A traditional Chinese medicine composition for treating liver cirrhosis and its preparation method

Abstract

This invention discloses a traditional Chinese medicine composition for treating liver cirrhosis and its preparation method, belonging to the technical field of anti-cirrhosis traditional Chinese medicine. The raw materials, by weight, are: 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of charred rhubarb, 10g of Coptis chinensis, 10g of charred Scutellaria baicalensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Carapax Trionycis, 10g of Areca catechu, 25g of calcined clay, and 2g of charred donkey-hide gelatin. By providing a traditional Chinese medicine composition formula for treating liver cirrhosis, the effectiveness and cure rate of drugs for liver cirrhosis are improved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology for treating liver cirrhosis, specifically relating to a traditional Chinese medicine composition for treating liver cirrhosis and its preparation method. Background Technology

[0002] Liver cirrhosis, a common chronic progressive liver disease, develops due to diffuse liver damage caused by long-term or repeated exposure to one or more etiologies. In my country, liver cirrhosis is mainly caused by post-hepatitis cirrhosis, while alcoholic cirrhosis and schistosomiasis-related cirrhosis are less common. Pathologically, it is characterized by extensive hepatocyte necrosis, nodular regeneration of surviving hepatocytes, connective tissue hyperplasia, and the formation of fibrous septa. These changes lead to the destruction of liver lobule structure and the formation of pseudolobules, causing the liver to gradually deform and harden, eventually developing into cirrhosis. In the early stages, due to the relatively strong compensatory function of the liver, patients may not experience obvious symptoms; however, in the later stages of the disease, liver dysfunction and portal hypertension become the main manifestations, accompanied by multi-system involvement. Late-stage patients often experience complications such as upper gastrointestinal bleeding, hepatic encephalopathy, secondary infections, hypersplenism, ascites, and cancer.

[0003] Therefore, the importance of treating cirrhosis is self-evident, and the effectiveness and cure rate of drug therapy are particularly crucial in treating cirrhosis or related diseases.

[0004] Existing prescription:

[0005] Softening the Liver and Shrinking the Spleen Formula (Zhao Shaoqin): Bupleurum 6 parts, Scutellaria baicalensis 10 parts, Cicada slough 6 parts, Bombyx mori 10 parts, Curcuma longa 6 parts, Rheum palmatum 1 part, Prepared turtle shell 20 parts, Raw oyster shell 20 parts, Polygonum hydropiper 10 parts, and 10 parts each of the three roasted herbs (Horse, Malt, and Crataegus pinnatifida). Indications: Early-stage cirrhosis. Clinically, it is often used for late-stage hepatitis, manifested as hypochondriac pain, abdominal distension, abdominal masses, ecchymosis on the tongue, white tongue coating, and a wiry, hesitant pulse, indicating qi stagnation and blood stasis. Limitations of this formula: Cirrhosis falls under the category of "accumulation syndrome," and "strong people do not have accumulation, but weak people do." Therefore, there are no specific herbs for tonifying liver qi and assisting liver function, nor for tonifying liver yin (blood) and nourishing the liver body. Even with the skillful use of Bupleurum chinense, Scutellaria baicalensis, and other similar formulas, it's difficult to achieve the desired effect without the necessary ingredients.

[0006] Softening Liver Decoction (by Jiang Chunhua): Raw rhubarb 6-9 parts, peach kernel 9 parts, ground beetle 3-9 parts, salvia miltiorrhiza 9 parts, processed pangolin scales 9 parts, turtle shell 9 parts, astragalus 9-30 parts, atractylodes macrocephala 15-60 parts, codonopsis pilosula 9-15 parts. Indications: Early-stage cirrhosis. Symptoms include abdominal masses, accumulations, hypochondriac pain, and ascites (early-stage cirrhosis with mild ascites). Limitations of this formula: The liver governs the free flow of qi, regulating its movement and ensuring its orderly ascending, descending, entering, and exiting; the liver also stores blood, enabling yin to generate yang and yin to control yang—this is the primary principle in treating the liver. This formula focuses on blood stasis. Blood stasis cannot exist in isolation. Liver stasis occurs in the collaterals. Treating liver stasis begins with harmonizing, which involves strengthening and repairing; secondly, it involves expelling stasis, which requires a forceful approach and should be gentle and nourishing. Harmonizing is best achieved by regulating qi and blood, and nourishing is best achieved by tonifying the liver. Ultimately, this achieves the goal of expelling blood stasis without damaging the liver collaterals. The liver is naturally active and ascending, possessing the inherent generative energy, which is its normal function. However, in cases of long-term liver disease, this normal function has been lost. Although the formula contains Astragalus membranaceus for its ascending effect and Trionyx sinensis for its descending effect, it is still difficult to restore the liver to its normal state. Therefore, one can refer to Zhao Shaoqin's use of "Ascending and Descending Powder". This formula lacks sufficient qi-regulating ingredients; modifications may be made in clinical practice, which can be used as a reference.

[0007] Shugan Kaifei Decoction (by Yin Huihe): Bupleurum 10 parts, Red Peony Root 30 parts, Angelica Root 15 parts, Salvia Root 30 parts, Oyster Shell 30 parts, Turmeric 10 parts, Peach Kernel 10 parts, Ground Beetle 10 parts, Aster Root 10 parts, Platycodon Root 10 parts, Sichuan Chinaberry 12 parts. It opens and disperses lung qi, soothes liver qi, and promotes circulation between the chest, ribs, and hypochondrium. It removes blood stasis and dissipates stagnation, regulates the body's vital energy, and relieves abdominal distension by harmonizing the qi mechanism.

[0008] Ronggan Decoction (Guan Youbo): Codonopsis pilosula, Atractylodes macrocephala, stir-fried Atractylodes lancea, Aucklandia lappa, Artemisia capillaris, Angelica sinensis, Paeonia lactiflora, Cyperus rotundus, Citrus medica, Crataegus pinnatifida, Lycopus lucidus, Ostrea gigas, Vaccaria segetalis. It is indicated for liver deficiency syndrome in early-stage cirrhosis, embodying the principles of "strengthening the spleen and replenishing qi, nourishing the earth and nourishing the wood" and "nourishing blood and softening the liver." In addition to the "eight principles" of syndrome differentiation, Guan Youbo added "qi and blood" differentiation, making it a "ten principles" differentiation. This formula primarily addresses qi and blood deficiency, qi stagnation and blood stasis. The selection of Cyperus rotundus and Citrus medica for regulating qi, and Crataegus pinnatifida, Lycopus lucidus, and Vaccaria segetalis for resolving blood stasis, demonstrates his thoughtful consideration. Regarding detoxification, Guan Youbo only included Artemisia capillaris, leaving room for further thought. "Deficiency," "toxicity," "stasis," and "stagnation" are the themes of the pathological evolution of chronic liver disease and the focus of treatment. Therefore, a deep understanding of these four factors is crucial. Whether simply strengthening the spleen and replenishing qi can "nourish the wood" is questionable. For treating liver cirrhosis caused by blood stasis in the liver meridians, mild blood-activating and stasis-removing agents such as hawthorn, eupatorium, and vaccaria seed are used, but their effectiveness is limited.

[0009] Wen Gan Tang (Guan Youbo): Astragalus membranaceus 30 parts, Aconitum carmichaelii 10 parts, Atractylodes macrocephala 10 parts, Cyperus rotundus 10 parts, Prunus armeniaca 10 parts, Citrus reticulata peel 10 parts, Codonopsis pilosula 12 parts, Placenta hominis 12 parts, Paeonia lactiflora 15 parts, Angelica sinensis 15 parts, Artemisia capillaris 15 parts. This formula uses herbs that are too drying, which contradicts the principle of seeking yang within yin. It fails to address the obstruction of liver meridians, which is not a treatment for cirrhosis.

[0010] Shugan Huazheng Decoction (Zhou Xinyou): Bupleurum chinense 9 parts, Artemisia capillaris 20 parts, Isatis indigotica 15 parts, Angelica sinensis 9 parts, Salvia miltiorrhiza 20 parts, Curcuma zedoaria 9 parts, Codonopsis pilosula 9 parts, stir-fried Atractylodes macrocephala 9 parts, Astragalus membranaceus 20 parts, Ligustrum lucidum 20 parts, Schisandra chinensis 15 parts, Poria cocos 9 parts. The explanation of the formula is somewhat forced; the understanding and application of regulating liver qi, unblocking meridians, harmonizing qi and blood, and ensuring normal organ function is not flexible enough, and the treatment of the liver's physiological characteristics is not fully reflected in the formula.

[0011] Softening Liver Decoction (Deng Tietao): 30 parts Codonopsis pilosula, 30 parts turtle shell, 15 parts Atractylodes macrocephala, 15 parts Poria cocos, 15 parts Broussonetia papyrifera fruit, 15 parts Cuscuta chinensis, 18 parts Dioscorea hypoglauca, 10 parts Salvia miltiorrhiza, 6 parts Glycyrrhiza uralensis, 3 parts Eupolyphaga sinensis. This formula lacks the ability to regulate the Qi, blood, Yin, and Yang of the liver.

[0012] However, current medications for treating cirrhosis or similar diseases have not achieved further improvements in efficacy and cure rates. Summary of the Invention

[0013] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition formula for treating cirrhosis, thereby improving the effectiveness and cure rate of drugs for cirrhosis.

[0014] The objective of this invention can be achieved through the following technical solutions:

[0015] A traditional Chinese medicine composition for treating liver cirrhosis, comprising the following raw materials in parts by weight:

[0016] 10g each of Polyporus umbellatus, Artemisia capillaris, Bupleurum chinense, Rheum palmatum (charred), Coptis chinensis, Scutellaria baicalensis (charred), Gardenia jasminoides, Lysimachia christinae (charred), Curcuma longa, Alisma plantago-aquatica, Paeonia lactiflora (red), Salvia miltiorrhiza (charred), Magnolia officinalis, Citrus aurantium (charred), Cyperus rotundus (charred), Sparganium stoloniferum (charred), Curcuma zedoaria (charred), Plantago asiatica (charred), Trionyx sinensis (charred), Areca catechu (charred), 25g each of charred donkey-hide gelatin (charred).

[0017] The method for preparing the above-mentioned traditional Chinese medicine composition for treating liver cirrhosis includes the following steps:

[0018] S1. Mix 2g of donkey-hide gelatin with 20mL of distilled water, heat at 60-80℃ for 50-80min, add 25g of hearth soil, stir for 8-10min, cool to 40-45℃ to obtain a mud-like mixture;

[0019] S2. While the mud-like mixture is still hot, knead it by hand and press it into a thin sheet. The thin sheet is used to wrap 10g of rhubarb powder and 10g of scutellaria powder. Then, roll it into a ball to obtain the coating.

[0020] S3. The coating material is charred at 350-400℃ for 10-20 minutes. After charring, it is quickly transferred to a ceramic jar and sealed for 20-30 minutes. It is then removed, cooled, and crushed to obtain carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal and donkey-hide gelatin charcoal.

[0021] S4. Mix 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Trionyx sinensis, 10g of Areca catechu, and carbonized materials. Soak in 2500mL of water. After soaking, bring the herbs to a boil over high heat, then simmer over low heat for 60-70 minutes. Filter and collect the filtrate to obtain the first concentrated liquid. Add 2500mL of water to the residue to cover it, bring to a boil over high heat, then simmer over low heat for 40-60 minutes. Filter and collect the filtrate to obtain the second concentrated liquid. Combine the first and second concentrated liquids to obtain the medicinal composition.

[0022] As a preferred technical solution of the present invention, boiling over high heat refers to simmering the medicinal materials at a water temperature of 100°C for 1-2 minutes, while simmering over low heat refers to simmering the medicinal materials at a water temperature of 80°C.

[0023] The beneficial effects of this invention are:

[0024] The present invention discloses a traditional Chinese medicine composition and preparation method for treating liver cirrhosis. This method involves mixing donkey-hide gelatin with hearth soil to create a coating layer that protects rhubarb powder and scutellaria powder during the carbonization and roasting process, resulting in charred rhubarb and charred scutellaria. This prevents excessive carbonization during cooling, and the coating forms a physical barrier during carbonization, reducing the damage to the effective components of rhubarb and scutellaria powder caused by high temperatures. This also avoids excessive loss of the medicinal components of rhubarb and scutellaria caused by roasting.

[0025] Furthermore, this application improves the effectiveness and cure rate of treating patients with liver cirrhosis by optimizing the formulation of traditional Chinese medicine compositions for treating liver cirrhosis:

[0026] Bupleurum soothes the liver, regulates qi, and relieves stagnation; Scutellaria baicalensis charcoal is bitter and cold, clears heat, and promotes bile secretion. When combined with Bupleurum, they clear and resolve liver and gallbladder stagnation and heat, thus having the effect of regulating the liver and restoring balance.

[0027] The combination of Salvia miltiorrhiza, Magnolia officinalis, Citrus aurantium, Cyperus rotundus, Sparganium stoloniferum, Curcuma zedoaria, Plantago asiatica, Trionyx sinensis, Areca catechu, calcined soil, and charred donkey-hide gelatin is a spleen-strengthening and qi-tonifying formula, which conforms to Zhang Zhongjing's principle of "when you see a liver disease, you know that the liver will affect the spleen, so you should first strengthen the spleen." It can invigorate blood and promote diuresis, remove blood stasis, transform dampness, eliminate stagnation and promote digestion, and stimulate appetite. It is good at opening up the internal and external channels, regulating the ascending and descending of qi, and harmonizing yin and yang qi and blood.

[0028] The combination of Polyporus umbellatus, Artemisia capillaris, Bupleurum chinense, Rheum palmatum (charred), Coptis chinensis, Scutellaria baicalensis (charred), Gardenia jasminoides, Lysimachia christinae, Curcuma longa, Alisma plantago-aquatica, Paeonia lactiflora, and Trionyx sinensis is used to disperse blood stasis and eliminate masses, thus promoting qi circulation, relieving stagnation, invigorating blood, promoting diuresis, softening the liver, and shrinking the spleen. The combination of Rheum palmatum (charred) and Colla corii asini excels at opening up the internal and external pathways, regulating the ascending and descending of qi, and harmonizing yin and yang qi and blood. Its focus is on the ascending, descending, entering, and exiting of qi, clearing blood stasis, cooling the blood, and reducing swelling.

[0029] Turtle shell is salty and cold in nature, and enters the liver, spleen and blood. It can nourish yin and reduce fever, and soften hardness and dissipate nodules. It has a good therapeutic effect on liver cirrhosis and splenomegaly. Alisma enters the liver and kidney. It can move the water below and make it rise with the water qi, and then make the water above flow down with the qi. It can drain the evil of water, dampness and fire in the liver and kidney meridians and help the mechanism of yin and yang rising and falling.

[0030] The combination of Artemisia capillaris, Bupleurum chinense, Rheum palmatum (charred), Coptis chinensis, Scutellaria baicalensis (charred), Gardenia jasminoides, Lysimachia christinae, Curcuma longa, Magnolia officinalis, Citrus aurantium, Cyperus rotundus, Sparganium stoloniferum, Curcuma zedoaria, and Plantago asiatica can promote the flow of lung qi, soothe liver qi, and facilitate the movement of blood and qi between the chest, ribs, and hypochondrium. Especially for patients with chronic illnesses, this combination can reach the affected area and regulate the body's functions. Combined with Polyporus umbellatus, Alisma plantago-aquatica, Paeonia lactiflora, Salvia miltiorrhiza, Carapax Trionycis, Areca catechu, calcined soil, and Colla corii asini (charred), it can both relieve liver qi stagnation and regulate qi stagnation in the blood, thus treating pain in the heart, abdomen, and hypochondrium, dispersing masses, harmonizing the middle jiao and strengthening the spleen. When new blood is generated, qi transformation is vigorous, and when qi transformation is vigorous, recovery is enhanced.

[0031] Furthermore, the charring process of rhubarb partially carbonizes its anthraquinone components, weakening its laxative effect and enhancing its astringent and hemostatic properties, which can help improve the risk of gastrointestinal bleeding caused by portal hypertension in cirrhosis. Meanwhile, charred scutellaria enhances the stability of flavonoids, improves antioxidant capacity, and inhibits liver inflammation. The synergistic effects of both carbonized rhubarb and scutellaria baicalensis prolong the drug's retention time in the intestines, slowing the progression of liver fibrosis and jointly regulating liver metabolism. The reduced laxative components of charred rhubarb also reduce patient intolerance to diarrhea. The partially neutralized cold properties of charred scutellaria baicalensis make it more suitable for patients with spleen and kidney yang deficiency in the later stages of cirrhosis, enhancing the therapeutic effect. Donkey-hide gelatin charcoal is a traditional Chinese medicine charcoal product made by carbonizing donkey-hide gelatin. It is rich in various amino acids, proteins and other nutrients, which can promote the synthesis of hemoglobin in the human body and have the effect of nourishing blood. It can also warm and moisten the intestines, lubricate the intestinal wall, and promote intestinal peristalsis. The various trace elements and nutrients in donkey-hide gelatin charcoal have antioxidant, anti-inflammatory and immune-enhancing effects, which help improve the body's resistance and strengthen the body. In addition, donkey-hide gelatin itself is greasy and difficult to digest, but the greasy nature of carbonized donkey-hide gelatin is reduced, making it easier for patients with cirrhosis and weak spleen and stomach to accept. This is conducive to the absorption and utilization of the drug, and also reduces the adverse effects on the gastrointestinal tract, which helps the patient's overall physical condition recover.

[0032] The combination of charred rhubarb, charred scutellaria, and charred donkey-hide gelatin enhances liver blood circulation, clears heat and cools the blood, astringes and consolidates, promotes the reduction of ascites, improves liver metabolism and excretion, and reduces inflammatory damage to hepatocytes. The combination of these three ingredients, when treating cirrhosis, not only focuses on symptomatic treatment such as hemostasis and clearing heat, but also takes into account the overall conditioning of nourishing blood and yin, so that the liver can be nourished and repaired, and the patient's overall condition can be improved. Detailed Implementation

[0033] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with embodiments, is provided below.

[0034] Example 1

[0035] A method for preparing a traditional Chinese medicine composition for treating liver cirrhosis includes the following steps:

[0036] S1. Mix 2g of donkey-hide gelatin and 20mL of distilled water, heat at 80℃ for 60min to melt, add 25g of hearth soil, stir for 10min, cool to 40℃ to obtain a mud-like mixture;

[0037] S2. While the mud-like mixture is still hot, knead it by hand and press it into a thin sheet. The thin sheet is used to wrap 10g of rhubarb powder and 10g of scutellaria powder. Then, roll it into a ball to obtain the coating.

[0038] S3. The coating material is charred at 380°C for 20 minutes. After charring, it is quickly transferred to a ceramic jar and sealed for 25 minutes. It is then removed, cooled, and crushed to obtain carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal and donkey-hide gelatin charcoal.

[0039] S4. Mix 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Carapax Trionycis, 10g of Areca catechu, and the carbonized material obtained in step S3. Soak the mixture in 2500mL of water. After soaking, bring the herbs to a boil over high heat, then simmer over low heat for 65 minutes. Filter the mixture and collect the filtrate to obtain the first concentrated liquid. Add 2500mL of water to the residue to cover it, bring the mixture to a boil over high heat, then simmer over low heat for 45 minutes. Filter the mixture and collect the filtrate to obtain the second concentrated liquid. Combine the first and second concentrated liquids to obtain the medicinal composition.

[0040] Comparative Example 1

[0041] A method for preparing a traditional Chinese medicine composition for treating liver cirrhosis includes the following steps:

[0042] S1. 10g of rhubarb powder, 10g of scutellaria powder and 2g of donkey-hide gelatin are charred at 380℃ for 20min. After charring, the mixture is quickly transferred to a ceramic jar and sealed for 25min. It is then removed, cooled and crushed to obtain carbonized material containing rhubarb char, scutellaria char and donkey-hide gelatin char.

[0043] S2. Mix 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Carapax Trionycis, 10g of Areca catechu, the carbonized material obtained in step S1, and 25g of hearth soil. Soak the mixture in 2500mL of water. After soaking, bring the herbs to a boil over high heat, then simmer over low heat for 65 minutes. Filter the mixture and collect the filtrate to obtain the first concentrated liquid. Add 2500mL of water to the residue to cover it, bring the mixture to a boil over high heat, then simmer over low heat for 45 minutes. Filter the mixture and collect the filtrate to obtain the second concentrated liquid. Combine the first and second concentrated liquids to obtain the medicinal composition.

[0044] Comparative Example 2

[0045] A method for preparing a traditional Chinese medicine composition for treating liver cirrhosis includes the following steps:

[0046] Mix 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Trionyx sinensis, 10g of Areca catechu, 10g of Rheum palmatum powder, 10g of Scutellaria baicalensis powder, 2g of donkey-hide gelatin, and 25g of hearth soil. Soak the mixture in 2500mL of water. After soaking, bring the herbs to a boil over high heat, then simmer over low heat for 65 minutes. Filter the mixture and collect the filtrate to obtain the first concentrated liquid. Add 2500mL of water to the residue, bring the mixture to a boil over high heat, then simmer over low heat for 45 minutes. Filter the mixture and collect the filtrate to obtain the second concentrated liquid. Combine the first and second concentrated liquids to obtain the medicinal composition.

[0047] Verification Example 1

[0048] 1) Establishment of a rat model of liver cirrhosis: Carbon tetrachloride and soybean oil were mixed to prepare a 20% carbon tetrachloride-soybean oil solution. The solution was injected intraperitoneally into 80 male SD rats at a dose of 5 mL / kg, twice a week for 7 weeks. Then, 5 rats with liver cirrhosis were randomly selected to observe the pathological morphology of their liver tissue. If there was extensive necrosis of hepatocytes, a large amount of collagen deposition and inflammatory infiltration in the liver tissue, the rat model of liver cirrhosis was considered to be successful.

[0049] 2) The above 80 SD rats were randomly divided into 4 groups, corresponding to Example 1, Comparative Example 1 and Comparative Example 2 and blank control group. The traditional Chinese medicine composition of Example 1, Comparative Example 1 and Comparative Example 2 of the present invention was administered by gavage at 50 mg / kg. The blank control group was administered by gavage at 50 mg / kg physiological saline. Each group was administered the medicine twice a day on average for 4 consecutive weeks.

[0050] 3) Take liver tissue samples from the above-mentioned SD rats and perform blood biochemical index detection of liver function. The results are shown in Table 1 below.

[0051] Table 1

[0052]

[0053] As shown in Table 1, the traditional Chinese medicine composition prepared in Example 1 of this application has a good therapeutic effect on liver cirrhosis in male SD rats. In Comparative Example 1, the lack of carbonization protection for rhubarb and scutellaria baicalensis led to a decrease in therapeutic effect; in Comparative Example 2, the lack of carbonization treatment for rhubarb, scutellaria baicalensis, and donkey-hide gelatin further reduced the therapeutic effect. These results indicate that the addition of charred rhubarb, charred scutellaria baicalensis, and charred donkey-hide gelatin is beneficial for the treatment of liver cirrhosis.

[0054] Verification Example 2

[0055] A total of 98 cases were selected from outpatient and inpatient liver diseases at the Traditional Chinese Medicine Hospital. The patients were aged between 25 and 55 years old, including 94 males and 4 females.

[0056] Diagnostic criteria: Standards for diagnosis and treatment of diseases in Traditional Chinese Medicine.

[0057] Treatment method: Patients take the medicine liquid of Example 1 of this invention, one dose per day, twice a day, morning and evening, for 3 months as one course of treatment, and two courses of treatment are performed.

[0058] Therapeutic criteria:

[0059]

[0060]

[0061] A rating of Grade A indicates that during treatment, the patient's symptoms related to cirrhosis, such as fatigue, weight loss, sallow complexion, decreased urine output, lower extremity edema, loss of appetite, abdominal distension, gastrointestinal dysfunction, and ascites, were significantly relieved and improved. Specifically, the patient experienced a return to physical strength, stable or increased weight, a rosier complexion, normal or increased urine output, reduction of lower extremity edema, significant improvement in appetite, reduced abdominal distension, gradual return to normal gastrointestinal function, and absorption or reduction of ascites.

[0062] Grade B: After treatment, the patient's symptoms of cirrhosis mentioned above have been alleviated. Although the symptoms have not completely disappeared, the patient will feel improvement, such as reduced fatigue, little change in weight without further decline, improved complexion, increased urine output, reduced lower extremity edema, improved appetite, less severe abdominal distension, improved gastrointestinal function, and reduced ascites.

[0063] Grade C: After a period of treatment, the patient's symptoms have not improved significantly. Symptoms persist and may even worsen, such as persistent fatigue, continued weight loss, a sallow complexion, no increase in urine output, no improvement in lower limb edema, no improvement in appetite, persistent abdominal distension, no improvement in gastrointestinal dysfunction, and no reduction in ascites.

[0064] Treatment results

[0065]

[0066] The above treatment results indicate that the traditional Chinese medicine composition of this application, consisting of 10g of Polyporus umbellatus, 10g of Artemisia capillaris, 10g of Bupleurum chinense, 10g of charred rhubarb, 10g of Coptis chinensis, 10g of charred Scutellaria baicalensis, 10g of Gardenia jasminoides, 15g of Lysimachia christinae, 10g of Curcuma longa, 10g of Alisma plantago-aquatica, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Sparganium stoloniferum, 10g of Curcuma zedoaria, 20g of Plantago asiatica, 10g of Carapax Trionycis, 10g of Areca catechu, 25g of calcined soil, and 2g of charred donkey-hide gelatin, has a good therapeutic effect on cirrhosis.

[0067] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating liver cirrhosis, characterized in that, Its raw material composition by mass parts is as follows: 10g each of Polyporus umbellatus, Artemisia capillaris, Bupleurum chinense, Rheum palmatum (charred), Coptis chinensis, Scutellaria baicalensis (charred), Gardenia jasminoides, Lysimachia christinae (charred), Curcuma longa, Alisma plantago-aquatica, Paeonia lactiflora (red), Salvia miltiorrhiza (charred), Magnolia officinalis, Citrus aurantium (charred), Cyperus rotundus (charred), Sparganium stoloniferum (charred), Curcuma zedoaria (charred), Plantago asiatica (charred), Trionyx sinensis (charred), Areca catechu (charred), 25g each of charred donkey-hide gelatin (charred).

2. The method for preparing the traditional Chinese medicine composition for treating liver cirrhosis according to claim 1, characterized in that, Includes the following steps: S1. Mix donkey-hide gelatin and distilled water, heat to melt, add hearth soil, stir, cool, and obtain a mud-like mixture; S2. Knead the mud-like mixture by hand, press it into a thin sheet, the thin sheet is used to wrap rhubarb powder and scutellaria powder, and then roll it into a ball to obtain the coating; S3. The coating material is charred. After charring, it is quickly transferred to a ceramic jar, sealed, taken out and cooled, and crushed to obtain carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal and donkey-hide gelatin charcoal. S4. Mix the following herbs: Polyporus umbellatus, Artemisia capillaris, Bupleurum chinense, Coptis chinensis, Gardenia jasminoides, Lysimachia christinae, Curcuma longa, Alisma plantago-aquatica, Paeonia lactiflora, Salvia miltiorrhiza, Magnolia officinalis, Citrus aurantium, Cyperus rotundus, Sparganium stoloniferum, Curcuma zedoaria, Plantago asiatica, Carapax Trionycis, Areca catechu, and carbonized materials. Soak in water and decoct to obtain the medicinal liquid, which is the aforementioned Chinese herbal composition.

3. The method for preparing a traditional Chinese medicine composition for treating liver cirrhosis according to claim 2, characterized in that, In step S1, the heating and melting refers to heating and melting at 60-80℃ for 50-80 minutes.

4. The method for preparing a traditional Chinese medicine composition for treating liver cirrhosis according to claim 2, characterized in that, In step S3, the charcoal roasting process refers to roasting at 350-400℃ for 10-20 minutes.

5. The traditional Chinese medicine composition for treating liver cirrhosis and its preparation method according to claim 2, characterized in that, In step S4, the specific steps of decocting are as follows: After soaking the herbs in water, bring them to a boil over high heat, then simmer over low heat, filter, and collect the filtrate to obtain the first concentrated liquid. Add water to the filter residue until it covers the residue, bring to a boil over high heat, simmer over low heat, filter, and take the filtrate to obtain the second concentrated liquid; The first concentrate and the second concentrate are combined to obtain the drug solution.

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