A composition of miao medicine for treating liver fibrosis and cirrhosis ascites and its preparation method and application
By using specific proportions and preparation processes of Miao medicine compositions, the problem of limited efficacy in existing Miao medicine prescriptions has been solved, achieving the reversal of liver fibrosis and rapid reduction of ascites, ensuring the stability and safety of the therapeutic effect.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- GUIZHOU MIAO YAO RENJIA PHARMACEUTICAL TECHNOLOGY CO LTD
- Filing Date
- 2026-05-26
- Publication Date
- 2026-07-03
AI Technical Summary
Existing Miao medicine formulas for treating liver fibrosis and ascites due to cirrhosis are simple in composition and have single efficacy, making it difficult to achieve the synergistic effects of clearing heat, removing blood stasis, promoting diuresis, and strengthening the body's resistance. This leads to recurrent ascites, difficulty in controlling the fibrosis process, and uncertain dosage, resulting in unstable efficacy.
This product is composed of 12 kinds of Miao medicinal materials, including *Ganhuangcao*, *Zhenzhucao*, and *Baihuasheshecao*. It is made into pills, capsules, tablets, granules, or powders according to specific proportions and preparation processes. Combining the Miao medicine's pathogenesis theory of "poisoning, blood stasis, water retention, and deficiency" with the traditional Chinese medicine concept of "seeing liver disease, knowing that the liver transmits to the spleen," the product achieves synergistic effects of the drugs.
It significantly reverses liver fibrosis, rapidly reduces ascites, improves serum albumin and coagulation function, ensures stable product quality, improves patient compliance, and avoids electrolyte imbalance and recurrent ascites.
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Figure CN122321080A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a Miao medicine composition for treating liver fibrosis and ascites due to liver cirrhosis, its preparation method, and its application. Background Technology
[0002] Liver fibrosis is an inevitable pathological process in the progression of various chronic liver diseases to cirrhosis. Its core mechanism lies in the activation of hepatic stellate cells and excessive deposition of extracellular matrix. When the disease enters the decompensated stage, patients often experience extremely low quality of life and survival rates due to portal hypertension, hypoalbuminemia, and severe ascites. Currently, the main treatment strategies in modern medicine include etiological control, diuresis, paracentesis, and transurethral resection of liver fibrosis (TIPS). However, there is still a lack of chemical drugs that can directly and effectively reverse liver fibrosis; long-term use of diuretics can easily lead to electrolyte imbalances and hepatorenal syndrome, while surgical intervention has the disadvantages of being highly invasive and having a high recurrence rate.
[0003] Miao medicine has developed unique experience in treating liver diseases through long-term practice, using herbs such as *Ganhuangcao* and *Zhenzhucao* to treat jaundice and ascites. While some Miao herbal formulas exist, their overall composition is relatively simple, focusing primarily on clearing heat and promoting diuresis. For the complex and compounded syndrome of "dampness, heat, blood stasis, toxins, water retention, and deficiency" in the decompensated stage of cirrhosis, traditional formulas struggle to achieve the synergistic effects of clearing heat, resolving blood stasis, promoting diuresis, and strengthening the body's resistance, leading to recurrent ascites and difficulty in controlling the fibrosis process. Furthermore, the significant differences in the composition and uncertain dosage ratios of traditional Chinese medicine formulas also make it difficult to replicate their therapeutic effects.
[0004] Therefore, providing a Miao medicine compound with a rigorous formulation, diverse targets, a combination of attack and supplementation, and experimentally verified synergistic effects is a technical problem that urgently needs to be solved in this field. Summary of the Invention
[0005] The present invention aims to provide a Miao medicine composition for treating liver fibrosis and cirrhotic ascites, in order to solve the problems of single efficacy, inability to regulate complex pathogenesis as a whole, unstable efficacy and poor patient compliance in the prior art.
[0006] To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition, the active ingredients of which are made from the following raw medicinal materials: 10-40 parts of *Gynostemma pentaphyllum*, 10-40 parts of *Hedyotis diffusa*, 10-40 parts of *Bupleurum chinense*, 15-50 parts of *Trionyx sinensis*, 10-40 parts of *Hedyotis diffusa*, 10-40 parts of *Cynanchum paniculatum*, 5-30 parts of *Sparganium stoloniferum*, 5-30 parts of *Curcuma zedoaria*, 5-20 parts of *Prunus persica*, 5-20 parts of *Rehmannia glutinosa*, 5-20 parts of *Astragalus membranaceus*, 5-20 parts of *Atractylodes macrocephala*, 5-20 parts of *Angelica sinensis*, 5-20 parts of *Salvia miltiorrhiza*, 5-20 parts of *Ostrea gigas*, 5-20 parts of *Areca catechu*, 5-20 parts of *Poria cocos*, 5-20 parts of *Curcuma longa*, 5-20 parts of *Rehmannia glutinosa* (processed), 5-20 parts of *Paeonia lactiflora*, and 5-20 parts of *Ligusticum chuanxiong*.
[0007] As a preferred embodiment, the raw medicinal materials are in the following weight proportions: 15-25 parts of *Ganhuangcao*, 15-25 parts of *Zhenzhucao*, 15-25 parts of *Baihuasheshecao*, 15-25 parts of *Chaihu*, 25-40 parts of *Biejia*, 15-25 parts of *Ruangancao*, 15-25 parts of *Maozhuacao*, 10-20 parts of *Sanleng*, 10-20 parts of *Ezhu*, 8-15 parts of *Taoren*, 8-15 parts of *Shengdihuang*, 8-15 parts of *Huangqi*, 8-15 parts of *Baizhu*, 8-15 parts of *Danggui*, 8-15 parts of *Danshen*, 8-15 parts of *Muli*, 8-15 parts of *Dafupi*, 8-15 parts of *Fuling*, 8-15 parts of *Yujin*, 8-15 parts of *Shudihuang*, 8-15 parts of *Baishao*, and 8-15 parts of *Chuanxiong*.
[0008] As the optimal formulation, the weight proportions of the raw medicinal materials are as follows: 20 parts of *Ganhuangcao*, 20 parts of *Zhenzhucao*, 20 parts of *Baihuasheshecao*, 20 parts of *Chaihu*, 30 parts of *Biejia*, 20 parts of *Ruangancao*, 20 parts of *Maozhuacao*, 15 parts of *Sanleng*, 15 parts of *Ezhu*, 10 parts of *Taoren*, 10 parts of *Shengdihuang*, 10 parts of *Huangqi*, 10 parts of *Baizhu*, 10 parts of *Danggui*, 10 parts of *Danshen*, 10 parts of *Muli*, 10 parts of *Dafupi*, 10 parts of *Fuling*, 10 parts of *Yujin*, 10 parts of *Shudihuang*, 10 parts of *Baishao*, and 10 parts of *Chuanxiong*.
[0009] Note: The term "ruan gan cao" used in this invention is a name commonly used in Miao medicine. To ensure the reproducibility of the technical solution, an etymological identification study has been conducted, and it has been identified as the dried whole herb of *Pteris vittata*, a plant belonging to the genus *Pteris vittata* of the family Pteridaceae (please fill in the botanical name according to the actual identification results). This medicinal material complies with the relevant provisions of the "Quality Standards for Traditional Chinese Medicine and Ethnic Medicines of Guizhou Province".
[0010] The best quality turtle shell is the vinegar-processed product, and the best quality oyster shell is the calcined product.
[0011] The compositions of the present invention can be formulated into oral preparations by adding pharmaceutically acceptable excipients, wherein the dosage form includes one of pills, capsules, tablets, granules, oral liquids or powders.
[0012] The present invention provides a method for preparing the above composition.
[0013] When the dosage form is pills, the following steps are included: (1) Weigh each raw medicinal material according to the weight proportions, clean and dry them; (2) Grind the turtle shell and oyster shell into very fine powder, and grind the remaining raw medicinal materials into fine powder, then mix them evenly. (3) Take refined honey, heat it to 70-80℃, add mixed medicinal powder, and mix thoroughly to make a soft material; (4) Make into pellets and dry them to obtain the product.
[0014] When the oral preparation is granules, the following steps are included: weigh each raw material according to the weight parts, soak in 8 times the amount of water for 40 minutes, decoct twice, the first time for 1.5 hours and the second time for 1 hour, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.12 at 60°C, add excipients and mix well, granulate, dry, granulate, and package to obtain the final product.
[0015] When the oral preparation is a capsule, it includes the following steps: weigh each raw material according to the weight parts, extract twice with 70% ethanol for 1 hour each time, combine the filtrates, recover the ethanol and concentrate it into a thick paste, vacuum dry and pulverize, add excipients and mix well, and fill into capsules to obtain the product.
[0016] This invention provides the use of the above composition in the preparation of a medicament for treating liver fibrosis and cirrhotic ascites.
[0017] Solution and Compatibility Principles The formulation of this invention is based on the Miao medicine theory of liver disease pathogenesis, which involves the interplay of "toxicity, stasis, water retention, and deficiency," and integrates the traditional Chinese medicine concept of "when liver disease is seen, it is known that the liver can transmit the disease to the spleen, so the spleen should be strengthened first."
[0018] Fang Zhong: The heat-clearing, detoxifying, dampness-reducing, and jaundice-relieving group includes: Ganhuangcao, Zhenzhucao, Baihuasheshecao, and Maozhuacao, targeting the causes of dampness, heat, and toxicity; The group for softening and dispersing nodules, resolving blood stasis and eliminating masses includes: turtle shell, oyster shell, liver-softening herb, sparganium rhizome, turmeric rhizome, peach kernel, salvia miltiorrhiza, and turmeric, targeting qi, blood, phlegm and blood stasis obstructing the collaterals; The liver-soothing, qi-regulating, diuretic, and swelling-reducing group consists of Bupleurum, Areca peel, and Poria, targeting qi stagnation and water retention. The group that invigorates qi and nourishes blood, and regulates and tonifies the liver and kidneys includes: Astragalus membranaceus, Atractylodes macrocephala, Angelica sinensis, raw / processed Rehmannia glutinosa, Paeonia lactiflora, and Ligusticum chuanxiong. It supports the body's vital energy and prevents excessive attack.
[0019] The five groups of drugs in the formula work synergistically to achieve the effect of eliminating pathogens without harming the body's vital energy and promoting diuresis without causing blood stasis.
[0020] Compared with the prior art, the beneficial effects of the present invention are: 1. Synergistic effect, effective in reversing fibrosis. Experiments have demonstrated that only under the specific formula and proportions of this invention can a highly significant improvement in liver fibrosis indicators be achieved. Data from Experiments 1-2 show that the efficacy decreased significantly after the absence of any ingredient or changes in the proportions, confirming a synergistic effect among the various ingredients. The composition of this invention can reduce the hydroxyproline (Hyp) content in rats with liver fibrosis to near-normal levels and has achieved a significant decrease in liver elasticity values in clinical practice, demonstrating its potential to reverse fibrosis.
[0021] 2. Quickly eliminates water and improves overall condition. In terms of reducing ascites, the composition of this invention is not only fast (average clinical time of 1-3 months), but also can simultaneously increase serum albumin and improve coagulation function, solving the problem that simple diuresis can easily lead to electrolyte imbalance and recurrent ascites.
[0022] 3. Controllable process and stable quality This invention provides precise preparation process parameters (such as particle size, mixing uniformity RSD < 5%, microwave drying, etc.) to ensure product uniformity. Accelerated and long-term stability tests have verified that the content of the marker components paeoniflorin and astragaloside A decreases by less than 5% within 24 months, ensuring the feasibility of industrialization.
[0023] 4. High safety and good adaptability No significant toxic reactions were observed in acute toxicity tests. Long-term use does not harm the body's vital energy and can significantly improve the patient's weakened state. Multiple dosage forms, such as chewable pills and granules, cater to the needs of different patients and improve long-term medication adherence. Attached Figure Description
[0024] Figure 1 Comparison of the effects of each group on serum indicators and ascites volume in rats with liver fibrosis chart; Figure 2 Comparison of hydroxyproline content and fibrosis area in liver tissues of different groups chart; Figure 3 Charts showing the changes in various indicators during the accelerated testing of honey pills (batch number: 20240501); Figure 4 This is a chart comparing key indicators before and after treatment in a typical clinical case. Detailed Implementation
[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0026] Example 1 (Honey Pill) Prescription: 20g of *Ganhuangcao*, 20g of *Zhenzhucao*, 20g of *Baihuasheshecao*, 20g of *Chaihu*, 30g of vinegar-processed turtle shell, 20g of *Ruangancao*, 20g of *Maozhuacao*, 15g of *Sanleng*, 15g of *Ezhu*, 10g of peach kernel, 10g of *Shengdihuang*, 10g of *Huangqi*, 10g of *Baizhu*, 10g of *Danggui*, 10g of *Danshen*, 10g of calcined oyster shell, 10g of *Dafupi*, 10g of *Fuling*, 10g of *Yujin*, 10g of prepared *Dihuang*, 10g of white peony root, 10g of *Chuanxiong*.
[0027] Preparation process: 1. Grind the vinegar-processed turtle shell and calcined oyster shell separately into extremely fine powder (pass through a 150-mesh sieve). After cleaning the remaining medicinal materials, dry them at below 60℃, mix them together, and grind them into fine powder (pass through a 100-mesh sieve).
[0028] 2. Add the above powder to a multidimensional mixer and mix at 15 r / min for 30 minutes. Detect the mixing uniformity (RSD 3.2%).
[0029] 3. Take 300g of honey, heat it to 118℃ (medium temperature), filter it while hot, and keep it at 70-80℃.
[0030] 4. Add the medicinal powder to the refined honey in a trough mixer and stir until it forms a soft material (it can be kneaded into a ball and crumbled when rubbed).
[0031] 5. The pills are made into strips and rolled into pills on a pill-making machine. The weight of the wet pills is adjusted to 11.3g. They are then microwave-dried at 60℃ until the moisture content is 11.5%, resulting in honey pills weighing 10g each.
[0032] Usage: Take one pill orally, three times a day, chew it and swallow with warm water.
[0033] Example 2 (Granules) Prescription: 25g of *Gynostemma pentaphyllum*, 25g of *Hedyotis diffusa*, 15g of *Hedyotis diffusa*, 25g of *Bupleurum chinense*, 40g of *Trionyx sinensis*, 15g of *Ligusticum striatum*, 25g of *Cynanchum paniculatum*, 10g of *Sparganium stoloniferum*, 20g of *Curcuma zedoaria*, 12g of *Prunus persica*, 12g of *Rehmannia glutinosa*, 15g of *Astragalus membranaceus*, 8g of *Atractylodes macrocephala*, 12g of *Angelica sinensis*, 8g of *Salvia miltiorrhiza*, 12g of *Ostrea gigas*, 8g of *Areca catechu*, 15g of *Poria cocos*, 12g of *Curcuma longa*, 8g of *Rehmannia glutinosa* (processed), 15g of *Paeonia lactiflora*, and 8g of *Ligusticum chuanxiong*.
[0034] Preparation process: Soak all medicinal materials in 8 times the amount of water for 40 minutes, decoct twice (1.5h, 1h), combine the filtrates, and concentrate under reduced pressure to a clear extract with a relative density of 1.12 (60℃). Add 150g of dextrin and 3g of stevioside, mix well, granulate through a 14-mesh granule, dry at 55℃, and granulate. Package to obtain the final product.
[0035] Usage: Dissolve one packet in boiling water and drink, three times a day.
[0036] Example 3 (Capsule) Prescription: Same as in Example 1.
[0037] Preparation process: All medicinal materials were extracted twice by reflux with 70% ethanol, 1 hour each time. The filtrates were combined, the ethanol was recovered and concentrated into a thick paste, vacuum dried (60℃), and pulverized through an 80-mesh sieve. 50g of microcrystalline cellulose and 1g of magnesium stearate were added, mixed well, and encapsulated to obtain 1000 capsules.
[0038] Dosage: Take 3-4 pills orally, 3 times a day.
[0039] Experiment Example 1: Formula Screening and Comparison Experiment To verify the scientific validity and efficacy of the formulation and proportions, the classic CCl4-induced rat liver fibrosis model was used in the experiment.
[0040] Model establishment and grouping: Eighty male SPF-grade SD rats were used. Ten rats were randomly selected as the normal control group, while the remaining rats were injected intraperitoneally with 40% CCl4 olive oil solution (3 ml / kg) twice a week for eight consecutive weeks. The successfully modeled rats were randomly divided into seven groups: the model group, the high-dose group (6 g crude drug / kg), the medium-dose group (3 g crude drug / kg), the low-dose group (1.5 g crude drug / kg), and three control groups. All control groups received 3 g crude drug / kg.
[0041] • Control group 1 (simplified prescription group): 30g of Gynostemma pentaphyllum, 30g of Trionyx sinensis, 15g of Sparganium stoloniferum, and 15g of Astragalus membranaceus.
[0042] • Control group 2 (flavorless group): The preferred formula of this invention, but with the removal of liver-softening herb and cat's claw herb.
[0043] • Control group 3 (ratio change group): Refer to the preferred formula of this invention, but adjust some of the drug ratios: 40 parts of Gynostemma pentaphyllum, 10 parts of Trionyx sinensis, and the rest are the same as the preferred ratio.
[0044] Each group received the medication once daily via gavage for four consecutive weeks.
[0045] Detection indicators and methods: After the last administration, the patient fasted for 12 hours, was anesthetized, and blood was drawn from the abdominal aorta. Serum was separated and ALT and AST were measured using a fully automated biochemical analyzer; serum hyaluronic acid (HA) and laminin (LN) were measured using radioimmunoassay. The abdominal cavity was opened, and ascites was completely aspirated with a syringe and accurately weighed.
[0046] Experimental results: See [link to experimental results] Figure 1 .
[0047] Depend on Figure 1 It can be seen that only the composition of this invention has a statistically significant effect on reducing ALT, AST, HA, LN, and ascites volume, and this effect is dose-dependent. The absence of any ingredient, a simple reduction in dosage, or a change in proportion will lead to a significant decrease in efficacy. This strongly demonstrates that the synergistic effect achieved by the formulation and proportions of this invention is not common knowledge and is therefore non-obvious.
[0048] Experiment Example 2: Reversal Experiment of Liver Tissue Fibrosis The left lobe of the liver from the rats in Experiment 1 was used, partly for detecting hydroxyproline (Hyp) content and partly for Masson staining. The percentage of collagen fiber area was analyzed using ImageJ software. The results are shown in [Figure 1]. Figure 2 .
[0049] As can be seen, this experiment, through the gold standard of histopathology, confirms that the composition of the present invention can significantly reduce the amount of collagen deposited in the liver, improve large-area fibrosis to mild fibrosis, and fundamentally intervene in the pathological progression of cirrhosis.
[0050] Experiment Example 3: Stability Tracking Experiment The quality stability of honey pills (batch number: 20240501) produced using the process of Example 1 was investigated.
[0051] Accelerated testing: Three batches of samples were stored at 40℃±2℃ and RH 75%±5% for 6 months, and samples were taken at 0, 1, 2, 3, and 6 months. The contents of paeoniflorin and astragaloside A were determined by HPLC. Results are shown below. Figure 3 .
[0052] Long-term testing: Three batches of samples were continuously tested for 24 months at 25℃±2℃ and RH 60%±10%. Results showed that the product properties remained stable within 24 months, with no significant changes in moisture content and dissolution time, and the microbial limits were met. The relative contents of paeoniflorin and astragaloside A at 24 months were 96.5% and 95.8% of those at 0 months, respectively, with a decrease of less than 5%. Based on this, the shelf life of this product is tentatively set at 24 months.
[0053] Experimental Example 4: Typical Clinical Case To demonstrate the actual efficacy of this invention, more comprehensive clinical feedback cases are provided below. All patients signed informed consent forms before treatment. Figure 4 .
[0054] Case Analysis: The above four typical cases covered different etiologies (hepatitis B, alcohol, hepatitis C, autoimmune diseases) and varying degrees of cirrhosis with ascites. Treatment results showed that the composition of this invention (the honey pills in Example 1) not only regularly reduced ascites (average 1-3 months), but also simultaneously improved liver elasticity, synthetic function (increased albumin, improved coagulation), and overall condition, demonstrating the advantages of multi-target, holistic treatment. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.
Claims
1. A Miao medicine composition for treating liver fibrosis and ascites due to cirrhosis, characterized in that, The active ingredients are made from the following raw medicinal materials in parts by weight: 10-40 parts of *Gynostemma pentaphyllum*, 10-40 parts of *Euphorbia pekinensis*, 10-40 parts of *Hedyotis diffusa*, 10-40 parts of *Bupleurum chinense*, 15-50 parts of *Trionyx sinensis*, 10-40 parts of *Gynostemma pentaphyllum*, 10-40 parts of *Uncaria rhynchophylla*, 5-30 parts of *Sparganium stoloniferum*, 5-30 parts of *Curcuma zedoaria*, 5-20 parts of *Prunus persica*, 5-20 parts of *Rehmannia glutinosa*, 5-20 parts of *Astragalus membranaceus*, 5-20 parts of *Atractylodes macrocephala*, 5-20 parts of *Angelica sinensis*, 5-20 parts of *Salvia miltiorrhiza*, 5-20 parts of *Ostrea gigas*, 5-20 parts of *Areca catechu*, 5-20 parts of *Poria cocos*, 5-20 parts of *Curcuma longa*, 5-20 parts of *Rehmannia glutinosa* (processed), 5-20 parts of *Paeonia lactiflora*, and 5-20 parts of *Ligusticum chuanxiong*. The herb in question is the dried whole plant of *Pteris vittata*, a plant belonging to the genus *Pteris* in the family Pteridaceae.
2. The Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to claim 1, characterized in that: The raw medicinal materials are in the following weight proportions: 15-25 parts of *Ganhuangcao*, 15-25 parts of *Zhenzhucao*, 15-25 parts of *Baihuasheshecao*, 15-25 parts of *Chaihu*, 25-40 parts of *Biejia*, 15-25 parts of *Ruangancao*, 15-25 parts of *Maozhuacao*, 10-20 parts of *Sanleng*, 10-20 parts of *Ezhu*, 8-15 parts of *Taoren*, 8-15 parts of *Shengdihuang*, 8-15 parts of *Huangqi*, 8-15 parts of *Baizhu*, 8-15 parts of *Danggui*, 8-15 parts of *Danshen*, 8-15 parts of *Muli*, 8-15 parts of *Dafupi*, 8-15 parts of *Fuling*, 8-15 parts of *Yujin*, 8-15 parts of *Shudihuang*, 8-15 parts of *Baishao*, and 8-15 parts of *Chuanxiong*.
3. The Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to claim 1, characterized in that: The raw medicinal materials are in the following weight proportions: 20 parts of *Ganhuangcao*, 20 parts of *Zhenzhucao*, 20 parts of *Baihuasheshecao*, 20 parts of *Chaihu*, 30 parts of *Biejia*, 20 parts of *Ruangancao*, 20 parts of *Maozhuacao*, 15 parts of *Sanleng*, 15 parts of *Ezhu*, 10 parts of *Taoren*, 10 parts of *Shengdihuang*, 10 parts of *Huangqi*, 10 parts of *Baizhu*, 10 parts of *Danggui*, 10 parts of *Danshen*, 10 parts of *Muli*, 10 parts of *Dafupi*, 10 parts of *Fuling*, 10 parts of *Yujin*, 10 parts of *Shudihuang*, 10 parts of *Baishao*, and 10 parts of *Chuanxiong*.
4. The Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to any one of claims 1-3, characterized in that, The turtle shell is a vinegar-processed product, and the oyster shell is a calcined product.
5. The Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to any one of claims 1-3, characterized in that: The composition is formulated into an oral preparation by adding pharmaceutically acceptable excipients, wherein the oral preparation is a pill, capsule, tablet, granule, oral liquid or powder.
6. The method for preparing the Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to any one of claims 1-3, characterized in that, When the oral preparation is a pill, the following steps are included: (1) Weigh each raw medicinal material according to the weight proportions, clean and dry them; (2) Grind the turtle shell and oyster shell into very fine powder, and grind the remaining raw medicinal materials into fine powder, and mix them evenly; (3) Take refined honey, heat it to 70-80℃, add mixed medicinal powder, and mix thoroughly to make a soft material; (4) Make into pellets and dry them to obtain the product.
7. The method for preparing the Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to any one of claims 1-3, characterized in that: When the oral preparation is granules, the following steps are included: weigh each raw material according to the weight parts, soak in 8 times the amount of water for 40 minutes, decoct twice, the first time for 1.5 hours and the second time for 1 hour, combine the filtrates, concentrate under reduced pressure to a clear extract with a relative density of 1.12 at 60°C, add excipients and mix well, granulate, dry, granulate, and package to obtain the final product.
8. The method for preparing the Miao medicine composition for treating liver fibrosis and cirrhotic ascites according to any one of claims 1-3, characterized in that: When the oral preparation is a capsule, it includes the following steps: weigh each raw material according to the weight parts, extract twice with 70% ethanol for 1 hour each time, combine the filtrates, recover the ethanol and concentrate it into a thick paste, vacuum dry and pulverize, add excipients and mix well, and fill into capsules to obtain the product.
9. The use of any of the Miao medicine compositions according to claims 1-3 in the preparation of a drug for treating liver fibrosis.
10. The use of any of the Miao medicine compositions according to claims 1-3 in the preparation of a drug for treating ascites in liver cirrhosis.