Anti-hepatic fibrosis traditional Chinese medicine compound preparation and application thereof

Abstract

The invention discloses an anti-hepatic fibrosis traditional Chinese medicine compound preparation and application thereof.The anti-hepatic fibrosis traditional Chinese medicine compound preparation is prepared from herba artemisiae scopariae, parched fructus gardeniae, roasted rhizoma atractylodis macrocephalae, turtle shells, radix bupleuri, rhizoma corydalis, herba desmodii styracifolii and herba scutellariae barbatae, all the medicines are compatible and have a synergistic effect, and the effects of clearing heat and promoting diuresis, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation and tonifying spleen and qi are achieved together; the liver fibrosis is intervened from a plurality of target spots. Heat clearing and diuresis promoting can eliminate damp-heat evil damaging the liver; blood circulation of the liver can be improved by promoting blood circulation to remove blood stasis, and blood stasis is eliminated; the liver fibrosis hyperplasia can be resisted by softening hardness to dissipate stagnation, and the liver tissue hardening trend can be reversed; spleen invigorating and qi replenishing can enhance healthy qi of the body and improve the self-repairing ability of the liver. The multi-target and all-around treatment mode not only conforms to the holism concept of traditional Chinese medicine, but also conforms to the understanding of modern medicine on multi-factor and multi-link pathogenesis of hepatic fibrosis.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to an anti-liver fibrosis traditional Chinese medicine compound preparation and application thereof. BACKGROUND

[0002] Liver fibrosis is a reaction produced by chronic liver damage caused by various factors, such as drinking, non-alcoholic steatohepatitis (NASH), viral hepatitis, autoimmune hepatitis, non-alcoholic fatty liver disease (NAFLD) and cholestatic liver disease. The common effect of these factors on the liver is chronic inflammation, which leads to an abnormal wound healing response. The production of fibrotic response in the liver leads to the accumulation of extracellular matrix (ECM) components, fibrous scarring. The presence of fibrous scars destroys the structure of the liver, leading to the loss of liver cells and the disorder of normal liver function, eventually leading to liver failure. Liver fibrosis is a reversible process, as long as the liver is not in the late cirrhosis stage, removing the substances that cause the liver fibrosis response will help to hinder the progression of fibrosis. Studies have shown that about 40% of liver fibrosis can progress to cirrhosis and even liver cancer, etc. end-stage liver disease. At present, cirrhosis causes about 1 million deaths per year, and there is no safe and effective drug to treat cirrhosis. Most drugs can only reduce complications, but cannot treat the root cause of liver fibrosis.

[0003] The treatment method of western medicine for liver fibrosis is mostly based on etiological treatment, such as selecting to clear virus first for viral-induced liver fibrosis, and at the same time, cooperating with anti-inflammatory, liver protection and other treatment measures. However, its effect cannot completely block the progression of liver fibrosis, and the international epidemiology of liver disease predicts that the mortality rate caused by cirrhosis and liver cancer is showing an increasing trend year by year. And western medicine has the problems of high price and many side effects, while the characteristics of traditional Chinese medicine, such as safety, effectiveness and moderate price, can make up for the deficiency in this regard. Therefore, it is urgent to further research and develop new anti-liver fibrosis treatment drugs to prevent or reverse liver fibrosis. SUMMARY

[0004] The application provides an anti-liver fibrosis traditional Chinese medicine compound preparation and application thereof, and aims to provide an anti-liver fibrosis traditional Chinese medicine compound preparation which is safe and effective and has a moderate price.

[0005] The application is realized by the following technical scheme:

[0006] The application discloses an anti-liver fibrosis traditional Chinese medicine compound preparation, which is prepared from the following raw materials: capillaris, fried radix scrophulariae, fried atractylodes, turtle shell, radix bupleuri, corydalis, herba lycopus lucidus and herba hedyotis diffusae.

[0007] As a further improvement, the traditional Chinese medicine compound preparation described in the application further comprises at least one of the following additional medicinal materials: coix seed, jujube, fried licorice, astragalus, salvia miltiorrhiza, poria cocos, curcuma zedoaria, giant knotweed, eusteralyx spp., sedum lineare, oldenlandia diffusa, millipede, centella asiatica, eupolyphaga, cat's claw, vinegar sparganium stoloniferum, and vinegar curcuma zedoary.

[0008] As a further improvement, the raw materials described in the application include radix bupleuri or vinegar radix bupleuri, rhizoma corydalis or vinegar rhizoma corydalis, salvia miltiorrhiza or wine salvia miltiorrhiza, fried atractylodes or bran-fried atractylodes.

[0009] As a further improvement, the traditional Chinese medicine compound preparation described in the application is prepared from the following raw materials in a weight ratio: 20-40 parts of gambir plant, 5-15 parts of charred gardenia, 5-15 parts of fried atractylodes, 10-20 parts of turtle shell, 10-20 parts of radix bupleuri, 5-15 parts of rhizoma corydalis, 10-20 parts of leonurus japonicus, and 20-40 parts of hemparrotia cordata.

[0010] As a further improvement, the traditional Chinese medicine compound preparation described in the application is prepared from the following raw materials in a weight ratio: 20-40 parts of gambir plant, 5-15 parts of charred gardenia, 5-15 parts of fried atractylodes, 10-20 parts of turtle shell, 10-20 parts of radix bupleuri, 5-15 parts of rhizoma corydalis, 10-20 parts of leonurus japonicus, and 20-40 parts of hemparrotia cordata.

[0011] As a further improvement, the weight ratio of the additional medicinal materials described in the application is as follows: 10-20 parts of coix seed, 10-30 parts of jujube, 10-30 parts of fried licorice, 5-20 parts of astragalus, 5-20 parts of salvia miltiorrhiza, 10-30 parts of poria cocos, 5-20 parts of curcuma zedoaria, 5-20 parts of giant knotweed, 10-30 parts of eusteralyx spp., 10-30 parts of sedum lineare, 20-40 parts of oldenlandia diffusa, 5-20 parts of millipede, 10-30 parts of centella asiatica, 10-30 parts of eupolyphaga, 10-30 parts of cat's claw, 10-30 parts of vinegar sparganium stoloniferum, and 10-30 parts of vinegar curcuma zedoary.

[0012] As a further improvement, the traditional Chinese medicine compound preparation described in the application is any one of a decoction, a mixture, an oral liquid, granules, capsules, and tablets.

[0013] The application further discloses an application of the traditional Chinese medicine compound preparation for resisting liver fibrosis in preparation of a medicine for resisting liver fibrosis.

[0014] As a further improvement, the application described in the application includes any one of liver function abnormalities, rib pain, hepatitis, liver cirrhosis, liver ascites, hepatic encephalopathy, viral hepatitis, drug-induced liver damage, fatty liver, self-immune liver, and liver cancer.

[0015] The beneficial effects of the application are as follows:

[0016] The traditional Chinese medicine compound preparation described in the present application is derived from the professional research and clinical practice of the Pharmacy Department of Xixi Hospital in Hangzhou, and is the result of the combination of traditional Chinese medicine theory and modern pharmaceutical research. The formula strictly follows the basic principles of TCM syndrome differentiation and treatment, and through precise selection of raw material composition and scientific control of dosage ratio, the components are mutually coordinated and promoted in the process of drug efficacy, forming a strong synergistic effect, providing a highly potential solution for the treatment of liver fibrosis.

[0017] In the composition design, the compound is centered on the TCM pathogenesis of liver fibrosis, and a hierarchical and clear drug system is constructed, fully embodying the TCM treatment thought of "treating the root and considering the branch".

[0018] The use of the monarch drug Artemisia capillaris directly targets one of the core pathogenesis of liver fibrosis, which is damp-heat in the liver and gallbladder. Artemisia capillaris is bitter and pungent in taste, slightly cold in nature, and belongs to the liver, gallbladder, spleen, and stomach meridians, with the effects of clearing damp-heat and promoting bile discharge. In TCM theory, damp-heat accumulation in the liver and gallbladder is an important cause of liver stagnation and blood stasis, leading to liver fibrosis. As the monarch drug, Artemisia capillaris can effectively clear damp-heat in the liver and gallbladder, fundamentally blocking the continuous damage of damp-heat evil to the liver, laying a foundation for subsequent treatment. Modern pharmacological studies have also confirmed that Artemisia capillaris contains effective components such as Artemisia capillaris and chlorogenic acid, which have the effects of protecting liver cells, promoting bile secretion, and inhibiting inflammatory reactions, providing scientific support for its effect of clearing damp-heat in the liver and gallbladder.

[0019] The combination of the ministerial drugs Focushan-zi and Trionyx sinensis further enhances the efficacy based on the monarch drug and plays a role in addressing the key pathological links of liver fibrosis. Focushan-zi is prepared from Gardenia jasminoides, and is bitter in taste, cold in nature, and belongs to the heart, liver, lung, stomach, and Sanjiao meridians, with the effects of clearing heat and dampness, cooling blood, and detoxifying, which are more gentle and lasting. It can assist the monarch drug Artemisia capillaris in enhancing the ability to clear heat and dampness, and its cooling blood and detoxifying effect can eliminate the heat and toxin generated by damp-heat stagnation, preventing further damage to liver collaterals by heat and toxin. Trionyx sinensis is salty in taste, slightly cold in nature, and belongs to the liver and kidney meridians, with the effects of nourishing yin and suppressing yang, and softening and resolving nodules. In the course of liver fibrosis, liver collaterals are obstructed and blood stasis is accumulated, leading to fibrosis and hardening of liver tissue, forming a mass of nodules. Trionyx sinensis is specialized in softening and resolving nodules, and can effectively resolve the mass of nodules formed by blood stasis, resisting the fibrosis process of the liver. Modern research has found that Trionyx sinensis contains various amino acids and collagen proteins, which have the effects of inhibiting the activation of hepatic stellate cells and reducing collagen protein synthesis, providing modern pharmacological evidence for its anti-fibrosis effect. Focushan-zi and Trionyx sinensis attack damp-heat and toxin and resolve blood stasis and nodules, and synergize with the monarch drug Artemisia capillaris to play a therapeutic role in addressing the main pathogenesis of liver fibrosis.

[0020] The four adjuvant herbs, including fried Atractylodes, Corydalis, Lysimachia and Herba Thunbergiae, work together to treat the main and secondary symptoms, and enhance the overall efficacy. Fried Atractylodes is sweet and bitter in taste, and warm in nature, and it is used to tonify the spleen and stomach. After being fried, its efficacy of tonifying the spleen and kidney is enhanced. In traditional Chinese medicine, it is believed that when the liver is diseased, the spleen should be tonified first. Liver fibrosis patients often have weak spleen and stomach, and the dysfunction of the spleen and stomach leads to deficiency of blood and qi, which cannot nourish the liver and also affects the absorption and transformation of drugs. Fried Atractylodes can tonify the spleen and kidney, enhance the function of the spleen and stomach, provide sufficient material basis for liver repair, and prevent further damage to the spleen and stomach. Corydalis is pungent and bitter in taste, and warm in nature, and it is used to promote blood circulation, regulate qi and relieve pain. Liver fibrosis patients often have blood stasis, and Corydalis can promote blood circulation, relieve pain, and improve the blood circulation of the liver, which is helpful for the repair of liver cells. Lysimachia is sweet and bitter in taste, and cool in nature, and it is used to clear heat and remove dampness, and promote urination. It can help the main herb, Herba Artemisiae Scopariae, and the ministerial herb, Radix Rubrus, to clear heat and remove dampness, and further remove damp-heat from the body, and reduce the metabolic burden of the liver. Herba Thunbergiae is pungent and bitter in taste, and cold in nature, and it is used to clear heat and resolve toxins, and promote blood circulation and promote urination. Its effect of clearing heat and resolving toxins can remove the heat and toxins from the liver, and its effect of promoting blood circulation can enhance the effect of Corydalis, and improve the blood stasis of the liver, and inhibit the progression of liver fibrosis.

[0021] Radix Bupleuri plays an important role in regulating and guiding the other herbs in the formula. Radix Bupleuri is pungent and bitter in taste, and slightly cold in nature, and it is used to soothe the liver and relieve depression, and lift up yang qi. The liver is responsible for the smooth flow of qi, and liver fibrosis patients often have liver qi stagnation and poor qi movement, which further aggravates the accumulation of blood stasis and damp-heat. Radix Bupleuri can soothe the liver and relieve depression, and regulate qi movement, which makes the liver qi smooth and the blood circulation unobstructed, and creates favorable conditions for the other herbs to work. At the same time, Radix Bupleuri has the function of guiding the other herbs to the liver and gallbladder, which increases the concentration of the other herbs in the diseased area and enhances the therapeutic effect. Modern pharmacological studies have shown that the saikosaponins in Radix Bupleuri have anti-inflammatory, liver-protective and immune-regulating effects, which further confirm its value in the formula.

[0022] The compatibility of the drugs synergizes and co-plays the effects of clearing heat and dampness, activating blood and resolving stasis, softening and resolving, and invigorating the spleen and replenishing qi, and interferes with liver fibrosis from multiple targets. Clearing heat and dampness can eliminate the damp-heat evil damaging the liver; activating blood and resolving stasis can improve the blood circulation of the liver and resolve blood stasis; softening and resolving can resist the fibrosis of the liver and reverse the hardening trend of the liver tissue; invigorating the spleen and replenishing qi can enhance the body's vital qi and improve the self-repairing ability of the liver. This multi-target and all-round treatment mode not only conforms to the holistic concept of traditional Chinese medicine, but also fits the understanding of the multi-factor and multi-link pathogenesis of liver fibrosis in modern medicine.

[0023] The compound preparation has significant advantages with the support of traditional Chinese medicine theory and modern pharmacology. In terms of efficacy, it has comprehensive effects and can play a role in multiple pathological links of liver fibrosis at the same time, not only improving the clinical symptoms of patients, such as liver pain, jaundice, abdominal distension, etc., but also delaying and even reversing the progression of liver fibrosis and protecting liver function. In terms of safety, the medicinal materials selected by the compound have high safety and few adverse reactions, which are suitable for long-term use by patients. The low cost is also a big advantage, as the medicinal materials are abundant and relatively cheap, which can reduce the economic burden of patients and improve the accessibility of treatment. In addition, it has a wide range of indications, not only suitable for liver fibrosis caused by various chronic liver diseases, such as viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver, etc., but also has a certain therapeutic effect on different stages of liver fibrosis.

[0024] In summary, the traditional Chinese medicine compound preparation has high clinical application value and good business prospects due to its scientific formula design, clear efficacy, good safety, low cost and wide indications, and is expected to bring good news to patients with liver fibrosis and occupy an important position in the medical market. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 Fig. 1 is a diagram of HE staining results of liver tissue of rats in each group;

[0026] In the figure, 1 = normal group, 2 = model group. DETAILED DESCRIPTION

[0027] The technical solutions of the present application will be further described below by specific embodiments in conjunction with the drawings of the specification:

[0028] Embodiment 1

[0029] A traditional Chinese medicine compound preparation for resisting liver fibrosis is composed of the following components: 30 parts of Yinchen, 10 parts of Jiaoshanzhi, 10 parts of Chao Baizhu, 15 parts of Biejia, 15 parts of Chaihu, 10 parts of Yansu, 15 parts of Guangjin Qiancao, and 30 parts of Banzhi Lian.

[0030] The traditional Chinese medicine compound preparation is a mixture, and the preparation process is as follows:

[0031] Step 1: Pretreatment of the first decoction. Take 15 g of carapax trionycis, and put it into a decoction container. Add 8-10 times (v / w) of purified water, and boil the liquid (temperature ≥ 100℃) for 30 minutes.

[0032] Step 2: Decoction of the main medicinal materials. Take the remaining medicinal materials (30 g of artemisia capillaris, 10 g of charred gardenia, 10 g of fried atractylodes, 15 g of bupleurum, 10 g of corydalis, 15 g of desmodium, and 30 g of herba thunbergiae), and add 6-8 times (v / w) of purified water. Soak the medicinal materials at room temperature for 30 minutes. Add the soaked medicinal materials and the soaking liquid into the decoction liquid of step 1, and boil the mixture. Then, change the fire to a small fire (maintain a state of slight boiling, temperature 90-95℃), and continue to decoct for 30 minutes.

[0033] Step 3: Separation and concentration of the medicinal liquid. After the first decoction is completed, filter the liquid with a 100-mesh sieve, and collect the filtrate. Add 5-6 times (v / w) of purified water to the residue, and boil the mixture. Then, decoct the mixture on a small fire for 20 minutes, filter the mixture again, and combine the two filtrates. Concentrate the combined filtrate under reduced pressure (60℃, -0.08 MPa) to a relative density of 1.10-1.15 (25℃). Stir the concentrated liquid evenly, and then divide it into appropriate containers. Thus, the mixture is obtained.

[0034] Example 2

[0035] A traditional Chinese medicine compound preparation for resisting liver fibrosis is prepared from the following components: artemisia capillaris 40 parts, charred gardenia 15 parts, fried atractylodes 15 parts, carapax trionycis 20 parts, bupleurum 20 parts, corydalis 15 parts, desmodium 20 parts, and herba thunbergiae 40 parts.

[0036] The traditional Chinese medicine compound preparation is a granule, and the preparation process is as follows:

[0037] Step 1: Preparation of the medicinal liquid. The medicinal liquid is prepared according to the method described in Example 1.

[0038] Step 2: Vacuum concentration and mixing with auxiliary materials. Concentrate the medicinal liquid under reduced pressure (60℃, -0.08 MPa) to a thick paste (relative density 1.30-1.35, 25℃). Then, add the thick paste and auxiliary materials (dextrin:soluble starch=1:1) into a mixing machine at a mass ratio of 1:1. Stir the mixture at a speed of 30 r / min for 20 minutes until it is homogeneous.

[0039] Step 3: Granulation and drying. The mixture is granulated into wet granules by a swinging granulator (sieve mesh 14-16). Then, spread the wet granules on a drying tray, and place the tray in a hot air circulation oven. Dry the wet granules at a temperature of 50-60℃ until the water content is less than 5%. Finally, pass the dried granules through a sifting machine (12-mesh sieve) to obtain granules. The granules are sealed in aluminum-plastic composite film bags. Thus, the granules are obtained.

[0040] Example 3

[0041] The raw materials of a traditional Chinese medicine compound preparation for anti-liver fibrosis are composed of the following components: 20 parts Artemisia capillaris, 5 parts Gardenia jasminoides (roasted), 5 parts Atractylodes macrocephala (fried), 10 parts Trionyx sinensis (turtle shell), 10 parts Bupleurum chinense, 5 parts Corydalis yanhusuo, 10 parts Lysimachia christinae, and 20 parts Scutellaria barbata.

[0042] The aforementioned traditional Chinese medicine compound preparation is a decoction, and its preparation process is as follows:

[0043] Step 1: Preparation of the medicinal solution. The decoction was prepared according to the method described in Example 1, and the filtrates were combined.

[0044] Step 2: Concentrate the filtrate to 150 ml, stir well, and dispense into portions to obtain the decoction.

[0045] Example 4

[0046] The raw materials of a traditional Chinese medicine compound preparation for anti-liver fibrosis are composed of the following components: 30 parts Artemisia capillaris, 10 parts Gardenia jasminoides (roasted), 10 parts Atractylodes macrocephala (fried), 15 parts Trionyx sinensis, 15 parts Bupleurum chinense, 10 parts Corydalis yanhusuo, 15 parts Lysimachia christinae, 30 parts Scutellaria barbata, 10 parts Coix lacryma-jobi, 10 parts Ziziphus jujuba, and 10 parts Glycyrrhiza uralensis (processed).

[0047] Example 5

[0048] The raw materials of a traditional Chinese medicine compound preparation for anti-liver fibrosis are composed of the following components: 30 parts Artemisia capillaris, 10 parts Gardenia jasminoides (roasted), 10 parts Atractylodes macrocephala (fried), 15 parts Trionyx sinensis, 15 parts Bupleurum chinense, 10 parts Corydalis yanhusuo, 15 parts Lysimachia christinae, 30 parts Scutellaria barbata, 10 parts Salvia miltiorrhiza, and 10 parts Poria cocos.

[0049] Comparative Example 1

[0050] Unlike Example 1, the ingredients were 0 parts Artemisia capillaris and 45 parts Bupleurum chinense, with the remaining conditions being the same as in Example 1.

[0051] Comparative Example 2

[0052] Unlike Example 1, the ingredients were 45 parts Artemisia capillaris and 0 parts Bupleurum chinense, with the remaining conditions being the same as in Example 1.

[0053] Comparative Example 3

[0054] Unlike Example 1, this example used 0 parts of Gardenia jasminoides and 25 parts of turtle shell, while the other conditions were the same as in Example 1.

[0055] Comparative Example 4

[0056] Unlike Example 1, the ingredients were 25 parts of Gardenia jasminoides and 0 parts of turtle shell, while the other conditions were the same as in Example 1.

[0057] animal testing

[0058] 1. Grouping: Eighty 6-week-old male SD rats were selected and, after one week of acclimatization feeding, were randomly divided into a normal group, a positive control group, a model group, and a traditional Chinese medicine group (Examples 1-3, Comparative Examples 1-4), with 8 rats in each group. The rats were provided by the Animal Center of Zhejiang University of Traditional Chinese Medicine.

[0059] 2. Modeling and Drug Administration: Except for the normal group, animals in the positive control group, model group, and traditional Chinese medicine treatment group were administered CCl4 (CCl4 / olive oil 1:1) for 8 weeks to induce liver fibrosis, via tube feeding (2 mL / kg) twice weekly. During the modeling period, the animals' mental state, diet, weight, and other general conditions were closely monitored. Simultaneously, the traditional Chinese medicine treatment group received the corresponding concentration of traditional Chinese medicine (calculated according to the "equivalent dose" method for experimental animals), administered by gavage at 10 mL / kg once daily; the positive control group received silymarin at a dose of 100 mg / kg once daily; the blank group and model group received an equal volume of 0.9% sodium chloride solution once daily. At the end of the 8th week of modeling, histopathological verification confirmed successful model establishment: Masson staining of the liver showed collagen deposition area ≥15% (normal group ≤3%). Verification results are shown below. Figure 1 .

[0060] Liver histopathological results showed ( Figure 1 In the normal group, the liver cells of the rats showed normal morphology, while in the model group, the livers of the rats exhibited extensive cell inflammation and necrosis, covering a large area, with significant thickening of the portal ducts. This indicates successful model establishment.

[0061] 3. Sampling: After the experimental period, rats were fasted for 12 hours and euthanized under chloral hydrate anesthesia. Blood was collected from the abdominal aorta, and the liver was removed. The liver was immediately frozen for biochemical testing or fixed in formalin for histopathological examination.

[0062] 4. Indicator detection: Serum liver function indicators (ALT, AST), serum liver fibrosis indicators (hyaluronic acid (HA), laminin (LN), type III procollagen (III-C) and type IV collagen (IV-C)).

[0063] The differences in components between the examples and the comparative examples are shown in Table 1.

[0064] Table 1. Component differences between the examples and comparative examples

[0065]

[0066]

[0067] The results of animal efficacy tests for the examples and comparative examples are as follows, and the specific data are shown in Table 2:

[0068] The ALT and AST levels in the model group were significantly higher than those in the normal group (*P<0.05), indicating successful modeling of liver injury. The ALT / AST levels in the positive control group and Examples 1-5 were significantly lower than those in the model group (△P<0.05), and the indicators in Examples 1-3 were significantly better than those in the positive control group (#P<0.05), suggesting that the hepatoprotective effect of the drugs in the examples (especially Example 1) was stronger. However, there was no statistically significant difference in ALT / AST levels between the comparative examples 1-4 and the model group (*P<0.05), indicating that the comparative examples were essentially ineffective.

[0069] Table 2. Serum liver function indicators from animal efficacy trials of the examples and comparative examples.

[0070]

[0071] Note: Compared with the normal group, * = P < 0.05; compared with the model group, △ = P < 0.05; compared with the positive control group, # = P < 0.05.

[0072] Compared with the normal group, the model group showed significantly elevated levels of HA, LN, III-C, and IV-C (aP<0.05), confirming the formation of liver fibrosis. The fibrosis indicators in the positive control group and Examples 1-5 were significantly lower than those in the model group (bP<0.05) and close to normal levels, indicating that the examples effectively inhibited fibrosis. All indicators in Comparative Examples 1-4 showed no difference from the model group (aP<0.05), especially in Comparative Example 1 where HA (50.12±3.18) remained high, suggesting that the anti-fibrotic effect of the comparative drug was weak.

[0073] Table 3. Serum liver fibrosis markers from animal efficacy trials of the examples and comparative examples.

[0074]

[0075] Note: Compared with the normal group, a = P < 0.05; compared with the model group, b = P < 0.05; HA = serum hyaluronic acid; LN = laminin; III-C = type III procollagen; IV-C = type IV collagen.

[0076] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating liver fibrosis, characterized in that, The traditional Chinese medicine compound preparation is made from the following raw materials: Artemisia capillaris, Gardenia jasminoides (fried), Atractylodes macrocephala (fried), Trionyx sinensis (turtle shell), Bupleurum chinense (bupleurum), Corydalis yanhusuo (corydalis), Lysimachia christinae (decoction), and Scutellaria barbata (scutellaria barbata).

2. The traditional Chinese medicine compound preparation for anti-liver fibrosis according to claim 1, characterized in that, The traditional Chinese medicine compound preparation also includes at least one of the following additional medicinal materials: coix seed, jujube, prepared licorice root, astragalus, salvia miltiorrhiza, poria cocos, turmeric, polygonum cuspidatum, aristolochic acid grass, sedum sarmentosum, oldenlandia diffusa, woodlice, centella asiatica, ground beetle, cat ginseng, vinegar-processed sparganium, and vinegar-processed turmeric.

3. The traditional Chinese medicine compound preparation according to claim 1 or 2, characterized in that, The raw materials include Bupleurum or vinegar-processed Bupleurum, Corydalis or vinegar-processed Corydalis, Salvia miltiorrhiza or wine-processed Salvia miltiorrhiza, and stir-fried Atractylodes macrocephala or bran-processed Atractylodes macrocephala.

4. The traditional Chinese medicine compound preparation according to claim 3, characterized in that, The traditional Chinese medicine compound preparation is made from the following raw materials in the indicated weight ratios: Artemisia capillaris 20-40 parts, Gardenia jasminoides 5-15 parts, Atractylodes macrocephala 5-15 parts, Trionyx sinensis 10-20 parts, Bupleurum chinense 10-20 parts, Corydalis yanhusuo 5-15 parts, Lysimachia christinae 10-20 parts, and Scutellaria barbata 20-40 parts.

5. The traditional Chinese medicine compound preparation according to claim 4, characterized in that, The traditional Chinese medicine compound preparation is made from the following raw materials in parts by weight: Artemisia capillaris 30 parts, Gardenia jasminoides 10 parts, Atractylodes macrocephala 10 parts, Trionyx sinensis 15 parts, Bupleurum chinense 15 parts, Corydalis yanhusuo 10 parts, Lysimachia christinae 15 parts, and Scutellaria barbata 30 parts.

6. The traditional Chinese medicine compound preparation according to claim 4, characterized in that, The weight ratio of the additional medicinal materials is as follows: 10-20 parts of Coix seed, 10-30 parts of jujube, 10-30 parts of prepared licorice root, 5-20 parts of Astragalus membranaceus, 5-20 parts of Salvia miltiorrhiza, 10-30 parts of Poria cocos, 5-20 parts of Curcuma longa, 5-20 parts of Polygonum cuspidatum, 10-30 parts of Abrus precatorius, 10-30 parts of Sedum sarmentosum, 20-40 parts of Hedyotis diffusa, 5-20 parts of Armadillidium vulgare, 10-30 parts of Centella asiatica, 10-30 parts of Eupolyphaga sinensis, 10-30 parts of Panax ginseng, 10-30 parts of vinegar-processed Sparganium stoloniferum, and 10-30 parts of vinegar-processed Curcuma zedoaria.

7. The traditional Chinese medicine compound preparation according to claim 5, characterized in that, The weight ratio of the additional medicinal materials is as follows: 10-20 parts of Coix seed, 10-30 parts of jujube, 10-30 parts of prepared licorice root, 5-20 parts of Astragalus membranaceus, 5-20 parts of Salvia miltiorrhiza, 10-30 parts of Poria cocos, 5-20 parts of Curcuma longa, 5-20 parts of Polygonum cuspidatum, 10-30 parts of Abrus precatorius, 10-30 parts of Sedum sarmentosum, 20-40 parts of Hedyotis diffusa, 5-20 parts of Armadillidium vulgare, 10-30 parts of Centella asiatica, 10-30 parts of Eupolyphaga sinensis, 10-30 parts of Panax ginseng, 10-30 parts of vinegar-processed Sparganium stoloniferum, and 10-30 parts of vinegar-processed Curcuma zedoaria.

8. The traditional Chinese medicine compound preparation according to claim 1, 2, 4, 5, 6, or 7, characterized in that, The aforementioned traditional Chinese medicine compound preparation is any one of the following: decoction, mixture, oral liquid, granules, capsules, or tablets.

9. The use of a traditional Chinese medicine compound preparation for treating liver fibrosis as described in claim 1, 2, 4, 5, 6, or 7 in the preparation of drugs for treating liver fibrosis.

10. The application of the traditional Chinese medicine compound preparation for anti-liver fibrosis according to claim 9 in the preparation of anti-liver fibrosis drugs, characterized in that, The anti-liver fibrosis treatment includes any one of the following: abnormal liver function, rib pain, hepatitis, cirrhosis, ascites, hepatic encephalopathy, viral hepatitis, drug-induced liver injury, fatty liver, autoimmune hepatitis, and liver cancer.

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