Traditional Chinese medicine composition for treating non-alcoholic fatty liver disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating a non-alcoholic fatty liver disease as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from lophatherum gracile, coix seeds, poria cocos, phaseolus calcaratus, pericarpium arecae, semen cassiae, chrysanthemum morifolium ramat, lotus leaves, raw hawthorn, oriental wormwood, sedum sarmentosum, schisandra chinensis, radix paeoniae rubra, angelica sinensis, salvia miltiorrhiza and amomum cardamomum. According to the traditional Chinese medicine composition, all the raw materials supplement each other and jointly achieve the effects of promoting diuresis and eliminating turbidity, and the traditional Chinese medicine composition has a good application prospect in preparation of the medicine for treating the non-alcoholic fatty liver disease.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, and a preparation method and use thereof. Background Art

[0002] Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological syndrome characterized by diffuse macrovesicular steatosis and fat accumulation in hepatocytes, excluding excessive alcohol consumption and other clear liver-damaging factors. While NAFLD lacks a specific name in ancient Chinese medical texts, its clinical manifestations can be classified as a "liver disorder." It is caused by a predilection for rich, sweet foods, inappropriate work and rest habits, emotional imbalance, and the transmission of other illnesses, leading to liver dysfunction and spleen dysfunction, resulting in the accumulation of excessive fatty and turbid qi in the liver. NAFLD can lead to inflammation, liver fibrosis, cirrhosis, liver cancer, and their complications. Current studies indicate that the global prevalence of NAFLD is approximately 25%. Its prevalence has been increasing in recent years due to changes in dietary habits and living standards.

[0003] Traditional Chinese Medicine (TCM) is characterized by its multi-level, multi-target, multi-angle, and holistic approach to regulating bodily dysfunction and pathologies, thereby achieving and maintaining a healthy state. TCM syndrome differentiation and treatment for non-alcoholic fatty liver disease primarily emphasizes strengthening the spleen and soothing the liver, resolving phlegm and dispelling dampness. Commonly used prescriptions include Xiaoyao Powder and modified Erchen Decoction, and commonly used herbs include Bupleurum, Curcuma Radix, Citrus Aurantium, White Peony Root, Ginseng, Raw Astragalus, Poria, Atractylodes, Tangerine Peel, Pinellia, Gynostemma Pentaphyllum, Sinapis Alba, Radish Seed, Trichosanthes Knotweed, Lotus Leaf, Raw Coix Seed, Fritillaria Thunbergii, and Licorice. However, current TCM treatment options are insufficient for clinical application, necessitating the development of new and effective TCM formulas for the treatment of non-alcoholic fatty liver disease. Summary of the Invention

[0004] The present invention aims to provide a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, a preparation method thereof and pharmaceutical use thereof.

[0005] The invention provides a traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18-22 parts of loquat leaves, 18-22 parts of poria cocos, 18-22 parts of coix seeds, 18-22 parts of wormwood, 18-22 parts of adzuki beans, 13-17 parts of dried tangerine peels, 18-22 parts of cassia seeds, 18-22 parts of lotus leaves, 18-22 parts of hawthorn, 18-22 parts of chrysanthemum, 18-22 parts of salvia miltiorrhiza, 18-22 parts of cardamom, 18-22 parts of creeping vine, 13-17 parts of schisandra chinensis, 18-22 parts of red peony root, and 8-12 parts of angelica sinensis.

[0006] Furthermore, the Chinese medicine composition is a preparation made from the following raw materials in parts by weight: 20 parts of loquat leaves, 20 parts of Poria cocos, 20 parts of Coix seeds, 20 parts of Artemisia capillaris, 20 parts of Adzuki beans, 15 parts of Cibotium bark, 20 parts of Cassia seeds, 20 parts of lotus leaves, 20 parts of hawthorn, 20 parts of chrysanthemum, 20 parts of Salvia miltiorrhiza, 20 parts of Cardamom, 20 parts of Creeping Herb, 15 parts of Schisandra chinensis, 20 parts of Red Peony Root, and 10 parts of Angelica sinensis.

[0007] Furthermore, the adzuki bean is red adzuki bean, the chrysanthemum is Hangzhou chrysanthemum, the hawthorn is raw hawthorn, and the cardamom is white cardamom.

[0008] Furthermore, the Chinese medicine composition is a preparation prepared with the powder of the raw material drug, the water extract of the raw material drug or the organic solvent extract of the raw material drug as the active ingredient, and pharmaceutically acceptable excipients.

[0009] Furthermore, the preparation is an oral preparation.

[0010] Furthermore, the oral preparation is a decoction, oral liquid, granules, capsules, powders, pills or tablets.

[0011] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps:

[0012] (1) Weigh each API according to weight;

[0013] (2) Prepare the drug powder of the raw material, the water extract of the raw material or the organic solvent extract of the raw material, and add pharmaceutically acceptable excipients to obtain the drug.

[0014] The present invention also provides use of the above-mentioned traditional Chinese medicine composition in preparing a medicament for preventing and / or treating non-alcoholic fatty liver disease.

[0015] Furthermore, the TCM syndrome type of the non-alcoholic fatty liver disease is internal stagnation of phlegm and dampness.

[0016] The traditional Chinese medicine composition provided by the present invention comprises bamboo leaf, coix seed, Poria, red bean, tangerine peel, cassia seed, chrysanthemum flower, lotus leaf, raw hawthorn, wormwood, schisandra chinensis, red peony root, Chinese angelica, salvia miltiorrhiza, and white cardamom. Bamboo leaf, coix seed, Poria, red bean, tangerine peel promotes dampness, while cassia seed, chrysanthemum flower, lotus leaf, raw hawthorn, and salvia miltiorrhiza clear turbidity. White cardamom is added to restore the key position of spleen and stomach qi movement. Furthermore, dampness-clearing and heat-clearing drugs such as wormwood, schisandra chinensis, schisandra chinensis, red peony root, and Chinese angelica are added. In the formula, bamboo leaf, Poria, and coix seed are the monarch drugs, while wormwood, red bean, tangerine peel, cassia seed, lotus leaf, and raw hawthorn are the assistant drugs. The adjuvant drugs are tangerine peel, schisandra chinensis, red peony root, and Chinese angelica. Although the three groups of medicines have the common properties of promoting dampness and removing turbidity, they are different from each other (strengthening the spleen and removing dampness, clearing away heat and removing dampness). In addition, white cardamom harmonizes the Qi of the middle burner, so that the body's fluids can be distributed smoothly, the fat and turbid evil can be discharged, and the Qi can flow smoothly while clearing the water channels. They complement each other and achieve the effect of promoting dampness and removing turbidity.

[0017] This prescription has been used in clinical practice for more than 20 years. Follow-up observations show that it can effectively reduce the weight, blood lipid levels, and insulin resistance levels of NAFLD patients, and to a certain extent reduce the occurrence of malignant liver diseases in the long term.

[0018] The Chinese medicine composition of the present invention has readily available raw materials, simple composition, simple preparation process, is suitable for industrial production, and has broad application prospects.

[0019] Obviously, based on the above contents of the present invention, according to common technical knowledge and customary means in this field, without departing from the above basic technical ideas of the present invention, other various forms of modifications, replacements or changes can be made.

[0020] The following further describes the above content of the present invention in detail through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention fall within the scope of the present invention. DETAILED DESCRIPTION

[0021] The raw materials and equipment used in the present invention are all known products and are obtained by purchasing commercially available products.

[0022] Example 1: Preparation of the Chinese medicine composition of the present invention

[0023] Recipe: 20g of light bamboo leaves, 20g of Poria cocos, 20g of Coix seed, 20g of Artemisia capillaris, 20g of red bean, 15g of dried tangerine peel, 20g of Cassia seed, 20g of lotus leaf, 20g of raw hawthorn, 20g of chrysanthemum, 20g of Salvia miltiorrhiza, 20g of white cardamom, 20g of creeping vine, 15g of Schisandra chinensis, 20g of red peony root, and 10g of Chinese angelica.

[0024] Preparation process: The above formula is crushed into fine powder to make oral powder, named Zhuyi Xiaogao Powder.

[0025] The following experimental examples demonstrate the beneficial effects of the Chinese medicine composition of the present invention.

[0026] Experimental Example 1: Clinical effect of the Chinese medicine composition of the present invention in treating non-alcoholic fatty liver disease

[0027] 1. Treatment target

[0028] A total of 120 patients with NAFLD admitted to Yuechi County Traditional Chinese Medicine Hospital from November 2023 to August 2024 were selected as research subjects and divided into a control group and an experimental group using the random number table method, with 60 subjects in each group.

[0029] In the control group, there were 32 males and 28 females, with a minimum and maximum age of 42 and 73 years, respectively, with a mean of (52.66±2.58) years. The longest and shortest disease durations were 10 and 1 year, respectively, with a mean of (6.22±1.02) years. In the experimental group, there were 33 males and 27 females, with a minimum and maximum age of 43 and 74 years, respectively, with a mean of (52.66±2.56) years. The longest and shortest disease durations were 11 and 1.5 years, respectively, with a mean of (6.65±1.42) years. Comparison of basic data between the two groups was P>0.05, indicating comparability.

[0030] Inclusion criteria:

[0031] (1) Aged 18-70 years; (2) Meet the Western medical diagnostic criteria for NAFLD, with color Doppler ultrasound results indicating fatty liver and elevated blood lipids, and diagnosed with phlegm-dampness retention in traditional Chinese medicine; (3) Voluntarily participate in the study and sign the informed consent form; (4) The patient's mental state is good and can objectively and accurately express the treatment effect.

[0032] Exclusion criteria:

[0033] (1) Patients with allergic constitution or allergy to the ingredients of this drug; (2) Patients with cirrhosis and liver tumors or ALT, AST ≥ 5 times the upper limit of normal, and patients with severe liver function damage; (3) Women who are pregnant, breastfeeding, or planning to become pregnant during the trial; (4) Patients with complications of viral hepatitis, alcoholic hepatitis, autoimmune liver disease, cirrhosis, hepatocellular carcinoma and other liver diseases, patients with severe heart, brain, and kidney diseases, such as chronic heart failure; (5) Patients with other serious diseases, such as tumors and other special blood diseases; (6) Patients with poor compliance and unable to cooperate in completing the trial.

[0034] 2. Treatment Methods

[0035] Control group: only received basic treatment and took placebo orally.

[0036] Experimental group: The patients were given the Chinese medicine composition of Example 1 of the present invention in addition to the basic treatment, 1 dose per day, 3 times a day, each time the medicine was brewed with 70°C drinking water and then taken orally, 4 weeks as a course of treatment, and three courses of treatment were used continuously, for a total of 12 weeks.

[0037] 3. Efficacy evaluation criteria

[0038] Efficacy evaluation: Based on the "Consensus on the Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease with Integrated Traditional Chinese and Western Medicine" developed in 2017 by the Digestive System Diseases Committee of the Chinese Association of Integrated Traditional Chinese and Western Medicine, the following criteria were defined: Cure: liver enzyme and blood lipid indicators return to normal, color Doppler ultrasound results are normal, and the percentage of efficacy improvement is ≥95%; Markedly effective: liver enzyme indicators decrease by ≥50%, triglycerides decrease by ≥40%, or blood lipid indicators, including total cholesterol, decrease by ≥20%, clinical symptoms essentially disappear, color Doppler ultrasound grade decreases by two or more grades, and the Traditional Chinese Medicine Syndrome Efficacy Index (TCI) is 70% or less and <95%; Effective: 30% liver enzymes decrease by <50%, 20% triglycerides decrease by <40%, or 10% TC decrease by <20%, clinical symptoms improve, and the liver color Doppler ultrasound grade decreases by one grade, and 30% TCM Syndrome Efficacy Index is <70%; Ineffective: no significant improvement in liver enzyme indicators (ALT, AST) and no relief of clinical symptoms. The total effective rate is calculated as the sum of cure rate + markedly effective rate + effective rate.

[0039] Blood lipid and blood glucose indicators: Blood lipid indicators include total cholesterol (TC) 2.93-5.23 mmol / L, triglycerides (TG) 0.64-2.58 mmol / L, low-density lipoprotein (LDL) 1.58-3.52 mmol / L, and high-density lipoprotein (HDL) 0.83-1.84 mmol / L. Blood glucose indicators include fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPBG), and glycosylated hemoglobin (HbA1c).

[0040] Statistical analysis: Data were analyzed using SPSS 21.0. Count data were expressed as (n, %) and the chi-square test was used. 2 The measurement data were expressed as (x±s) and the data were tested by t test. P<0.05 was considered statistically significant.

[0041] 4. Treatment effect

[0042] (1) Comparison of treatment effects

[0043] The total effective rate of the experimental group was higher than that of the control group, with statistical significance (P<0.05). See Table 1.

[0044] Table 1 Comparison of treatment effects [n, %]

[0045] Group cure Significant effect efficient invalid Total effective rate of treatment Control group (n=60) 12 20 15 13 47(78.33) Experimental group (n=60) 20 30 8 2 58(96.67) 5.253 P-value 0.000

[0046] The experimental results showed that compared with the total effective rate of 78.33% in the control group, the total effective rate of the Chinese medicine composition of the present invention in the experimental group reached 96.67%, and the Chinese medicine composition of the present invention had a significant effect in treating non-alcoholic fatty liver disease.

[0047] (2) Comparison of blood lipid indicators

[0048] Before treatment, there was no statistically significant difference in the various blood lipid indicators between the two groups (P>0.05). After treatment, the experimental group had lower levels of TC, TG, and LDL, and higher levels of HDL, which were statistically significant compared with the control group (P<0.05). See Table 2.

[0049] Table 2 Comparison of blood lipid indexes (x±s, mmol / L)

[0050]

[0051] (3) Comparison of blood sugar and liver function index levels

[0052] Before treatment, there was no statistically significant difference in blood sugar and liver function between the two groups (P>0.05); after treatment, the blood sugar and liver function levels in the experimental group were significantly lower than those in the control group (P<0.05). See Table 3.

[0053] Table 3 Comparison of blood sugar and liver function index levels (x±s)

[0054]

[0055] In summary, the Chinese medicine composition of the present invention (Zhu Yi Xiao Gao San) is a prescription based on the applicant's many years of clinical experience. It is a clinically effective prescription for the treatment of NAFLD based on the method of promoting dampness and removing turbidity. The experimental results of the present invention showed that after treatment, the total effective rate of the experimental group was higher than that of the control group, which was statistically significant (P<0.05); the levels of blood lipids, blood sugar, and liver function indicators in the experimental group were lower than those in the control group, which was statistically significant (P<0.05). It can be seen that the Chinese medicine composition of the present invention can effectively improve the clinical symptoms of NAFLD patients and has good application prospects in the preparation of drugs for the treatment of non-alcoholic fatty liver disease.

Claims

1. A Chinese medicine composition, characterized in that The traditional Chinese medicine composition is a preparation prepared from the following raw materials in parts by weight: 18-22 parts of loquat leaves, 18-22 parts of poria cocos, 18-22 parts of coix seeds, 18-22 parts of wormwood, 18-22 parts of adzuki beans, 13-17 parts of dried tangerine peels, 18-22 parts of cassia seeds, 18-22 parts of lotus leaves, 18-22 parts of hawthorn, 18-22 parts of chrysanthemum, 18-22 parts of salvia miltiorrhiza, 18-22 parts of cardamom, 18-22 parts of creeping vine, 13-17 parts of schisandra chinensis, 18-22 parts of red peony root, and 8-12 parts of angelica sinensis.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is a preparation prepared from the following raw materials in parts by weight: 20 parts of bamboo leaves, 20 parts of poria cocos, 20 parts of coix seeds, 20 parts of wormwood, 20 parts of adzuki beans, 15 parts of dried tangerine peels, 20 parts of cassia seeds, 20 parts of lotus leaves, 20 parts of hawthorn, 20 parts of chrysanthemum, 20 parts of salvia miltiorrhiza, 20 parts of cardamom, 20 parts of creeping vine, 15 parts of schisandra chinensis, 20 parts of red peony root, and 10 parts of angelica.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that The adzuki bean is red adzuki bean, the chrysanthemum is Hangzhou chrysanthemum, the hawthorn is raw hawthorn, and the cardamom is white cardamom.

4. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is a preparation prepared by taking the powder of the raw material medicine, the water extract of the raw material medicine or the organic solvent extract of the raw material medicine as the active ingredient and adding pharmaceutically acceptable excipients.

5. The Chinese medicine composition according to claim 4, characterized in that The preparation is an oral preparation.

6. The Chinese medicine composition according to claim 5, characterized in that The oral preparation is a decoction, oral liquid, granule, capsule, powder, pill or tablet.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 6, characterized in that: The method comprises the following steps: (1) Weigh each API according to weight; (2) Prepare the drug powder of the raw material, the water extract of the raw material or the organic solvent extract of the raw material, and add pharmaceutically acceptable excipients to obtain the drug.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for preventing and / or treating non-alcoholic fatty liver disease.

9. The use according to claim 8, characterized in that The TCM syndrome type of the non-alcoholic fatty liver disease is internal stagnation of phlegm and dampness.

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