Traditional Chinese medicine composition for treating hepatic fibrosis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating hepatic fibrosis, aiming at solving the problems of insufficient curative effect specificity, liver and kidney toxicity and the like in the current treatment of hepatic fibrosis, the traditional Chinese medicine composition for treating hepatic fibrosis comprises the following components in parts by weight: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 20 parts of mallotus root, 20 parts of turtle shell, 20 parts of salvia miltiorrhiza, 10 parts of codonopsis pilosula, 10 parts of prepared polygonum multiflorum, 13.2 parts of capillary artemisia, 10 parts of rhizoma sparganii, 10 parts of white paeony root and 10 parts of poria cocos. , 8 parts of radix curcumae, 4 parts of endothelium corneum gigeriae galli and 4 According to the traditional Chinese medicine composition disclosed by the invention, through reasonable compounding of the components and optimization of the dosage, the traditional Chinese medicine composition disclosed by the invention can be used for remarkably improving the weight gain and the liver-spleen index of a hepatic fibrosis model mouse, reducing the expression level of inflammatory factors and fibrosis indexes in hepatic tissues and serum, relieving hepatic tissue inflammation infiltration and collagen deposition, and improving the hepatic fibrosis rate. The curative effect on hepatic fibrosis is obvious, and liver and kidney toxicity is avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating liver fibrosis, a preparation method and an application thereof. Background Art

[0002] Hepatic fibrosis (HF) is a core pathological stage in the progression of various chronic liver diseases (including viral hepatitis, alcoholic liver disease, and metabolic fatty liver disease) to cirrhosis and liver cancer. It is essentially the result of an imbalance between excessive deposition and degradation of the extracellular matrix (ECM) during the liver's ongoing injury and repair process, leading to sinusoidal capillarization, pseudolobule formation, and abnormal remodeling of the liver parenchyma. In the early stages of the disease, fibrosis is somewhat reversible, but without timely intervention, it will eventually progress to irreversible cirrhosis. Therefore, blocking or reversing fibrosis is a strategic need for the prevention and treatment of end-stage liver disease.

[0003] Current clinical treatments for liver fibrosis still face significant challenges: on the one hand, while etiological treatments (such as antiviral treatment, alcohol abstinence, and metabolic regulation) can slow disease progression, they have limited effectiveness in reversing established liver fibrosis. On the other hand, candidate drugs that directly target HSC activation and ECM metabolism (such as pirfenidone and nintedanib) have yet to achieve clinical breakthroughs due to insufficient efficacy specificity and hepato-renal toxicity. Against this backdrop, Traditional Chinese Medicine (TCM), based on the principles of "holistic approach" and "treatment based on syndrome differentiation," demonstrates its unique advantage in "combining disease and syndrome" treatment through the combined effects of multiple components and targets, including synergistic regulation of the HSC activation / apoptosis balance, inhibition of the inflammatory-oxidative stress cascade, and regulation of the intestinal microecology and immune homeostasis. This provides a new strategy for the prevention and treatment of liver fibrosis. Summary of the Invention

[0004] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a Chinese medicine composition for treating liver fibrosis, a preparation method and an application thereof.

[0005] According to the pathological changes and clinical manifestations of liver fibrosis (including cirrhosis), most TCM disease names are classified into categories such as "accumulation", "liver accumulation", and "side pain". The primary causes of liver fibrosis vary, and although the clinical manifestations are different, the basic pathogenesis is the deficiency of the body's vital energy and the prevalence of evil, the long-term accumulation of evil toxins, the damage of the liver meridians, and the stagnation of qi and blood, which can be summarized as "deficiency and accumulation" (Guidelines for the Diagnosis and Treatment of Liver Fibrosis with Integrated Traditional Chinese and Western Medicine (2019 Edition)). Depending on the patient's condition, there may be clinical manifestations of different pathogenesis such as cold and heat transformation, liver qi stagnation, spleen dysfunction, internal accumulation of damp heat, and cold stagnation. However, the root cause of the disease must be sought. Liver fibrosis is essentially a physical damage to the liver, with a loss of yin essence, which cannot be used to transform qi, resulting in the stagnation of qi and blood, and the accumulation of blood coagulation. Among them, "deficiency" is mainly manifested in spleen qi deficiency, liver qi deficiency and liver and kidney yin essence deficiency. Qi deficiency reflects the damage and reduction of body functions, while liver and kidney yin essence deficiency refers to damage to the liver's morphology and is a deeper pathological change of deficiency.

[0006] Therefore, the principle of treatment should be to address both the symptoms and the root cause, using both attacking and supplementing methods. It is necessary to strengthen the body's vital energy to replenish deficient vital energy, while also removing blood stasis and unblocking the meridians to dissipate tangible symptoms. The treatment approach should be based on the coordinated development of the liver, spleen, and kidney organs, strengthening the spleen and liver to strengthen the root, nourishing the kidneys to replenish essence and restore the body, while simultaneously supplementing with blood circulation and blood stasis, softening and dispersing nodules to treat the symptoms. Through multi-level intervention, the circulation of qi and blood in the liver meridians is restored, improving the physical and qualitative damage of the liver. This treatment system aligns with the Traditional Chinese Medicine theory that "when vital energy remains within, pathogenic factors cannot enter," and is also consistent with modern anti-fibrosis treatment strategies.

[0007] To achieve the above objectives, the present invention provides a first aspect of a Chinese medicine composition for treating liver fibrosis, wherein the Chinese medicine composition is composed of the following raw materials in parts by weight:

[0008] 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of processed Polygonum multiflorum, 5-15 parts of Artemisia capillaris, 5-10 parts of Trigonum multiflorum, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Chicken's Gizzard Stone, and 2-6 parts of Eupolyphaga sinensis.

[0009] Preferably, it is composed of the following raw materials in parts by weight:

[0010] 10 parts of Astragalus, 10 parts of Polygonatum, 20 parts of Radix Scutellariae, 20 parts of Carapax Trionycis, 20 parts of Salvia miltiorrhiza, 10 parts of Codonopsis pilosula, 10 parts of processed Polygonum multiflorum, 13.2 parts of Artemisia capillaris, 10 parts of Rhizoma Sparganii, 10 parts of the White Peony Roots, 10 parts of Poria, 8 parts of Curcuma aromatica, 4 parts of Gallus corneum gizzard lining, 4 parts of Eupolyphaga sinensis.

[0011] The second aspect of the present invention provides a pharmaceutical preparation consisting of the above-mentioned traditional Chinese medicine composition.

[0012] Preferably, the pharmaceutical preparation is in the form of pills or granules.

[0013] The third aspect of the present invention provides a method for preparing a pharmaceutical preparation, wherein the preparation of the granules comprises the following steps:

[0014] S1. Weigh 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of Polygonum multiflorum (prepared), 5-15 parts of Artemisia capillaris, 5-10 parts of Rhizoma Trigonidis, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Gallus gallus domesticus, and 2-6 parts of Eupolyphaga sinensis, and set aside.

[0015] S2. Decoction the white back leaf root and astragalus obtained in step S1 twice, the first time for 1.5 hours and the second time for 1 hour, combine the two decoctions, filter, and concentrate the filtrate into a thick paste;

[0016] S3, the polygonatum, turtle shell, salvia miltiorrhiza, codonopsis pilosula, prepared polygonum multiflorum, capillaries, sparganium, white peony root, poria, curcuma, chicken's gizzard lining and earthworm weighed in step S1 are mixed and crushed and sieved to obtain a fine drug powder;

[0017] S4, adding the fine powder of the medicine obtained in step S3 to the thick paste obtained in step S2, mixing, drying, and crushing to obtain a dry powder of the traditional Chinese medicine;

[0018] S5. Pressing the dried Chinese medicine powder obtained in step S4 into thin slices, crushing the thin slices into granules, and sieving to obtain Chinese medicine granules.

[0019] The preparation method of the pills is as follows: the Chinese medicine granules obtained in step S5 are added with refined honey to make water-honeyed pills to obtain the pills.

[0020] A fourth aspect of the present invention provides an application of a traditional Chinese medicine composition in the preparation of a medicament for treating liver fibrosis.

[0021] Compared with the prior art, the technical solution provided by the present invention has the following beneficial effects or advantages:

[0022] The traditional Chinese medicine composition provided by the present invention comprises astragalus, polygonatum, radix scutellariae, turtle shell, salvia miltiorrhiza, codonopsis pilosula, processed polygonum multiflorum, capillaries, triangularis lancea, white peony root, poria, turmeric, chicken's gizzard lining and earthworm. The main medicinal ingredients are astragalus, polygonatum, radix scutellariae and turtle shell as the main ingredients: astragalus (sweet and slightly warm) replenishes qi and elevates yang, promotes fluid production and nourishes blood, and is mainly used to treat various symptoms of spleen deficiency; polygonatum (sweet and mild) replenishes qi and nourishes yin, strengthens the spleen and tonifies the kidney, and is used in synergy with astragalus to tonify the spleen and kidney to nourish the liver and achieve the effects of harmonizing essence and blood, and restoring the liver's blood storage and regulating the flow of qi; the combination of radix scutellariae (slightly bitter and astringent) clears heat and detoxifies, dispels dampness and promotes blood circulation, and turtle shell (salty and slightly cold) nourishes the kidney, clears deficiency heat, softens and disperses lumps, and the two ingredients work together to clear away evil toxins in the liver meridians, dredge the meridians and eliminate accumulations, achieving both attacking and tonifying effects without damaging the vital energy and retaining the evil. The auxiliary drugs are composed of Salvia miltiorrhiza, Codonopsis pilosula, processed Polygonum multiflorum, Artemisia capillaris, and Trigonosciadium japonicum: Salvia miltiorrhiza (bitter and slightly cold) has the same function as the Four Ingredients, which can promote blood circulation, remove blood stasis, relieve menstruation and relieve pain, clear the heart and relieve restlessness, and help the main drugs to nourish the liver and dredge the meridians, and treat both the symptoms and the root causes; Codonopsis pilosula (sweet and mild) can strengthen the spleen and nourish the blood, and processed Polygonum multiflorum is bitter (sweet, astringent and slightly warm) can nourish the liver and kidneys, and benefit the essence and blood. The two can help Astragalus membranaceus and Polygonatum sibiricum to strengthen the spleen, kidney and liver; Artemisia capillaris (bitter, pungent and slightly cold) can clear away damp-heat in the liver and gallbladder, and cooperate with the root of the white leaf to enhance the effect of clearing heat, detoxifying and relieving jaundice; Trigonosciadium japonicum (pungent, pungent and mild) can break blood and promote qi circulation, eliminate accumulation and dredge the meridians, and help nourish the liver and relieve pain. The adjuvant system utilizes white peony root (bitter, sour, and slightly cold) to nourish blood, soften the liver, and relieve pain; poria (sweet, mild, and neutral) to strengthen the spleen and calm the heart; and turmeric (pungent, bitter, and cold) to promote qi, relieve depression, and cool the blood. Together, these three herbs regulate liver blood storage and release, and regulate emotions; chicken gizzard lining (sweet and neutral) to invigorate the spleen and stomach, promoting qi and blood production, while also dissolving symptoms and resolving stagnation. The guiding agent is the earthworm (salty and cold), which not only dispels blood stasis and directly enters the liver meridians, but also leverages the insect's roving nature to guide the drug to its intended destination.

[0023] The Chinese medicine composition is based on the principle of "strengthening the spleen and nourishing the liver, consolidating the foundation, promoting blood circulation, softening hard masses and dredging the meridians", treating both the symptoms and the root cause, targeting common symptoms of liver fibrosis such as dull pain in the ribs, abdominal distension and poor appetite, fatigue, dull complexion or yellowing of the body and eyes, etc., through Astragalus, Polygonatum, Codonopsis, and processed Polygonum multiflorum to strengthen the spleen and replenish qi, replenish essence and nourish blood to restore metabolism, turtle shell, Trillium, Chicken Gizzard Stone, and Earthworm to soften hard masses and eliminate symptoms, break up blood stasis and dredge the meridians to relieve liver accumulation, Salvia miltiorrhiza, Curcuma, White Peony Root, and Poria to promote blood circulation and qi, soften the liver and calm the mind to dredge the liver meridians, Artemisia capillaris and Scutellaria baicalensis root to eliminate dampness and reduce jaundice, detoxify and disperse nodules to relieve stagnation, in line with the purpose of "nourishing the liver and softening hard masses", and highlighting the essence of the cubic formula with orderly attack and supplementation, and taking both form and spirit into consideration. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention.

[0025] In the attached figure:

[0026] Figure 1 Comparison of body weight and liver and spleen index of mice in each group after drug intervention:

[0027] in, Figure 1 Middle A is the weight change trend chart; Figure 1 Middle B is a comparison chart of liver index; Figure 1 Middle C is a comparison chart of spleen index (compared with the Control group, ***P<0.001; compared with the Model group, # P<0.05, ## P<0.01, ### P < 0.001);

[0028] Figure 2 Comparison of liver tissue morphology, pathological structure, inflammatory indexes, and liver fibrosis indexes in each group of mice after drug intervention (compared with the Control group, **P<0.01, ***P<0.001; compared with the Model group, # P<0.05, ## P<0.01, ### P < 0.001);

[0029] in, Figure 2 Middle A: Comparison of liver morphology; Figure 2 Middle B is a comparison of HE staining and Masson staining of liver tissue; Figure 2 Middle CE is a comparison of the mRNA expressions of IL-1b, IL-6, and TNF-a, the inflammation indicators in mouse liver tissue; Figure 2 Figures G and J are comparisons of the mRNA expressions of α-SMA, COL1A1, COL3A1, and FN1, indicators of liver fibrosis in mouse liver tissue.

[0030] Figure 3 Comparison of the expression levels of four liver fibrosis items and inflammatory factors in the serum of mice in each group after drug intervention (compared with the Control group, ***P<0.001; compared with the Model group, # P<0.05, ## P<0.01, ### P < 0.001):

[0031] in, Figure 3 Middle and AD are the expression levels of four liver fibrosis indicators Co1-Ⅳ, HA, LN, and PCⅢ in mouse serum; Figure 3 EF is the expression level of mouse serum inflammatory factors TNF-a and IL-6;

[0032] Figure 4 Comparison of liver and kidney function in each group of mice after drug intervention:

[0033] in, Figure 4 AD are the comparison of AST, ALT, CRE and Urea expression levels in each group of mice (compared with the Control group, **P<0.01, ***P<0.001; compared with the Model group, # P<0.05, ###P<0.001). DETAILED DESCRIPTION

[0034] The following is combined with Figure 1-Figure 4 The preferred embodiments of the present invention are described. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0035] Example 1:

[0036] A traditional Chinese medicine composition for treating liver fibrosis, comprising the following raw materials in parts by weight:

[0037] 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of processed Polygonum multiflorum, 5-15 parts of Artemisia capillaris, 5-10 parts of Trigonum multiflorum, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Chicken's Gizzard Stone, and 2-6 parts of Eupolyphaga sinensis.

[0038] The best solution consists of the following raw materials in parts by weight:

[0039] 10 parts of Astragalus, 10 parts of Polygonatum, 20 parts of Radix Scutellariae, 20 parts of Carapax Trionycis, 20 parts of Salvia miltiorrhiza, 10 parts of Codonopsis pilosula, 10 parts of processed Polygonum multiflorum, 13.2 parts of Artemisia capillaris, 10 parts of Rhizoma Sparganii, 10 parts of the White Peony Roots, 10 parts of Poria, 8 parts of Curcuma aromatica, 4 parts of Gallus corneum gizzard lining, 4 parts of Eupolyphaga sinensis.

[0040] Example 2:

[0041] A pharmaceutical preparation, comprising the above-mentioned traditional Chinese medicine composition, is in the form of pills or granules.

[0042] Example 3:

[0043] The preparation method of the pharmaceutical preparation comprises the following steps:

[0044] S1. Weigh 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of Polygonum multiflorum (prepared), 5-15 parts of Artemisia capillaris, 5-10 parts of Rhizoma Trigonidis, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Gallus gallus domesticus, and 2-6 parts of Eupolyphaga sinensis, and set aside.

[0045] S2. Decoction the white back leaf root and astragalus obtained in step S1 twice, the first time for 1.5 hours and the second time for 1 hour, combine the two decoctions, filter, and concentrate the filtrate into a thick paste;

[0046] S3, the polygonatum, turtle shell, salvia miltiorrhiza, codonopsis pilosula, prepared polygonum multiflorum, capillaries, sparganium, white peony root, poria, turmeric, chicken's gizzard lining and earthworm weighed in step S1 were mixed and crushed, and sieved through a 20-mesh sieve to obtain a fine drug powder;

[0047] S4, adding the fine powder of the medicine obtained in step S3 to the thick paste obtained in step S2, mixing, drying, and crushing to obtain a dry powder of the traditional Chinese medicine;

[0048] S5. Press the dried Chinese medicine powder obtained in step S4 into 1-3 mm flakes, crush the flakes into granules, and sieve through a 40-mesh sieve to obtain Chinese medicine granules.

[0049] The preparation method of pills is:

[0050] The dried Chinese medicine powder obtained in step S5 is added with 35-50 g of refined honey per 100 g of powder to prepare water-honeyed pills to obtain pills.

[0051] Example 4:

[0052] A use of the traditional Chinese medicine composition as described in Example 1 in preparing a medicament for treating liver fibrosis.

[0053] Pharmacological experiments:

[0054] 1. Establishment of a Mouse Model of Liver Fibrosis and Experimental Design

[0055] After two weeks of adaptive feeding, C57BL / 6 mice were randomly divided into a blank control (Control), a model control (Model), a positive control (Silibinin), a low-dose Chinese medicine (YRW-L), and a high-dose Chinese medicine (YRW-H) group, with 10 mice in each group. Except for the Control group, which received an equal volume of corn oil intraperitoneally, the mice in the other groups were intraperitoneally injected with 5 ml / kg of corn oil solution containing 10% carbon tetrachloride (CCL4) twice a week to induce a liver fibrosis model. During the six-week modeling period, drugs were administered simultaneously. According to the clinical dose and animal administration dose conversion formula, mice in the YRW-L and YRW-H groups were orally administered with 2.25 and 4.50 g / kg / d of the optimally formulated Chinese medicine composition of the present invention, respectively. Mice in the Silibinin group were orally administered with 47.42 mg / kg / d of Silibinin solution. Mice in the Control and Model groups were orally administered with an equal volume of pure water.

[0056] The specific design is as follows:

[0057] Control group: intraperitoneal injection of equal volume of olive oil, twice a week, for 6 weeks; oral gavage of equal volume of normal saline, once a day, for 6 weeks;

[0058] Model group: 10% CCL4 was injected intraperitoneally twice a week for 6 weeks; an equal volume of normal saline was gavage once a day for 6 weeks;

[0059] Silibinin group: 10% CCL4 was injected intraperitoneally twice a week for 6 weeks; silibinin solution 47.42 mg / kg / d was administered orally once a day for 6 weeks;

[0060] YRW-L group: 10% CCL4 was intraperitoneally injected twice a week for 6 weeks; the Chinese medicine composition of Example 1 of the present invention was administered orally at 2.25 g / kg / d, once a day for 6 weeks;

[0061] YRW-H group: 10% CCL4 was intraperitoneally injected twice a week for 6 weeks; and the Chinese medicine composition of Example 1 of the present invention was given by gavage at 4.5 g / kg / d once a day for 6 weeks;

[0062] After 6 weeks of treatment, the body weight, liver weight, and spleen weight of each group of mice were weighed, and the liver and spleen index was calculated. The morphological changes of liver tissue were observed, and the pathological structural changes of liver tissue in mice were evaluated by HE and Masson staining. The expression of liver tissue inflammatory indicators (IL-1b, IL-6, TNF-a) and fibrosis markers (α-SMA, COL1A1, COL3A1, FN1) was detected by qRT-PCR. The expression levels of four liver fibrosis items (Co1-Ⅳ, HA, LN, PCⅢ) and inflammatory factors (TNF-a, IL-6) in mouse serum were detected by a kit, and the therapeutic effect of the optimal ratio of the Chinese medicine composition of the present invention on the CCL4-induced liver fibrosis mouse model was evaluated in many aspects. The expression levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CRE), and urea (Urea) in the serum samples of each group of mice were detected using an automatic biochemical analyzer to clarify the effect of the Chinese medicine composition of Example 1 of the present invention on the liver and kidney function of the liver fibrosis mouse model.

[0063] II. Interventional effect of the traditional Chinese medicine composition provided in Example 1 of the present invention on the liver fibrosis mouse model

[0064] 1. Changes in body weight, liver index and spleen index of mice in each group

[0065] like Figure 1 As shown, during the 6-week drug intervention, the weight gain of the Model group mice was slower than that of the Control mice ( Figure 1 Middle A), liver index ( Figure 1 Middle B), spleen index ( Figure 1C) significantly increased (p < 0.001). After 6 weeks of drug treatment, all dose groups of the Chinese medicine composition of Example 1 of the present invention and the Silibinin group were able to significantly improve the above pathological indicators (p < 0.05). The high-dose group of the Chinese medicine composition of Example 1 of the present invention showed a superior effect to the Silibinin group in improving the weight gain and liver and spleen index of HF mice (p < 0.05), and showed a clear dose-dependent effect.

[0066] Table 1 Body weight, liver index and spleen index of mice in each group

[0067]

[0068] 2. Changes in liver tissue morphology, pathological structure, inflammatory indicators, and expression of liver fibrosis markers in each group of mice

[0069] like Figure 2 As shown in Figures AB, the livers of the mice in the Model group showed obvious pathological changes compared with the Control group. Macroscopic observation showed that the surface of the liver in the Model group was rough, the edges were blunt, and the color was dark red; HE staining showed disordered liver lobule structure and a large number of inflammatory cells infiltrating, and Masson staining showed obvious blue collagen fiber deposition. After 6 weeks of treatment, the disordered liver lobule structure, collagen fiber deposition and inflammatory cell infiltration of mice in each dose group of the traditional Chinese medicine composition of Example 1 of the present invention and the Silibinin group were significantly improved, and the degree of improvement in the low-dose and high-dose groups of the traditional Chinese medicine composition of Example 1 of the present invention was significantly better than that in the positive drug Silibinin group.

[0070] like Figure 2 qPCR results of CJ showed that compared with the control group, the expression levels of inflammatory indicators (IL-1b, IL-6 and TNF-a) and liver fibrosis markers (TGF-β, α-SMA, COL1A1, COL3A1 and FN1) in the liver tissue of mice in the Model group were significantly increased (p < 0.01). After intervention with the Chinese herbal composition of Example 1 of the present invention and silibinin, the expression of the above indicators showed a downward trend, among which the downregulation level in the high-dose group of the Chinese herbal composition of Example 1 of the present invention was the most significant, and all other indicators except FN1 showed statistical differences.

[0071] Table 2 Expression of inflammatory indicators and liver fibrosis markers mRNA in each group of mice

[0072]

[0073] 3. Changes in the expression levels of four serum liver fibrosis items and inflammatory factors in each group of mice

[0074] The expression levels of four liver fibrosis indicators (CoI-IV, HA, PC III, LN) and inflammatory factors (TNF-a, IL-6) in the serum of each group of mice were detected by ELISA to evaluate the degree of liver fibrosis in each group of mice after drug intervention. The test results are shown in Figure 2. Figure 3 As shown. Compared with the Control group, the expression levels of four serum liver fibrosis indicators (Co1-Ⅳ, HA, LN, PCⅢ) and inflammatory factors (TNF-a, IL-6) in the Model group were significantly increased (p < 0.001). After intervention with the Chinese medicine composition of Example 1 of the present invention and Silibinin, the expression levels of the above indicators were all downregulated to varying degrees, and the intervention effect of the high-dose group of the Chinese medicine composition of Example 1 of the present invention was the best.

[0075] Table 3 Expression of four liver fibrosis items and inflammatory factors in serum of mice in each group

[0076]

[0077] III. Effect of the Traditional Chinese Medicine Composition Provided in Example 1 of the Present Invention on Liver and Kidney Function in a Mouse Model of Liver Fibrosis

[0078] The expression levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CRE), and urea (Urea) in the serum samples of each group of mice were detected using a fully automatic biochemical analyzer to clarify the effect of the Chinese medicine composition provided in Example 1 on the liver and kidney function of the liver fibrosis mouse model. The test results are shown in Tables 4 and Figure 4 shown. Figure 4 Figures AD are comparisons of the expression levels of AST, ALT, CRE and Urea in each group of mice.

[0079] Table 4 Expression of AST, ALT, CRE and Urea in serum of mice in each group

[0080]

[0081] The expression levels of AST and ALT in the liver fibrosis mice in the Model group were significantly higher than those in the normal mice in the Control group. After 6 weeks of treatment with the positive control drug (silybin) and the low and high doses of the Chinese medicine composition of Example 1 of the present invention, the AST and ALT levels of the liver fibrosis mice decreased significantly, among which the transaminase decrease in the YRW-H group was the best, indicating that the Chinese medicine composition of Example 1 of the present invention did not damage the liver function of the liver fibrosis mice, and could reverse the liver function damage caused by the CCL4 chemical inducer to a certain extent and prevent hepatotoxicity. In addition, the test results also showed that the CRE and Urea levels of the liver fibrosis mice in the model group were significantly higher than those of the normal mice in the control group; after drug treatment, the CRE and Urea levels of the Silibinin-treated mice were slightly reduced, but there was no significant difference compared with the normal mice in the control group, while the CRE and Urea levels of the mice in each dose group of the traditional Chinese medicine showed a significant downward trend, and compared with the model group, the improvement level in the YRW-H group was statistically significant, indicating that the traditional Chinese medicine composition of Example 1 of the present invention had no damage to the renal function of mice with liver fibrosis, and could improve the renal function damage caused by the CCL4 chemical inducer to a certain extent.

[0082] As described above, the basic principles, main features and advantages of the present invention are well described. The above embodiments and descriptions are merely descriptions of preferred embodiments of the present invention, and the present invention is not limited to the above embodiments. Various changes and improvements made to the technical solutions of the present invention by those skilled in the art without departing from the spirit and scope of the present invention should fall within the scope of protection determined by the present invention.

Claims

1. A Chinese medicine composition for treating liver fibrosis, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of processed Polygonum multiflorum, 5-15 parts of Artemisia capillaris, 5-10 parts of Trigonum multiflorum, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Chicken's Gizzard Stone, and 2-6 parts of Eupolyphaga sinensis.

2. The Chinese medicine composition for treating liver fibrosis according to claim 1, characterized in that It is composed of the following raw materials in parts by weight: 10 parts of Astragalus, 10 parts of Polygonatum, 20 parts of Radix Scutellariae, 20 parts of Carapax Trionycis, 20 parts of Salvia miltiorrhiza, 10 parts of Codonopsis pilosula, 10 parts of processed Polygonum multiflorum, 13.2 parts of Artemisia capillaris, 10 parts of Rhizoma Sparganii, 10 parts of the White Peony Roots, 10 parts of Poria, 8 parts of Curcuma aromatica, 4 parts of Gallus corneum gizzard lining, 4 parts of Eupolyphaga sinensis.

3. A pharmaceutical preparation, characterized in that The invention is composed of the Chinese medicine composition according to claim 1 or 2.

4. The pharmaceutical preparation according to claim 3, characterized in that The pharmaceutical preparation is in the form of pills or granules.

5. The method for preparing the pharmaceutical preparation according to claim 4, characterized in that: The preparation of granules comprises the following steps: S1. Weigh 6-30 parts of Astragalus, 5-15 parts of Polygonatum, 10-30 parts of Radix Scutellariae, 15-25 parts of Carapax Trionycis, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of Codonopsis pilosula, 6-15 parts of Polygonum multiflorum (prepared), 5-15 parts of Artemisia capillaris, 5-10 parts of Rhizoma Trigonidis, 5-15 parts of White Peony Root, 5-15 parts of Poria, 3-10 parts of Curcuma aromatica, 3-10 parts of Gallus gallus domesticus, and 2-6 parts of Eupolyphaga sinensis, and set aside. S2. Decoction the white back leaf root and astragalus obtained in step S1 twice, the first time for 1.5 hours and the second time for 1 hour, combine the two decoctions, filter, and concentrate the filtrate into a thick paste; S3, the polygonatum, turtle shell, salvia miltiorrhiza, codonopsis pilosula, prepared polygonum multiflorum, capillaries, sparganium, white peony root, poria, turmeric, chicken's gizzard lining and earthworm weighed in step S1 are mixed and crushed, and sieved to obtain a fine drug powder; S4, adding the fine powder of the medicine obtained in step S3 to the thick paste obtained in step S2, mixing, drying, and crushing to obtain a dry powder of the traditional Chinese medicine; S5. Pressing the dried Chinese medicine powder obtained in step S4 into thin slices, crushing the thin slices into granules, and sieving to obtain Chinese medicine granules.

6. The method for preparing the pharmaceutical preparation according to claim 5, characterized in that: The preparation method of the pills is as follows: the Chinese medicine granules obtained in step S5 are added with refined honey to make water-honeyed pills to obtain the pills.

7. Use of the traditional Chinese medicine composition according to claim 1 in preparing a medicament for treating liver fibrosis.

Images