Homogenize a small piece of the liver and measure the levels of triglyceride TG and total cholesterol TC. Take another small piece of the liver to measure the hydroxyproline (HYP) level. At the same time, take the middle lobe of the liver and fix it in 10% formalin for pathological section observation. The results are shown in Table 2 and Figure 1. Table 2 shows the detection results of liver lipid, hydroxyproline and other indicators in NASH mice, and Figure 1 shows the histopathological pictures of NASH liver tissue in MCD-induced MSG mice in each group.

[0071] Table 2 Detection results of liver lipids, hydroxyproline and other indicators in NASH mice

[0072] In Table 2, compared with the NASH model group: *P<0.05, **P<0.01, ***P<0.001. Compared with Comparative Example 1: #P<0.05.

[0073] As shown in Table 2, after one month of consumption of the MCD diet, the liver TC, TG, and HYP levels of MSG obese mice were significantly increased, with statistically significant differences compared to the control group. Examples 4, 5, and 6 all significantly reduced the liver TG, TC, and HYP levels of NASH mice, with statistically significant differences compared to the NASH model group and compared to Comparative Example 1.

[0074] In Figure 1, A is the control group, with clear liver lobule structure, normal liver cell morphology, no interstitial hyperplasia and inflammatory cell infiltration, and normal structure. B is the NASH model, with a large number of liver cell vacuoles, focal liver cell necrosis with inflammatory cell infiltration in multiple lobules, inflammatory cell infiltration in the portal area, and fibrosis formation; C is

[0075] Example 4: A few hepatocyte vacuoles were formed, and a small amount of inflammatory cells infiltrated in the portal area; D: Example 5: A few hepatocyte vacuoles were formed, and a small amount of inflammatory cells infiltrated in the portal area; E: Example 6: Partial hepatocyte vacuoles were formed, and a small amount of inflammatory cells infiltrated in the portal area; F: Comparative Example 1: Partial hepatocyte vacuoles were formed, and a small amount of inflammatory cells infiltrated in the portal area; G: Comparative Example 2: Partial hepatocyte vacuoles were formed, focal hepatocyte necrosis with inflammatory cell infiltration in the lobule, and a small amount of inflammatory cells infiltrated in the portal area; H: Comparative Example 3: A large number of hepatocyte vacuoles were formed, hepatocyte necrosis with inflammatory cell infiltration in multiple lobules, and inflammatory cells infiltrated in the portal area.

[0076] As shown in Figure 1, under the microscope, the liver structure of the control group mice was normal; in the livers of the model group mice, moderate to severe fatty degeneration of hepatocytes, moderate to mild intralobular inflammation, moderate portal inflammation, and mild interstitial fibrosis were observed. The livers of the mice in Examples 4, 5, and 6 showed mild fatty degeneration of hepatocytes and mild intralobular inflammation, and the degree of lesions was significantly reduced compared with the model group. The livers of the mice in Comparative Examples 1 to 3 showed moderate to severe fatty degeneration of hepatocytes, mild intralobular inflammation, and mild fibrotic lesions, and the degree of lesions was reduced compared with the model group, but there was no significant difference. There was no significant difference between the livers of the mice in Comparative Examples 2 to 3 and the livers of the mice in Comparative Example 1.

[0077] The above description of the disclosed embodiments will enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is to be construed in the widest manner consistent with the principles and novel features disclosed herein.

Claims

1. A composition for preventing and / or treating non-alcoholic steatohepatitis, characterized in that: The invention comprises a scutellaria baicalensis extract and a schisandra chinensis extract; wherein the schisandra chinensis extract is prepared according to the following method: The schisandra chinensis is mixed with water for extraction, and the residue is obtained after filtering; After extracting the drug residue with ethanol aqueous solution, the obtained oily precipitate is not subjected to silica gel column chromatography to obtain the Schisandra chinensis extract; Calculated on the basis of the raw materials of scutellaria baicalensis and schisandra chinensis, the mass ratio of the scutellaria baicalensis extract to the schisandra chinensis extract is 1:0.5-3.

2. The composition according to claim 1, characterized in that The mass ratio of the scutellaria baicalensis extract to the schisandra chinensis extract is 1:0.5-2.

3. The composition according to claim 1, characterized in that In the Schisandra chinensis extract, the content of Schisandra chinensis lignin is 30wt% to 50wt%, wherein the content of Schisandra chinensis ester A is 0.5wt% to 10wt%, and the content of Schisandrin A is 0.5wt% to 10wt%.

4. The composition according to claim 3, characterized in that The Schisandra chinensis is Schisandra chinensis chinensis or Schisandra chinensis chinensis.

5. The composition according to any one of claims 1 to 4, characterized in that The scutellaria baicalensis extract is prepared according to the following method: The scutellaria baicalensis root is mixed with water for extraction, and a filtrate is obtained after filtering; The pH value of the filtrate is adjusted to 1.0-2.0, and the filtrate is kept at 60-100° C. The obtained precipitate is washed with water, low-concentration ethanol aqueous solution and high-concentration ethanol aqueous solution in sequence until the pH value is 5.0-6.0 to obtain the Scutellaria baicalensis extract.

6. The composition according to claim 5, characterized in that In the scutellaria baicalensis extract, the content of scutellaria baicalensis flavonoids is 40wt% to 80wt%, wherein the content of baicalin is 20wt% to 60wt%.

7. Use of the composition according to any one of claims 1 to 6 in the preparation of a medicament for preventing and / or treating non-alcoholic steatohepatitis.

8. The use according to claim 7, characterized in that: The non-alcoholic fatty liver disease is non-alcoholic fatty liver disease caused by MCD.

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