A traditional Chinese medicine composition for treating cirrhosis ascites and a preparation method and use thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating ascites in liver cirrhosis, its preparation method, and its uses. The traditional Chinese medicine composition is made from raw materials including tortoise shell, turtle shell, polygonatum, glehnia root, ophiopogon root, oyster shell, chicken gizzard lining, schisandra fruit, licorice root, citron, raw atractylodes rhizome, water lily seed, and paper mulberry fruit. It has the effects of nourishing yin and softening hardness, resolving blood stasis and promoting diuresis, and strengthening the spleen and regulating qi. It is mainly used to treat ascites in liver cirrhosis. This invention's traditional Chinese medicine composition targets the core pathogenesis of liver cirrhosis ascites—liver and kidney yin deficiency, blood stasis, and spleen deficiency with dampness—achieving both symptomatic and root-cause treatment, effectively improving patient symptoms and enhancing clinical efficacy. Furthermore, this invention provides a preparation method for the traditional Chinese medicine composition, ensuring its stable and controllable quality, suitable for industrial production.

Description

Technical Field

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

[0002] Ascites in cirrhosis is one of the most representative and common complications after cirrhosis enters the decompensated stage, and it is also a highly challenging problem in clinical diagnosis and treatment. Recent clinical statistics show that more than half of cirrhosis patients develop ascites during the course of the disease. Once ascites appears, it not only signifies that liver function has entered an irreversible decline stage, but also significantly increases the patient's one-year mortality rate, seriously threatening the patient's life, health, and quality of life. In the traditional Chinese medicine theory system, ascites in cirrhosis falls under the category of "abdominal distension" and is listed as one of the four major difficult syndromes in TCM. Its pathogenesis is complex and not caused by a single organ lesion. It mostly stems from long-term liver stagnation and spleen deficiency, irregular diet, and internal damage from overwork and excessive sexual activity, gradually affecting the liver and kidneys. Ultimately, this leads to an imbalance in the coordination of the liver, spleen, and kidneys, dysfunction of qi transformation, and subsequent stagnation of qi, blood stasis, and fluid metabolism disorders. Ultimately, the three pathological products of qi stagnation, blood stasis, and dampness combine and accumulate in the abdomen, forming the typical symptom of abdominal distension resembling a drum.

[0003] Currently, the mainstream treatment for ascites in Western medicine for cirrhosis mainly focuses on symptomatic relief. Conventional methods include using diuretics such as spironolactone and furosemide to promote water and sodium excretion, intravenous albumin infusion to correct hypoalbuminemia, and paracentesis for rapid decompression when abdominal pressure is too high and symptoms are severe. Some end-stage patients may also undergo invasive interventions such as ascites concentration and reinfusion, or transjugular intrahepatic portosystemic shunt. While these treatments can quickly relieve symptoms such as abdominal distension and oliguria in the short term, they fail to address the root cause of the disease. Ascites is commonly recurrent after discontinuation of these medications, and long-term use of diuretics can easily lead to electrolyte imbalances and increase the burden on liver and kidney function. Paracentesis also carries risks of secondary infection and excessive protein loss. These limitations make it difficult for Western medicine to achieve ideal long-term efficacy.

[0004] In years of clinical practice, Traditional Chinese Medicine (TCM) has gradually demonstrated its irreplaceable and unique advantages in treating chronic and complex diseases such as ascites caused by cirrhosis. Unlike Western medicine's symptomatic approach, TCM treatment adheres to the core concept of holistic regulation. It differentiates and treats patients based on their specific symptoms, constitution, and disease course, addressing the root causes by adjusting organ function and regulating the flow of Qi, blood, and body fluids. This not only improves clinical symptoms such as fatigue, abdominal distension, and loss of appetite, and promotes the resolution of ascites, but also helps protect residual liver function, slows disease progression, and improves the overall quality of life for patients, reducing the probability of ascites recurrence. These advantages have gained increasing recognition and attention in clinical practice.

[0005] However, it is undeniable that many traditional Chinese medicine formulas currently used in clinical practice still have unresolved issues in the treatment of ascites due to cirrhosis. The most prominent problem is the lack of precise targeting in formula composition, leading to unstable overall efficacy and significant differences in treatment outcomes among different patients using the same formula. Many traditional formulas are limited by the traditional approach of "relieving bloating and promoting diuresis," focusing solely on quickly alleviating the external symptoms of ascites with strong purgatives, completely ignoring the underlying pathogenesis of cirrhotic ascites patients—most chronic patients suffer from fundamental problems of liver and kidney yin deficiency and blood stasis. Attacking only the pathogenic factors without supporting the body's vital energy not only fails to consolidate the therapeutic effect but may also deplete the body's vital energy and worsen the condition. Other formulas aim for comprehensiveness, using as many as twenty or thirty herbs, resulting in a complex composition. This not only hinders the identification of core effective components but also poses significant difficulties for subsequent industrial extraction, production, and quality control of finished products. It makes it difficult to transform traditional formulas into standardized, large-scale modern Chinese medicine products, failing to meet the current widespread clinical needs.

[0006] Therefore, by combining the traditional Chinese medicine theory of ascites with modern clinical research findings, a novel Chinese herbal medicine composition for treating ascites in cirrhosis can be developed. This composition is characterized by its simplified and rational formulation, definite and stable clinical efficacy, and high safety profile. It can not only make up for the shortcomings of existing treatment options and provide better treatment choices for patients with ascites in cirrhosis, further improving clinical treatment outcomes, but also has significant clinical importance and broad market application value in promoting the standardization and industrialization of Chinese medicine treatment for ascites in cirrhosis. Summary of the Invention

[0007] The present invention aims to overcome the shortcomings of the prior art and solve the following core technical problems: how to provide a traditional Chinese medicine composition for treating ascites in liver cirrhosis, its preparation method and uses.

[0008] Specifically, the present invention is achieved through the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating ascites due to liver cirrhosis, the composition being made from the following raw materials in parts by weight: 15-40 parts tortoise shell, 15-40 parts turtle shell, 15-40 parts polygonatum, 10-30 parts glehnia littoralis, 10-30 parts ophiopogon japonicus, 80-120 parts oyster shell, 5-25 parts chicken gizzard lining, 1-15 parts schisandra chinensis, 1-15 parts licorice, 1-15 parts citronella, 15-40 parts raw atractylodes macrocephala, 10-30 parts water lily seed, and 10-30 parts paper mulberry fruit.

[0009] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 25-35 parts of tortoise shell, 25-35 parts of turtle shell, 25-35 parts of polygonatum, 15-25 parts of glehnia root, 15-25 parts of ophiopogon root, 90-110 parts of oyster shell, 10-20 parts of chicken gizzard lining, 5-15 parts of schisandra fruit, 5-15 parts of licorice root, 5-15 parts of citron, 25-35 parts of raw atractylodes macrocephala, 15-25 parts of water lily seed, and 15-25 parts of paper mulberry fruit.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts tortoise shell, 30 parts turtle shell, 30 parts polygonatum, 20 parts glehnia littoralis, 20 parts ophiopogon japonicus, 100 parts oyster shell, 15 parts chicken gizzard lining, 10 parts schisandra chinensis, 10 parts licorice, 10 parts citron, 30 parts raw atractylodes macrocephala, 20 parts water lily seeds, and 20 parts paper mulberry fruit.

[0011] Alternatively, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of nourishing yin and softening hard masses, resolving blood stasis and promoting diuresis, and strengthening the spleen and regulating qi.

[0012] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect above, the method comprising the following steps: weighing each raw material in the weight proportions described in the first aspect above, pre-treatment, extraction, and concentration.

[0013] Preferably, in the above preparation method, the traditional Chinese medicine composition of the present invention can be prepared using conventional methods known in the art.

[0014] Preferably, the extraction methods used in this invention include, but are not limited to, decoction extraction, reflux extraction, ultrasonic extraction, and supercritical extraction.

[0015] Preferably, water, commonly used organic solvents in the art, or mixtures thereof can be used to extract the treated active pharmaceutical ingredient.

[0016] Preferably, the organic solvent is methanol, ethanol, propanol, butanol, ethyl acetate, petroleum ether, etc.

[0017] Preferably, the process includes weighing each raw material, pulverizing, extracting, and concentrating.

[0018] Preferably, the extraction method is decoction, and / or the extraction solvent is water or ethanol, and / or the number of decoctions is 1-3, and / or the decoction time for each decoction is 1-3 hours.

[0019] Alternatively, in the above preparation method, the preparation method includes the following steps: Step 1: Weigh each raw material according to the specified weight, wash and dry them; Step 2: Crush the tortoise shell, turtle shell, and oyster shell into coarse powder, add 8-12 times the amount of water, soak for 1-2 hours, decoct 2-3 times, 1-2 hours each time, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20 (60℃); Step 3: Crush the remaining raw materials into coarse powder, add 6-10 times the amount of 70%-90% ethanol, reflux extract 2-3 times, 1-2 hours each time, combine the extracts, filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.10-1.20 (60℃). Step 4: Combine the extracts obtained in Step 2 and Step 3, stir evenly, dry, and pulverize into fine powder to prepare the traditional Chinese medicine composition.

[0020] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above, or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of a medicament for treating ascites due to liver cirrhosis.

[0021] Alternatively, in the above-described uses, the drug may be in solid, semi-solid, or liquid form.

[0022] Alternatively, in the above-described uses, the drug may be a decoction, powder, oral liquid, ointment, granules, tablet, or capsule.

[0023] Compared with the prior art, the present invention has the following beneficial effects: The traditional Chinese medicine composition of this invention follows the principles of nourishing yin and softening hard masses, resolving blood stasis and promoting diuresis, and strengthening the spleen and regulating qi. It targets the core pathogenesis of liver cirrhosis with ascites, characterized by liver and kidney yin deficiency, internal obstruction of blood stasis, and spleen deficiency with dampness, achieving both symptomatic and root-cause treatment. This effectively improves patient symptoms and enhances clinical efficacy. Furthermore, this invention provides a method for preparing the aforementioned traditional Chinese medicine composition, ensuring stable and controllable quality suitable for industrial production. Detailed Implementation

[0024] The traditional Chinese medicine composition of this invention is made from raw materials such as tortoise shell, turtle shell, polygonatum, sand ginseng, ophiopogon japonicus, oyster shell, chicken gizzard lining, schisandra chinensis, licorice, citron, raw atractylodes macrocephala, water lily seed, and paper mulberry seed. It has the effects of nourishing yin and softening hardness, removing blood stasis and promoting diuresis, and strengthening the spleen and regulating qi. It is mainly used to treat ascites due to liver cirrhosis.

[0025] The compatibility mechanism and formulation explanation of the traditional Chinese medicine composition of this invention are as follows: The core treatment principle is "nourishing yin and softening hard masses, resolving blood stasis and promoting diuresis, and strengthening the spleen and regulating qi." It addresses the complex pathogenesis of liver and kidney yin deficiency, internal obstruction of blood stasis, and spleen deficiency with dampness, taking into account both supporting the body's resistance and eliminating pathogenic factors, with the aim of reversing masses and reducing ascites.

[0026] Applicable syndrome types: This invention embodies the TCM treatment philosophy of "strengthening the body's resistance without clinging to pathogens, and eliminating pathogens without harming the body's resistance." It is applicable to patients with ascites due to liver cirrhosis who have liver and kidney yin deficiency and blood stasis with water retention, and whose symptoms include: distended and hard abdomen, sallow complexion, five-center heat (heat in the palms, soles, and chest), dry mouth and tongue, scanty urine, red tongue with little coating, and thready and rapid pulse.

[0027] The traditional Chinese medicine composition of this invention uses tortoise shell and turtle shell as the principal ingredients, which nourish yin and subdue yang, soften hardness and dissipate nodules, targeting the fundamental pathogenesis of liver and kidney yin deficiency and internal accumulation of masses; oyster shell, polygonatum, glehnia root, and ophiopogon root are the assistant ingredients, which enhance the effects of softening hardness and dissipating nodules, nourishing yin and moistening dryness; water lily seed, paper mulberry fruit, chicken gizzard lining, raw atractylodes macrocephala, and citron are the adjuvant ingredients, which promote blood circulation, diuresis, and spleen function, while also addressing the symptoms; licorice and schisandra are the guiding ingredients, which harmonize the effects of the other ingredients and astringe yin to consolidate the foundation. The entire formula is meticulously formulated with principal, assistant, adjuvant, and guiding ingredients, treating both the root cause and the symptoms, and working together to nourish yin, soften hardness, promote blood circulation, diuresis, spleen function, and qi regulation.

[0028] The efficacy and indications of each herb in the traditional Chinese medicine composition described in this invention are as follows: "Tortoise shell" refers to the turtle, an animal belonging to the genus *Tortoise* in the family Geoem Chinemys reevesi(Gray) The shell of a plant. It tastes salty and sweet, and is cold in nature; it enters the liver and kidney meridians. It has the effects of nourishing yin and suppressing yang, tonifying the kidneys and strengthening bones, nourishing blood and replenishing the heart, and consolidating the menstrual flow and stopping uterine bleeding. It is mainly used to treat yin deficiency with internal heat, night sweats, late-stage febrile diseases, persistent low-grade fever, yin deficiency cough, hemoptysis and epistaxis, liver yang dizziness, internal wind due to deficiency, weakness of muscles and bones, delayed closure of the fontanelle, palpitations due to heart deficiency, insomnia and forgetfulness, metrorrhagia, leukorrhea, syphilis, carbuncles, and boils.

[0029] "Turtle shell" refers to the shell of a turtle, an animal belonging to the genus *Trionyx* in the family Tri Trionyx sinensis Wiegmann The carapace of the plant. Salty in taste, slightly cold in nature; it enters the liver and kidney meridians. It has the effects of nourishing yin and suppressing yang, reducing fever and eliminating steaming sensation, softening hardness and dissipating nodules. It is commonly used for yin deficiency fever, bone steaming fever, yin deficiency with yang hyperactivity, dizziness, internal wind due to deficiency, amenorrhea, abdominal masses, and chronic malaria.

[0030] "Polygonatum" refers to the plant Polygonatum sibiricum, belonging to the Liliaceae family. Polygonatum sibiricum Red. Polygonatum multiflorum Polygonatum cyrtonema Hua Or Yunnan Polygonatum Polygonatum kingianum Coll.et Hemsl. The dried rhizome. It is neutral in nature, sweet in taste, and enters the spleen, lung, and kidney meridians. It has the effects of replenishing qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. It is mainly used to treat spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, consumptive cough with hemoptysis, deficiency of essence and blood, soreness and weakness of the waist and knees, premature graying of hair, and internal heat and thirst.

[0031] "Adenophora" refers to the plant Adenophora stricta, belonging to the Campanulaceae family. Adenophora strict Miq. Apricot Leaf Sand Ginseng Adenophora hunanensis Nannf. Adenophora stricta Adenophora tetraphylla(Thunb.)Fisch. Yunnan sand ginseng Adenophora khasiana(Hook.f.et Thoms.)Coll.et Hemsl Soaking sand ginseng Adenophora potaninii Korsh.It is the root of several plants in the same genus. It tastes sweet and slightly bitter, and is slightly cold in nature; it enters the lung and stomach meridians. It has the effects of nourishing yin and clearing heat, moistening the lungs and resolving phlegm, and benefiting the stomach and promoting the production of body fluids. It is commonly used for chronic cough due to yin deficiency, consumptive cough with hemoptysis, dry cough with little phlegm, sore throat due to deficiency heat, and thirst due to fluid depletion.

[0032] "Ophiopogon japonicus" refers to the plant Ophiopogon japonicus, belonging to the Liliaceae family. Ophiopogon japonicus (Lf)Ker-Gawl. The dried tuberous root. It tastes sweet and slightly bitter, is slightly cold in nature, and enters the stomach, lung, and heart meridians. It has the effects of nourishing yin and moistening the lungs, benefiting the stomach and promoting fluid production, and clearing the heart and relieving irritability. It is mainly used to treat dry cough due to lung dryness, cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0033] "Oyster" refers to the Pacific oyster, an animal belonging to the genus Oyster in the family Ostreidae. Thunberg's giant oyster Dalian Bay Oysters Oysters talienwhanensis Crosse Or Omi oyster Gould's rivularis oyster Seashells. Salty in taste, slightly cold in nature; enters the liver, gallbladder, and kidney meridians. It has the effects of calming the mind, nourishing yin and yang, softening hardness and dissipating nodules. It is mainly used to treat palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, and abdominal masses.

[0034] "Chicken gizzard lining" refers to the lining of the domestic chicken (Pheasantidae family). Gallus gallus domesticus Brisson The inner wall of the bladder. Sweet in taste and neutral in nature; it enters the spleen, stomach, small intestine, and bladder meridians. It has the effects of strengthening the stomach and promoting digestion, astringing essence and stopping seminal emission, and clearing urinary stones and dissolving stones. It is mainly used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, seminal emission, painful urination with stones, and gallbladder distension and hypochondriac pain.

[0035] "Schisandra" refers to the schisandra plant, belonging to the Magnoliaceae family. Schisandra chinensis(Turcz.)Baill. Or Schisandra chinensis Schisandra sphenanthera Rehd. et Wils. The dried, ripe fruit. It tastes sour and sweet, and is warm in nature; it enters the lung, heart, and kidney meridians. It has astringent and consolidating effects, replenishes qi and generates fluids, tonifies the kidneys and calms the mind. It is used to treat chronic cough and wheezing, nocturnal emission, frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations, and insomnia.

[0036] "Licorice" refers to the legume plant *Glycyrrhiza uralensis*. Glycyrrhiza uralensis Fisch. licorice root Glycyrrhiza inflate Bat. Or licorice root Glycyrrhiza glabra L . The dried roots and rhizomes of the plant. Sweet in taste and neutral in nature; it enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, and relieving spasms and pain. It is often used to treat spleen and stomach weakness, insufficient heart qi, heat toxicity syndrome, cough, abdominal or limb spasms and pain. It can also harmonize other herbs, alleviate drug toxicity, and balance the properties of medicinal materials, and is widely used in prescriptions.

[0037] "Buddha's Hand" refers to the citrus plant (Citrus medica var. sarcodactylis) belonging to the Rutaceae family and the Citrus genus. Citrus medica L. var. sarcodactylis SwingleThe dried fruit of the plant. It has a pungent, bitter, and sour taste, and is warm in nature; it enters the liver, spleen, stomach, and lung meridians. It has the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. It is mainly used for liver and stomach qi stagnation, chest and rib distension and pain, epigastric fullness, poor appetite and vomiting, and cough with excessive phlegm.

[0038] "Raw Atractylodes macrocephala" comes from the dried rhizome of Atractylodes macrocephala, a plant in the Asteraceae family. It tastes bitter and sweet, is warm in nature, and enters the spleen and stomach meridians. It has many effects such as strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is often used to treat symptoms such as spleen qi deficiency, spontaneous sweating due to qi deficiency, and threatened abortion.

[0039] "Water Red Flower Seed" refers to the Polygonum hydropiper, a plant in the Polygonaceae family. Polygonum orientale L. The dried, ripe fruit. Salty in taste, slightly cold in nature; it enters the liver and stomach meridians. It has the effects of dispersing blood stasis and eliminating masses, relieving pain, and promoting diuresis and reducing swelling. It is used to treat abdominal masses, goiter, indigestion, stomach distension and pain, and edema with ascites.

[0040] "Broussonetia papyrifera fruit" refers to the fruit of the paper mulberry tree, a plant belonging to the genus Broussonetia in the family Moraceae. Broussonetia papyrifera(L.)Vent. The dried, ripe fruit. It has a sweet taste and cold nature; it enters the liver and kidney meridians. It has the effects of tonifying the kidneys and clearing the liver, improving eyesight, and promoting urination. It is mainly used to treat liver and kidney deficiency, soreness and weakness of the lower back and knees, consumptive fever with bone steaming, dizziness, blurred vision, pterygium, and edema.

[0041] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0042] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0043] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0044] Unless otherwise stated, all percentages and parts in this invention refer to weight percentages and weight parts.

[0045] Preparation Example: Example 1: A traditional Chinese medicine composition for treating ascites due to liver cirrhosis, the composition being made from the following raw materials: 30 g tortoise shell, 30 g turtle shell, 30 g polygonatum, 20 g glehnia littoralis, 20 g ophiopogon japonicus, 100 g oyster shell, 15 g chicken gizzard lining, 10 g schisandra chinensis, 10 g licorice root, 10 g citron, 30 g raw atractylodes macrocephala, 20 g water lily seeds, and 20 g paper mulberry fruit.

[0046] The preparation method of the traditional Chinese medicine composition includes the following steps: Step 1: Weigh each raw material according to the specified weight, wash and dry them; Step 2: Crush the tortoise shell, turtle shell, and oyster shell into coarse powder, add 10 times the amount of water, soak for 1.5 hours, decoct 3 times, 1.6 hours each time, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.15 (60℃). Step 3: Crush the remaining raw materials into coarse powder, add 8 times the amount of 80% ethanol, reflux and extract 3 times, 1.5 hours each time, combine the extracts, filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.15 (60℃). Step 4: Combine the extracts obtained in Step 2 and Step 3, stir evenly, dry, and pulverize into fine powder to prepare the traditional Chinese medicine composition.

[0047] Comparative Example 1: A traditional Chinese medicine composition, said composition being made from the following raw materials: 60 g of turtle shell, 30 g of polygonatum rhizome, 20 g of glehnia root, 20 g of ophiopogon root, 100 g of oyster shell, 15 g of chicken gizzard lining, 10 g of schisandra fruit, 10 g of licorice root, 10 g of citron, 30 g of raw atractylodes rhizome, 20 g of water lily seed, and 20 g of paper mulberry fruit.

[0048] The preparation method of the traditional Chinese medicine composition includes the following steps: Step 1: Weigh each raw material according to the specified weight, wash and dry them; Step 2: Crush the turtle shell and oyster shell into coarse powder, add 10 times the amount of water, soak for 1.5 hours, decoct 3 times, 1.6 hours each time, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.15 (60℃); Step 3: Crush the remaining raw materials into coarse powder, add 8 times the amount of 80% ethanol, reflux and extract 3 times, 1.5 hours each time, combine the extracts, filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.15 (60℃). Step 4: Combine the extracts obtained in Step 2 and Step 3, stir evenly, dry, and pulverize into fine powder to prepare the traditional Chinese medicine composition.

[0049] Comparative Example 2: A traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is made from the following raw materials: 30 g of tortoise shell, 30 g of turtle shell, 30 g of polygonatum, 20 g of glehnia littoralis, 20 g of ophiopogon japonicus, 100 g of oyster shell, 15 g of chicken gizzard lining, 10 g of schisandra chinensis, 10 g of licorice root, 10 g of citron, 30 g of raw atractylodes macrocephala, and 40 g of safflower seeds.

[0050] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0051] Comparative Example 3: A traditional Chinese medicine composition, said composition being made from the following raw materials: 30 g of tortoise shell, 30 g of turtle shell, 30 g of polygonatum, 20 g of glehnia littoralis, 20 g of ophiopogon japonicus, 100 g of oyster shell, 15 g of chicken gizzard lining, 10 g of salvia miltiorrhiza, 10 g of licorice, 10 g of citronella, 30 g of raw atractylodes macrocephala, 20 g of safflower seed, and 20 g of paper mulberry fruit.

[0052] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0053] Example of effect: 1. Materials and Methods This experiment established a rat model of cirrhotic ascites using a CCl4-induced combined intraperitoneal injection of olive oil method. CCl4 and olive oil were mixed in a specific ratio to prepare a 40%-60% CCl4 oil solution, which was then injected intraperitoneally at a dose of 2 mL / kg body weight, twice a week for 10 consecutive weeks. Sixty successfully modeled SD rats were randomly divided into five groups of 12 rats each: model control group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. Ten normal rats served as a blank control group. Each treatment group received 10 g of crude drug / kg daily via gavage, while the model control group and blank control group received an equal volume of physiological saline. The treatment continued for 4 weeks.

[0054] After the experiment, the ascites volume, liver function indicators, and liver fibrosis-related indicators of the rats were measured using conventional methods.

[0055] 2. Data Processing Statistical analysis was performed using SPSS v21.0 (SPSS, USA). Data are expressed as mean ± standard deviation. The Shapiro-Wilk method was used for normality testing, the independent samples t-test was used for comparisons between two groups, and one-way ANOVA was used for comparisons among multiple groups. P A value <0.05 is considered statistically significant.

[0056] 3. Experimental Results 3.1 Observation results of general conditions The rats in the blank control group had normal diet, activity, and defecation, smooth and shiny fur, and stable weight gain. The rats in the model control group showed reduced activity, lethargy, decreased food intake, dry and easily falling fur, and obvious abdominal distension after modeling. At the end of the experiment, the average weight of the rats was 15.2% lower than that of the blank control group, and the mortality rate was 16.7% (2 / 12).

[0057] The general condition of rats in each drug administration group was improved to varying degrees compared with the model control group. The improvement was most obvious in the Example 1 group: at the end of the experiment, the rats were basically normal in activity, their food intake was close to normal, the degree of abdominal distension was significantly reduced, only 1 rat was in poor condition, and there were no deaths. The improvement in the Comparative Example 3 group was the second best, with only 2 rats still having obvious abdominal distension and no deaths. In the Comparative Example 1 and Comparative Example 2 groups, 3 to 4 rats still had symptoms of lethargy and abdominal distension. In the Comparative Example 1 group, 1 rat died, with a mortality rate of 8.3%.

[0058] 3.2 Results of Ascites Volume and Weight Change Detection The changes in ascites volume and body weight of rats in each group after 4 weeks of intervention are shown in Table 1 below.

[0059] Table 1 Note: Compared with the blank control group, P <0.05、 P <0.001; compared with the model control group, # P <0.05、 ## P <0.01、 ### P <0.001.

[0060] As shown in Table 1, the ascites volume in the model control group was significantly higher than that in the blank control group, while the weight gain was significantly lower, indicating successful model establishment. All treatment groups showed significantly lower ascites volume and significantly higher weight gain than the model control group; among them, the reduction in ascites volume in Example 1 group was the greatest, significantly lower than that in the three comparative groups, suggesting that the traditional Chinese medicine composition of Example 1 of this invention has a better effect on reducing ascites in liver cirrhosis than the comparative groups.

[0061] 3.3 Liver function test results After the experiment, the serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and albumin (ALB) levels of rats in each group were measured. The results are shown in Table 2 below.

[0062] Table 2 Note: Compared with the blank control group, P <0.05、 P <0.01、 P <0.001; compared with the model control group, # P <0.05、 ## P <0.01、 ### P <0.001.

[0063] As shown in Table 2, the levels of ALT, AST, and TBIL in the model control group were significantly higher than those in the blank control group, while the level of ALB was significantly lower, indicating that the rats with cirrhotic ascites had significant liver function impairment. All treatment groups showed significant improvement in liver function indicators compared to the model control group, with the most significant improvement observed in the Example 1 group. The decrease in ALT, AST, and TBIL levels and the increase in ALB were significantly greater than those in the three comparative groups, suggesting that the herbal composition in Example 1 had a better repair effect on liver function impairment in rats with cirrhotic ascites than the comparative groups.

[0064] 3.4 Results of Liver Fibrosis Indicators The levels of hydroxyproline (Hyp) in rat liver tissue and serum hyaluronic acid (HA) and laminin (LN) were measured, and the results are shown in Table 3.

[0065] Table 3 Note: Compared with the blank control group, P <0.05、 P <0.01、 P <0.001; compared with the model control group, # P <0.05、 ## P <0.01、 ### P <0.001.

[0066] Hyp, HA, and LN are core indicators reflecting the degree of liver fibrosis. As shown in Table 3, all three indicators in the model control group were significantly higher than those in the blank control group, indicating that the model rats had significant liver fibrosis. All three indicators in each treatment group were significantly lower than those in the model control group. The reduction in the Example 1 group was significantly greater than that in the three comparative groups, indicating that the traditional Chinese medicine composition of Example 1 of this invention has the best anti-liver fibrosis effect.

[0067] 3.5 Experimental Conclusions The results of this animal model experiment show that the traditional Chinese medicine composition described in this invention can effectively promote the regression of ascites in cirrhosis, improve liver function, and significantly reduce the degree of liver fibrosis. The overall therapeutic effect is significantly superior to that of the comparative groups. Comparing Comparative Group 1 (removing only the tortoise shell and increasing the dosage of turtle shell) and Comparative Group 2 (removing Broussonetia papyrifera fruit and increasing the dosage of Polygonum hydropiper seed), it is shown that the equal dosage of tortoise shell and turtle shell can exert a synergistic effect of softening the liver and dispersing nodules, which is superior to doubling the dosage of a single drug. Although Broussonetia papyrifera fruit and Polygonum hydropiper seed have similar effects, they cannot be omitted from the traditional Chinese medicine composition, indicating a certain degree of synergistic effect between them. Comparing Comparative Group 3 (replacing Schisandra chinensis with Salvia miltiorrhiza), it is shown that although both Salvia miltiorrhiza and Schisandra chinensis have hepatoprotective, enzyme-lowering, and anti-liver fibrosis effects, the efficacy of Schisandra chinensis in the traditional Chinese medicine composition of this invention cannot be replaced by Salvia miltiorrhiza. Schisandra chinensis, combined with the overall formula, can achieve better therapeutic effects.

[0068] In summary, the formulation of Example 1 of this invention conforms to the TCM diagnostic approach for liver cirrhosis with ascites due to liver and kidney yin deficiency. It takes into account softening the liver and dispersing nodules, nourishing yin and promoting diuresis, and strengthening the spleen and regulating the middle jiao. The combination of each drug is reasonable, and the therapeutic effect on liver cirrhosis with ascites is definite, which has good development and application value.

[0069] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating ascites due to liver cirrhosis, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-40 parts tortoise shell, 15-40 parts turtle shell, 15-40 parts polygonatum, 10-30 parts glehnia littoralis, 10-30 parts ophiopogon japonicus, 80-120 parts oyster shell, 5-25 parts chicken gizzard lining, 1-15 parts schisandra chinensis, 1-15 parts licorice, 1-15 parts citron, 15-40 parts raw atractylodes macrocephala, 10-30 parts water lily seeds, and 10-30 parts paper mulberry fruit.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 25-35 parts tortoise shell, 25-35 parts turtle shell, 25-35 parts polygonatum, 15-25 parts glehnia littoralis, 15-25 parts ophiopogon japonicus, 90-110 parts oyster shell, 10-20 parts chicken gizzard lining, 5-15 parts schisandra chinensis, 5-15 parts licorice, 5-15 parts citron, 25-35 parts raw atractylodes macrocephala, 15-25 parts water lily seeds, and 15-25 parts paper mulberry fruit.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts tortoise shell, 30 parts turtle shell, 30 parts polygonatum, 20 parts glehnia littoralis, 20 parts ophiopogon japonicus, 100 parts oyster shell, 15 parts chicken gizzard lining, 10 parts schisandra chinensis, 10 parts licorice root, 10 parts citron, 30 parts raw atractylodes macrocephala, 20 parts water lily seeds, and 20 parts paper mulberry fruit.

4. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition has the effects of nourishing yin and softening hard masses, removing blood stasis and promoting diuresis, and strengthening the spleen and regulating qi.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method includes the following steps: weighing each raw material according to the weight proportions of any one of claims 1 to 4, pre-treating, extracting, and concentrating.

6. The preparation method according to claim 5, characterized in that: The preparation method includes the following steps: Step 1: Weigh each raw material according to the specified weight, wash and dry them; Step 2: Crush the tortoise shell, turtle shell, and oyster shell into coarse powder, add 8-12 times the amount of water, soak for 1-2 hours, decoct 2-3 times, 1-2 hours each time, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20 (60℃); Step 3: Crush the remaining raw materials into coarse powder, add 6-10 times the amount of 70%-90% ethanol, reflux extract 2-3 times, 1-2 hours each time, combine the extracts, filter, recover the ethanol from the filtrate, and concentrate to a clear extract with a relative density of 1.10-1.20 (60℃). Step 4: Combine the extracts obtained in Step 2 and Step 3, stir evenly, dry, and pulverize into fine powder to prepare the traditional Chinese medicine composition.

7. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4, or the traditional Chinese medicine composition prepared by the preparation method according to claim 5 or claim 6, in the preparation of a medicament for treating ascites due to liver cirrhosis.

8. The use according to claim 7, characterized in that: The drug is in solid, semi-solid, or liquid form.

9. The use according to claim 8, characterized in that: The medicine is in the form of decoction, powder, oral liquid, ointment, granules, tablets or capsules.

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