Application of traditional Chinese medicine composition in preparation of medicine for treating hepatic fibrosis

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating hepatic fibrosis. The traditional Chinese medicine composition is prepared from the following components: rheum officinale, astragalus membranaceus, white mulberry root-bark, radix sophorae flavescentis, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, radix polygoni multiflori preparata, radix paeoniae alba, salvia miltiorrhiza, ligusticum wallichii, chrysanthemum, ginger processed pinellia, plantain herb, radix bupleuri and liquorice. According to the application of the traditional Chinese medicine composition in preparation of the medicine for treating and / or preventing hepatic fibrosis, experimental results show that the traditional Chinese medicine composition can reduce the concentration of AST, ALT and AKP in serum and the content of HYP in liver tissue; the content of hyaluronic acid and laminin in liver tissues and the content of III-type procollagen and IV-type collagen in serum are reduced; and the contents of tumor necrosis factor-alpha and interleukin 6 in the liver are reduced. The traditional Chinese medicine composition is simple in formula, wide in ingredient source, simple in preparation method and good in hepatic fibrosis treatment effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and particularly relates to the use of a traditional Chinese medicine composition in the preparation of a drug for treating liver fibrosis. Background Art

[0002] Liver fibrosis is a repair response after chronic liver injury caused by various etiologies. The disease course is protracted and reversible. Without active and effective intervention measures, it can progress to liver cirrhosis, and then trigger a series of serious complications such as liver failure, hepatic encephalopathy, and rupture and bleeding of gastroesophageal varices. At present, the clinical treatment of liver fibrosis mainly focuses on eliminating the causes, including antiviral treatment, alcohol abstinence and weight loss, and eliminating pathogenic factors, as well as liver protection treatment, such as Fuzheng Huayu Capsule, Biejia Ruangan Tablets, and Biejia Jian Pills. However, they can only delay the progression of the disease and cannot achieve the purpose of curing liver fibrosis. Moreover, due to the complex composition of the compound, numerous targets, and unclear mechanism of action, their treatment cycle is long, the curative effect varies from person to person, and it is easy to produce side effects that are difficult to evaluate.

[0003] Traditional Chinese medicine believes that "dampness-heat stasis-toxin" causes chronic liver injury, and "dampness-heat stasis-toxin" is also the initiating factor of liver fibrosis and the continuous pathogenic cause. The dampness-toxin pathogen stagnates in the liver collaterals and blood aspect, the liver collaterals are injured, the toxin causes stasis, and the blood stasis fails to transform and helps dampness generate heat. The accumulation of "dampness-heat stasis-toxin" in the liver collaterals is the main factor for the formation and aggravation of liver fibrosis. The continuous existence of dampness-heat stasis-toxin damages the healthy qi, leading to weakness of the spleen qi and deficiency of the liver and kidney yin, and then deficiency of the spleen and kidney yang, ultimately forming intractable syndromes such as accumulation and tympanites. The treatment of liver fibrosis in traditional Chinese medicine mainly focuses on promoting blood circulation to remove stasis and supplementing qi and nourishing yin as an adjunct.

[0004] The effect of Chinese herbal medicines and their preparations against liver fibrosis has always been one of the key research topics of domestic and foreign medical research institutions. Liver fibrosis can be interpreted as the syndrome of spleen deficiency and dampness-heat in traditional Chinese medicine syndromes for chronic liver diseases. Relevant compound traditional Chinese medicine preparations for anti-liver fibrosis have emerged, but they are all crude preparations of large compound traditional Chinese medicines, with disadvantages such as large dosage, long treatment cycle, inaccurate curative effect, and difficult research on the treatment mechanism, and it is difficult to meet the needs of anti-liver fibrosis patients in the market. In view of this, there is an urgent need in this field to develop a traditional Chinese medicine composition with better effect in treating liver fibrosis. Summary of the Invention

[0005] The present invention aims at the problems existing in the prior art and provides the use of a traditional Chinese medicine composition in the preparation of a drug for treating liver fibrosis.

[0006] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] Use of a traditional Chinese medicine composition in the preparation of a medicament for treating and / or preventing liver fibrosis, wherein the traditional Chinese medicine composition is composed of the following components: rhubarb, astragalus root, mulberry bark, lightyellow sophora root, pilose asiabell root, largehead atractylodes rhizome, poria, prepared fleeceflower root, white peony root, salvia miltiorrhiza, chuanxiong rhizome, chrysanthemum, pinellia ternata, plantain herb, bupleurum root and licorice root.

[0008] Preferably, the application of the composition in the preparation of a medicament for reducing the concentrations of AST, ALT and AKP in serum and the content of HYP in liver tissue.

[0009] Preferably, the application of the composition in the preparation of a medicament for reducing the contents of hyaluronic acid and laminin in liver tissue and type III procollagen and type IV collagen in serum.

[0010] Preferably, the application of the composition in the preparation of a medicament for reducing the contents of tumor necrosis factor-α and interleukin 6 in the liver.

[0011] Preferably, the liver fibrosis is liver fibrosis caused by viral hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease or cholestatic liver disease.

[0012] Preferably, the mass ratio of rhubarb, astragalus root, mulberry bark, lightyellow sophora root, pilose asiabell root, largehead atractylodes rhizome, poria, prepared fleeceflower root, white peony root, salvia miltiorrhiza, chuanxiong rhizome, chrysanthemum, pinellia ternata, plantain herb, bupleurum root and licorice root is 1:3-5:2-4:1-3:2-4:4-6:3-7:4-6:2-4:4-6:2-4:2-3:1-4:3-6:1-2:0.5-1.5.

[0013] More preferably, the mass ratio of rhubarb, astragalus root, mulberry bark, lightyellow sophora root, pilose asiabell root, largehead atractylodes rhizome, poria, prepared fleeceflower root, white peony root, salvia miltiorrhiza, chuanxiong rhizome, chrysanthemum, pinellia ternata, plantain herb, bupleurum root and licorice root is 1:4:3:2:3:5:5:5:3:5:3:2.5:2:5:1.5:0.9.

[0015] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps: first decoct each medicinal material with water, filter, concentrate to obtain a clear paste, and then add auxiliary materials to obtain the composition.

[0016] Preferably, the decoction includes decocting with 3-8 times the weight of water for 2-3 times, 1-3 h each time, and filtering and combining the decoction liquid.

[0017] More preferably, the decoction includes decocting with 4-6 times the weight of water for 2-3 times, 1-2 h each time.

[0018] Preferably, the relative density of the clear paste at 80-90 °C is 1.1-1.3 g / mL, and vacuum drying or freeze drying is also carried out after obtaining the clear paste.

[0019] Preferably, the adjuvant includes at least one of sucrose, dextrin and starch.

[0020] Preferably, the drug further includes a pharmaceutically acceptable carrier.

[0021] Preferably, the carrier is selected from one or more of fillers, binders, wetting agents, disintegrants, flavoring agents, lubricants and preservatives.

[0022] Preferably, the dosage form of the drug is tablets, pills, granules, powders or solutions.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] (1) The present invention provides the use of a traditional Chinese medicine composition in the preparation of a drug for treating and / or preventing liver fibrosis. The experimental results show that the traditional Chinese medicine composition can reduce the concentrations of AST, ALT and AKP in serum and the content of HYP in liver tissue; reduce the contents of hyaluronic acid, laminin, type III procollagen and type IV collagen in serum; and reduce the contents of tumor necrosis factor-α and interleukin 6 in the liver.

[0025] (2) The traditional Chinese medicine composition provided by the present invention has a concise formula, wide sources of ingredients, a simple preparation method and good effects in treating liver fibrosis. Detailed implementation manners

[0026] It should be noted that the raw materials used in the present invention are all ordinary commercially available products.

[0027] Example 1

[0028] A traditional Chinese medicine composition, and its preparation method is as follows:

[0029] Weigh 50 g of Rheum palmatum, 200 g of Astragalus membranaceus, 150 g of Morus alba L. root-bark, 100 g of Sophora flavescens, 150 g of Codonopsis pilosula, 250 g of Atractylodes macrocephala, 250 g of Poria cocos, 250 g of Polygonum multiflorum Thunb., 150 g of Paeonia lactiflora Pall., 250 g of Salvia miltiorrhiza Bunge, 150 g of Ligusticum chuanxiong Hort., 125 g of Chrysanthemi Flos, 100 g of Pinelliae Rhizoma Praeparatum, 250 g of Plantago asiatica L., 75 g of Bupleurum chinense DC. and 45 g of Glycyrrhiza uralensis Fisch. Crush the 16 kinds of medicinal materials through an 80-mesh sieve, mix them, decoct with 5 times the weight of water for 3 times, 2 h each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.3 g / mL at 80 °C, and vacuum dry to obtain a dry powder. Add 1 g of dextrin to each gram of dry powder, granulate, and you will get it.

[0030] Example 2

[0031] A traditional Chinese medicine composition, and its preparation method is as follows:

[0032] Weigh 50 g of Rheum palmatum, 150 g of Astragalus membranaceus, 100 g of Morus alba root bark, 50 g of Sophora flavescens, 100 g of Codonopsis pilosula, 200 g of Atractylodes macrocephala, 150 g of Poria cocos, 200 g of Polygonum multiflorum preparatum, 100 g of Paeonia lactiflora, 200 g of Salvia miltiorrhiza, 100 g of Ligusticum wallichii, 100 g of Chrysanthemum morifolium, 50 g of Pinellia ternata processed with ginger, 150 g of Plantago asiatica, 50 g of Bupleurum chinense, and 25 g of Glycyrrhiza uralensis. Crush the 16 herbs through an 80-mesh sieve, mix them, decoct with 3 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.2 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of sucrose to each gram of dry powder, granulate, and you will get it.

[0033] Example 3

[0034] A traditional Chinese medicine composition, and its preparation method is as follows:

[0035] Weigh 50 g of Rheum palmatum, 250 g of Astragalus membranaceus, 200 g of Morus alba root bark, 150 g of Sophora flavescens, 200 g of Codonopsis pilosula, 300 g of Atractylodes macrocephala, 350 g of Poria cocos, 300 g of Polygonum multiflorum preparatum, 200 g of Paeonia lactiflora, 300 g of Salvia miltiorrhiza, 200 g of Ligusticum wallichii, 150 g of Chrysanthemum morifolium, 200 g of Pinellia ternata processed with ginger, 300 g of Plantago asiatica, 100 g of Bupleurum chinense, and 75 g of Glycyrrhiza uralensis. Crush the 16 herbs through an 80-mesh sieve, mix them, decoct with 8 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.1 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of starch to each gram of dry powder, granulate, and you will get it.

[0036] Comparative Example 1

[0037] Same as Example 1, the only difference is that the formula does not contain Rheum palmatum.

[0038] A traditional Chinese medicine composition, and its preparation method is as follows:

[0039] Weigh 200 g of Astragalus membranaceus, 150 g of Morus alba root bark, 100 g of Sophora flavescens, 150 g of Codonopsis pilosula, 250 g of Atractylodes macrocephala, 250 g of Poria cocos, 250 g of Polygonum multiflorum preparatum, 150 g of Paeonia lactiflora, 250 g of Salvia miltiorrhiza, 150 g of Ligusticum wallichii, 125 g of Chrysanthemum morifolium, 100 g of Pinellia ternata processed with ginger, 250 g of Plantago asiatica, 75 g of Bupleurum chinense, and 45 g of Glycyrrhiza uralensis. Crush the 15 herbs through an 80-mesh sieve, mix them, decoct with 5 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.3 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of dextrin to each gram of dry powder, granulate, and you will get it.

[0040] Comparative Example 2

[0041] Same as Example 1, the only difference is that Polygonum multiflorum preparatum in the formula is replaced with Schisandra chinensis.

[0042] A traditional Chinese medicine composition, and its preparation method is as follows:

[0043] Weigh 50 g of Rheum officinale, 200 g of Astragalus membranaceus, 150 g of Mori Cortex, 100 g of Sophora flavescens, 150 g of Codonopsis pilosula, 250 g of Atractylodes macrocephala, 250 g of Poria cocos, 250 g of Schisandra chinensis, 150 g of Paeonia lactiflora, 250 g of Salvia miltiorrhiza, 150 g of Ligusticum chuanxiong, 125 g of Chrysanthemi Flos, 100 g of Pinelliae Rhizoma Praeparatum, 250 g of Plantaginis Herba, 75 g of Bupleuri Radix and 45 g of Glycyrrhizae Radix. Pulverize the 16 medicinal materials through an 80-mesh sieve, mix them, decoct with 5 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.3 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of dextrin to each gram of dry powder, granulate, and you will get it.

[0044] Comparative Example 3

[0045] It is the same as Example 1, with the only difference being that Poria cocos is replaced by Ramulus Cinnamomi.

[0046] A traditional Chinese medicine composition, and its preparation method is as follows:

[0047] Weigh 50 g of Rheum officinale, 200 g of Astragalus membranaceus, 150 g of Mori Cortex, 100 g of Sophora flavescens, 150 g of Codonopsis pilosula, 250 g of Atractylodes macrocephala, 250 g of Ramulus Cinnamomi, 250 g of Polygonum multiflorum preparatum, 150 g of Paeonia lactiflora, 250 g of Salvia miltiorrhiza, 150 g of Ligusticum chuanxiong, 125 g of Chrysanthemi Flos, 100 g of Pinelliae Rhizoma Praeparatum, 250 g of Plantaginis Herba, 75 g of Bupleuri Radix and 45 g of Glycyrrhizae Radix. Pulverize the 16 medicinal materials through an 80-mesh sieve, mix them, decoct with 5 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.3 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of dextrin to each gram of dry powder, granulate, and you will get it.

[0048] Comparative Example 4

[0049] It is the same as Example 1, with the only difference being that the proportion of each component in the formula is different.

[0050] A traditional Chinese medicine composition, and its preparation method is as follows:

[0051] Weigh 50 g of Rheum officinale, 50 g of Astragalus membranaceus, 150 g of Mori Cortex, 100 g of Sophora flavescens, 200 g of Codonopsis pilosula, 250 g of Atractylodes macrocephala, 50 g of Poria cocos, 250 g of Polygonum multiflorum preparatum, 150 g of Paeonia lactiflora, 300 g of Salvia miltiorrhiza, 150 g of Ligusticum chuanxiong, 125 g of Chrysanthemi Flos, 200 g of Pinelliae Rhizoma Praeparatum, 250 g of Plantaginis Herba, 75 g of Bupleuri Radix and 100 g of Glycyrrhizae Radix. Pulverize the 16 medicinal materials through an 80-mesh sieve, mix them, decoct with 5 times the weight of water for 3 times, 2 hours each time, and filter and combine the decoction. Filter, concentrate the filtrate to a clear paste with a relative density of 1.3 g / mL at 80 °C, and obtain dry powder by vacuum drying. Add 1 g of dextrin to each gram of dry powder, granulate, and you will get it.

[0052] Test Example

[0053] Pharmacodynamic experiments were conducted on the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4 in CCl4-induced liver fibrosis rats. The specific methods are as follows:

[0054] 1. Experimental materials:

[0055] (1) Research objects: The traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4.

[0056] (2) Experimental animals: 100 SPF-grade male SD rats with a body weight of 170-200 g were selected and provided by Beijing Vital River Laboratory Animal Technology Co., Ltd. Animal license: SCXK (Beijing) 2016-0006. The environmental temperature was 18-22 °C, and the relative humidity was 40-50%. They had free access to water and food.

[0057] 2. Liver fibrosis animal model establishment: Rats were intraperitoneally injected with CCl4 (2 mL / kg) prepared with olive oil (30%) twice a week for a total of 8 weeks. According to the literature (Liu Fahe, Zeng Hailian, Zheng Xiaojiang, etc. The role of serum liver fibrosis indexes, AST / ALT ratio and platelet detection in the diagnosis of liver fibrosis [J]. Experimental and Laboratory Medicine, 2011, 29(03): 251-252), there was a correlation (P<0.05), and even a significant correlation (P<0.01) between the liver fibrosis indexes and the AST / ALT ratio mentioned in part 2.2. The success of the model establishment was verified by collecting blood from the rat tail vein.

[0058] 3. Experimental method: 100 SD rats were divided into 10 groups, with 10 rats in each group, namely the model group, the control group, the positive drug group, the groups of Examples 1-3 and the groups of Comparative Examples 1-4. Rats in the model group, the positive drug group, the groups of Examples 1-3 and the groups of Comparative Examples 1-4 were intraperitoneally injected with CCl4 prepared with olive oil according to the liver fibrosis animal model establishment method, and the rats in the control group were intraperitoneally injected with the same volume of olive oil.

[0059] One week after model establishment, drug administration began. The positive drug group was given silybin by gavage at a dose of 100 mg / kg; the groups of Examples 1-3 and the groups of Comparative Examples 1-4 were given the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4 by gavage at a dose of 150 mg / kg, and the administration volume was 2 mL / kg; the model group and the control group were given the same volume of normal saline by gavage. Drug administration was continued for 7 weeks. After the last drug administration, the rats were fasted but not water-deprived for 12 h, anesthetized by intraperitoneal injection of 40 mg / kg pentobarbital sodium, blood was taken from the abdominal aorta, left to stand at 4 °C for 2 h, centrifuged at 4000 rpm for 10 min, the supernatant was aliquoted into centrifuge tubes and stored at -80 °C for later use. The animals were sacrificed, the liver tissues of the rats were removed, placed in cryopreservation tubes, quenched with liquid nitrogen, and stored in an ultra-low temperature refrigerator at -80 °C for later use.

[0060] 4. Index Detection:

[0061] (1) Detection of the Contents of AST, ALT and AKP in Serum: According to the kit instructions, the enzyme-linked immunosorbent assay was used to detect the AST, ALT and AKP indexes.

[0062] (2) Detection of the Content of HYP in Liver Tissue: The mass of the liver tissue was accurately weighed, and 9 times the amount of normal saline was added according to the mass-volume ratio for mechanical homogenization to prepare a 10% homogenate. It was centrifuged at 12,000 rpm for 10 min at 4 °C, and the supernatant was transferred to an EP tube. The HYP level was detected according to the kit instructions.

[0063] (3) Detection of the Contents of Hyaluronic Acid, Laminin, Type III Procollagen and Type IV Collagen: According to the kit instructions, the contents of hyaluronic acid and laminin in liver tissue and type III procollagen and type IV collagen in serum were detected.

[0064] (4) Detection of the Contents of Tumor Necrosis Factor-α and Interleukin 6: The liver tissue was finely ground and centrifuged at 4,000 rpm for 10 min at 4 °C. The supernatant was taken and transferred to an EP tube. According to the kit instructions, the absorbance value at a wavelength of 450 nm was measured with an enzyme-labeled instrument to detect tumor necrosis factor-α and interleukin 6.

[0065] 5. Statistical Methods

[0066] The experimental results were statistically analyzed using GraphPad Prism 8 software. One-way analysis of variance was used to compare the statistical differences between groups. P < 0.05 indicates that the difference is statistically significant.

[0067] 6. Experimental Results:

[0068] (1) Effects of the Traditional Chinese Medicine Composition of the Present Invention on the Contents of AST, ALT and AKP in the Serum of Rats, the Content of HYP in Liver Tissue and the AST / ALT Ratio

[0069] The experimental results are shown in Table 1. As can be seen from Table 1, compared with the control group, the contents of AST, ALT and AKP in the serum of rats in the model group, the content of HYP in liver tissue and the AST / ALT ratio were significantly increased (P < 0.05 or P < 0.01), indicating that the modeling was successful. Compared with the model group, the contents of AST, ALT, AKP, the content of HYP in liver tissue and the AST / ALT ratio in the rats in Example 1-3 groups were significantly decreased (P < 0.05 or P < 0.01); there were no significant differences in the contents of AST, ALT and AKP in the serum of rats in Comparative Example 1-4 groups, the content of HYP in liver tissue and the AST / ALT ratio, indicating that the traditional Chinese medicine composition prepared in Example 1-3 of the present invention can improve liver fibrosis, thus achieving the prevention and treatment effects of liver fibrosis diseases.

[0070] Changes in the contents of AST, ALT and AKP in the serum of rats, the content of HYP in liver tissue, and the ratio of AST / ALT

[0071] Group AST (U / L) ALT (U / L) AST / ALT AKP (U / L) HYP (μg / mL) Model group <![CDATA[186.34±29.14 ## > <![CDATA[76.27±8.43 # > <![CDATA[2.44±0.47 # > <![CDATA[36.26±4.72 ## > <![CDATA[0.69±0.13 ## > Control group <![CDATA[75.43±6.32 ** > <![CDATA[45.42±3.18 * > <![CDATA[1.66±0.17 * > <![CDATA[12.42±1.13 ** > <![CDATA[0.27±0.11 ** > Positive drug group <![CDATA[95.76±12.47 * > <![CDATA[48.53±2.79 * > <![CDATA[1.72±0.14 * > <![CDATA[17.57±1.26 ** > <![CDATA[0.29±0.17 ** > Example 1 <![CDATA[93.14±10.36 * > <![CDATA[52.36±3.71 * > <![CDATA[1.78±0.22 * > <![CDATA[18.73±1.38 ** > <![CDATA[0.34±0.20 ** > Example 2 <![CDATA[96.25±10.18 * > <![CDATA[60.19±3.01 * > <![CDATA[1.60±0.19 ** > <![CDATA[19.68±1.46 ** > <![CDATA[0.31±0.21 ** > Example 3 <![CDATA[95.81±10.43 * > <![CDATA[51.42±3.13 * > <![CDATA[1.86±0.22 * > <![CDATA[19.92±1.53 ** > <![CDATA[0.33±0.23 ** > Comparative example 1 <![CDATA[168.24±17.46 # > <![CDATA[75.16±7.86 # > <![CDATA[2.24±0.29 # > <![CDATA[30.38±3.01 # > 0.59±0.43 Comparative example 2 133.46±12.82 60.82±6.45 2.19±0.26 <![CDATA[28.47±2.61 # > 0.51±0.47 Comparative example 3 140.73±14.91 63.34±6.59 <![CDATA[2.22±0.26 # > <![CDATA[29.73±2.72 # > 0.56±0.48 Comparative example 4 <![CDATA[154.17±15.73 # > <![CDATA[72.41±7.64 # > 2.13±0.27 <![CDATA[28.45±2.45 # > <![CDATA[0.60±0.51 # >

[0072] Note: Compared with the control group, # indicates P < 0.05, ## indicates P < 0.01; compared with the model group, * indicates P < 0.05, ** indicates P < 0.01.

[0073] (2) Effects of the traditional Chinese medicine composition of the present invention on the contents of hyaluronic acid, laminin in the liver tissue of rats and type III procollagen and type IV collagen in the serum

[0074] The experimental results are shown in Table 2. It can be seen from Table 2 that compared with the control group, the contents of hyaluronic acid, laminin in the liver tissue of rats in the model group and Comparative Example 1-4 groups, and the contents of type III procollagen and type IV collagen in the serum were all significantly increased (P < 0.05 or P < 0.01); compared with the model group, the contents of hyaluronic acid, laminin in the liver tissue of rats in Examples 1-3 groups and the contents of type III procollagen and type IV collagen in the serum were significantly decreased (P < 0.05 or P < 0.01).

[0075] Table 2 Comparison of liver fibrosis indexes in rats

[0076]

[0077]

[0078] Note: Compared with the control group, # indicates P < 0.05, ## indicates P < 0.01; compared with the model group, * indicates P < 0.05, ** indicates P < 0.01.

[0079] (3) Effects of the traditional Chinese medicine composition of the present invention on the inflammatory factors in the serum of rats

[0080] The experimental results are shown in Table 3. It can be seen from Table 3 that compared with the control group, the contents of tumor necrosis factor-α and interleukin 6 in the serum of rats in the model group and Comparative Example 1 group were both significantly increased (P < 0.05 or P < 0.01); compared with the model group, the contents of tumor necrosis factor-α and interleukin 6 in the serum of rats in Examples 1-4 groups were both significantly decreased (P < 0.01).

[0081] Table 3 Comparison of the contents of inflammatory factors in the serum of rats

[0082] Group Tumor necrosis factor-α (ng / mL) Interleukin 6 (ng / mL) Model group <![CDATA[123.81±11.47 ## > <![CDATA[62.86±5.29 ## > Control group <![CDATA[33.42±2.36 ** > <![CDATA[16.71±2.07 ** > Positive drug group <![CDATA[41.53±3.41 ** > <![CDATA[21.57±2.16 ** > Example 1 <![CDATA[45.31±3.81 ** > <![CDATA[24.73±2.73 ** > Example 2 <![CDATA[47.28±3.94 ** > <![CDATA[23.64±2.85 ** > Example 3 <![CDATA[46.68±3.75 ** > <![CDATA[25.17±2.80 ** > Comparative example 1 <![CDATA[114.24±10.73 ## > <![CDATA[58.56±5.35 # > Comparative example 2 91.82±9.16 48.46±4.39 Comparative example 3 98.73±9.84 52.73±5.17 Comparative example 4 <![CDATA[108.39±9.97 # > <![CDATA[56.94±5.29 # >

[0083] Note: Compared with the control group, # indicates P < 0.05, ## compared with the model group, ** indicates P < 0.01.

[0084] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than limiting the protection scope of the present invention. Any simple modification or equivalent replacement made by those of ordinary skill in the art to the technical solution of the present invention shall not depart from the essence and scope of the technical solution of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in the preparation of a medicament for treating and / or preventing liver fibrosis, characterized in that, The traditional Chinese medicine composition is composed of the following components: rhubarb, astragalus membranaceus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria cocos, processed fleece-flower root, white peony root, salvia miltiorrhiza, ligusticum wallichii, chrysanthemum, pinellia ternata processed with ginger, plantain herb, bupleurum chinense, and licorice root.

2. The use according to claim 1, wherein, Use of the composition in the preparation of a medicament for reducing the concentrations of AST, ALT, and AKP in serum and the content of HYP in liver tissue.

3. The use according to claim 1, wherein Use of the composition in the preparation of a medicament for reducing the contents of hyaluronic acid and laminin in liver tissue and type III procollagen and type IV collagen in serum.

4. The use according to claim 1, characterized in that, Use of the composition in the preparation of a medicament for reducing the contents of tumor necrosis factor-α and interleukin 6 in the liver.

5. The use according to claim 1, characterized in that, The liver fibrosis is liver fibrosis caused by viral hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, or cholestatic liver disease.

6. The use according to claim 1, characterized in that, The mass ratio of rhubarb, astragalus membranaceus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria cocos, processed fleece-flower root, white peony root, salvia miltiorrhiza, ligusticum wallichii, chrysanthemum, pinellia ternata processed with ginger, plantain herb, bupleurum chinense, and licorice root is 1:3 - 5:2 - 4:1 - 3:2 - 4:4 - 6:3 - 7:4 - 6:2 - 4:4 - 6:2 - 4:2 - 3:1 - 4:1 - 2:0.5 - 1.

5.

7. The use according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition comprises the following steps: first, decoct each medicinal material with water, filter, and concentrate to obtain a clear paste, and then add excipients to obtain the composition.

8. The use according to claim 7, characterized in that, The decoction includes decocting with 3 - 8 times the weight of water for 2 - 3 times, each time for 1 - 3 h, filtering and combining the decoction; the relative density of the clear paste at 80 - 90 °C is 1.1 - 1.3 g / mL, and after obtaining the clear paste, vacuum drying or freeze-drying is also carried out; the excipients include at least one of sucrose, dextrin, and starch.

9. The use according to any one of claims 1-8, characterized in that, The medicament further includes a pharmaceutically acceptable carrier, and the dosage form of the medicament is tablet, pill, granule, powder, or solution.

10. The use according to claim 9, characterized in that, The carrier is selected from one or more of fillers, binders, wetting agents, disintegrants, flavoring agents, lubricants, and preservatives.

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