Traditional Chinese medicine compound preparation for preventing hepatic fibrosis and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine compound preparation for preventing hepatic fibrosis. The traditional Chinese medicine compound preparation is prepared by extracting the following traditional Chinese medicine decoction pieces in parts by weight: 10-20 parts of orange peel, 5-10 parts of rhizoma cyperi, 8-12 parts of citron, 5-10 parts of radix aucklandiae, 20-30 parts of white paeony root, 5-10 parts of rose, 15-25 parts of ligusticum wallichii, 10-20 parts of codonopsis pilosula, 8-12 parts of bighead atractylodes rhizome, 20-30 parts of poria cocos, 10-20 parts of coix seed, 20-30 parts of hawthorn, 10-20 parts of malt and 8-12 parts of endothelium corneum gigeriae galli. Pharmacodynamic test results of the traditional Chinese medicine compound preparation show that the traditional Chinese medicine compound preparation has the effect of remarkably preventing hepatic fibrosis lesion injury.

Description

Technical Field

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

[0002] Liver fibrosis refers to the diffuse excessive deposition and abnormal distribution of extracellular matrix such as collagen and proteoglycans after repeated destruction of liver cells during the development of chronic liver disease. Further development of liver fibrosis can cause structural disorder of the liver, nodular regeneration of liver cells, and the formation of pseudolobular structure, i.e., cirrhosis. Common diseases that cause liver fibrosis include viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, cholestasis, autoimmune liver disease, etc. Liver fibrosis cannot heal on its own, and it is difficult to heal after treatment. The prognosis of liver fibrosis varies greatly among different patients, mainly depending on whether the primary disease can be effectively controlled. If the cause is removed through standardized treatment, such as reversal of fatty liver, eradication of viruses, and discontinuation of hepatotoxic drugs, the condition of liver fibrosis can remain stable for a long time or even reverse. If chronic liver damage persists in patients, the condition gradually progresses, and after several years to decades, it can progress to cirrhosis, eventually leading to death. However, there is currently no clinically effective treatment strategy for liver fibrosis. How to effectively prevent and treat liver fibrosis is a major problem that plagues the medical community today. Therefore, the development of safe and effective drugs for the prevention and treatment of liver fibrosis has extremely important clinical significance.

[0003] In order to solve the above problems, our laboratory, based on a large number of experimental studies, provides a Chinese herbal compound preparation that is both medicine and food and is used in the preparation of a medicine to prevent liver fibrosis. This belongs to the field of Chinese medicine pharmaceutical manufacturing. The Chinese herbal compound preparation is a Chinese medicine composition. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicinal compound preparation for preventing liver fibrosis and a preparation method thereof.

[0005] A traditional Chinese medicine compound preparation for preventing liver fibrosis is prepared by extracting the following traditional Chinese medicine pieces in parts by weight: 10-20 parts of tangerine peel, 5-10 parts of cyperus rotundus, 8-12 parts of citron, 5-10 parts of costusroot, 20-30 parts of white peony root, 5-10 parts of rose, 15-25 parts of chuanxiong, 10-20 parts of codonopsis pilosula, 8-12 parts of atractylodes macrocephala, 20-30 parts of tuckahoe, 10-20 parts of coix seed, 20-30 parts of hawthorn, 10-20 parts of malt, and 8-12 parts of chicken's gizzard lining.

[0006] The traditional Chinese medicine compound preparation for preventing liver fibrosis is prepared by extracting the following Chinese herbal pieces by weight: 15 parts of tangerine peel, 8 parts of cyperus rotundus, 10 parts of citron, 8 parts of costus root, 25 parts of white peony root, 8 parts of rose flower, 20 parts of ligusticum wallichii, 15 parts of codonopsis pilosula, 10 parts of atractylodes macrocephala, 25 parts of poria cocos, 15 parts of coix seed, 25 parts of hawthorn fruit, 15 parts of fructus hordei germinatus, and 10 parts of endothelium corneum gigeriae galli.

[0007] The preparation method of the traditional Chinese medicine compound preparation for preventing liver fibrosis includes the following steps:

[0008] (1) Take tangerine peel, cyperus rotundus, citron, costus root, and ligusticum wallichii, extract volatile oil by steam distillation method, and reserve it after cyclodextrin inclusion.

[0009] (2) Take the residues of tangerine peel, cyperus rotundus, citron, costus root, and ligusticum wallichii after steam distillation, combine them with other Chinese herbal pieces, add the aromatic water used for extracting volatile oil, then add water to 10 times the total weight of the Chinese herbal pieces, decoct for 2 hours, filter, add water to the residues to 10 times the total weight of the Chinese herbal pieces again, decoct for 2 hours, filter, combine the decoction liquids, and concentrate to a concentrated liquid with a relative density of 1.15 at 25°C.

[0010] (3) In the concentrated liquid obtained in step (2), add 95% ethanol, adjust the alcohol content to 75%, stand for 48 hours, take the supernatant, and concentrate to an extract with a relative density of 1.30 at 25°C.

[0011] (4) Take the extract obtained in step (3), spray dry it, add the volatile oil cyclodextrin inclusion complex and auxiliary materials, and prepare it into one of granules, tablets, and capsules.

[0012] The application of the traditional Chinese medicine compound preparation for preventing liver fibrosis in the preparation of drugs for preventing liver fibrosis.

[0013] There is no record of the disease name "liver fibrosis" in traditional Chinese medicine. It can be summarized by the TCM disease name according to the patient's clinical manifestations, and it is often classified into the categories of "accumulation" and "flank pain". The primary causes of liver fibrosis vary, and although the clinical manifestations are different, the basic pathogenesis is that the body is weak and the evil is strong, the evil poison has been long-term, the liver collaterals are damaged, and the qi is stagnant and blood is stagnant, which can be summarized as "deficiency leads to accumulation". Among them, liver depression and spleen deficiency are the most common clinical syndromes. In traditional Chinese medicine theory, the liver is responsible for regulating emotions. It likes to be smooth and hates depression. It regulates emotions. Long-term emotional discomfort, such as depression, anger, anxiety and other negative emotions, can lead to liver qi stagnation. When emotions are not smooth, the liver loses its ability to vent and the liver loses its ability to be smooth, thus forming liver depression. The dysfunction of the liver's venting function will first affect the circulation of qi and blood. When qi flows, blood flows, and when qi stagnates, blood stagnates. From the perspective of modern medicine, this blood stasis state may be related to microcirculation disorders in the liver. At the same time, liver depression will also affect the excretion of bile. If bile is not excreted smoothly, symptoms such as fullness in the ribs and bitter taste in the mouth may occur. Moreover, if liver depression lasts for a long time, it will turn into fire and generate heat, causing irritability, red eyes and other hot symptoms, further aggravating the pathological changes of the liver. Secondly, if patients with chronic liver disease have long-term bad eating habits such as irregular diet, overeating, overeating raw, cold and greasy food, it is also a common cause of spleen deficiency. The spleen and stomach are responsible for transporting and transforming the essence of water and grain. When the diet damages the spleen and stomach, the transportation and transformation function of the spleen and stomach is weakened, resulting in the inability to distribute the essence of water and grain throughout the body, and the lack of source for the production of qi and blood. In addition to diet, in the theory of the five elements, the liver wood overcomes the spleen earth. After liver depression, the liver qi goes against the spleen. The liver depression overcoming the spleen will cause the spleen and stomach to have abnormal transportation and ascending and descending functions, and digestive disorders such as diarrhea or constipation will occur. Liver depression and spleen deficiency will lead to abnormal metabolism of qi, blood and body fluids. Liver depression will cause qi stagnation and blood stasis, and spleen deficiency will cause poor transportation and transformation of water and moisture. Blood stasis and water and moisture will fight each other in the liver to form pathological products. From the perspective of modern medicine, the accumulation of these pathological products will stimulate the proliferation of fibrous tissue in the liver. Blood stasis and water dampness will cause changes in the microenvironment of liver cells, prompting the activation of hepatic stellate cells, which will then secrete a large amount of extracellular matrix, such as collagen, leading to the occurrence of liver fibrosis.

[0014] In summary, liver fibrosis is essentially liver parenchymal injury, with deficiency of yin essence, which fails to transform qi for use, resulting in stagnation of qi and blood, and coagulation of blood accumulating and not dispersing, forming stasis. Among them, the syndrome of liver depression and spleen deficiency is the most common in clinical practice. The traditional Chinese medicine compound preparation of medicated diet homologous in this invention is created for this common clinical syndrome type. Based on the modification of Chaihu Shugan Powder, it selects the medicated diet homologous traditional Chinese medicines with the effect of soothing the liver and regulating qi, and adds traditional Chinese medicines for strengthening the spleen and eliminating stasis. The whole formula is composed of medicated diet homologous traditional Chinese medicine ingredients, with low toxicity and few side effects, having the dual effects of nutrition and health care, and being easily accepted by patients. Among them, tangerine peel and cyperus rotundus are used as the monarch drugs, playing a synergistic effect in promoting qi and relieving depression. Tangerine peel focuses on dispersing qi stagnation, while cyperus rotundus focuses on soothing the liver and regulating qi. The combination of the two can more effectively regulate qi movement, enhance the effect of soothing the liver and relieving depression, so that the liver qi can be relieved, and relieve the symptoms such as hypochondriac pain and poor mood caused by liver depression. White peony root, costus root, citron, codonopsis pilosula, atractylodes macrocephala, poria cocos, and coix seed are the ministerial drugs. Among them, white peony root soothes the liver, enabling the qi and blood of the liver to be harmonized. "Ben Cao Qiu Zhen" expounds on white peony root: "White peony root has the power of astringing yin and nourishing the nutrient qi, so it can nourish blood and soothe the liver, suppress the hyperactive liver yang, and relieve spasm and pain." Costus root and citron promote qi movement and drive the circulation of qi and blood. Costus root mainly acts on the spleen and stomach. "Ben Cao Hui Yan" states about costus root: "Costus root is the general medicine for regulating qi, harmonizing the stomach qi,......, regulating the ascending and descending qi, reaching the exterior qi, and dredging the interior qi, managing all qi in the body, both inside and outside." The spleen and stomach are the pivotal points for the ascending and descending of qi movement. When qi stagnation occurs, the ascending and descending function is disordered, causing symptoms such as abdominal distension and belching. Costus root is pungent and warm in nature, promoting qi movement, entering the spleen and stomach meridians, dispelling qi stagnation in the spleen and stomach, and restoring its orderly ascending and descending. Citron focuses on soothing the liver and regulating qi, enabling the liver depression to be resolved and the qi and blood to be unobstructed. "Xue Zheng Lun" says: "The liver belongs to wood. When the qi of wood is harmonious, smooth and unobstructed, it will not be suppressed, then the blood vessels will be unobstructed." The combination of the three enables qi movement to promote blood circulation. In the disease state of liver depression and qi stagnation, qi and blood stasis, this compatibility can improve the blood supply of the liver and surrounding tissues and prevent the formation of blood stasis. Codonopsis pilosula and atractylodes macrocephala strengthen the spleen and replenish qi; poria cocos and coix seed promote diuresis and percolate dampness. "Codonopsis pilosula can strengthen the spleen and nourish the stomach, moisten the lungs and promote fluid production, strengthen the middle qi,......, vibrate the middle qi, without the disadvantage of being dry and rigid." Codonopsis pilosula focuses on strengthening the spleen and nourishing the stomach, strengthening the transportation and transformation of the middle qi, with a mild nature, nourishing the yin of the spleen and stomach without being dry. Atractylodes macrocephala is good at removing dampness and drying dampness, strengthening the spleen and replenishing qi, being able to remove dampness in the spleen and stomach and invigorate the yang qi of the spleen and stomach. The combination of the two, one moistening and one drying, restricts and synergizes with each other. The spleen prefers dryness to dampness. Adding poria cocos and coix seed to promote diuresis and percolate dampness, especially for the internal retention of water and dampness caused by spleen deficiency and failure of transportation and transformation in the syndrome of liver depression and spleen deficiency, such as edema, diarrhea and other symptoms, and at the same time helps to restore the function of the spleen and stomach. The combination of the two with codonopsis pilosula and atractylodes macrocephala jointly plays the effect of strengthening the spleen and removing dampness.

[0015] Rose, Ligusticum wallichii, Hawthorn, Fructus Hordei Germinatus, and Endothelium Corneum Gigeriae Galli are adjuvant drugs. Among them, rose and Ligusticum wallichii promote blood circulation and qi movement, soothe the liver and relieve depression. In "Supplements to Compendium of Materia Medica", rose is recorded as "regulating blood, activating blood circulation, regulating qi". "Collected Commentaries on Materia Medica" states that Ligusticum wallichii "ascends to the head, regulates menstruation downward, and relieves stasis in the middle". The combination of rose and Ligusticum wallichii can regulate both qi and blood. Ligusticum wallichii focuses on promoting blood circulation, while rose focuses on regulating blood and relieving qi stagnation and depression. The combination of the two can enhance the effects of promoting qi and blood circulation and soothe the liver and relieve depression. In liver fibrosis with liver depression and spleen deficiency syndrome, qi and blood stasis is the main pathological link. After the two drugs are combined, it can improve the qi and blood circulation of the liver, make the stagnant qi and blood unobstructed, relieve the blood stasis state of the liver, and prevent or delay the process of liver fibrosis.

[0016] In liver fibrosis with liver depression and spleen deficiency syndrome, liver depression can horizontally invade the spleen, resulting in the spleen losing its transportation and transformation function, and food cannot be digested and absorbed normally, easily leading to food retention. Long-term food retention will produce pathological products such as dampness and heat, which in turn will aggravate the state of liver depression and spleen deficiency, forming a vicious cycle. Therefore, hawthorn, Fructus Hordei Germinatus, and Endothelium Corneum Gigeriae Galli are added to the formula to promote digestion and harmonize the stomach. Hawthorn not only has the effect of promoting digestion, but also has the effect of promoting blood circulation and removing blood stasis, which can improve the blood circulation of the liver. Fructus Hordei Germinatus also has a certain effect of soothe the liver and relieve depression; "Medical Compendium of Chinese and Western Medicine" records that Endothelium Corneum Gigeriae Galli "can eliminate accumulations no matter where they are in the viscera". The whole formula has the effects of soothe the liver and regulate qi, tonify qi and strengthen the spleen, and has a definite curative effect on liver fibrosis with liver depression and spleen deficiency syndrome.

[0017] Experimental studies have shown that prophylactic administration of the present invention can reduce the levels of ALT, AST, ALP, LDH, and TBIL in the serum of model mice, reduce the levels of HA, LN, PC-III, and IV-C in the serum of model mice, reduce the level expression of fibrosis-specific marker α-SMA in the liver, and reduce the deposition of collagen fibers in the liver. Description of the Drawings

[0018] Appendix Figure 1 This is the pharmacodynamic study on the prevention of liver fibrosis by the present invention, in which Figure 1 -A shows the effect of the present invention on serum liver injury indicators (ALT, AST, ALP, LDH, and TBIL) in fibrotic mice; Figure 1 -B shows the effect of the present invention on serum liver injury indicators (levels of HA, LN, PC-III, and IV-C) in fibrotic mice; Figure 1 -C shows the effect of the present invention on the level of fibrosis-specific marker α-SMA in the liver of fibrotic mice; Figure 1 -D shows the effect of the present invention on the deposition of collagen fibers in the liver of fibrotic mice.

[0019] Appendix Figure 2 This is the effect of the present invention on other organs of fibrotic mice (pathological section HE staining). Detailed Embodiments

[0020] The preparation of the traditional Chinese medicine compound preparation with both medicinal and edible properties and its efficacy in preventing liver fibrosis according to the present invention will be further described below through examples.

[0021] Example 1: Take 150 g of tangerine peel, 80 g of cyperus rotundus, 100 g of citron, 80 g of costus root, 250 g of white peony root, 80 g of rose flower, 200 g of chuanxiong rhizome, 150 g of codonopsis pilosula, 100 g of atractylodes macrocephala, 250 g of poria cocos, 150 g of coix seed, 250 g of hawthorn fruit, 150 g of malt, and 100 g of chicken gizzard-membrane. The preparation method includes the following steps:

[0022] (1) Take tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome, and extract the volatile oil by steam distillation. After inclusion with cyclodextrin, it is reserved for later use.

[0023] (2) Take the residues of tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome after steam distillation, combine them with other traditional Chinese medicine pieces, add the aromatic water during the extraction of the volatile oil, then add water to 10 times the total weight of the traditional Chinese medicine pieces, decoct for 2 hours, filter. Add water to the residues again to 10 times the total weight of the traditional Chinese medicine pieces, decoct for 2 hours, filter. Combine the decoction liquids and concentrate to a concentrated liquid with a relative density of 1.15 at 25°C.

[0024] (3) In the concentrated liquid obtained in step (2), add 95% ethanol to adjust the alcohol content to 75%, stand for 48 hours, take the supernatant, and concentrate to an extract with a relative density of 1.30 at 25°C.

[0025] (4) Take the extract obtained in step (3), spray dry it, add the cyclodextrin inclusion complex of the volatile oil and starch, and prepare it into granules.

[0026] Example 2: Take 150 g of tangerine peel, 80 g of cyperus rotundus, 100 g of citron, 80 g of costus root, 250 g of white peony root, 80 g of rose flower, 200 g of chuanxiong rhizome, 150 g of codonopsis pilosula, 100 g of atractylodes macrocephala, 250 g of poria cocos, 150 g of coix seed, 250 g of hawthorn fruit, 150 g of malt, and 100 g of chicken gizzard-membrane. The preparation method includes the following steps:

[0027] (1) Take tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome, and extract the volatile oil by steam distillation. After inclusion with cyclodextrin, it is reserved for later use.

[0028] (2) Take the residues of tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome after steam distillation, combine them with other traditional Chinese medicine pieces, add the aromatic water during the extraction of the volatile oil, then add water to 10 times the total weight of the traditional Chinese medicine pieces, decoct for 2 hours, filter. Add water to the residues again to 10 times the total weight of the traditional Chinese medicine pieces, decoct for 2 hours, filter. Combine the decoction liquids and concentrate to a concentrated liquid with a relative density of 1.15 at 25°C.

[0029] (3) In the concentrated solution obtained in step (2), add 95% ethanol to adjust the alcohol content to 75%, let it stand for 48 hours, take the supernatant, and concentrate it to an extract with a relative density of 1.30 at 25°C;

[0030] (4) Take the extract obtained in step (3), spray-dry it, add the volatile oil cyclodextrin clathrate and dextrin, and prepare into tablets.

[0031] Example 3: Take 150 g of tangerine peel, 80 g of cyperus rotundus, 100 g of citron, 80 g of costus root, 250 g of white peony root, 80 g of rose flower, 200 g of chuanxiong rhizome, 150 g of codonopsis pilosula, 100 g of atractylodes macrocephala, 250 g of poria cocos, 150 g of coix seed, 250 g of hawthorn fruit, 150 g of malt, and 100 g of chicken gizzard-membrane. The preparation method includes the following steps:

[0032] (1) Take tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome, extract the volatile oil by steam distillation method, and reserve it after cyclodextrin clathration;

[0033] (2) Take the residues of tangerine peel, cyperus rotundus, citron, costus root, and chuanxiong rhizome after steam distillation, combine them with other traditional Chinese medicine pieces, add the aromatic water during the extraction of volatile oil, then add water to 10 times the total weight of the traditional Chinese medicine pieces, decoct for 2 hours, filter, add water to the residues to 10 times the total weight of the traditional Chinese medicine pieces again, decoct for 2 hours, filter, combine the decoction liquids, and concentrate to a concentrated solution with a relative density of 1.15 at 25°C;

[0034] (3) In the concentrated solution obtained in step (2), add 95% ethanol to adjust the alcohol content to 75%, let it stand for 48 hours, take the supernatant, and concentrate it to an extract with a relative density of 1.30 at 25°C;

[0035] (4) Take the extract obtained in step (3), spray-dry it, add the volatile oil cyclodextrin clathrate and starch, and prepare into capsules.

[0036] Example 4: Pharmacological action research on the prevention of liver fibrosis of the present invention

[0037] 4.1 Animal model preparation: 50 male ICR mice (body weight 18 g - 22 g) were randomly divided into a normal control group, a model group, a positive medicine silymarin group (dose 100 mg / kg), a low-dose group of the granule of Example 1 of the present invention (Low, dose: 300 mg crude drug equivalent / kg), and a high-dose group of the granule of Example 1 of the present invention (High, dose: 600 mg crude drug equivalent / kg), with 10 mice in each group. After the mice were sent to the GLP experimental animal center, they were given free access to food and water. The mouse feed met the Chinese standard (LAD1000), and the mouse drinking water met the requirements of "Laboratory Animal Environment and Facilities" (GB14925 - 2010). The mice were given a standard light cycle of 14 hours of light and 10 hours of darkness, the room temperature was controlled between 18 - 26 °C, the relative humidity was maintained between 40 - 70%, the noise was controlled below 85 decibels, the ammonia concentration was maintained below 20 ppm, and the ventilation was 8 - 12 times per hour. After 1 week of adaptive feeding, all the mice were subjected to subsequent experiments. CCl 4 was mixed with olive oil at a volume ratio of 1:9 to prepare a 10% CCl 4 solution for establishing a liver fibrosis model.

[0038] 4.2 Administration regimen: The traditional Chinese medicine composition prepared according to Example 1 was used for prophylactic drug administration. Four weeks before CCl 4 modeling, the high- and low-dose groups of the traditional Chinese medicine composition were first prophylactically administered, intragastrically at the above doses, once a day for 4 weeks. After that, except for the normal control group, the other 4 groups of mice were intraperitoneally injected with 10% CCl 4 solution at a dose of 0.2 ml / 20 g, 3 times a week for 4 weeks. The normal control group of mice was intraperitoneally injected with the same volume of olive oil at the same time point and similar position as a blank control. During the 4-week process of intraperitoneal injection of 10% CCl 4 solution, the positive medicine silymarin group and the high- and low-dose groups of the traditional Chinese medicine composition were continuously intragastrically administered at the above doses, once a day for 4 weeks. After all the experiments were completed, in strict accordance with the standard operating procedures (SOP) for euthanasia of experimental animals (rats and rabbits), each mouse was weighed and recorded, and then anesthetized by intraperitoneal injection of 50 mg / kg pentobarbital solution. Blood was quickly collected by eye enucleation. Then, the abdomen was opened to separate the liver, and a complete liver picture of each mouse was collected using a camera. Each liver was weighed and recorded using an analytical balance. After the collected blood samples were allowed to stand at room temperature for 2 hours, they were centrifuged at 3500 revolutions per minute for 15 minutes, the supernatant was aspirated, and stored at -20 °C for subsequent serological index detection. A small part of each mouse liver was fixed in 10% formalin solution for subsequent histopathological examination.

[0039] 4.3 Experimental results:

[0040] 4.3.1 Effects of the present invention on serum liver injury indicators in fibrotic mice

[0041] We detected the serum liver injury indicators in fibrotic mice using a biochemical analyzer. The results showed that prophylactic administration of the traditional Chinese medicine composition of the present invention could significantly reduce the levels of ALT, AST, ALP, LDH, and TBIL in the serum of model mice ( Figure 1 -A). In addition, this traditional Chinese medicine composition could also significantly reduce the levels of HA, LN, PC-III, and IV-C ( Figure 1 -B).

[0042] 4.3.2 Effects of the present invention on the level of the fibrotic specific marker α-SMA in fibrotic mice

[0043] The staining results of liver pathological sections showed that prophylactic administration of this traditional Chinese medicine composition could improve the degree of liver injury and simultaneously reduce the level of the fibrotic specific marker α-SMA in the liver ( Figure 1 -C).

[0044] 4.3.3 Effects of the present invention on collagen fiber deposition in the liver of fibrotic mice

[0045] The staining results of liver pathological sections showed that prophylactic administration of the present invention could reduce collagen fiber deposition in the liver of fibrotic mice ( Figure 1 -D).

[0046] Example 5: Effects of the present invention on other organs of liver fibrotic mice

[0047] We performed HE staining on pathological sections of the heart, brain, spleen, lung, and kidney of mice after continuously administering the high-dose traditional Chinese medicine composition of the present invention for 8 weeks ( Figure 2 ), and preliminarily evaluated the safety of the traditional Chinese medicine composition of the present invention in mice. The results showed that compared with the normal control group, the high dose of the traditional Chinese medicine composition of the present invention had no obvious toxicity to the heart, brain, spleen, lung, and kidney of mice, indicating that the traditional Chinese medicine composition of the present invention has good safety.

[0048] In summary, we found that the medicated diet homologous traditional Chinese medicine compound preparation of the present invention could significantly prevent and reduce the levels of serum glutamic oxaloacetic transaminase and glutamic pyruvic transaminase in liver fibrotic model mice, reduce collagen deposition in the fibrotic liver, and improve the pathological damage of the fibrotic liver. And compared with the traditional liver fibrosis treatment drug silymarin group, prophylactic administration of the low dose of the present invention could achieve a similar effect of improving liver fibrosis, while prophylactic administration of the high dose of the present invention could produce a better effect of improving liver fibrosis than silymarin.

Claims

1. A Chinese medicinal compound preparation for preventing liver fibrosis, characterized in that: The Chinese medicine compound preparation is prepared by extracting the following Chinese medicine pieces in parts by weight: 10-20 parts of tangerine peel, 5-10 parts of cyperus rotundus, 8-12 parts of citron, 5-10 parts of costusroot, 20-30 parts of white peony root, 5-10 parts of rose, 15-25 parts of chuanxiong, 10-20 parts of codonopsis pilosula, 8-12 parts of atractylodes macrocephala, 20-30 parts of tuckahoe, 10-20 parts of coix seed, 20-30 parts of hawthorn, 10-20 parts of malt, and 8-12 parts of chicken's gizzard lining.

2. The Chinese medicinal compound preparation for preventing liver fibrosis according to claim 1, characterized in that: The Chinese medicine compound preparation is prepared by extracting the following Chinese medicine pieces in parts by weight: 15 parts of tangerine peel, 8 parts of cyperus rotundus, 10 parts of citron, 8 parts of costus root, 25 parts of white peony root, 8 parts of rose, 20 parts of chuanxiong, 15 parts of codonopsis pilosula, 10 parts of atractylodes macrocephala, 25 parts of poria, 15 parts of coix seed, 25 parts of hawthorn, 15 parts of malt, and 10 parts of chicken gizzard lining.

3. The Chinese medicinal compound preparation for preventing liver fibrosis according to claim 1, characterized in that: The preparation method comprises the following steps: (1) Extract volatile oil from orange peel, cyperus rotundus, citron, costusroot and ligusticum chuanxiong by steam distillation, and then encapsulate with cyclodextrin for later use; (2) taking the residues of tangerine peel, cyperus rotundus, citron, costus root and ligusticum chuanxiong after steam distillation, combining them with other Chinese herbal medicine pieces, adding the aromatic water used to extract the volatile oil, adding water to 10 times the total weight of the Chinese herbal medicine pieces, decocting for 2 hours, filtering, adding water to the residues to 10 times the total weight of the Chinese herbal medicine pieces, decocting for 2 hours, filtering, combining the decoctions, and concentrating to a concentrate having a relative density of 1.15 at 25° C.; (3) adding 95% ethanol to the concentrated solution obtained in step (2) to adjust the alcohol content to 75%, leaving it to stand for 48 hours, taking the supernatant, and concentrating it to an extract having a relative density of 1.30 at 25° C.; (4) taking the extract obtained in step (3), spray drying it, adding volatile oil cyclodextrin inclusion compound and auxiliary materials, and preparing it into one of granules, tablets and capsules.

4. Use of the Chinese medicinal compound preparation for preventing liver fibrosis as claimed in claim 1 in preparing drugs for preventing liver fibrosis.

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