A traditional Chinese medicine composition for treating cirrhosis ascites

Abstract

This invention relates to a traditional Chinese medicine composition for treating ascites in patients with liver cirrhosis. The composition is prepared from the following herbs in parts by weight: Astragalus membranaceus 20-40 parts, Poria cocos 20-40 parts, Codonopsis pilosula 5-25 parts, stir-fried Atractylodes macrocephala 5-25 parts, Angelica sinensis 5-20 parts, Cornus officinalis 5-20 parts, stir-fried Citrus aurantium 3-15 parts, stir-fried Bupleurum chinense 1-10 parts, stir-fried chicken gizzard lining 1-10 parts, charred ginger 1-10 parts, and prepared licorice root 1-10 parts. This traditional Chinese medicine composition warms and tonifies the spleen and kidneys, replenishes qi and nourishes blood, and promotes diuresis and reduces swelling. It can effectively treat ascites in patients with liver cirrhosis due to spleen and kidney yang deficiency, and simultaneously increase serum albumin levels and improve nutritional status, fundamentally improving the patient's pathological state of "spleen and kidney yang deficiency" and breaking the vicious cycle of "ascites-malnutrition".

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition for treating ascites due to liver cirrhosis. Background Technology

[0002] Ascites is a common and serious complication of decompensated cirrhosis. Once it occurs, the 1-year mortality rate is approximately 15%, and the 5-year mortality rate can reach 44%-85%. Meanwhile, malnutrition occurs in 23%-61% of cirrhosis patients, and even reaches 50%-90% in decompensated patients, and is an independent risk factor affecting patient prognosis. Ascites and malnutrition interact, creating a vicious cycle: portal hypertension and ascites compression can lead to anorexia, early satiety, and impaired nutrient intake and absorption; while malnutrition, especially hypoalbuminemia and sarcopenia, exacerbates ascites, increases the risk of complications such as infection, and raises mortality.

[0003] Modern medicine's treatment for cirrhosis with ascites and malnutrition mainly includes diuretics, sodium restriction, and human serum albumin supplementation for ascites, as well as nutritional support therapy for malnutrition. Nutritional support advocates supplementing adequate energy and protein through enteral or parenteral routes. However, this approach has significant limitations: 1) Standardized calorie and protein supplementation ranges are difficult to implement for individualized and precise treatment, making it difficult for patients to follow outside the hospital; 2) Commonly used branched-chain amino acids, human serum albumin, and special medical purpose foods are expensive, increasing the economic burden on patients; 3) Long-term use may be accompanied by adverse reactions such as electrolyte imbalance, abdominal distension, and diarrhea; 4) There is a lack of targeted nutritional interventions for spleen and kidney yang deficiency, a common TCM syndrome in cirrhosis with ascites.

[0004] Traditional Chinese medicine (TCM) has unique advantages in the treatment of ascites in liver cirrhosis, especially emphasizing syndrome differentiation and treatment. Late-stage ascites in liver cirrhosis often falls under the TCM category of "abdominal distension," with the pathogenesis primarily involving deficiency of the root and excess of the branch, and spleen and kidney yang deficiency being one of the key mechanisms. The spleen and stomach are the foundation of acquired constitution and the source of qi and blood; the kidneys are the foundation of innate constitution and govern water metabolism. Spleen and kidney yang deficiency leads to impaired digestion and absorption, resulting in internal retention of dampness and stagnation, while simultaneously causing insufficient production of qi, blood, and essence, leading to the co-occurrence of "water retention" and "consumptive disease." Therefore, starting with "warming and tonifying the spleen and kidneys, strengthening the foundation and nourishing the source," it is hoped that while eliminating ascites, the patient's overall nutritional status can be improved.

[0005] While some existing traditional Chinese medicine (TCM) formulas are used for ascites in liver cirrhosis, there are no reports of specific compound TCM preparations that directly target "spleen and kidney yang deficiency syndrome" and focus on simultaneously increasing albumin levels and improving nutritional status. Therefore, there is an urgent need to develop a TCM compound preparation with minimal clinical side effects and good efficacy in treating ascites in liver cirrhosis. Summary of the Invention

[0006] To solve the above-mentioned technical problems, the present invention includes the following aspects: The first aspect of the present invention provides a traditional Chinese medicine composition for treating ascites due to liver cirrhosis, the traditional Chinese medicine composition being prepared from Astragalus membranaceus, Poria cocos, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Angelica sinensis, Cornus officinalis, stir-fried Citrus aurantium, stir-fried Bupleurum chinense, stir-fried chicken gizzard lining, charred ginger and prepared licorice.

[0007] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 20-40 parts by weight, Poria cocos 20-40 parts by weight, Codonopsis pilosula 5-25 parts by weight, stir-fried Atractylodes macrocephala 5-25 parts by weight, Angelica sinensis 5-20 parts by weight, Cornus officinalis 5-20 parts by weight, stir-fried Citrus aurantium 3-15 parts by weight, stir-fried Bupleurum chinense 1-10 parts by weight, stir-fried chicken gizzard lining 1-10 parts by weight, charred ginger 1-10 parts by weight, and prepared licorice root 1-10 parts by weight.

[0008] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 25-35 parts by weight, Poria cocos 25-35 parts by weight, Codonopsis pilosula 10-20 parts by weight, stir-fried Atractylodes macrocephala 10-20 parts by weight, Angelica sinensis 8-15 parts by weight, Cornus officinalis 8-15 parts by weight, stir-fried Citrus aurantium 6-12 parts by weight, stir-fried Bupleurum chinense 2-8 parts by weight, stir-fried chicken gizzard lining 2-8 parts by weight, charred ginger 2-8 parts by weight, and prepared licorice root 2-8 parts by weight.

[0009] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 25-30 parts by weight, Poria cocos 25-30 parts by weight, Codonopsis pilosula 15-20 parts by weight, stir-fried Atractylodes macrocephala 15-20 parts by weight, Angelica sinensis 10-15 parts by weight, Cornus officinalis 10-15 parts by weight, stir-fried Citrus aurantium 8-12 parts by weight, stir-fried Bupleurum chinense 4-8 parts by weight, stir-fried chicken gizzard lining 4-8 parts by weight, charred ginger 4-8 parts by weight, and prepared licorice root 4-8 parts by weight.

[0010] Most preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 30 parts by weight, Poria cocos 30 parts by weight, Codonopsis pilosula 15 parts by weight, stir-fried Atractylodes macrocephala 15 parts by weight, Angelica sinensis 12 parts by weight, Cornus officinalis 12 parts by weight, stir-fried Citrus aurantium 9 parts by weight, stir-fried Bupleurum chinense 6 parts by weight, stir-fried chicken gizzard lining 6 parts by weight, charred ginger 6 parts by weight, and prepared licorice root 6 parts by weight.

[0011] Preferably, the ascites due to liver cirrhosis is of the spleen and kidney yang deficiency type.

[0012] Preferably, the ascites due to cirrhosis is cirrhosis complicated with malnutrition. More preferably, the ascites due to cirrhosis is spleen-kidney yang deficiency type cirrhosis complicated with malnutrition.

[0013] Preferably, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0014] Preferably, the traditional Chinese medicine composition is an oral preparation.

[0015] Preferably, the dosage form of the traditional Chinese medicine composition is selected from decoction, tablet, capsule, granule, pill, powder or oral liquid.

[0016] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, the method comprising the following steps: (1) Take the prescribed amount of each of the above-mentioned Chinese medicinal materials, clean them, and remove impurities; (2) Place each herb in a decoction container, add drinking water at 4-6 times the total weight of the herbs, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30-60 minutes, and filter out the liquid; after filtering, add drinking water at 4-6 times the total weight of the herbs to the dregs, bring to a boil over high heat, then simmer over low heat for 30-60 minutes, and filter out the liquid, and combine the two filtered liquids; (3) Concentrate the medicinal liquid to make its weight 1-2 times the total weight of the initial added Chinese medicinal materials.

[0017] Preferably, in step (2), drinking water is added at a ratio of 4 times the total weight of the medicinal materials.

[0018] Preferably, the simmering time in step (2) is 30 minutes.

[0019] Preferably, in step (3), the concentrated medicinal liquid is made to have a weight of 1-1.5 times the total weight of the initially added Chinese medicinal materials.

[0020] A third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating ascites in liver cirrhosis.

[0021] Preferably, the ascites due to liver cirrhosis is of the spleen and kidney yang deficiency type.

[0022] Preferably, the ascites due to cirrhosis is cirrhosis complicated with malnutrition. More preferably, the ascites due to cirrhosis is spleen-kidney yang deficiency type cirrhosis complicated with malnutrition.

[0023] A fourth aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating cirrhosis or liver fibrosis.

[0024] The common pharmacological effects of the traditional Chinese medicine raw materials selected in this invention in this field are as follows: Astragalus: Sweet and warm in nature, it enters the lung and spleen meridians. Astragalus tonifies qi and strengthens the exterior, promotes diuresis and eliminates toxins, drains pus, and promotes tissue regeneration. It is used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncles that are difficult to heal, chronic ulcers that do not heal, anemia and chlorosis, and internal heat and thirst.

[0025] Poria cocos: sweet and bland in taste, neutral in nature, acts on the heart, spleen and kidney meridians. Poria cocos has the effects of inducing diuresis to drain dampness, strengthening the spleen and harmonizing the stomach, and calming the heart to tranquilize the mind. It is used to treat dampness-related symptoms such as difficulty in urination, edema and fullness, phlegm-retention cough, poor appetite and epigastric stuffiness, diarrhea, dizziness, palpitation, insomnia, nocturnal emission, white turbidity, dribbling of urine, and leukorrhagia.

[0026] Codonopsis pilosula: neutral in nature, sweet in taste, acts on the spleen meridian and lung meridian, with the effects of tonifying middle qi, strengthening the spleen and nourishing the lung. Codonopsis pilosula is used for treating weakness of the spleen and lung, shortness of breath and palpitation, poor appetite and loose stools, dyspnea due to deficiency and cough, internal heat and diabetes. It has the effects of enhancing the body's stress capacity, improving immune function, delaying aging, and resisting ulcers.

[0027] Atractylodes macrocephala: bitter and sweet in taste, warm in nature, with the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and preventing miscarriage. It is used for treating symptoms such as weakness of spleen qi, fatigue and weakness, poor appetite and abdominal distension, loose stools, internal retention of fluid, difficulty in urination, edema, phlegm-retention dizziness, warm bi syndrome with aching pain, spontaneous sweating due to qi deficiency, and threatened abortion.

[0028] Angelica sinensis: sweet and pungent in taste, warm in nature, acts on the liver, heart and spleen meridians. Angelica sinensis can tonify and activate blood, regulate menstruation and relieve pain, moisten dryness and relax the bowels. It is used for treating various blood deficiency syndromes, irregular menstruation, amenorrhea and dysmenorrhea, mass accumulation, metrorrhagia, cold deficiency abdominal pain, flaccidity and bi syndrome, skin numbness, intestinal dryness and difficult defecation, dysentery with tenesmus after clearing, carbuncle and sore, and traumatic injury.

[0029] Cornus officinalis: hot in nature, pungent and bitter in taste, acts on the liver meridian, spleen meridian, stomach meridian and kidney meridian. Cornus officinalis can dispel cold to relieve pain, check adverse rising qi to stop vomiting, and assist yang to stop diarrhea. It is used for treating Jueyin headache, dysmenorrhea caused by deficiency cold of thoroughfare and conception vessels and blood stasis block, swollen painful beriberi caused by cold-dampness, and cold epigastric pain caused by stomach cold or deficiency cold of spleen and stomach. It has pharmacological effects such as analgesia, anti-gastric ulcer, blood pressure lowering, anti-thrombosis, insecticidal and antibacterial.

[0030] Aurantii Fructus Immaturus: bitter and pungent in taste, slightly cold in nature, acts on the spleen and stomach meridians. Aurantii Fructus Immaturus can break qi to remove food retention, resolve phlegm and dissipate masses. It is mainly used for treating internal retention of food stagnation, fullness and distension and pain, dysentery with tenesmus after defecation, constipation, phlegm stagnation and qi obstruction, chest arthralgia, chest binding, and visceroptosis.

[0031] Bupleurum: pungent and bitter in taste, slightly cold in nature, acts on the liver, gallbladder and lung meridians. Bupleurum can harmonize the exterior and interior, soothe the liver to relieve depression, raise yang to lift prolapse, reduce fever to stop malaria. It is used for treating cold and fever, alternating cold and heat, chest and hypochondriac distension and pain, irregular menstruation, uterine prolapse and prolapse of anus.

[0032] Gizzard Lining: sweet in taste, neutral in nature, acts on the spleen, stomach, small intestine and bladder meridians. It has the effects of strengthening the stomach to promote digestion, astringe essence to stop enuresis, and promote diuresis to dissolve stones. It is used for treating indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, spermatorrhea, stranguria with stone pain, and biliary distension and hypochondriac pain. Gizzard Lining is crisp in texture, easy to crush, and can enhance the effect of strengthening the spleen and eliminating accumulation. It is used for treating indigestion, food stagnation, liver deficiency diarrhea and infantile malnutrition.

[0033] Ginger charcoal: Ginger charcoal is a traditional Chinese medicine made by charring dried ginger. It is bitter, astringent, and warm in nature, and enters the spleen, stomach, and kidney meridians. It has the effects of warming the meridians and stopping bleeding, warming the middle and dispelling cold, and stopping diarrhea. It is suitable for bleeding due to deficiency and cold or deficiency and cold syndrome of the middle jiao.

[0034] Licorice: It is neutral in nature and sweet in taste, and enters the heart, stomach, spleen, and lung meridians. Licorice tonifies the spleen and replenishes qi, relieves cough and eliminates phlegm, alleviates spasms and pain, and harmonizes the properties of other herbs. It is used to treat spleen and stomach weakness, insufficient qi, cough and asthma, carbuncles and boils, abdominal cramps and pain, and to moderate the harshness of other herbs. It also has anti-inflammatory, anti-ulcer, anti-cancer, antibacterial, antiviral, and immune-regulating effects.

[0035] The herbal formula of this invention is based on traditional Chinese medicine theories such as "when the liver is diseased, it is known that the liver will affect the spleen, so the spleen should be strengthened first," "life depends on stomach qi, death depends on the absence of stomach qi," and "bloating indicates the decline of the spleen and stomach." It focuses on simultaneously tonifying the liver, spleen, and kidneys, supporting the body's resistance to expel pathogens, promoting diuresis without harming the body's vital energy, and resolving blood stasis without depleting yin. This formula prioritizes supporting the body's resistance while protecting stomach qi throughout the entire treatment process; it is warming without being drying, nourishing without being cloying, and combining tonification and purgation. It can improve patients' clinical symptoms ("stomach qi"), liver function, and nutritional indicators, achieving a complementary effect between traditional Chinese and Western medicine. This formula breaks through the limitations of simply clearing heat and dampness, promoting blood circulation and removing blood stasis, and regulating qi and promoting diuresis in chronic severe liver disease, correcting the misconception that "treating the liver only with cold and cooling herbs." Its core principles are warming yang and transforming qi, nourishing the liver and softening the body, and strengthening the body's foundation and protecting the stomach.

[0036] The traditional Chinese medicine formula of this invention follows the principle of "warming yang, nourishing the liver, and consolidating the foundation." The principal herbs are Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala, which greatly tonify the spleen and stomach qi, strengthen the middle jiao, and aid in the generation of qi and blood. The assistant herbs are Cornus officinalis, which nourishes the yin essence of the liver and kidneys, seeking yang within yin; and charred ginger, which warms and tonifies the yang of the spleen and kidneys, generating qi with a gentle heat, thus achieving the effect of warming yang and consolidating the foundation. The adjuvant herbs are Poria cocos, which promotes diuresis to treat the symptoms; Angelica sinensis, which nourishes and invigorates blood to remove blood stasis and unblock the meridians; and Citrus aurantium, which regulates qi and relieves fullness to address the symptoms of abdominal distension and qi stagnation. Bupleurum chinense soothes the liver, regulates qi, eliminates stagnation, and disperses masses. Chicken gizzard membrane invigorates the spleen, promotes digestion, and consolidates essence. The guiding herb is Glycyrrhiza uralensis, which harmonizes the effects of all the herbs. The entire formula works to warm and tonify the spleen and kidneys, replenish qi and blood, invigorate blood and qi, and promote diuresis and reduce swelling. By restoring the spleen's function of transportation and transformation and the kidneys' function of qi transformation, it promotes the body's own synthesis of albumin, improves digestive and absorptive functions, and increases muscle synthesis, thereby fundamentally increasing albumin levels, improving malnutrition, and promoting the reduction of ascites.

[0037] The technical effects of this invention are as follows: 1. Based on extensive screening experiments, this invention has obtained a traditional Chinese medicine composition with excellent therapeutic effects on liver fibrosis, cirrhosis and ascites by optimizing the components and proportions of traditional Chinese medicine (for example, the traditional Chinese medicine decoction of Example 1 is preferred, and in vivo animal experiments have confirmed that its therapeutic effect in rat models of cirrhosis and ascites is significantly better than that of other examples).

[0038] 2. The traditional Chinese medicine composition of the present invention warms and tonifies the spleen and kidneys, nourishes qi and blood, and promotes diuresis and reduces swelling. It can effectively treat ascites in patients with spleen and kidney yang deficiency type liver cirrhosis, and can simultaneously increase the patient's serum albumin level and improve nutritional status. It fundamentally improves the patient's pathological state of "spleen and kidney yang deficiency", breaks the vicious cycle of "ascites-malnutrition", and achieves synergistic effect of ascites reduction and nutritional status improvement.

[0039] 3. The traditional Chinese medicine composition of the present invention overcomes the problems of insufficient individualization, high economic cost and many side effects of existing nutritional support programs, and provides an individualized clinical treatment option based on the theory of syndrome differentiation in traditional Chinese medicine, which has the advantages of low cost, few side effects and good patient tolerance. Attached Figure Description

[0040] Figure 1 This invention describes the therapeutic effect of the traditional Chinese medicine composition on rats with cirrhosis and ascites. Detailed Implementation

[0041] Example 1 Weigh out 30g of Astragalus membranaceus, 30g of Poria cocos, 15g of Codonopsis pilosula, 15g of stir-fried Atractylodes macrocephala, 12g of Angelica sinensis, 12g of Cornus officinalis, 9g of stir-fried Citrus aurantium, 6g of stir-fried Bupleurum chinense, 6g of stir-fried chicken gizzard lining, 6g of charred ginger, and 6g of prepared Glycyrrhiza uralensis. Mix them together and add 600mL of drinking water. Soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Add the dregs back to 600mL of drinking water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Combine the two liquids and concentrate to 200mL.

[0042] Example 2 Weigh out 15g of Astragalus membranaceus, 15g of Poria cocos, 30g of Codonopsis pilosula, 30g of stir-fried Atractylodes macrocephala, 12g of Angelica sinensis, 12g of Cornus officinalis, 9g of stir-fried Citrus aurantium, 6g of stir-fried Bupleurum chinense, 6g of stir-fried chicken gizzard lining, 6g of charred ginger, and 6g of prepared Glycyrrhiza uralensis. Mix them together and add 600mL of drinking water. Soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Add the dregs back to 600mL of drinking water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Combine the two liquids and concentrate to 200mL.

[0043] Example 3 Weigh out 12g of Astragalus membranaceus, 12g of Poria cocos, 15g of Codonopsis pilosula, 15g of stir-fried Atractylodes macrocephala, 30g of Angelica sinensis, 30g of Cornus officinalis, 9g of stir-fried Citrus aurantium, 6g of stir-fried Bupleurum chinense, 6g of stir-fried chicken gizzard lining, 6g of charred ginger, and 6g of prepared Glycyrrhiza uralensis. Mix them together and add 600mL of drinking water. Soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Add the dregs back to 600mL of drinking water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Combine the two liquids and concentrate to 200mL.

[0044] Example 4 Weigh out 6g of Astragalus membranaceus, 6g of Poria cocos, 15g of Codonopsis pilosula, 15g of stir-fried Atractylodes macrocephala, 12g of Angelica sinensis, 12g of Cornus officinalis, 9g of stir-fried Citrus aurantium, 30g of stir-fried Bupleurum chinense, 30g of stir-fried chicken gizzard lining, 6g of charred ginger, and 6g of prepared Glycyrrhiza uralensis. Mix them together and add 600mL of drinking water. Soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Add the dregs back to 600mL of drinking water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Combine the two liquids and concentrate to 200mL.

[0045] Experimental Example 1: The therapeutic effect of the traditional Chinese medicine composition of the present invention on rats with cirrhosis and ascites. 1. Test Methods 1.1. Construction of an animal model of liver cirrhosis with ascites and drug administration regimen Thirty-five male SD rats aged 6-8 weeks were randomly divided into 5 groups after one week of acclimatization. The following groups received drug intervention: (A) Normal group (n=3): 0.3 ml / 100 g olive oil was injected subcutaneously twice a week, with normal drinking water, for 12 consecutive weeks; (B) CCl4 + ethanol group (model group) (n=8): 40% CCl4 + olive oil mixture was injected subcutaneously, initially 0.5 ml / 100 g, followed by 0.3 ml / 100 g each time, twice a week, with 10% ethanol as the only drinking water, for 12 consecutive weeks; (C) CCl4 + ethanol + low-dose traditional Chinese medicine group (n=8): The modeling method was the same as the above model groups, with low-dose (3.4 ml / rat / day) traditional Chinese medicine prepared in Example 1 administered via gavage starting in week 7; (D) CCl4 + ethanol + medium-dose traditional Chinese medicine group (n=8): The modeling method was the same as the above model groups, with medium-dose (5 ml / rat / day) traditional Chinese medicine administered starting in week 7. (1) The rats were treated with a high dose of the traditional Chinese medicine prepared in Example 1 via gavage (ml / rat / day); (2) The rats were treated with a high dose of the traditional Chinese medicine prepared in Example 1 via gavage, consisting of CCl4 + ethanol + high-dose traditional Chinese medicine (n=8). The modeling method was the same as the above model groups. Starting from week 7, the rats were treated with a high dose (6ml / rat / day) of the traditional Chinese medicine prepared in Example 1 via gavage. During the experiment, the physiological status of the rats (stool characteristics, hair, diet) was recorded. Data on the body weight and abdominal circumference of the rats in each group were collected at weeks 1, 6, 9, and 12. After the experiment, the rats in each group were sacrificed, and rat feces, peripheral blood, spleen, and liver tissue were collected. The tissues were photographed and weighed after being removed.

[0046] 1.2 Evaluation Index Measurement 1.2.1 Detection of liver function related indicators: Biochemical detection of serum AST and ALT for liver function, BUN and Scr for kidney function, and sodium for electrolytes. 2+ index 1) Sample preparation: After the collected blood is left to stand at room temperature for about 30 minutes, it is centrifuged at 3000 rpm for 15 minutes and the supernatant is collected and stored.

[0047] 2) Preparation of working reagents: For the single-reagent method, use directly; for the double-reagent method, use R1 and R2 respectively.

[0048] 3) Set the appropriate parameters on the fully automated biochemical analyzer.

[0049] 4) Sample loading and automatic determination by the fully automated biochemical analyzer; 5) Experimental results are exported from the fully automated biochemical analyzer.

[0050] 1.2.2 Jamall method for determining hydroxyproline (HYP) content in liver tissue 1) Sample hydrolysis: Weigh 80-100mg of tissue sample, cut it into small pieces and place it in a ground glass tube. Add 1mL of 6mol / L hydrochloric acid and hydrolyze it at 95℃ (or boiling water bath) or 100℃ oven for 5h.

[0051] 2) pH adjustment: After the running water is cooled, add 10 μL of indicator to each tube, mix well, and then add 1.5 mL of pH adjustment solution A and 0.2 mL of pH adjustment solution B in sequence. After mixing well, measure the pH (about 5-6). Add solution B dropwise and mix well until the solution turns yellow-green. At this time, the pH is 6.0-6.8.

[0052] 3) Impurity removal and supernatant preparation: Dilute to 10 mL with double-distilled water, mix well, take 3-4 mL of the solution, add 20-30 mg of activated carbon, mix well, centrifuge at 3500 r / min for 10 min until the supernatant is clear after centrifugation, and take 1 mL of the supernatant as the detection solution.

[0053] 4) Sample tube preparation: Add 1 mL of double-distilled water and 0.5 mL of reagent one to the blank tube; add 1 mL of 5 μg / mL standard working solution and 0.5 mL of reagent one to the standard tube; add 1 mL of test solution and 0.5 mL of reagent one to the test tube. Mix well after adding samples to each tube and let stand for 10 min.

[0054] 5) Colorimetric reaction: Add 0.5 mL of reagent II to each tube, mix well and let stand for 5 min; then add 0.5 mL of reagent III, mix well, incubate in a 60℃ water bath for 15 min, cool and centrifuge at 3500 r / min for 10 min.

[0055] 6) Measurement: Measure the absorbance of each tube at a wavelength of 550 nm.

[0056] 7) Calculation: Hydroxyproline content (μg / mg tissue) = (A determination - A blank) / (A standard - A blank) × C standard × V hydrolysate / W C standard: Standard solution concentration, 5µg / mL; V hydrolysate: Total volume of hydrolysate, 10 mL; W: Fresh weight of the sample, mg.

[0057] 1.2.3. Liver histopathological staining 1.2.3.1 HE staining 1) Dewaxing paraffin sections to water: Place the sections in xylene I (20 min) - xylene II (20 min) - anhydrous ethanol I (5 min) - anhydrous ethanol II (5 min) - 75% ethanol (5 min) in sequence, and wash with tap water.

[0058] 2) Hematoxylin staining: Immerse the sections in hematoxylin staining solution for 3-5 minutes, wash with tap water, differentiate with differentiation solution, wash with tap water, blue back solution, and rinse with running water.

[0059] 3) Eosin staining: The sections were dehydrated in 85% and 95% graded alcohol solutions for 5 min each, and then stained in eosin staining solution for 5 min.

[0060] 4) Dehydration and mounting: The sections were sequentially placed in anhydrous ethanol I (5 min) - anhydrous ethanol II (5 min) - anhydrous ethanol III (5 min) - xylene I (5 min) - xylene II (5 min) and then mounted with clear, neutral resin.

[0061] 5) Microscopic examination, image acquisition and analysis.

[0062] 1.2.3.2 Sirius Red Staining 1) Dewaxing paraffin sections to water: Immerse the sections sequentially in environmentally friendly dewaxing solution I (20 min) - environmentally friendly dewaxing solution II (20 min) - anhydrous ethanol I (5 min) - anhydrous ethanol II (5 min) - 75% ethanol (5 min), then rinse with tap water. Frozen sections are then thawed and fixed: Remove the frozen sections from the -20°C freezer and allow them to reach room temperature. Fix with tissue fixative for 15 min, then rinse with running water.

[0063] 2) Mordant staining: Immerse the sections in Sirius A solution and place them in a 65℃ oven for 30 minutes; 3) Sirius red staining: Shake off the water slightly and immerse the sections in modified Sirius red B solution for 2 min; rinse slightly with water and immerse in modified Sirius red C solution for 30 min.

[0064] 4) Dehydration and mounting: Wash the sections slightly with water, rinse them quickly in three tanks of anhydrous ethanol for 3-5 seconds each, then place them in clean xylene for 5 minutes to clear them, and finally mount them with neutral resin.

[0065] 5) Microscopic examination, image acquisition and analysis 1.2.4 Western blot analysis of CoL1 expression, a marker of liver cirrhosis. 1) Tissue sample: Cut an appropriate amount of tissue into an EP tube on ice, add an appropriate amount of protein lysis buffer and grind the tissue with a tissue homogenizer; place on ice for 10 min, centrifuge at 4℃ and 14000 rpm for 10 min; take the supernatant and place it in another EP tube, centrifuge again at 4℃ and 14000 rpm for 10 min, and take the supernatant.

[0066] 2) Protein concentration determination: Add 0.5 mg / ml standard bovine serum albumin (BSA) at concentrations of 0 μl, 1 μl, 2 μl, and 4 μl to the wells of a 96-well plate; add 2 mg / ml standard BSA at concentrations of 2 μl, 3 μl, 4 μl, and 5 μl to the wells of a 96-well plate. Add 1 μl of protein sample to each well. Mix solutions A and B at a ratio of 24:1, add 200 μl of the AB mixture to each well, mix thoroughly, and incubate at 37°C for 30 min. Measure the absorbance at 570 nm and calculate the protein concentration of the sample based on the standard curve.

[0067] 3) Protein storage: Add an equal volume of 2×SDS sample buffer, vortex to mix, centrifuge briefly, boil at 100℃ for 10 min to denature, and store in a -20℃ refrigerator.

[0068] 4) Polyacrylamide gel electrophoresis a) Preparation of separating gel: Measure equal volumes of 2.5 ml of lower gel solution and 2.5 ml of lower gel buffer, mix gently, add 50 μl of modified coagulant to the above mixture, and mix well.

[0069] b) Preparation of stacking gel: Measure equal volumes of 0.75 ml of top layer gel solution and 0.75 ml of colored top layer gel buffer, mix gently, add 15 μl of modified coagulant to the above mixture, and mix well.

[0070] c) Gel Preparation: Clean the glass plates thoroughly and fix them on the support. Pour the separating gel prepared according to the table above between the glass plates, and immediately seal the surface with anhydrous ethanol. Polymerize at room temperature. When a clear interface appears between the liquid seal layer and the separating gel layer, the polymerization of the separating gel is complete. Discard the anhydrous ethanol, blot dry with filter paper, then pour in 8% concentrated gel, insert the comb, and after the gel solidifies, carefully remove the comb. Set aside for later use.

[0071] d) Sample preparation before loading: The protein loading amount is 20 μg per lane. Each sample is supplemented with 1×SDS to the same volume, vortexed and mixed, and then centrifuged.

[0072] e) Electrophoresis: Add 1× electrophoresis buffer to the electrophoresis tank, turn on the power, and electrophore at a constant voltage of 200V until the bromophenol blue migrates to the lower edge of the separating gel, which takes about 49 minutes. Then turn off the power and stop the electrophoresis.

[0073] 5) Transfer: Prepare transfer buffer in advance. First, soak the PVDF membrane in methanol for about 15 seconds, then soak it in 1× transfer buffer for 30 minutes. Place the filter paper and gel in 1× transfer buffer. Arrange the filter paper, gel, PVDF membrane, and filter paper in the sandwich method in that order, carefully remove all air bubbles, and transfer at a constant current of 1.3A for 10 minutes.

[0074] 6) Sealing: Immerse the PVDF membrane in a sealing solution containing 5% BSA, place it on a shaker and shake it slowly at room temperature for 2 hours.

[0075] 7) Incubation with primary antibody: Take out the blocked PVDF membrane, immerse it in 1×PBST buffer, wash it 3 times on a shaker for 10 min each time, transfer it to the primary antibody dilution solution containing the primary antibody, and incubate overnight at 4°C.

[0076] 8) Washing the membrane: Take out the strip after incubation with the primary antibody and immerse it in 1×PBST buffer. Wash it slowly on a shaker for 10 minutes each time.

[0077] 9) Incubation with secondary antibody: Transfer the washed band to 1×PBST containing secondary antibody and incubate slowly on a shaker at room temperature for 2 hours.

[0078] 10) Washing the membrane: Take out the strip after incubation with the secondary antibody and immerse it in 1×PBST buffer. Wash it slowly on a shaker for 10 minutes each time.

[0079] 11) ECL chemiluminescence development: Take an appropriate amount of ECL kit, mix equal volumes of solution A and solution B, place the prepared ECL mixture on ice, and immerse the exposed strips in the ECL mixture for 10-15 seconds. After soaking, arrange the strips neatly on the exposure area of ​​the plate with a certain interval. Open the darkroom door and immediately insert the platform plate into the corresponding slot. Open the software, select the "chemiluminescence" mode, take a picture and save it.

[0080] 1.2.5. Detection of the distribution of T cell subsets in liver tissue using double fluorescence labeling. 1) Dewaxing paraffin sections to water: The paraffin sections are placed in environmentally friendly dewaxing solution I for 10 min, environmentally friendly dewaxing solution II for 10 min, environmentally friendly dewaxing solution III for 10 min, anhydrous ethanol I for 5 min, anhydrous ethanol II for 5 min, anhydrous ethanol III for 5 min, and then washed with distilled water.

[0081] 2) Antigen retrieval: During this process, excessive evaporation of the buffer solution should be prevented, and the slide should not be dried out. After natural cooling, place the slide in pH 7.4 PBS and wash it three times on a pendulum shaker for 5 minutes each time.

[0082] 3) Circle drawing and hydrogen peroxide blocking: After slightly drying the slides, draw circles around the tissue using an immunohistochemical pen. Place the slides flat in a light-protected humidified chamber, add 3% hydrogen peroxide solution, and incubate at room temperature in the dark for about 25 minutes to block endogenous peroxidase. Place the slides in pH 7.4 PBS and wash them three times on a pendulum shaker for 5 minutes each time.

[0083] 4) Serum blocking: Place the slide flat in a light-proof, humidified chamber and add serum for blocking at room temperature for 30 minutes. If the primary antibody is of goat origin, use 10% rabbit serum for blocking; if the primary antibody is of other origin, use 3% BSA for blocking.

[0084] 5) Add the first primary antibody: Gently shake off the blocking solution, drop the primary antibody prepared with sterile PBS in a certain ratio onto the slide, and place the slide flat in a light-proof humidified box and incubate overnight at 4°C (add a small amount of water to the humidified box to prevent antibody evaporation).

[0085] 6) Add the corresponding species-specific HRP-labeled secondary antibody: Place the slide in pH 7.4 PBS and wash it three times on a pendulum shaker for 5 minutes each time. After slightly drying the slide, place it flat in a light-proof humidified box and add HRP-labeled secondary antibody corresponding to the species of the primary antibody to cover the tissue. Incubate at room temperature for 50 minutes.

[0086] 7) Add the corresponding TSA: Place the slide in pH 7.4 PBS and wash three times on a pendulum shaker, 5 min each time. After slightly drying the slide, place it flat in a light-protected humidified chamber and add the corresponding TSA to the circle. Incubate at room temperature in the dark for 10 min. After incubation, place the slide in TBST and wash three times on a pendulum shaker, 5 min each time.

[0087] 8) Microwave treatment: Place the tissue sections in a repair box filled with pH 6.0 citric acid repair solution and heat in a microwave oven, maintaining boiling for about 10 minutes to remove the primary and secondary antibodies that have been bound to the tissue. During this process, prevent excessive evaporation of the buffer solution and do not dry the sections.

[0088] 9) Serum blocking: Place the slide flat in a light-proof, humidified chamber and add serum for blocking at room temperature for 30 minutes. If the primary antibody is of goat origin, use 10% rabbit serum for blocking; if the primary antibody is of other origin, use 3% BSA for blocking.

[0089] 10) Add a second primary antibody: Gently shake off the blocking solution, drop the primary antibody prepared with sterile PBS in a certain ratio onto the slide, and place the slide flat in a light-proof humidified box and incubate overnight at 4°C (add a small amount of water to the humidified box to prevent antibody evaporation).

[0090] 11) HRP-labeled secondary antibody: Place the slide in pH 7.4 PBS and wash three times on a pendulum shaker for 5 minutes each time. After slightly drying the slide, place it flat in a light-proof humidified box and add HRP-labeled secondary antibody corresponding to the species of the primary antibody to cover the tissue. Incubate at room temperature for 50 minutes.

[0091] 12) Add the corresponding TSA: Place the slide in pH 7.4 PBS and wash three times on a pendulum shaker, 5 min each time. After slightly drying the slide, place it flat in a light-protected humidified chamber and add the corresponding TSA to the circle. Incubate at room temperature for 10 min in the dark. After incubation, place the slide in TBST and wash three times on a pendulum shaker, 5 min each time.

[0092] 13) DAPI counterstaining of cell nuclei: After slightly drying the slides, place them flat in a light-protected humidified chamber and add DAPI staining solution to the circle. Incubate at room temperature for 10 min in the dark. Place the slides in pH 7.4 PBS and wash them three times on a pendulum shaker for 5 min each time.

[0093] 14) Autofluorescence quenching: After slightly drying the slides, place them flat in a light-proof humidified box, add autofluorescence quenching agent to the circle for 5 minutes, and rinse with running water for 10 minutes.

[0094] 15) Mounting: Place the slide in pH 7.4 PBS and wash three times on a pendulum shaker for 5 minutes each time. After slightly drying the sections, mount them with anti-fluorescence quenching mounting medium.

[0095] 2. Test Results 2.1 Confirmation of the establishment of a rat model of liver cirrhosis with ascites A rat model of liver cirrhosis with ascites was established according to the methods described in this experiment. At week six, 1-2 rats were randomly selected for laparotomy to observe liver tissue damage. The control group showed smooth, soft liver surfaces and well-developed, rosy liver lobes. The model group showed rough liver surfaces and blunted edges; after dissection, the liver tissue was significantly enlarged (see [link to experimental data]). Figure 1 (A and 1B).

[0096] To further evaluate the model establishment, histopathological examination of rat liver tissue was performed. HE staining showed that in the control group, hepatic cords were arranged radially from the central vein outwards, the lobular structure was intact, and the hepatocyte morphology was normal. In the model group, the lobular structure was disordered, with extensive inflammatory cell infiltration in the portal areas, swollen and irregularly arranged hepatocytes, and extensive fatty degeneration and hepatocyte necrosis were observed (see...). Figure 1 C).

[0097] To more clearly observe the distribution of collagen fibers in rat liver tissue, a Sirius red staining experiment was performed. The results showed that, compared with the control group, the collagen fiber content in the liver tissue of the model group rats was significantly increased, and the liver fibrosis in the model group rats was more severe, indicating that the liver cirrhosis model was successfully established (see...). Figure 1 D).

[0098] 2.2 Therapeutic effect of traditional Chinese medicine composition on rats with cirrhotic ascites During the experiment, the control group rats had shiny fur, strong activity levels, and good mental state; before treatment, the model group rats gradually showed reduced food and water intake, dry fur, and frizzy fur. Before the modeling process began, there were no significant differences in body weight and abdominal circumference among the five groups; from the sixth week onwards, the body weight and abdominal circumference of the model group and the treatment group decreased compared to the control group, and this difference persisted until the end of the experiment. After treatment with medium and high doses of traditional Chinese medicine, the rats' body weight recovered somewhat, while their abdominal circumference did not change significantly (see...). Figure 1 H and 1I). After administration, peripheral blood samples were collected, serum was prepared, and then rats in each group were sacrificed. Liver tissue was dissected, weighed, and photographed. The liver surface of the control group rats was smooth, shiny, and red, without swelling, while the liver of the model group rats became hard, with an uneven and granular surface. After treatment with the herbal formula of this invention, the granular surface of the rat liver was reduced, the gloss gradually recovered, and the damage was significantly reduced. Moreover, the effect became more obvious with increasing dosage (see [link to traditional Chinese medicine formula]). Figure 1 E).

[0099] To investigate the therapeutic effect of the herbal formula of this invention on liver injury in rats, liver tissue of rats was stained with hematoxylin and eosin (HE). The results showed that the liver tissue structure of the control group was intact, with hepatic cords arranged radially along the central vein, hepatocytes tightly packed, and normal cell morphology, without obvious lesions. In the model group, hepatocytes were disordered, exhibiting fatty degeneration, increased lipid droplets, significant cell swelling, and varying degrees of necrosis and inflammatory cell infiltration. After drug intervention, the damaged liver tissue showed a dose-dependent repair effect, with the therapeutic effect increasing with increasing dosage: the low-dose group showed a reduction in the area of ​​inflammatory infiltration; the medium-dose group showed a more orderly arrangement of hepatocytes and further reduction of the inflammatory response; and by the high-dose group, the liver tissue structure was close to normal, and fatty cavities were further reduced (see...). Figure 1 F). The above experimental results suggest that the traditional Chinese medicine formula of this invention has the effect of inhibiting liver tissue damage and improving the liver tissue structure of cirrhotic rats.

[0100] To investigate the effects of the herbal formula of this invention on liver fibrosis, rat liver fibrosis-related indicators were detected by Sirius red staining, Western blotting, and acid hydrolysis. Sirius red staining results showed that, compared with the control group, the model group exhibited significant excessive collagen deposition in liver tissue, with dense, strongly positive red staining signals visible in the portal areas and perilobular regions. After drug intervention, fibrous septa were significantly reduced, and the effect became more pronounced with increasing dosage. At the high-dose group, the fibrosis deposition level approached the normal range (see...). Figure 1 G), consistent with HE results. Western blot analysis of the fibrosis-associated protein COL1 showed that, compared to the control group, the protein expression level of COL1 in the model group was significantly increased, and after treatment, the protein expression level of COL1 was significantly reduced (see...). Figure 1 J).

[0101] To further explore the mechanism by which the traditional Chinese medicine formula of this invention alleviates liver fibrosis, the content of hydroxyproline (HYP) was measured. The results showed that, compared with the control group, the HYP content in the model group was significantly increased, while the HYP content in the treatment group was significantly decreased compared with the model group, and the higher the concentration, the better the therapeutic effect (see...). Figure 1 K).

[0102] In summary, the traditional Chinese medicine formula of this invention can effectively alleviate the pathological indicators of liver fibrosis in animal models. Since cirrhosis is an end-stage disease resulting from the continuous progression of liver fibrosis, and ascites is a common complication in the late stage of cirrhosis, it is expected that the traditional Chinese medicine formula of this invention can effectively improve the symptoms of cirrhosis and ascites in patients clinically.

[0103] Experimental Example 2: Clinical therapeutic effect of the traditional Chinese medicine composition of the present invention on patients 1. Test Methods 1.1 Source of Cases Patients diagnosed with cirrhosis with ascites and hypoalbuminemia-type malnutrition in the Department of Hepatology, Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine, between November 2025 and January 2026 were included in this study. Nutrition experts conducted ward rounds together, and medical records were entered by two people using a unified database.

[0104] 12. Trial grouping and dosing regimen This trial employed a randomized controlled study, randomly assigning 61 enrolled patients to two groups: a control group (n=31) and a treatment group (n=30). The treatment group received routine Western medicine treatment plus nutritional support and traditional Chinese medicine treatment, while the control group received routine Western medicine treatment plus nutritional support. Western medicine treatment included bed rest, sodium restriction, hepatoprotective drugs, diuretics (such as spironolactone and furosemide), and albumin. For example, patients with HBV-DNA positivity due to hepatitis B cirrhosis received antiviral therapy; patients with ascites received paracentesis and oral diuretics; and patients with hypoalbuminemia received infusions of human albumin and homologous frozen plasma. The target energy intake for nutritional support was 30-35 kcal / kg / day and protein 1.2-1.5 g / kg / day, divided into 4-6 meals, to prevent muscle loss. Patients with hepatic encephalopathy could use plant protein or branched-chain amino acids instead. Oral feeding was preferred, supplemented with oral nutritional supplements if insufficient; critically ill patients received tube feeding or parenteral nutrition. The subjects were treated with the traditional Chinese medicine decoction prepared in Example 1 of this invention, one dose per day, divided into two oral administrations, 100 mL each time, for two consecutive months. On days 1, 7, 14, and 28 of hospitalization, the subjects' gastric qi injury syndrome score, ascites volume, liver function, coagulation function, and nutritional metabolism were measured. Outpatient follow-up was conducted within one month after treatment.

[0105] 1.3 Diagnostic Criteria 1) Diagnostic criteria for ascites in cirrhosis are based on the "Guidelines for the Diagnosis and Treatment of Ascites and Related Complications in Cirrhosis" issued by the Chinese Society of Hepatology in 2017: The diagnosis of cirrhosis requires comprehensive consideration of multiple factors, including etiology, medical history, clinical manifestations, complications, laboratory tests, imaging, and histology. Ascites in cirrhosis is a complication that occurs when cirrhosis progresses to the decompensated stage, with portal hypertension as the initiating factor, leading to leakage of fluid into the abdominal cavity exceeding 200 ml.

[0106] 2) The diagnostic criteria for malnutrition are based on the "Clinical Nutrition Guidelines for End-Stage Liver Disease" issued by the Chinese Medical Association's Hepatology Branch in 2019: ① Body composition assessment: A BMI or dry weight BMI < 18.5 is sufficient to diagnose malnutrition. BMI (kg / m²) 2 = weight (kg) / height squared (m) 2 For patients with fluid retention, calculate their dry body mass (BMI) (kg / m²). 2 ), dry body mass BMI (kg / m 2 = Dry weight (kg) / Height squared (m) 2 Dry weight (DW) is calculated by subtracting a certain amount of body weight from the clinically assessed severity of ascites (5% for mild, 10% for moderate, and 15% for severe; if peripheral edema is present, subtract another 5%). The amount of ascites is determined by ultrasound: small amount of ascites: depth on ultrasound <3cm; moderate amount of ascites: depth on ultrasound 3-10cm; large amount of ascites: depth on ultrasound >10cm.

[0107] ②SGA: Includes 8 indicators, namely (i) the patient's recent weight change trend, (ii) the fluctuation of dietary intake, (iii) persistent gastrointestinal symptoms (such as nausea, vomiting, abdominal distension), (iv) the degree of limitation of daily activities, (v) the stress metabolic state of the disease itself, (vi) subcutaneous fat reserves (such as triceps skinfold thickness), (vii) skeletal muscle consumption, and (viii) a visual assessment of fluid retention (edema or ascites).

[0108] Results evaluation: Among the 8 assessment criteria, if there are 5 or more grade C criteria, the overall assessment is grade C, indicating severe malnutrition; if there are 5 or more grade B criteria, or if there are grade C criteria but less than 5 grade C criteria, the overall assessment is grade B, indicating mild to moderate malnutrition; if there are fewer than 5 grade B and C criteria, the overall assessment is grade A, indicating adequate nutrition.

[0109] A diagnosis can be made if either of the above two conditions is met.

[0110] 3) The diagnostic criteria for hypoalbuminemia are as follows, referring to the relevant content in "Practical Internal Medicine": serum albumin <35g / L, or serum total protein <60g / L, and other diseases that cause a decrease in serum total protein and serum albumin can be excluded. A diagnosis can be made if these criteria are met.

[0111] 1.4 Inclusion Criteria (1) The diagnosis of cirrhosis with ascites and hypoalbuminemia-type malnutrition is met; (2) The patient's age is between 18 and 80 years old, regardless of gender; (3) The Chlid-Pugh classification is B or above (including B); (4) The ascites is graded as 1, 2 or 3 by ultrasound; (5) The patient is willing to participate, understands and signs the informed consent form; (6) The patient has good compliance and complete clinical data and examination indicators.

[0112] 1.5 Exclusion Criteria (1) Those under 18 years of age or over 80 years of age; (2) Special populations such as pregnant women or those preparing for pregnancy, or those with mental illness; (3) Those with other serious primary diseases, such as heart failure, respiratory failure, gastrointestinal infection, peptic ulcer disease, and abnormal renal function; (4) Those with cardiac, renal, or tuberculous ascites; (5) Those allergic to the relevant research drugs; (6) Those who are unwilling to sign the informed consent form.

[0113] 1.6 Elimination Criteria (1) Patients who were mistakenly included but did not meet the inclusion criteria; (2) Patients who were not treated according to the randomization protocol after inclusion, or whose treatment regimen was insufficient; (3) Patients with poor compliance who could not follow the treatment or examination protocol, or whose test results were incomplete and could not be evaluated for treatment effectiveness.

[0114] 1.7 Observation Indicators (1) Traditional Chinese Medicine symptoms Quantitative assessment of stomach qi (appetite, abdominal distension, upward flow of stomach qi, diarrhea, fatigue, complexion, nutritional status, tongue coating, and pulse).

[0115] (2) Pharmacodynamic evaluation indicators i) Biochemical indicators: liver function (ALT, AST, TBIL, ALB, PAB, TRF), coagulation function (PT, PTA, ATPP), electrolytes (Na) + K + ), renal function (BUN, Scr), serum proteins (total protein and albumin).

[0116] ii) Body composition assessment indicators: SMI, PA, basal metabolic rate, intracellular water, extracellular water, BMI, AC, TSF, AMC, grip strength.

[0117] iii) Prognostic assessment: The MELD-Na scoring criteria refer to Evidence-based incorporation of serum sodium concentration into MELD[J]. (Biggins SW, Kim WR, Terrault NA, et al. Gastroenterology. 2006, 130(6): 1652-1660); The Child-Pugh scoring criteria refer to Clinical Evaluation of Oxidative Stress Biomarkers in Cirrhosis: Associations with Child-Pugh Class and Hepatic Encephalopathy[J]. (Pădureanu V, Rădulescu VM, Moise CG, et al. Diagnostics (Basel). 2025, 15(22): 2853).

[0118] iv) Nutritional assessment: SGA score.

[0119] v) Other indicators: B-ultrasound examination of ascites depth (cm), weight (kg), abdominal circumference (cm), 24-hour urine output (ml), portal vein diameter (cm), spleen thickness (mm), and blood ammonia level.

[0120] 1.8 Evaluation of therapeutic effect (1) Evaluation of TCM symptoms and therapeutic effects The efficacy was determined in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" and based on the total score of TCM symptoms (quantitative assessment of stomach qi). The efficacy index was calculated using the nimodipine method: Efficacy Index = [(Total score before treatment - Total score after treatment) ÷ Total score before treatment] × 100%; Cure: Efficacy Index ≥ 95%; Significant effect: Efficacy Index ≥ 70% and < 95%; Effective: Efficacy Index ≥ 50% and < 70%; Ineffective: Efficacy Index < 50%.

[0121] (2) Evaluation of the efficacy of Western medicine Abdominal circumference measurement: After the patient wakes up in the morning on an empty stomach and empties their bladder, they should lie flat with their legs straight and relaxed. A soft measuring tape should be used to horizontally encircle the abdomen around the center of the umbilicus (or the midpoint of the line connecting the xiphoid process and the pubic symphysis). The reading should be accurate to 0.1 cm.

[0122] Measurement of ascites depth: The patient is placed in a supine position for abdominal ultrasound. The ultrasound probe is placed below the right costal margin or in the intercostal space along the anterior axillary line to clearly visualize the hepatorenal recess (Morison's pouch). The vertical distance between the anechoic area between the liver capsule and the kidney capsule is measured. If the patient cannot lie supine, the depth of the anechoic area above the pubic symphysis in the lower abdomen can be measured in a sitting position. The depth of ascites varies with the patient's position. The depth of the hepatorenal recess in the supine position is usually used as the grading criterion (<3cm is a small amount, 3~10cm is a moderate amount, and >10cm is a large amount). In cases of large ascites, the maximum depth should be measured to help assess the safety of the puncture drainage route.

[0123] 1.9 Statistical Processing SPSS software was used for data processing and statistical analysis. This trial employed a randomized block design. For normally distributed, homogeneous variance-based continuous data, two-way classification ANOVA was used. The SNK-q test was used for comprehensive pairwise comparisons of means among multiple samples. For non-normally distributed and / or heterogeneous variance-based data, variable transformation was performed before using two-way classification ANOVA or the Friedman M test. Univariate ANOVA with repeated measures was used to compare continuous data before and after treatment. Continuous data were statistically described as mean ± standard deviation (mean ± SD); count data were expressed as number of cases or rates using the chi-square test. 2 The difference was considered statistically significant when p < 0.05.

[0124] 2. Test Results 2.1 Comparison of TCM syndrome efficacy after treatment After treatment, the efficacy of TCM syndrome differentiation was compared between the two groups of patients, and the difference was statistically significant (P<0.05), indicating that the efficacy of TCM syndrome differentiation in the treatment group was better than that in the control group. The specific experimental results are shown in Table 1.

[0125] Table 1 Comparison of TCM syndrome efficacy before and after treatment in the two groups of patients 2.2 Comparison of serum nutritional and metabolic indicators after treatment After treatment, the levels of ALB, TP, and PAB in the treatment group increased more significantly than those in the control group (P < 0.05). The specific experimental results are shown in Table 2.

[0126] Table 2 Comparison of serum nutritional and metabolic indicators before and after treatment in the two groups of patients 2.3 Comparison of Child-Pugh and MELD-Na scores after treatment After treatment, the reduction in Child-Pugh score and MELD-Na score in the treatment group was greater than that in the control group, and the difference was statistically significant (P<0.05). The specific experimental results are shown in Table 3.

[0127] Table 3 Comparison of Child-Pugh and MELD-Na scores before and after treatment in the two groups of patients. 2.4 Comparison of SGA grading after treatment After treatment, the control group consisted of 6 patients with severe malnutrition, 21 patients with mild to moderate malnutrition, and 4 patients without malnutrition. The treatment group consisted of 4 patients with moderate to severe malnutrition, 16 patients with mild to moderate malnutrition, and 10 patients without malnutrition. The SGA (Social Gastrointestinal Scale) classification of the two groups was compared after treatment. The results showed that the treatment group was more effective than the control group in improving SGA classification (P < 0.05). Detailed experimental results are shown in Table 4.

[0128] Table 4 Comparison of SGA grading between the two groups of patients after treatment 2.5 Comparison of abdominal circumference and ascites depth after treatment After treatment, the abdominal circumference and ascites depth of the two groups were compared, and the differences were statistically significant (P<0.05), indicating that the treatment group was superior to the control group in reducing the abdominal circumference and ascites depth. The specific experimental results are shown in Table 5.

[0129] Table 5 Comparison of abdominal circumference and ascites depth before and after treatment in the two groups of patients. In summary, the traditional Chinese medicine composition of the present invention has significant efficacy in improving malnutrition caused by cirrhosis with ascites and hypoalbuminemia, providing clinical experience for the integrated treatment of cirrhosis with ascites and malnutrition using traditional Chinese and Western medicine, and has significant clinical and socioeconomic value.

[0130] Although specific embodiments of the invention have been described, those skilled in the art will recognize that various changes and modifications can be made to the invention without departing from its scope or spirit. Therefore, the invention is intended to cover all such changes and modifications falling within the scope of the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating ascites due to liver cirrhosis, characterized in that, The traditional Chinese medicine composition is prepared from Astragalus membranaceus, Poria cocos, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Angelica sinensis, Cornus officinalis, stir-fried Citrus aurantium, stir-fried Bupleurum chinense, stir-fried chicken gizzard lining, charred ginger, and prepared licorice root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 20-40 parts by weight, Poria cocos 20-40 parts by weight, Codonopsis pilosula 5-25 parts by weight, stir-fried Atractylodes macrocephala 5-25 parts by weight, Angelica sinensis 5-20 parts by weight, Cornus officinalis 5-20 parts by weight, stir-fried Citrus aurantium 3-15 parts by weight, stir-fried Bupleurum chinense 1-10 parts by weight, stir-fried chicken gizzard lining 1-10 parts by weight, charred ginger 1-10 parts by weight, and prepared licorice root 1-10 parts by weight.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 25-35 parts by weight, Poria cocos 25-35 parts by weight, Codonopsis pilosula 10-20 parts by weight, stir-fried Atractylodes macrocephala 10-20 parts by weight, Angelica sinensis 8-15 parts by weight, Cornus officinalis 8-15 parts by weight, stir-fried Citrus aurantium 6-12 parts by weight, stir-fried Bupleurum chinense 2-8 parts by weight, stir-fried chicken gizzard lining 2-8 parts by weight, charred ginger 2-8 parts by weight, and prepared licorice root 2-8 parts by weight.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 25-30 parts by weight, Poria cocos 25-30 parts by weight, Codonopsis pilosula 15-20 parts by weight, stir-fried Atractylodes macrocephala 15-20 parts by weight, Angelica sinensis 10-15 parts by weight, Cornus officinalis 10-15 parts by weight, stir-fried Citrus aurantium 8-12 parts by weight, stir-fried Bupleurum chinense 4-8 parts by weight, stir-fried chicken gizzard lining 4-8 parts by weight, charred ginger 4-8 parts by weight, and prepared licorice root 4-8 parts by weight.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Astragalus membranaceus 30 parts by weight, Poria cocos 30 parts by weight, Codonopsis pilosula 15 parts by weight, stir-fried Atractylodes macrocephala 15 parts by weight, Angelica sinensis 12 parts by weight, Cornus officinalis 12 parts by weight, stir-fried Citrus aurantium 9 parts by weight, stir-fried Bupleurum chinense 6 parts by weight, stir-fried chicken gizzard lining 6 parts by weight, charred ginger 6 parts by weight, and prepared licorice root 6 parts by weight.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The preparation method includes the following steps: (1) Take the prescribed amount of each of the above-mentioned Chinese medicinal materials, clean them, and remove impurities; (2) Place each herb in a decoction container, add drinking water at 4-6 times the total weight of the herbs, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30-60 minutes, and filter out the liquid; after filtering, add drinking water at 4-6 times the total weight of the herbs to the dregs, bring to a boil over high heat, then simmer over low heat for 30-60 minutes, and filter out the liquid, and combine the two filtered liquids; (3) Concentrate the medicinal liquid to make its weight 1-2 times the total weight of the initial added Chinese medicinal materials.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating ascites due to liver cirrhosis.

8. The application according to claim 7, characterized in that, The aforementioned ascites due to cirrhosis refers to ascites due to cirrhosis combined with malnutrition.

9. The application according to claim 7, characterized in that, The aforementioned cirrhotic ascites is a type of cirrhotic ascites due to spleen and kidney yang deficiency combined with malnutrition.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating cirrhosis or liver fibrosis.

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