A Chinese medicine composition for treating liver fibrosis and its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a Chinese medicine composition for treating liver fibrosis, and a preparation method and application thereof. The Chinese medicine composition includes the following raw materials and their dosages: 22-25 parts by weight of Eucommia ulmoides leaves, 22-25 parts by weight of Blue Buzheng, 5-8 parts by weight of Fenugreek, 5-7 parts by weight of Ginseng Leaves, 5-8 parts by weight of Campsis Creeper, and 2-5 parts by weight of Acorus calamus. The Chinese medicine composition has the basic effects of tonifying the kidney and spleen, warming the kidney and benefiting the lungs, and promoting qi and resolving phlegm. Animal experiments show that high doses and medium doses of the new Chinese medicine composition can improve serum transaminase and its hyaluronic acid index, inflammatory mediator index, antioxidant index, liver transforming growth factor-β1, etc. of experimental model Kunming (male) mice, while having no effect on the organ index and body weight of the main organs of the experimental model Kunming (male) mice. The present invention provides a new technical means for treating liver fibrosis.

Description

Technical Field

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

[0002] Liver fibrosis is one of the common diseases of the digestive system (Li S, Zhou B, Xue M, et al. Macrophage-specific FGF12 promotes liver fibrosis progression in mice [J]. Hepatology, 2023, 77 (3): 816-833.), and the lesions are mainly located in the liver. The occurrence and development of liver fibrosis is often related to viral infections, such as hepatitis B virus infection (Yardeni D, Chang KM, Ghany MG. Current Best Practice in Hepatitis B Management and Understanding Long-term Prospects for Cure [J]. Gastroenterology, 2023, 164 (1): 42-60.), hepatitis A virus infection, hepatitis C virus infection, etc. Other common diseases such as schistosomiasis, obesity (Lee KC, Wu PS, Lin HC. Pathogenesis and treatment of non-alcoholic steatohepatitis and its fibrosis [J]. Clin Mol Hepatol, 2023, 29 (1): 77-98.), heavy drinking, staying up late, and irregular lifestyle can affect the structure and function of liver tissue, thereby promoting the occurrence and development of liver fibrosis and endangering the body's life safety.

[0003] The incidence of liver fibrosis has been increasing year by year, and the mortality rate has also been increasing year by year. This is related to the combined effects of hepatitis B virus infection (Loureiro D, Tout I, Narguet S, et al. Mitochondrial stress in advanced fibrosis and cirrhosis associated with chronic hepatitis B chronic hepatitis Cor nonalcoholic steatohepatitis [J]. Hepatology, 2023, 77 (4): 1348-1365.), hepatitis A virus infection, hepatitis C virus infection, schistosomiasis, excessive obesity (Quek J, Chan KE, Wong ZY, et al. Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population a systematic review and meta-analysis [J]. Lancet Gastroenterol Hepatol, 2023, 8 (1): 20-30.), heavy drinking, staying up late, and irregular lifestyle. Liver fibrosis causes changes in the basic structure of the liver. For example, after a large amount of fibrous tissue proliferates, normal liver lobules can be irregularly divided, central veins are absent or displaced, the arrangement structure of liver plates is abnormal, the three main types of ducts in the portal area are absent, and the permeability of hepatic sinusoidal endothelial cells is increased (Jiang T, Wu X, Zhou H, et al. Pathological Changes in Hepatic Sinusoidal Endothelial Cells in Schistosoma japonicum-Infected Mice [J]. Trop Med Infect Dis, 2023, 8 (2): 124.), etc. This will be the pathological structural basis for further development into cirrhosis.

[0004] In the population with liver fibrosis, from the perspective of gender, liver fibrosis is more common in men (Ajmera V, Cepin S, Tesfai K, et al. A prospective study on the prevalence of NAFLD advancedfibrosis cirrhosis and hepatocellularcarcinoma in people with type 2 diabetes [J]. J Hepatol, 2023, 78 (3): 471-478.), which is related to the fact that many men drink a lot of alcohol, stay up late, and have irregular lifestyles for social activities. From the perspective of age, liver fibrosis is more common in older people, which is related to the aging of the liver with the increase of body age, accompanied by liver function decline. From the perspective of viral infection, liver fibrosis is more common in hepatitis B virus infection (Robinson A, Wong R, Gish RG. Chronic Hepatitis B Virus and Hepatitis D Virus New Developments[J]. Clin Liver Dis, 2023, 27(1): 17-25.), and less common in hepatitis A virus infection and hepatitis C virus infection. This is related to the strong pathogenicity of hepatitis B virus and the fact that the main component of hepatitis B virus is a special type of deoxyribonucleic acid.

[0005] Generally speaking, the clinical symptoms of liver fibrosis are not very obvious (Loomba R, Huang DQ, Sanyal AJ, et al. Liver stiffness thresholds to predict disease progression and clinical outcomes in bridging fibrosis and cirrhosis [J]. Gut, 2023, 72 (3): 581-589.), which depends on the basic structure of each individual's liver and the compensatory capacity of the liver. Usually, normal liver cells can regenerate and replace partial liver damage quickly. Early liver fibrosis usually has no clinical symptoms, but there are some adverse phenomena, such as liking to drink a lot, staying up all night, and irregular diet, etc. These situations are often not taken seriously (Hernandez-Tejero M, Clemente-Sanchez A, Bataller R. Spectrum, Screening and Diagnosis of Alcohol-related Liver Disease [J]. J Clin Exp Hepatol, 2023, 13 (1): 75-87.). As time goes by, the proliferation of a large amount of fibrous tissue causes the liver to gradually harden, liver lesions will gradually worsen, and the clinical symptoms of liver fibrosis will become more and more obvious, often accompanied by yellowish complexion, weakness in the limbs, and less food intake. Severe liver fibrosis may also cause cachexia, subcutaneous ecchymosis, severe pain in the liver area, and even endanger the life of the body.

[0006] Clinical diagnosis of liver fibrosis requires testing of blood indicators, and liver puncture and sampling can be performed when necessary. Liver fibrosis detection often requires testing of changes in blood indicators, such as increased levels of laminin (Ezhilarasan D, Najimi M. Intercellular communication among liver cells in the perisinusoidal space of the injured liver Pathophysiology and therapeutic directions [J]. J Cell Physiol, 2023, 238 (1): 70-81.), hyaluronic acid, aspartate aminotransferase, alanine aminotransferase, etc., which are common changes in blood indicators of liver fibrosis. In fact, aspartate aminotransferase and alanine aminotransferase are special enzymes that work in liver cells. At this time, the levels of aspartate aminotransferase and alanine aminotransferase increase, which usually indicates liver cell damage, incomplete liver cell membrane structure, and release of liver cytoplasmic contents, causing aspartate aminotransferase and alanine aminotransferase to enter the blood (Ezpeleta M, Gabel K, Cienfuegos S, et al. Effect of alternateday fasting combined with aerobic exercise on non-alcoholic fatty liver disease A randomized controlled trial[J]. Cell Metab, 2023, 35(1): 56-70.), causing liver function to decline and unable to perform the basic functions of detoxification, protein synthesis, and bile synthesis.

[0007] Liver fibrosis often shows an increase in blood enzyme indicators, which indicates liver cell damage. The mitochondrial structure will also be damaged, causing changes in mitochondrial function, accompanied by abnormal lipid metabolism and increased free radical production. The main enzymes that remove free radicals in the body include catalase (CAT), superoxide dismutase (SOD) (Wei Y, Gao C, Wang H, et al. Morifructus aqueous extracts attenuates liver injury by inhibiting ferroptosis via the Nrf2pathway[J]. J Anim Sci Biotechnol, 2023, 14 (1): 56.), and glutathione peroxidase (GSH-PX). These enzymes can quickly remove free radicals produced in the body and reduce malondialdehyde (MDA) produced by free radical metabolism (Qin L, Wang Y, Liang Y, et al. Astragaloside IV Alleviates Atorvastatin-Induced Hepatotoxicity via AMPK / SIRT1Pathway[J].Pharmacology, 2023, 108(1):74-82.), to avoid oxidative stress and cell damage in body tissues. In fact, the increase in free radical production is often accompanied by a decrease in CAT, SOD, and GSH-PX activities, and an increase in MDA content, indicating that the body's total antioxidant capacity is weakened and metabolites are increased; conversely, the decrease in free radical production is often accompanied by an increase in CAT, SOD, and GSH-PX activities, and a decrease in MDA content, indicating that the body's total antioxidant capacity is enhanced and metabolites are reduced.

[0008] Liver fibrosis often causes damage to the connecting structure between hepatocytes. The special type of macrophages present in the hepatic sinusoids, namely hepatic macrophages, are constantly activated, exerting the phagocytic function of hepatic macrophages, engulfing useless substances and playing an active role as scavengers. At the same time, after activation, hepatic macrophages can also release many different types of inflammatory mediators, such as tumor necrosis factor-α (Niture S, Gadi S, Lin M, et al. Cadmium modulates steatosis fibrosis and oncogenic signaling in liver cancer cells by activating notch and AKT / mTOR pathways [J]. Environ Toxicol, 2023, 38 (4): 783-797.), interleukin-6, interleukin-1β, etc., all increase in release. The release of inflammatory mediators interleukin-6, tumor necrosis factor-α, and interleukin-1β (Liu X, Zhou J, Wu H, et al. Fibrotic immune microenvironment remodeling mediates superior anti-tumor efficacy of anano-PD-L1 trap in hepatocellular carcinoma [J]. Mol Ther, 2023, 31 (1): 119-133.) is like a double-edged sword. On the one hand, it reduces the inflammatory response through the blood circulation system, and on the other hand, it can also increase the release of liver transforming growth factor-β1 in the body. Liver transforming growth factor-β1 will promote further aggravation of liver tissue fibrosis, forming a positive feedback system, which is very unfavorable for liver fibrosis.

[0009] Nowadays, Western medicine can be used to treat liver fibrosis, such as interferon (Omar H, Waked I, Elakel W, et al. Evolution of liver fibrosis after interferon-based anti-hepatitis C virus therapy failure in 3049 chronic hepatitis C patients without cirrhosis [J]. Arab J Gastroenterol, 2023, 24 (1): 65-72.), colchicine, pentoxifylline, collagenase, D-penicillamine (Deme P, Sheffield A, Alick-Lindstrom S. Wilsons disease: neuropsychiatric presentation and delayed diagnosis [J]. BMJ Case Rep, 2022, 15 (7): e246296.), telbivudine, lamivudine (Okan HD, Karabay O, Guclu E, et al. Comparison of patients using lamivudine, entecavir and tenofovir according to liver fibrosis markers fibrosis-4and aspartate aminotransferase-to-platelet ratioindex scores[J]. Indian J Pharmacol, 2023, 55(1): 14-20.), glucocorticoids, etc. can effectively relieve the clinical symptoms of liver fibrosis. However, these drugs such as interferon (Wang Y, Wang Q, Yang TW, et al. Analysis of Immune and Inflammatory Microenvironment Characteristics of Noncancer End-Stage Liver Disease[J]. J Interferon Cytokine Res, 2023, 43(2): 86-97.), colchicine, pentoxifylline, collagenase, D-penicillamine, telbivudine, lamivudine (Ramji A, Doucette K, Cooper C, et al.Nationwide retrospective study of hepatitis B virological response and liver stiffness improvement in 465 patients on nucleos tide analogue [J]. World J Gastroenterol, 2022, 28 (31): 4390-4398.), the side effects of glucocorticoids are also very obvious, and there is a lack of overall regulatory effect. Therefore, it is very important to choose traditional Chinese medicine with overall regulatory effect and less side effects. .

[0010] Traditional Chinese medicine theory generally believes that the liver is an organ that stores blood, and it will promptly dredge the qi mechanism and regulate the distribution of body fluids, blood, and qi. In different stages of liver fibrosis, we can see abnormalities in the distribution of body fluids, blood, and qi, which leads to worsening of the disease. At the same time, combined with the mixed activation of multiple pathways of liver fibrosis, it interferes with the distribution of body fluids, blood, and qi, and then promotes the deterioration of the body's condition. Therefore, liver fibrosis requires active and timely liver nourishment. The spleen is an important organ for transportation and transformation. It will promptly transport and transform, and raise the essence of water and grain. It can also coordinate blood and work closely with the liver. Liver fibrosis often has poor diet and abnormal transportation of water and grain essence, which is related to the basic dysfunction of the spleen. The ability of the spleen to nourish the kidneys is reduced, which will promote the occurrence and development of liver fibrosis, so liver fibrosis requires spleen strengthening. The essence of kidney water can accelerate the liver nourishing function, promote the continuous enhancement of liver function, help the liver to perform its detoxification function, and regulate the distribution of body fluid, blood, and qi. Liver fibrosis is often caused by excessive drinking interfering with liver function, parasitic infection damaging liver structure, and long-term chronic infection with various hepatitis viruses, which promotes the accumulation of dampness and wind toxins, and the accumulation of qi. This causes the essence of kidney water to be insufficient to nourish the liver, which is not conducive to the active detoxification function of the liver, and causes the subtle substances derived from kidney water to be unable to complete the two-way material exchange between the special type of endothelial cells in the liver sinusoid wall and hepatocytes, ultimately affecting the liver's metabolic function. Therefore, liver fibrosis requires timely warming of the kidneys. The lung belongs to metal, and it can play the function of descending and intervening the changes of liver fire and liver qi. Once the lung function is disordered, the rise of liver fire and liver qi is restricted, which induces liver disease. In liver fibrosis, it cannot play the basic role of metal overcoming wood, which aggravates the condition of liver fibrosis. Combined with the sluggish liver qi at this time, the body's essential body fluid, a nutrient, cannot nourish the bones and moisturize the skin, resulting in the inability to metabolize fat, sugar, and protein, which will promote the occurrence and development of liver fibrosis. Therefore, liver fibrosis needs to benefit the lung in time. Only when the body's qi is smooth, the liver function will be normal, and the distribution of body fluid, blood, and qi will be normal. Liver fibrosis often has sluggish qi, abnormal distribution, and weakened gasification, which causes the liver's ability to process fat, sugar, and protein to weaken, and cannot complete the active material exchange. This is related to the disorder of the body's qi movement in and out, so liver fibrosis needs to be timely qi. Liver fibrosis is accompanied by abnormal distribution of body fluids, blood, and qi. Combined with excessive drinking that interferes with liver function, parasitic infections that damage liver structure, and long-term chronic infections with various hepatitis viruses, phlegm and toxins invade the body, accelerating damage to liver tissue structure, causing poor collateral flow, reduced appetite, fatigue, and yellowing. Expectorant drugs can be selected to treat liver fibrosis, so liver fibrosis requires active phlegm reduction. Therefore, active and effective treatment of liver fibrosis requires tonifying the liver and spleen, warming the kidneys and benefiting the lungs, and promoting qi and resolving phlegm. Traditional Chinese medicine with the functions of tonifying the liver and spleen, warming the kidneys and benefiting the lungs, and promoting qi and resolving phlegm can be effectively selected for the treatment of liver fibrosis, which is very beneficial for improving the clinical symptoms of liver fibrosis. Summary of the invention

[0011] The purpose of the present invention is to solve the deficiencies of the prior art and provide a Chinese medicine composition for treating liver fibrosis and a preparation method and application thereof, specifically adopting the following technical scheme:

[0012] A traditional Chinese medicine composition for treating liver fibrosis. The raw materials and dosages of the traditional Chinese medicine composition include: 22-25 parts by weight of eucommia leaves, 22-25 parts by weight of blueberry, 5-8 parts by weight of fenugreek, 5-7 parts by weight of ginseng leaves, 5-8 parts by weight of trumpet creeper, and 2-5 parts by weight of calamus.

[0013] The invention discloses a Chinese medicine composition for treating liver fibrosis, a preparation method and application thereof. The Chinese medicine composition is composed of 6 medicinal materials, namely, Eucommia ulmoides leaf, Lanbuzheng, Fenugreek, Ginseng leaf, Trumpet creeper and Acorus calamus. Among them, Eucommia ulmoides leaf, also known as Sizhong leaf, belongs to the kidney meridian and liver meridian, and has the basic effects of nourishing the liver and strengthening tendons, nourishing the kidney and strengthening bones; Lanbuzheng, also known as Phoenix Nest, Roadside Yellow, Old Shesao, etc., has a cool nature, a sweet and bitter taste, belongs to the lung meridian, spleen meridian and liver meridian, and has the basic effects of invigorating the spleen and moistening the lungs, nourishing blood and resolving phlegm, and invigorating qi and nourishing yin; Fenugreek, also known as Quartet Bean, Fenugreek, coumarin, etc. are warm in nature and bitter in taste. They belong to the kidney meridian and have the basic effects of warming the kidney and relieving pain, dispelling cold and replenishing deficiency; ginseng leaves, also known as ginseng seedlings and ginseng leaves, are cold in nature and sweet and bitter in taste. They belong to the stomach meridian and lung meridian, and have the basic effects of benefiting the lungs and producing body fluids, dispelling heat and replenishing qi; trumpet creeper, also known as hanging wall flower, five-clawed dragon, tree-climbing dragon, hanging fuchsia, etc., are cold in nature and sour and sweet in taste. They belong to the pericardium meridian and liver meridian, and have the basic effects of promoting qi and dispelling wind, cooling blood and removing blood stasis; nine-section calamus, also known as section calamus, small calamus, chicken claw lotus, etc., are warm in nature and spicy in taste. They belong to the stomach meridian, liver meridian and heart meridian, and have the basic effects of resolving phlegm and calming the mind, invigorating the spleen and opening the orifices.

[0014] As a further preferred embodiment, the raw materials and their dosages of the above-mentioned traditional Chinese medicine composition include: 22.5 parts by weight of Eucommia ulmoides leaves, 24.5 parts by weight of Indigofera chinensis, 6.75 parts by weight of Fenugreek, 6.5 parts by weight of Ginseng leaves, 6.75 parts by weight of Campsis creeper, and 3.75 parts by weight of Acorus calamus.

[0015] In the present invention, the new Chinese medicine composition for treating liver fibrosis is composed of Chinese herbal medicines Eucommia ulmoides leaves, blue buzheng, fenugreek, ginseng leaves, trumpet creeper, and calamus. Among them, the monarch medicine is Eucommia ulmoides leaves and blue buzheng, which have the basic effects of tonifying the kidney and strengthening the spleen; the ministerial medicine is fenugreek and ginseng leaves, which have the basic effects of warming the kidney and benefiting the lungs; the adjuvant is trumpet creeper, which has the basic effect of promoting qi; the messenger is calamus, which has the basic effect of resolving phlegm. It can be seen that the new Chinese medicine composition has the basic effects of tonifying the kidney and strengthening the spleen, warming the kidney and benefiting the lungs, and promoting qi and resolving phlegm. This experiment selects a new Chinese medicine composition composed of Eucommia ulmoides leaves, blue buzheng, fenugreek, ginseng leaves, trumpet creeper, and calamus to carry out experiments, and evaluates the effect of the new Chinese medicine composition composed of Eucommia ulmoides leaves, blue buzheng, fenugreek, ginseng leaves, trumpet creeper, and calamus on liver fibrosis.

[0016] The Chinese medicine composition of the present invention can also be used in the preparation of health products and medicines for treating liver fibrosis. The health products include the Chinese medicine composition of the present invention and excipients acceptable in the field of health products.

[0017] As a further preferred embodiment, the above-mentioned health care product dosage forms include powders, granules, capsules, tablets and solutions.

[0018] Furthermore, the present invention also provides a clinically suitable drug for treating liver fibrosis, which is prepared by adding the auxiliary materials required for preparation molding to the Chinese medicine composition of the present invention and following the conventional method for preparing drug preparations.

[0019] As a further preferred embodiment, the above-mentioned medicine is in an oral dosage form. Preferably, the oral dosage form is a decoction, powder, capsule, pill, granule, tablet or oral liquid.

[0020] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0021] (1) Weighing each raw material according to the weight of the above-mentioned Chinese medicine composition;

[0022] (2) After mixing the raw materials weighed in step (1), adding distilled water in an amount of 5 to 15 times the total weight of the raw materials, soaking for 1.5 to 2.5 hours, then decocting for 1.5 to 2.5 hours, filtering, and obtaining a first Chinese medicine composition filtrate and a residue;

[0023] (3) adding the same volume of distilled water as that in step (1) to the residue of the traditional Chinese medicine composition obtained in step (2), soaking the residue of the traditional Chinese medicine composition for 1.5-2.5 hours, decocting the residue of the traditional Chinese medicine composition for 1.5-2.5 hours, filtering, and obtaining a second filtrate of the traditional Chinese medicine composition;

[0024] (4) The first filtrate of the Chinese medicine composition and the second filtrate of the Chinese medicine composition are combined and mixed to obtain a water decoction of the Chinese medicine composition for liver fibrosis.

[0025] As a further preferred embodiment, the above-mentioned filtration is gauze filtration, and 2 layers of gauze filtration, 4 layers of gauze filtration, 10 layers of gauze, and 20 layers of gauze are used in sequence for filtration.

[0026] The beneficial effects of the present invention are as follows: the present invention provides a Chinese medicine composition for treating liver fibrosis, and a preparation method and application thereof. The novel Chinese medicine composition comprises Eucommia ulmoides leaves, Blue Buzheng, Fenugreek, Ginseng leaves, Campsis creeper, and Acorus calamus. The novel Chinese medicine composition has the basic effects of tonifying the kidney and spleen, warming the kidney and benefiting the lungs, and promoting qi and resolving phlegm. Animal experiments show that the high dose (18.40 g / kg) and the medium dose (9.20 g / kg) of the novel Chinese medicine composition can improve the serum transaminase and its hyaluronic acid index, inflammatory mediator index, antioxidant index, liver transforming growth factor-β1, etc. of the experimental model Kunming (male) mice, while having no effect on the organ index and body weight of the main organs of the experimental model Kunming (male) mice, indicating that the novel Chinese medicine composition composed of Eucommia ulmoides leaves, Blue Buzheng, Fenugreek, Ginseng leaves, Campsis creeper, and Acorus calamus is effective for liver fibrosis and has no side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 Shown is the effect of the Chinese herbal medicine composition on specific alanine aminotransferase in the experimental model Kunming (male) mice;

[0028] Figure 2 Shown is the effect of the Chinese herbal medicine composition on specific aspartate aminotransferase in the experimental model Kunming (male) mice;

[0029] Figure 3 Shown is the effect of the Chinese herbal medicine composition on hyaluronic acid in the experimental model Kunming (male) mice;

[0030] Figure 4 Shown is the effect of the Chinese herbal medicine composition on laminin in the experimental model Kunming (male) mice;

[0031] Figure 5 Shown is the effect of the Chinese medicine composition on the SOD content of the experimental model Kunming (male) mice;

[0032] Figure 6 Shown is the effect of the Chinese herbal medicine composition on the MDA content of the experimental model Kunming (male) mice;

[0033] Figure 7 Shown is the effect of the Chinese medicine composition on the serum tumor necrosis factor-α content of the experimental model Kunming (male) mice;

[0034] Figure 8 Shown is the effect of the Chinese medicine composition on the serum interleukin-1β content of the experimental model Kunming (male) mice;

[0035] Fig. 9 Shown is the effect of the Chinese herbal medicine composition on liver transforming growth factor-β1 protein in the experimental model Kunming (male) mice;

[0036] Fig.10 Shown is the effect of the Chinese herbal medicine composition on the liver transforming growth factor-β1 gene of the experimental model Kunming (male) mice;

[0037] Fig.11 Shown is the effect of the Chinese medicine composition on the kidney index and brain index of the experimental model Kunming (male) mice;

[0038] Fig.12 Shown is the effect of the Chinese medicine composition on the cardiac index and lung index of the experimental model Kunming (male) mice;

[0039] Fig.13 Shown is the effect of the Chinese herbal medicine composition on the body weight of the experimental model Kunming (male) mice. DETAILED DESCRIPTION

[0040] The concept, specific structure and technical effects of the present invention will be clearly and completely described below in combination with the embodiments and drawings to fully understand the purpose, scheme and effect of the present invention.

[0041] Example 1

[0042] A Chinese medicine composition for treating liver fibrosis

[0043] A traditional Chinese medicine composition for treating liver fibrosis, which is composed of the following raw materials by weight: 22.5 g of Eucommia ulmoides leaves, 24.5 g of Lanbuzheng, 6.75 g of Fenugreek, 6.5 g of Ginseng leaves, 6.75 g of Campsis creeper, and 3.75 g of Acorus calamus.

[0044] Example 2

[0045] A preparation method of a water decoction of a traditional Chinese medicine composition for treating liver fibrosis comprises the following steps:

[0046] (1) Weigh each API according to the following weight proportions:

[0047] 22.5 g of Eucommia ulmoides leaves, 24.5 g of blue purslane, 6.75 g of fenugreek, 6.5 g of ginseng leaves, 6.75 g of trumpet creeper, and 3.75 g of calamus are uniformly mixed to obtain 70.75 g of a Chinese medicine composition, and 6 sets of the Chinese medicine composition are prepared in total to obtain 424.5 g of the Chinese medicine composition, and then the mixture of 424.5 g of the medicinal materials is cut into pieces and put into a 20000 mL round-bottom flask;

[0048] (2) After mixing the raw materials weighed in step (1), add distilled water 10 times the total weight of the raw materials, soak for 2 hours, and then boil at 100°C for 2.5 hours;

[0049] (3) filtering the cooled drug solution in step (2) through 2 layers of gauze, 4 layers of gauze, 10 layers of gauze, and 20 layers of gauze, respectively, to obtain a first filtrate and drug residue;

[0050] (4) adding the same volume of distilled water as that in step (2) to the residue of the Chinese medicine composition obtained in step (3), soaking the residue of the Chinese medicine composition for 2 h, decocting the residue of the Chinese medicine composition for 2.5 h, filtering, and obtaining a second Chinese medicine composition filtrate;

[0051] (5) The first filtrate of the Chinese medicine composition and the second filtrate of the Chinese medicine composition are combined and mixed to obtain a water decoction of the Chinese medicine composition for liver fibrosis.

[0052] Example 3

[0053] A preparation method of a dry paste of a traditional Chinese medicine composition for treating liver fibrosis comprises the following steps:

[0054] The decoction obtained in Example 2 was placed in a forced air drying oven at a temperature of 65°C for drying for 6 days to obtain 109 g of a Chinese medicine composition dry paste. The yield of the Chinese medicine composition dry paste was calculated to be 109 g / 424.5 g×100%=25.67%.

[0055] Example 4

[0056] A preparation method of a dry powder of a Chinese medicine composition for treating liver fibrosis comprises the following steps:

[0057] The dry paste of the Chinese medicine composition obtained in Example 3 was placed in a grinder for three times of crushing, grinding, and filtering through 4 mesh, 10 mesh, 50 mesh, and 100 mesh sieves in sequence to obtain 105 g of dry powder of the Chinese medicine composition. The dry powder yield of the Chinese medicine composition was 105 g / 424.5 g×100%=24.73%.

[0058] Example 5

[0059] Experimental study on the efficacy of the Chinese medicine composition of the present invention in treating liver fibrosis

[0060] 1. Research Materials

[0061] 1.1 Study Animals and Study Drugs

[0062] The research animals, Kunming (male) mice, weighed (20.5±0.5) g. The Kunming (male) mice were 6-month-old clean grade (SCXK (black) 2019-001). There were 42 Kunming (male) mice. The Kunming (male) mice were raised in the Experimental Animal Center (Heilongjiang University of Chinese Medicine). The Kunming (male) mice were raised in single cages and given sufficient purified water, clean bedding, and special food for Kunming (male) mice. The new Chinese medicine composition involved in the research drug includes 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Calamus tatarinowii. Six copies of this new Chinese medicine composition are needed, including 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Calamus tatarinowii, totaling 424.5g. Professor Tian Ming (Heilongjiang University of Chinese Medicine) is responsible for the identification and extraction of the new Chinese medicine composition, including 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Calamus tatarinowii. According to the Jiangsu local standard (1989), the ingredients include 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Acorus calamus.

[0063] 1.2 Research reagents and related instruments

[0064] Colchicine (Shanghai Yuanye Biotechnology Co., Ltd.); carbon tetrachloride (Shanghai Jizhi Biochemical Co., Ltd.); alanine aminotransferase (Nanjing Jiancheng Co., Ltd.); aspartate aminotransferase (Nanjing Jiancheng Co., Ltd.); laminin (Boster Co., Ltd.); hyaluronic acid (Nanjing Jiancheng Co., Ltd.); interleukin-1β (Boster Co., Ltd.); tumor necrosis factor-α (Nanjing Jiancheng Co., Ltd.); β-action antibody (Merck); liver transforming growth factor-β1 (Merck); other routine reagents were provided by the Guangxi Zhuang Autonomous Region Traditional Chinese Medicine In Vivo Medicinal Chemistry Database Construction and Application Engineering Research Center (Youjiang Medical College for Nationalities) and (Heilongjiang University of Chinese Medicine). -80℃ refrigerator (Wuxi Guanya Company, BC-8LEX); microplate reader (RT Company, model 6100); slicer (Leica Company, CM1900); centrifuge (Shanghai Anting Company, TGL-16G); electronic balance (Shanghai Matou Company, JYT-20); pulverizer (Linda Machinery Company, FW-100); sterile workbench (Suxin Company, YJ); micropipette (Jiaxing Boshi Company, TopPette); constant temperature drying oven (Shenzhen Jiangcheng Company, 101A); other instruments were provided by (Heilongjiang University of Chinese Medicine) and (Heilongjiang University of Chinese Medicine).

[0065] 2. Research Methods

[0066] 2.1 Grouping of research subjects

[0067] The research subjects of the present invention patent are 42 Kunming (male) mice, which are classified according to the random number table and randomly divided into 6 groups, each with 7 Kunming (male) mice, and the groups are respectively a lower dose group, a higher dose group, a medium treatment group, a model demonstration group, a positive intervention group, and a negative blank group. The 42 Kunming (male) mice were raised in the Experimental Animal Center (Heilongjiang University of Traditional Chinese Medicine), and the diet, drinking water, bedding, etc. of the 42 Kunming (male) mice were observed at any time. The mental state, whether they live in groups, and the cleanliness of their hair were also observed.

[0068] 2.2 Preparation of the model used in the study

[0069] 42 Kunming (male) mice were randomly divided into a lower dose group, a higher dose group, a medium treatment group, a model demonstration group, a positive intervention group, and a negative blank group. Carbon tetrachloride and olive oil (30%) were mixed in proportion, and the final concentration of carbon tetrachloride was 1mL / kg. The Kunming (male) mouse was grasped with the left hand, and the Kunming (male) mouse was held with a syringe in the right hand. The abdominal skin of the Kunming (male) mouse was disinfected, and the Kunming (male) mouse was injected intraperitoneally. The Kunming (male) mouse was injected at 8 am and 2 pm every day. The injection time of Kunming (male) mice lasted for 8 weeks. The establishment of the liver fibrosis model of Kunming (male) mice was verified by measuring the tail vein blood of Kunming (male) mice. After 8 weeks of continuous injection of Kunming (male) mice, no Kunming (male) mice died, and the blood verified that the liver fibrosis model was successfully established. The negative blank group only injected an equal volume of olive oil into the abdominal cavity of Kunming (male) mice, and no additional intervention was required.

[0070] 2.3 Measurement conversion analysis

[0071] The dosage of the new Chinese medicine composition containing 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Calamus tatarinowii needs to be analyzed according to the ratio of 0.0026:1. Each portion of 22.5g of Eucommia ulmoides leaves, 24.5g of Lanbuzheng, 6.75g of Fenugreek, 6.5g of Ginseng leaves, 6.75g of Trumpet creeper, and 3.75g of Calamus tatarinowii is 70.75g. The calculated dosage of the medium treatment group for Kunming (male) mice is 9.20g / kg, the dosage of the smaller dose group for Kunming (male) mice is 4.60g / kg, and the dosage of the larger dose group for Kunming (male) mice is 18.40g / kg. The positive intervention group was for Kunming (male) mice, and the dose of colchicine was 0.001g / kg. The model demonstration group and the negative blank group were given equal amounts of saline by gavage to Kunming (male) mice. The experiment was divided into a lower dose group, a higher dose group, a medium treatment group, a model demonstration group, a positive intervention group, and a negative blank group, including a lower dose group (4.60g / kg), a higher dose group (18.40g / kg), a medium treatment group (9.20g / kg), a model demonstration group (equal amounts of saline), a positive intervention group (0.001g / kg), and a negative blank group (equal amounts of saline). The duration of gavage in each group, including the lower dose group, the higher dose group, the medium treatment group, the model demonstration group, the positive intervention group, and the negative blank group, was 30 days.

[0072] 2.4 Assessment of liver markers

[0073] For Kunming (male) mice in each group, including the lower dose group, the higher dose group, the medium treatment group, the model demonstration group, the positive intervention group, and the negative blank group, the Kunming (male) mice were gavaged for 30 days, and then the Kunming (male) mice were fasted for 15 hours. The Kunming (male) mice were grabbed with the left hand, and the eyeballs of the Kunming (male) mice were directly removed with ophthalmic forceps in the right hand to obtain the mixed blood of the Kunming (male) mice. The mixed blood of the Kunming (male) mice was left to stand, and the mixed blood of the Kunming (male) mice was observed. After blood stratification, centrifuge (Shanghai Anting Company, TGL-16G) was used for centrifugation at 3000 rpm for 10 minutes. The supernatant of the mixed blood of Kunming (male) mice was retained and packaged. The samples were stored in a -80°C refrigerator (Wuxi Guanya Company, BC-8LEX). According to the instructions of the kit, the contents of aspartate aminotransferase, alanine aminotransferase, hyaluronic acid, laminin, SOD, and MDA were calculated to evaluate the liver indicators of Kunming (male) mice in each group.

[0074] 2.5 Evaluation of liver inflammatory mediators

[0075] For Kunming (male) mice in each group including lower dose group, higher dose group, medium treatment group, model demonstration group, positive intervention group and negative blank group, the duration of gavage for Kunming (male) mice was 30 days. On a sterile workbench (Suxin Company, YJ), chloral hydrate was used to anesthetize Kunming (male) mice, the heads and limbs of Kunming (male) mice were fixed, the abdomen of Kunming (male) mice was exposed, the hair and skin of the abdomen of Kunming (male) mice were cut off, the liver on the right side of Kunming (male) mice was exposed, the liver of Kunming (male) mice was collected, ground and homogenized, and placed in a 4°C refrigerator. A centrifuge (Shanghai Anting Company, TGL-16G) was used, the centrifugal speed was 3000 rpm, the centrifugal time was 20 minutes, the liver supernatant of Kunming (male) mice was packaged, and the absorbance value of the liver supernatant of Kunming (male) mice was measured at a wavelength of 450nm using an enzyme marker (RT Company, Model 6100), and the interleukin-1β and tumor necrosis factor-α contents of Kunming (male) mice were detected.

[0076] 2.6 Evaluation of liver-related protein expression

[0077] For Kunming (male) mice in each group, including the lower dose group, the higher dose group, the medium treatment group, the model demonstration group, the positive intervention group, and the negative blank group, the duration of gavage of Kunming (male) mice was 30 days later. On a sterile workbench (Suxin Company, YJ), chloral hydrate was used to anesthetize Kunming (male) mice, the head of Kunming (male) mice was fixed, the limbs of Kunming (male) mice were fixed, the chest of Kunming (male) mice was exposed, the hair and skin on the chest of Kunming (male) mice were cut off, the heart of Kunming (male) mice was exposed, the apex of the heart of Kunming (male) mice was found, the infusion needle was inserted into the apex of the heart of Kunming (male) mice, 70mL of normal saline was infused, and then 70mL of formalin solution was infused. On a sterile workbench (Suxin Company, YJ), the liver of Kunming (male) mice was collected. After the routine basic staining process, the liver images of Kunming (male) mice were observed and analyzed under a microscope. The average optical density value was calculated using software to evaluate the expression level of transforming growth factor-β1 protein in the liver of Kunming (male) mice.

[0078] 2.7 Evaluation of liver-related gene expression

[0079] For Kunming (male) mice in each group, including the lower dose group, the higher dose group, the medium treatment group, the model demonstration group, the positive intervention group, and the negative blank group, the duration of gavage of Kunming (male) mice was 30 days later. On a sterile workbench (Suxin Company, YJ), chloral hydrate was used to anesthetize Kunming (male) mice, the head of Kunming (male) mice was fixed, the limbs of Kunming (male) mice were fixed, the abdomen of Kunming (male) mice was exposed, the hair and skin of the abdomen of Kunming (male) mice were cut off, the liver on the right side of Kunming (male) mice was exposed, the liver of Kunming (male) mice was taken, the liver mRNA of Kunming (male) mice was extracted, and reverse transcribed into cDNA. Primers for liver transforming growth factor-β1 and β-action were designed, among which the upstream primer of β-action was 5'-AGT TGA ATG GCT ATG ATCCGA-3'; the downstream primer of β-action was 3'-GCT TAG CTA GTT CATTGCATA-5'; the upstream primer of liver transforming growth factor-β1 was 5'-AGC CTG ATG CTA GCT CATGTA-3'; the downstream primer of liver transforming growth factor-β1 was 3'-TCG CGT ACT GCT ATG CTTGAT-5'. Fluorescent material (SYBR GreenI) was added, the reaction parameters of the system were designed, and the relative expression of liver transforming growth factor-β1 gene in Kunming (male) mice was evaluated using a PCR instrument with 2min (50℃), 10min (95℃), 15s (95℃), 1min (60℃), and 40 cycles.

[0080] 2.8 Determination of organ index and body weight

[0081] For Kunming (male) mice in each group, including the lower dose group, the higher dose group, the medium treatment group, the model demonstration group, the positive intervention group, and the negative blank group, the duration of gavage of Kunming (male) mice was 30 days later. The time points of Kunming (male) mice 0 days, Kunming (male) mice 15 days, and Kunming (male) mice 30 days were selected, and the weight of Kunming (male) mice was weighed respectively. On a sterile workbench (Suxin Company, YJ), Kunming (male) mice were killed by cervical vertebral dissection, and the heart, kidney, lung, and brain of Kunming (male) mice were quickly collected, and the heart, kidney, lung, and brain of Kunming (male) mice were dried with filter paper. The formula for calculating the organ index of Kunming (male) mice is: Kunming (male) mouse organ index = Kunming (male) mouse organ mass (mg) / Kunming (male) mouse body weight (g). The unit of organ index is mg / g.

[0082] 2.9 Statistical analysis of research data

[0083] SPSS 19.0 software was used to analyze the research data. ±s), and the data were compared with each other using one-way analysis of variance.

[0084] 3 Research results

[0085] 3.1 Effect of the new Chinese medicine composition on specific alanine aminotransferase in the experimental model Kunming (male) mice

[0086] The results showed that compared with the negative blank group, the specific alanine aminotransferase of Kunming (male) mice in the model demonstration group increased significantly (P < 0.05), and the data difference was statistically significant; compared with the model demonstration group, the specific alanine aminotransferase of Kunming (male) mice in the positive intervention group, the higher dose group, and the medium treatment group decreased significantly (P < 0.05), and the data difference was statistically significant; compared with the model demonstration group, the specific alanine aminotransferase of Kunming (male) mice in the lower dose group did not change significantly (P > 0.05), and the data difference was not statistically significant. See Table 1. Figure 1 The horizontal axis of the figure is the group, and the vertical axis is the specific alanine aminotransferase (U / L).

[0087] Table 1 Effects of the novel Chinese medicine composition on specific alanine aminotransferase in the experimental model Kunming (male) mice ( ±s)

[0088]

[0089] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0090] 3.2 Effect of the new Chinese medicine composition on specific aspartate aminotransferase in the experimental model Kunming (male) mice

[0091] The results showed that compared with the negative blank group, the specific aspartate aminotransferase of Kunming (male) mice in the model demonstration group increased significantly ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the positive intervention group, the high-dose group, and the medium-treatment group experimental model Kunming (male) mouse specific aspartate aminotransferase was significantly reduced ( P ＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the specific aspartate aminotransferase of Kunming (male) mice in the experimental model of the lower dose group did not change significantly ( P>0.05), the data difference is not statistically significant. See Table 2. Figure 2 The horizontal axis of the figure is the group, and the vertical axis is the specific aspartate aminotransferase (U / L).

[0092] Table 2 Effects of the novel Chinese medicine composition on specific aspartate aminotransferase in the experimental model Kunming (male) mice ( ±s)

[0093]

[0094] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0095] 3.3 Effect of the new Chinese medicine composition on hyaluronic acid in the experimental model Kunming (male) mice

[0096] The results showed that compared with the negative blank group, the hyaluronic acid in the Kunming (male) mice in the model demonstration group increased significantly ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the positive intervention group, the high dose group, and the medium treatment group experimental model Kunming (male) mice hyaluronic acid was significantly reduced ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the hyaluronic acid changes in Kunming (male) mice in the experimental model of the lower dose group were not obvious ( P >0.05), the data difference is not statistically significant. See Table 3. Figure 3 The horizontal axis of the figure is the group, and the vertical axis is hyaluronic acid (mg / mL).

[0097] Table 3 Effects of the novel Chinese medicine composition on hyaluronic acid in the experimental model Kunming (male) mice ( ±s)

[0098]

[0099] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0100] 3.4 Effect of the new Chinese medicine composition on laminin in the experimental model Kunming (male) mice

[0101] The results showed that compared with the negative blank group, the laminin level of Kunming (male) mice in the model demonstration group increased significantly ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the positive intervention group, the high-dose group, and the medium-treatment group experimental model Kunming (male) mouse laminin was significantly reduced ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the lower dose experimental model Kunming (male) mouse laminin changes were not obvious ( P >0.05), the data difference is not statistically significant. See Table 4. Figure 4 , the horizontal axis of the figure is the group, and the vertical axis is laminin (mg / mL).

[0102] Table 4 Effects of the novel Chinese medicine composition on laminin in the experimental model Kunming (male) mice ( ±s)

[0103]

[0104] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0105] 3.5 Effect of the new Chinese medicine composition on the SOD content of the experimental model Kunming (male) mice

[0106] The results showed that compared with the negative blank group, the SOD content of Kunming (male) mice in the model demonstration group was significantly reduced ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the SOD content of Kunming (male) mice in the positive intervention group, the high-dose group, and the medium-treatment group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the SOD content of Kunming (male) mice in the experimental model group with a lower dose did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 5. Figure 5 The horizontal axis of the figure is the group, and the vertical axis is the SOD content (U / mg).

[0107] Table 5 Effects of the new Chinese medicine composition on the SOD content of Kunming (male) mice in the experimental model ( ±s)

[0108]

[0109] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0110] 3.6 Effect of the new Chinese medicine composition on the MDA content of the experimental model Kunming (male) mice

[0111] The results showed that compared with the negative blank group, the MDA content of Kunming (male) mice in the model demonstration group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the MDA content of Kunming (male) mice in the positive intervention group, the high-dose group, and the medium-treatment group was significantly reduced ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the MDA content of Kunming (male) mice in the experimental model group with a lower dose did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 6. Figure 6 The horizontal axis of the figure is the group, and the vertical axis is the MDA content (mg / mL).

[0112] Table 6 Effect of the novel Chinese medicine composition on the MDA content of the experimental model Kunming (male) mice ( ±s)

[0113]

[0114] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0115] 3.7 Effect of the new Chinese medicine composition on serum tumor necrosis factor-α content in experimental model Kunming (male) mice

[0116] The results showed that compared with the negative blank group, the serum tumor necrosis factor-α content of Kunming (male) mice in the model demonstration group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the serum tumor necrosis factor-α content of Kunming (male) mice in the positive intervention group, the high-dose group, and the medium-treatment group was significantly reduced ( P＜0.05), the data difference was statistically significant; compared with the model demonstration group, the serum tumor necrosis factor-α content of Kunming (male) mice in the experimental model group with a lower dose did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 7. Figure 7 The horizontal axis of the figure is the group, and the vertical axis is tumor necrosis factor-α (ng / L).

[0117] Table 7 Effect of the novel Chinese medicine composition on the serum tumor necrosis factor-α content of the experimental model Kunming (male) mice ( ±s)

[0118]

[0119] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0120] 3.8 Effect of the new Chinese medicine composition on serum interleukin-1β content in Kunming (male) mice

[0121] The results showed that compared with the negative blank group, the serum interleukin-1β content of Kunming (male) mice in the model demonstration group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the serum interleukin-1β content of Kunming (male) mice in the positive intervention group, the high-dose group, and the medium-treatment group was significantly reduced ( P ＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the serum interleukin-1β content of Kunming (male) mice in the experimental model group with a lower dose did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 8. Figure 8 The horizontal axis of the figure is the group, and the vertical axis is interleukin-1β (pg / mL).

[0122] Table 8 Effect of the novel Chinese medicine composition on serum interleukin-1β content in Kunming (male) mice ( ±s)

[0123]

[0124] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group:# P <0.05, ## P >0.05

[0125] 3.9 Effect of the new Chinese medicine combination on liver transforming growth factor-β1 protein in Kunming (male) mice

[0126] The results showed that compared with the negative blank group, the liver transforming growth factor-β1 protein of Kunming (male) mice in the model demonstration group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the positive intervention group, the high-dose group, and the medium-treatment group experimental model Kunming (male) mouse liver transforming growth factor-β1 protein was significantly reduced ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the lower dose experimental model Kunming (male) mice liver transforming growth factor-β1 protein did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 9. Fig. 9 The horizontal axis of the figure is the group, and the vertical axis is the liver transforming growth factor-β1 protein (average optical density value).

[0127] Table 9 Effects of the novel Chinese medicine composition on the liver transforming growth factor-β1 protein in the experimental model Kunming (male) mice ( ±s)

[0128]

[0129] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0130] 3.10 Effect of the new Chinese medicine combination on the transforming growth factor-β1 gene in the liver of Kunming (male) mice

[0131] The results showed that compared with the negative blank group, the expression of transforming growth factor-β1 gene in the liver of Kunming (male) mice in the model demonstration group was significantly increased ( P＜ 0.05), the data difference was statistically significant; compared with the model demonstration group, the positive intervention group, the high dose group, and the medium treatment group experimental model Kunming (male) mouse liver transforming growth factor-β1 gene was significantly reduced ( P＜0.05), the data difference was statistically significant; compared with the model demonstration group, the lower dose experimental model Kunming (male) mice liver transforming growth factor-β1 gene changes were not obvious ( P >0.05), the data difference is not statistically significant. See Table 10. Fig.10 , the horizontal axis of the figure is the group, and the vertical axis is the liver transforming growth factor-β1 gene (relative expression level).

[0132] Table 10 Effects of the novel Chinese medicine composition on the transforming growth factor-β1 gene in the liver of Kunming (male) mice ( ±s)

[0133]

[0134] Note: Compared with the negative blank group: ** P <0.05; compared with the model demonstration group: # P <0.05, ## P >0.05

[0135] 3.11 Effects of the new Chinese medicine composition on the renal index and brain index of the experimental model Kunming (male) mice

[0136] The results showed that compared with the negative blank group, the renal index and brain index of the model demonstration group mice did not change significantly ( P >0.05), the data difference was not statistically significant; compared with the model demonstration group, the kidney index and brain index of mice in the positive intervention group, the higher dose group, the medium treatment group, and the lower dose group did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 11. Fig.11 The horizontal axis of the figure is the group; the vertical axis is the kidney index (mg / g) and the brain index (mg / g).

[0137] Table 11 Effects of the novel Chinese medicine composition on the renal index and brain index of the experimental model Kunming (male) mice ( ±s, n=7)

[0138]

[0139] Note: Compared with the negative blank group: ** P >0.05; compared with the model demonstration group: ## P >0.05

[0140] 3.12 Effects of the new Chinese medicine combination on the cardiac index and lung index of the experimental model Kunming (male) mice

[0141] The results showed that compared with the negative blank group, the heart index and lung index of the model demonstration group mice did not change significantly ( P >0.05), the data difference was not statistically significant; compared with the model demonstration group, the heart index and lung index of mice in the positive intervention group, the higher dose group, the medium treatment group, and the lower dose group did not change significantly ( P >0.05), the data difference is not statistically significant. See Table 12. Fig.12 The horizontal axis of the figure is the group; the vertical axis is the heart index (mg / g) and the lung index (mg / g).

[0142] Table 12 Effects of the new Chinese medicine composition on the cardiac index and lung index of the experimental model Kunming (male) mice ( ±s, n=7)

[0143]

[0144] Note: Compared with the negative blank group: ** P >0.05; compared with the model demonstration group: ## P >0.05

[0145] 3.13 Effect of the new Chinese medicine composition on the body weight of Kunming (male) mice

[0146] The results showed that compared with the negative blank group Kunming (male) mice on days 0, 15 and 30, the body weight of the model demonstration group Kunming (male) mice on days 0, 15 and 30 did not change significantly ( P >0.05), the data difference was not statistically significant; compared with the Kunming (male) mice in the model demonstration group on days 0, 15, and 30, the weight changes of the Kunming (male) mice in the positive intervention group, the higher dose group, the medium treatment group, and the lower dose group were not obvious on days 0, 15, and 30 ( P >0.05), the data difference is not statistically significant. See Table 13. Fig.13 The horizontal axis of this figure is the group; the vertical axis of this figure is the weight (g) of Kunming (male) mice.

[0147] Table 13 Effects of the novel Chinese medicine composition on the body weight of the experimental model Kunming (male) mice ( ±s, n=7)

[0148]

[0149] Note: Compared with the negative blank group: ** P >0.05; compared with the model demonstration group:## P >0.05

[0150] In summary, the present invention uses liver function indicators to evaluate the basic changes in liver fibrosis. The results showed that compared with the negative blank group, the specific alanine aminotransferase and specific aspartate aminotransferase of Kunming (male) mice in the model demonstration group experimental model increased significantly ( P＜ 0.05), indicating that the model was successfully established and the liver function level decreased; compared with the model demonstration group, the positive intervention group, the high-dose group, and the medium-treatment group experimental model Kunming (male) mice specific alanine aminotransferase and specific aspartate aminotransferase were significantly reduced ( P＜ 0.05), the changes of specific alanine aminotransferase and specific aspartate aminotransferase in Kunming (male) mice in the experimental model of the lower dose group were not obvious ( P >0.05), indicating that the high dose and medium dose of the novel Chinese medicine composition of the present invention can improve liver function indicators, which is beneficial for liver fibrosis. At the same time, animal experiments show that the high dose (18.40g / kg) and medium dose (9.20g / kg) of the novel Chinese medicine composition can improve serum transaminase and its hyaluronic acid index, inflammatory mediator index, antioxidant index, liver transforming growth factor-β1, etc. of the experimental model Kunming (male) mice, but have no effect on the organ index and body weight of the main organs of the experimental model Kunming (male) mice, indicating that the novel Chinese medicine composition of the present invention is effective for liver fibrosis and has no side effects.

[0151] Although the description of the present invention has been quite detailed and specifically describes several described embodiments, it is not intended to be limited to any of these details or embodiments or any particular embodiment, but should be regarded as providing a broad possible interpretation of these claims in view of the prior art by reference to the appended claims, thereby effectively covering the intended scope of the present invention. In addition, the above description of the present invention is based on the embodiments foreseeable by the inventor, and its purpose is to provide a useful description, and those non-substantial changes to the present invention that have not yet been foreseen may still represent equivalent changes to the present invention.

Claims

1. A Chinese medicine composition for treating liver fibrosis, characterized in that: The raw materials and dosages of the traditional Chinese medicine composition are: 22-25 parts by weight of Eucommia ulmoides leaves, 22-25 parts by weight of Rhizoma Cynomorii, 5-8 parts by weight of Fenugreek, 5-7 parts by weight of Ginseng leaves, 5-8 parts by weight of Campsis creeper, and 2-5 parts by weight of Acorus calamus.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials and dosages of the traditional Chinese medicine composition are as follows: 22.5 parts by weight of Eucommia ulmoides leaves, 24.5 parts by weight of Rhizoma Cynomorii, 6.75 parts by weight of Fenugreek, 6.5 parts by weight of Ginseng leaves, 6.75 parts by weight of Campsis creeper, and 3.75 parts by weight of Acorus calamus.

3. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating liver fibrosis.

4. A clinically suitable drug for treating liver fibrosis, characterized in that: The Chinese medicine composition according to any one of claims 1 to 2 is added with auxiliary materials required for preparation molding and is prepared according to a conventional method for preparing pharmaceutical preparations.

5. The drug according to claim 4, characterized in that The drug is in oral dosage form.

6. The drug according to claim 5, characterized in that The oral dosage form is decoction, powder, capsule, pill, granule, tablet or oral liquid.

7. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: (1) Weigh the raw materials according to the weight proportions described in claim 1 or 2; (2) After mixing the raw materials weighed in step (1), adding distilled water in an amount of 5 to 15 times the total weight of the raw materials, soaking for 1.5 to 2.5 hours, then decocting for 1.5 to 2.5 hours, filtering, and obtaining a first Chinese medicine composition filtrate and a residue; (3) adding the same volume of distilled water as that in step (1) to the residue of the traditional Chinese medicine composition obtained in step (2), soaking the residue of the traditional Chinese medicine composition for 1.5-2.5 hours, decocting the residue of the traditional Chinese medicine composition for 1.5-2.5 hours, filtering, and obtaining a second filtrate of the traditional Chinese medicine composition; (4) The first filtrate of the Chinese medicine composition and the second filtrate of the Chinese medicine composition are combined and mixed to obtain a water decoction of the Chinese medicine composition for liver fibrosis.

8. The method according to claim 7, characterized in that The filtration is performed through gauze, and 2 layers of gauze, 4 layers of gauze, 10 layers of gauze, and 20 layers of gauze are used in sequence for filtration.

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