Traditional Chinese medicine composition for treating liver cirrhosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating liver cirrhosis and a preparation method thereof, and belongs to the technical field of anti-liver cirrhosis traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 10g of polyporus umbellatus, 10g of herba artemisiae scopariae, 10g of radix bupleuri, 10g of charred rheum officinale, 10g of rhizoma coptidis, 10g of charred radix scutellariae, 10g of fructus gardeniae, 15g of herba hyperici japonici, 10g of radix curcumae, 10g of rhizoma alismatis, 10g of radix paeoniae rubra, 10g of radix salviae miltiorrhizae, 10g of cortex magnoliae officinalis, 10g of fructus aurantii, 10g of rhizoma cyperi, 10g of rhizoma sparganii, 10g of rhizoma curcumae, 20g of plantain herb, 10g of turtle shell, 10g of pericarpium arecae, 25g of oven earth and 2g of charred colla corii asini. By providing the traditional Chinese medicine composition formula for treating the liver cirrhosis, the effective rate and the cure rate of the medicine for treating the liver cirrhosis are improved.

Description

Technical Field

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

[0002] Cirrhosis is a common, chronic, progressive liver disease. It develops as a result of diffuse liver damage caused by the long-term or recurrent effects of one or more etiologies. In my country, cirrhosis primarily comprises post-hepatitis cirrhosis, with alcoholic cirrhosis and schistosomal cirrhosis accounting for a smaller proportion. Histopathological features include extensive hepatocyte necrosis, nodular regeneration of residual hepatocytes, connective tissue hyperplasia, and the formation of fibrous septa. These changes lead to the destruction of hepatic lobular architecture and the formation of pseudolobules, which gradually deform and harden the liver, ultimately progressing to cirrhosis. In the early stages, patients may be asymptomatic due to the liver's relatively strong compensatory function. However, in the later stages of the disease, liver impairment and portal hypertension become predominant manifestations, accompanied by multisystem involvement. In advanced stages, patients often develop complications such as upper gastrointestinal bleeding, hepatic encephalopathy, secondary infection, hypersplenism, ascites, and cancer.

[0003] In view of this, the importance of treating cirrhosis is self-evident, and the effectiveness and cure rate of drug treatment are particularly critical in the treatment of cirrhosis or related diseases.

[0004] Existing prescriptions:

[0005] Softening the Liver and Shrinking the Spleen Recipe (by Zhao Shaoqin): 6 parts Bupleurum, 10 parts Scutellaria, 6 parts Cicada Periostra, 10 parts Bombyx Batryticatus, 6 parts Curcuma, 1 part Rhubarb, 20 parts Roasted Turtle Shell, 20 parts Raw Oyster, 10 parts Polygonum Multiflorum Fruit, and 10 parts each of the three roasted herbs. Indications: Early-stage liver cirrhosis. Clinically, it is often used for patients with late-stage hepatitis, characterized by symptoms such as flank pain, abdominal distension, masses, ecchymosis on the tongue, white fur, and a wiry, wiry pulse, which are symptoms of qi stagnation and blood stasis. However, this recipe has its shortcomings: Liver cirrhosis falls under the category of "accumulation syndrome," meaning that "strong individuals do not experience accumulation, but weak individuals do." Therefore, it lacks specific ingredients for tonifying liver qi and supporting liver function, or tonifying liver yin (blood), nourishing the liver's body. Even with the ingenuity of Bupleurum and Scutellaria and Shengjiang San, it's difficult to achieve success without the necessary ingredients.

[0006] Soft Liver Decoction (by Jiang Chunhua): 6-9 parts raw rhubarb, 9 parts peach kernel, 3-9 parts earthworm, 9 parts salvia miltiorrhiza, 9 parts roasted pangolin scales, 9 parts turtle shell, 9-30 parts astragalus, 15-60 parts white atractylodes, 9-15 parts codonopsis. Indications: Early-stage liver cirrhosis. Masses, accumulations, flank pain, and bloating (early-stage liver cirrhosis, mild ascites). The shortcomings of this prescription are: The liver governs the flow of qi, regulating the flow of qi and ensuring its orderly rise and fall. The liver also governs the storage of blood, enabling yin to generate yang and yin to control yang, which is the first step in treating the liver. This prescription focuses on blood stasis, but how can blood stasis exist alone? Liver stasis is located in the collaterals. Treating liver stasis primarily focuses on harmonization, meaning strengthening and repairing; the second key is expulsion, which implies forceful movement, so a gentle, moistening approach is recommended. Harmonization is best achieved by regulating qi and blood, while moistening is best achieved by nourishing the liver. Ultimately, this approach achieves the removal of blood stasis without damaging the liver collaterals. The liver is active and promotes growth, naturally carrying a vital energy that generates growth. This is its normal nature. However, with age-related liver disease, this normal state has been lost. Although the formula contains the ascending properties of Astragalus and the descending properties of Biejia, it is still difficult to restore this normal state. Therefore, please refer to Zhao Shaoqin's "Shengjiang San." This formula lacks the vital energy to promote growth, so clinical modifications are possible, which can be used as a reference.

[0007] Shugan Kaifei Decoction (Yinhuihe): Bupleurum 10 parts, Red Peony Root 30 parts, Chinese Angelica 15 parts, Salvia miltiorrhiza 30 parts, Oyster 30 parts, Curcuma 10 parts, Peach Kernel 10 parts, Eupolyphaga Scolopendra 10 parts, Aster 10 parts, Platycodon 10 parts, Toosendan Fruit 12 parts. It invigorates and promotes lung qi, dredges liver qi, circulates qi between the chest, flanks, and ribs, dissipates blood stasis, and regulates the vital organs, regulating qi and alleviating abdominal distension.

[0008] Ronggan Decoction (Guan Youbo): Codonopsis pilosula, Atractylodes macrocephala, stir-fried Atractylodes lancea, costus root, Artemisia capillaris, Chinese Angelica sinensis, white peony root, Cyperus rotundus, Citron, Crataegus pinnatifida, Eupatorium fortunei, Oyster, and Vaccaria segetalis. It primarily treats liver deficiency in the early stages of cirrhosis, emphasizing the principles of "strengthening the spleen and replenishing Qi, nourishing the earth and nourishing the wood," and "nourishing the blood and softening the liver." Guan Youbo added the "Qi and Blood" dialectic to the "Eight Principles" dialectic, creating a total of "Ten Principles." This prescription primarily addresses Qi and Blood deficiency, Qi stagnation, and blood stasis. The selection of Cyperus rotundus and Citron for regulating Qi, and Crataegus pinnatifida, Eupatorium fortunei, and Vaccaria segetalis for dissolving blood stasis warrants careful consideration. Regarding detoxification, Guan Youbo only included Artemisia capillaris, leaving room for further consideration. "Deficiency," "toxicity," "stasis," and "depression" are the key themes of chronic liver disease's pathological evolution and the focal points of treatment. Therefore, a deep understanding of these four is crucial. Whether simply strengthening the spleen and replenishing Qi can "replenish the wood" is questionable. In the treatment of liver cirrhosis caused by blood stasis in the liver meridians, light blood-dissolving agents such as hawthorn, zedoaria, and fenugreek are effective.

[0009] Wengan Decoction (Guan Youbo): Astragalus 30 parts, Aconite 10 parts, Atractylodes 10 parts, Cyperus 10 parts, Apricot kernel 10 parts, Tangerine peel 10 parts, Codonopsis pilosula 12 parts, Placenta 12 parts, White Peony Root 15 parts, Angelica 15 parts, Artemisia capillaris 15 parts. This prescription uses dry herbs, contradicting the principle of seeking yang within yin. It ignores liver meridian stasis and is not suitable for treating cirrhosis.

[0010] Shugan Huazheng Decoction (by Zhou Xinyou): 9 parts Bupleurum, 20 parts Artemisia capillaris, 15 parts Isatis root, 9 parts Angelica sinensis, 20 parts Salvia miltiorrhiza, 9 parts Curcuma zedoaria, 9 parts Codonopsis pilosula, 9 parts stir-fried Atractylodes macrocephala, 20 parts Astragalus, 20 parts Ligustrum lucidum fruit, 15 parts Schisandra chinensis, 9 parts Poria. The explanation of the prescription is somewhat far-fetched; the understanding and application of the liver's principles of regulating qi, unblocking the meridians, harmonizing qi and blood, and normalizing the function of internal organs and tissues is not fully applied, and the prescription's treatment of the liver's physiological characteristics is insufficiently reflected.

[0011] Soft Liver Decoction (Deng Tietao): 30 parts of Pseudostellariae Radix, 30 parts of Carapace of Turtle, 15 parts of Atractylodes macrocephala, 15 parts of Poria, 15 parts of Cuscuta australis, 15 parts of Cuscuta australis, 18 parts of Radix Dichroae, 10 parts of Salvia miltiorrhiza, 6 parts of Licorice, 3 parts of Euphorbia pulex. Lack of regulating the liver's Qi, blood, yin and yang.

[0012] However, current drugs for treating cirrhosis or similar diseases have failed to achieve further improvements in efficacy and cure rates during treatment. Summary of the Invention

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

[0014] The purpose of the present 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 mass:

[0016] Poria 10g, Artemisia capillaris 10g, Bupleurum 10g, Rhubarb charcoal 10g, Coptis chinensis 10g, Scutellaria baicalensis charcoal 10g, Gardenia jasminoides 10g, Rhizoma Atractylodis Macrocephalae 15g, Curcuma aromatica 10g, Alisma orientalis 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Magnolia officinalis 10g, Citrus aurantium 10g, Cyperus rotundus 10g, Trillium 10g, Curcuma 10g, Plantago asiatica 20g, Carapax tricolor 10g, Citrus grandiflora bark 10g, Stove heart soil 25g, and donkey-hide gelatin charcoal 2g.

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

[0018] S1. Mix 2g of donkey-hide gelatin and 20mL of distilled water, heat and melt at 60-80°C for 50-80min, add 25g of stove core soil, stir for 8-10min, and cool to 40-45°C to obtain a muddy mixture;

[0019] S2, kneading the muddy mixture while it is still hot and pressing it into a thin sheet, which is used to wrap 10g of rhubarb powder and 10g of scutellaria powder, and then forming it into a ball to obtain a coating;

[0020] S3, roasting the coated material at 350-400° C. for 10-20 min, quickly placing it in a ceramic jar and sealing it for 20-30 min, taking it out and letting it cool, and crushing it to obtain a carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal, and donkey-hide gelatin charcoal;

[0021] S4. Mix 10g of Poria, 10g of Artemisia capillaris, 10g of Bupleurum, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Radix Achyranthis Bidentatae, 10g of Curcuma aromatica, 10g of Rhizoma Alismatis, 10g of Radix Paeoniae Rubra, 10g of Salvia miltiorrhizae, 10g of Magnolia officinalis, 10g of Fructus Aurantii Immaturus, 10g of Cyperus rotundus, 10g of Trigonella ternate, 10g of Curcuma zedoariae, 20g of Plantago, 10g of Carapax Trionycis, 10g of Cortex Ceratitis, and carbonized materials, soak them in 2500mL of water, boil the soaked medicinal materials over high heat, continue to decoct on low heat for 60-70min, filter, and obtain the filtrate to obtain a first concentrated solution. Take the filter residue and continue to add 2500mL of water to cover the residue, boil over high heat, continue to decoct on low heat for 40-60min, filter, and obtain the filtrate to obtain a second concentrated solution. The medicinal liquid obtained by combining the first concentrated solution and the second concentrated solution is the Chinese medicine composition.

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

[0023] Beneficial effects of the present invention:

[0024] The disclosed traditional Chinese medicine composition for treating liver cirrhosis and its preparation method comprises a coating layer prepared by mixing donkey-hide gelatin with stove core soil, which is then coated with rhubarb powder and scutellaria baicalensis powder for carbonization and frying to provide a protective effect. The resulting rhubarb charcoal and scutellaria baicalensis charcoal prevent excessive carbonization during cooling. The coating forms a physical barrier during the carbonization process, reducing the damage to the active ingredients of the rhubarb powder and scutellaria baicalensis powder caused by high temperature, thereby preventing excessive loss of the active ingredients of the rhubarb and scutellaria baicalensis powders due to frying.

[0025] Furthermore, the present application improves the efficacy and cure rate of treating patients with liver cirrhosis by optimizing the formula of the Chinese medicine composition for treating liver cirrhosis:

[0026] Bupleurum root soothes the liver, regulates qi and relieves stagnation, while scutellaria baicalensis charcoal has a bitter and cold nature, clears heat and promotes bile secretion. Combined with bupleurum root, it can clear away stagnant heat in the liver and gallbladder, and has the effect of regulating the liver and turning the key points.

[0027] The combination of Danshen, Magnolia officinalis, Citrus aurantium, Cyperus rotundus, Trigonosciadium japonicum, Curcuma zedoaria, Plantago asiatica, Carapace of Turtle, Cortex truncatum, Heartwood, and charcoal donkey-hide gelatin is a spleen-tonifying and Qi-invigorating herb, in line with Zhang Zhongjing's principle of "seeing liver disease, knowing that the liver transmits to the spleen, and first strengthening the spleen." It invigorates blood circulation and promotes diuresis, removes blood stasis, transforms dampness, eliminates accumulation and stagnation, stimulates appetite, and is good at opening up the interior and exterior, balancing the ascending and descending, and regulating yin and yang, qi, and blood.

[0028] Poria, Artemisia capillaris, Bupleurum root, Rhubarb charcoal, Coptis chinensis, Scutellaria baicalensis charcoal, Gardenia jasminoides, Rhizoma Atractylodis Macrocephalae, Curcuma aromatica, Alisma orientalis, Paeonia lactiflora, and Carapax tricolor are combined to disperse blood stasis and resolve symptoms, promoting qi circulation, relieving depression, promoting blood circulation, promoting diuresis, and softening the liver and contracting the spleen. Rhubarb charcoal and donkey-hide gelatin are combined to open up the interior and exterior, balance ascending and descending, and regulate yin and yang qi and blood, focusing on the ascending and descending movement of qi, clearing blood stasis, cooling blood, and reducing swelling.

[0029] Turtle shell is salty and cold in nature, entering the liver, spleen, and blood. It can nourish yin and reduce fever, soften and disperse hard masses, and has a good therapeutic effect on splenomegaly caused by cirrhosis. Alisma orientalis enters the liver and kidneys, and can move the water below to rise with the water qi, and make the water above flow downward with the flow of qi. It can reduce the dampness, fire, and heat in the liver and kidney meridians and help the rise and fall of yin and yang.

[0030] The combination of Artemisia capillaris, Bupleurum chinense, Rhubarb charcoal, Coptis chinensis, Scutellaria baicalensis charcoal, Gardenia jasminoides, Rhizoma Coptidis, Curcuma aromatica, Magnolia officinalis, Citrus aurantium, Cyperus rotundus, Trillium gracile, Curcuma zedoaria, and Plantago asiatica has the ability to promote the flow of lung qi, relieve liver qi, and circulate blood stasis and resolve stagnation between the chest, flanks, and ribs. It is especially effective for those who have been ill for a long time. The combined use can deeply reach the affected area and mediate the key points. Combined with Poria cocos, Alisma orientalis, Paeonia lactiflora, Salvia miltiorrhiza, Carapax tricolor, Citrus grandiflora bark, Sophora flavescens, and donkey-hide gelatin charcoal, it can not only relieve the depression of liver qi, but also regulate blood stasis, treat heart, abdomen, and flank pain, dissipate lumps, harmonize the spleen to strengthen the middle burner, and when new blood is produced, qi will be prosperous, and when qi is prosperous, recovery will be enhanced.

[0031] Furthermore, rhubarb charcoal partially carbonizes anthraquinone components through the charcoal roasting process, weakening the laxative effect and enhancing the astringent and hemostatic effects, which can help improve the risk of gastrointestinal bleeding caused by portal hypertension in cirrhosis; Scutellaria baicalensis charcoal enhances the stability of flavonoid compounds, improves antioxidant capacity, and inhibits liver inflammatory response. After carbonization, the two have synergistic effects, prolonging the retention time of drugs in the intestine, delaying the process of liver fibrosis, and jointly regulating liver metabolic function. After carbonization, the laxative components of rhubarb charcoal are reduced, reducing patients' diarrhea intolerance; the cold nature of Scutellaria baicalensis charcoal is partially neutralized, which is more suitable for spleen and kidney yang deficiency in the late stage of cirrhosis, and enhances the therapeutic effect. Donkey-hide gelatin charcoal is a traditional Chinese medicine charcoal product made from carbonized donkey-hide gelatin. It is rich in various nutrients such as amino acids and proteins. It can promote the synthesis of human hemoglobin and has the effect of nourishing blood; it can warm 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 immunity-enhancing effects, which help to improve the body's resistance and enhance physical fitness; in addition, donkey-hide gelatin itself has a greasy texture and is not easy to digest, while the greasy texture of carbonized donkey-hide gelatin is reduced, making it easier for patients with cirrhosis and weak spleen and stomach to accept, which is beneficial to the absorption and utilization of drugs, while also reducing adverse effects on the gastrointestinal tract and helping to restore the patient's overall physical condition.

[0032] Through the synergistic effect of the combination of rhubarb charcoal, scutellaria baicalensis charcoal, and donkey-hide gelatin charcoal, the blood circulation of the liver is improved, heat is cleared away and blood is cooled, astringency and consolidation are achieved, the disappearance of ascites is promoted, the metabolism and excretion function of the liver are improved, and inflammatory damage to liver cells is reduced. The combination of the three, when treating cirrhosis of the liver, not only focuses on symptomatic treatment such as hemostasis and clearing heat, but also takes into account the overall conditioning of nourishing blood and nourishing yin, so that the liver is nourished and repaired, and the overall condition of the patient is improved. DETAILED DESCRIPTION

[0033] In order to further illustrate the technical means and effects adopted by the present invention to achieve the predetermined purpose of the invention, the specific implementation methods, structures, features and effects of the present invention are described in detail below in combination with the embodiments.

[0034] Example 1

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

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

[0037] S2, kneading the muddy mixture while it is still hot and pressing it into a thin sheet, which is used to wrap 10g of rhubarb powder and 10g of scutellaria powder, and then forming it into a ball to obtain a coating;

[0038] S3, roasting the coated material at 380°C for 20 minutes, quickly placing it in a ceramic jar and sealing it for 25 minutes, taking it out and letting it cool, and crushing it to obtain a carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal and donkey-hide gelatin charcoal;

[0039] S4, 10g of Poria, 10g of Artemisia capillaris, 10g of Bupleurum, 10g of Coptidis, 10g of Gardenia, 15g of Radix Achyranthis Bidentatae, 10g of Curcuma, 10g of Rhizoma Alismatis, 10g of Radix Paeoniae Rubra, 10g of Radix Salviae Miltiorrhizae, 10g of Magnolia officinalis, 10g of Fructus Aurantii Immaturus, 10g of Rhizoma Cyperi, 10g of Rhizoma Trigonellae, 10g of Rhizoma Curcumae, 20g of Herba Plantaginis, 10g of Carapax Trionycis, 10g of Cortex Cervi Paniculatae, and the carbonized material obtained in step S3 were mixed, and the mixture was soaked in 2500mL of water, and the soaked medicinal materials were boiled over high heat, and decocted on low heat for 65min, filtered, and the filtrate was taken to obtain a first concentrated solution, and the filter residue was continued to be added with 2500mL of water to cover the residue, boiled over high heat, and decocted on low heat for 45min, filtered, and the filtrate was taken to obtain a second concentrated solution; the first concentrated solution and the second concentrated solution were combined to obtain a medicinal liquid, which is the Chinese medicine composition.

[0040] Comparative Example 1

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

[0042] S1. Stir-fry 10g of rhubarb powder, 10g of scutellaria baicalensis powder, and 2g of donkey-hide gelatin at 380°C for 20min. After charring, quickly transfer the mixture to a sealed ceramic jar for 25min, remove the mixture, let it cool, and crush it to obtain a carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal, and donkey-hide gelatin charcoal.

[0043] S2, 10g of Poria, 10g of Artemisia capillaris, 10g of Bupleurum, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Radix Achyranthis Bidentatae, 10g of Curcuma aromatica, 10g of Rhizoma Alismatis, 10g of Radix Paeoniae Rubra, 10g of Salvia miltiorrhizae, 10g of Magnolia officinalis, 10g of Fructus Aurantii Immaturus, 10g of Cyperus rotundus, 10g of Rhizoma Trigonellae, 10g of Rhizoma Curcumae, 20g of Herba Plantaginis, 10g of Carapax Trionycis, 10g of Cortex Phellodendri, the carbonized material obtained in step S1, and 25g of stove core soil were mixed, and the mixture was soaked in 2500mL of water, and the soaked medicinal materials were boiled over high heat, and decocted on low heat for 65min, filtered, and the filtrate was taken to obtain a first concentrated solution, and the filter residue was continued to add 2500mL of water to cover the residue, boiled over high heat, and decocted on low heat for 45min, filtered, and the filtrate was taken to obtain a second concentrated solution; the first concentrated solution and the second concentrated solution were combined to obtain a medicinal liquid, which is the Chinese medicine composition.

[0044] Comparative Example 2

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

[0046] 10g of Poria, 10g of Artemisia capillaris, 10g of Bupleurum, 10g of Coptis chinensis, 10g of Gardenia jasminoides, 15g of Radix Angelicae Dahuricae, 10g of Curcuma aromatica, 10g of Rhizoma Alismatis, 10g of Radix Paeoniae Rubra, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Fructus Aurantii Immaturus, 10g of Cyperus rotundus, 10g of Trigonella ternate, 10g of Curcuma zedoaria, 20g of Plantago, 10g of Carapax Trionycis, 10g of Cortex Phellodendri, 10g of Rhubarb powder, 10g of Scutellaria baicalensis powder, 2g of donkey-hide gelatin and 25g of stove heart soil are mixed and soaked in 2500ml of water. After the medicinal materials are thoroughly soaked in water, they are boiled over high heat, decocted over low heat for 65min, filtered, and the filtrate is taken to obtain a first concentrated solution. 2500ml of water is added to the filter residue to cover the residue, boiled over high heat, decocted over low heat for 45min, filtered, and the filtrate is taken to obtain a second concentrated solution. The first concentrated solution and the second concentrated solution are combined to obtain a medicinal liquid, which is the Chinese medicine 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% by volume 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. Five model rats were randomly selected and their liver tissue pathology was observed. If there was a large amount of necrosis of liver cells, a large amount of collagen deposition and inflammatory infiltration in the liver tissue, the model of liver cirrhosis was considered 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 a blank control group, and the Chinese medicine composition of Example 1, Comparative Example 1 and Comparative Example 2 of the present invention was administered orally at 50 mg / kg, and the blank control group was administered orally at 50 mg / kg of normal saline, an average of 2 times per day per group, for 4 consecutive weeks.

[0050] 3) Liver tissue samples of the SD rats were collected and tested for liver function and blood biochemical indicators. The test results are shown in Table 1 below.

[0051] Table 1

[0052]

[0053] As shown in Table 1, the Chinese medicine composition prepared in Example 1 of the present application has a good therapeutic effect on liver cirrhosis in male SD rats. In Comparative Example 1, the rhubarb and scutellaria root were not carbonized, resulting in a reduced therapeutic effect. In Comparative Example 2, the rhubarb, scutellaria root, and donkey-hide gelatin were not carbonized, resulting in a further reduction in the therapeutic effect. These results demonstrate that the addition of charcoalized rhubarb, scutellaria root, and donkey-hide gelatin is beneficial for the treatment of liver cirrhosis.

[0054] Verification Example 2

[0055] A total of 98 patients with liver disease in outpatient and inpatient clinics of a traditional Chinese medicine hospital were selected, aged between 25 and 55 years, including 94 males and 4 females.

[0056] Diagnostic criteria: "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases".

[0057] Treatment method: The patient takes the medicinal solution of Example 1 of the present invention, 1 dose per day, taken twice a day, morning and evening, 3 months as a course of treatment, and 2 courses of treatment are performed.

[0058] Efficacy criteria:

[0059]

[0060]

[0061] Grade A: During treatment, patients experience significant relief and improvement in cirrhosis-related symptoms such as fatigue, weight loss, dull complexion, decreased urine output, lower limb edema, loss of appetite, abdominal distension, gastrointestinal dysfunction, and ascites. Specifically, patients experience a return of strength, stable or increased weight, a rosy complexion, normal or increased urine output, subsided lower limb edema, significantly improved appetite, reduced abdominal distension, a gradual return to normal gastrointestinal function, and absorption or reduction of ascites.

[0062] Grade B: After treatment, the patient's aforementioned cirrhosis symptoms have been alleviated. Although the symptoms have not completely disappeared, the patient will notice some improvement, such as decreased fatigue, minimal weight loss, improved complexion, increased urine output, reduced lower limb edema, improved appetite, less intense abdominal distension, improved gastrointestinal dysfunction, and reduced ascites.

[0063] Grade C: After a period of treatment, the patient's symptoms have not significantly improved. Symptoms persist and may even worsen, such as persistent fatigue, continued weight loss, a dark 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 outcomes

[0065]

[0066] The above treatment results show that the traditional Chinese medicine composition of the present application, which is composed of 10g of Poria, 10g of Artemisia capillaris, 10g of Bupleurum, 10g of Rhubarb charcoal, 10g of Coptis chinensis, 10g of Scutellaria baicalensis charcoal, 10g of Gardenia jasminoides, 15g of Radix Achyranthis Bidentatae, 10g of Curcuma aromatica, 10g of Alisma orientalis, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 10g of Magnolia officinalis, 10g of Citrus aurantium, 10g of Cyperus rotundus, 10g of Trillium, 10g of Curcuma zedoaria, 20g of Plantago, 10g of Carapax tricolor, 10g of Cortex truncatum, 25g of Stove Heart Soil, and 2g of donkey-hide gelatin charcoal, has a good effect on the treatment of cirrhosis.

[0067] The above description is merely a preferred embodiment of the present invention and does not constitute any form of limitation to the present invention. Although the present invention has been disclosed as above in terms of a preferred embodiment, it is not intended to limit the present invention. Any person skilled in the art can, without departing from the scope of the technical solution of the present invention, make some changes or modifications to equivalent embodiments using the technical contents disclosed above. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating liver cirrhosis, characterized in that: The raw material composition is as follows in parts by mass: Poria 10g, Artemisia capillaris 10g, Bupleurum 10g, Rhubarb charcoal 10g, Coptis chinensis 10g, Scutellaria baicalensis charcoal 10g, Gardenia jasminoides 10g, Rhizoma Atractylodis Macrocephalae 15g, Curcuma aromatica 10g, Alisma orientalis 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Magnolia officinalis 10g, Citrus aurantium 10g, Cyperus rotundus 10g, Trillium 10g, Curcuma 10g, Plantago asiatica 20g, Carapax tricolor 10g, Citrus grandiflora bark 10g, Stove heart soil 25g, and donkey-hide gelatin charcoal 2g.

2. The method for preparing the Chinese medicine composition for treating liver cirrhosis according to claim 1, wherein The following steps are involved: S1. Mix donkey-hide gelatin and distilled water, heat and melt, add stove core soil, stir, and cool to obtain a muddy mixture; S2, kneading the mud-like mixture and pressing it into a thin sheet, which is used to wrap the rhubarb powder and the scutellaria powder, and then forming it into a ball to obtain a coating; S3, charring the coated material, quickly placing it in a ceramic jar after charring, sealing it, taking it out and letting it cool, and crushing it to obtain a carbonized material containing rhubarb charcoal, scutellaria baicalensis charcoal and donkey-hide gelatin charcoal; S4. Mix Poria, Artemisia capillaris, Bupleurum, Coptidis, Gardenia, Rhizoma Citri Reticulatae, Curcuma, Rhizoma Alismatis, Paeonia lactiflora, Salvia miltiorrhiza, Magnolia officinalis, Fructus Aurantii, Rhizoma Cyperi, Rhizoma Trigonellae, Rhizoma Curcumae, Plantago, Carapace of Trionycis, Cortex Cervi Paniculatae and carbonized materials, soak in water and boil to obtain a medicinal liquid, which is the Chinese medicine composition.

3. The method for preparing a Chinese medicine composition for treating liver cirrhosis according to claim 2, wherein: In step S1, the heating to melt refers to heating to melt at 60-80° C. 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 treatment refers to roasting at 350-400° C. for 10-20 minutes.

5. A Chinese medicine composition for treating liver cirrhosis and a preparation method according to claim 2, characterized in that: In step S4, the specific steps of decocting are: After being soaked in water, the medicinal materials are boiled over high heat, then decocted over low heat, filtered, and the filtrate is taken to obtain the first concentrated solution; Take the filter residue and continue to add water until it covers the residue, boil over high heat, continue to simmer over low heat, filter, and take the filtrate to obtain the second concentrated solution; The medicinal solution is obtained by combining the first concentrated solution and the second concentrated solution.

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