Traditional Chinese medicine composition for treating metabolism-related fatty liver disease and application

Abstract

The invention relates to a traditional Chinese medicine composition for treating metabolism-related fatty liver diseases. The traditional Chinese medicine composition is prepared from the following raw material medicines: 18 parts of ephedra, 15 parts of gypsum, 9 parts of mint, 30 parts of talc, 15 parts of raw rhubarb, 15 parts of fructus forsythiae and 15 parts of radix puerariae. The invention also provides application of the traditional Chinese medicine composition in preparation of medicines, health-care products or tea drinks for preventing and treating MAFLD. Compared with the prior art, the traditional Chinese medicine composition starts from the thought of separately eliminating upper, middle and lower jiao, the pathogenesis of MAFLD is summarized as damp-heat stagnation and three-jiao congestion, and the whole formula jointly achieves the damp-heat eliminating effect of freeing the upper part, clearing the middle part and smoothing the lower part. When being used for treating the MAFLD, the pharmaceutical composition disclosed by the invention can be used for remarkably improving fat deposition (MRI-PDFF), CAP value, BMI, TG, FINS, HbA1c and HOMA-IR levels in the liver of a patient, and can be used for effectively preventing and treating the MAFLD.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a traditional Chinese medicine composition for treating metabolism-related fatty liver disease and its application. Background Art

[0002] Non-alcoholic fatty liver disease (NAFLD) generally refers to a liver disease associated with metabolic dysfunction based on hepatic fatty degeneration combined with overweight / obesity, type 2 diabetes, and metabolic dysfunction.

[0003] With the modernization, urbanization, westernization of dietary structure and the prevalence of sedentary lifestyle in my country, obesity and its related metabolic disorders have become important risk factors that endanger the health of Chinese people. At present, the prevalence of overweight and obesity in Chinese adults is as high as 34.8% and 14.1%, respectively, the prevalence of prediabetes and T2DM is as high as 35.2% and 12.8%, respectively, and the aggregate prevalence of metabolic syndrome is as high as 24.5%. The related NAFLD has also become an increasingly serious public health event for adults in my country. The diagnostic criteria for NAFLD and MAFLD are not exactly the same. MAFLD can coexist with other liver diseases such as alcoholic fatty liver disease and chronic hepatitis B, and chronic liver diseases with two or more causes are more harmful. Therefore, the prevention and control of MAFLD has become an urgent task.

[0004] Clinically, the main treatments used are drugs such as improving lifestyle, lowering blood sugar, protecting the liver, and regulating intestinal flora, but the long-term efficacy has not met expectations and the incidence of adverse reactions is high.

[0005] Chinese patent document CN106421040A discloses a Chinese medicine composition for treating external cold and internal heat and both external and internal fullness: fangfeng, jingjiesui, mint, kudzu root, ephedra, jujube, rhubarb, mirabilite, lindera, gardenia, talc, platycodon, gypsum, chuanxiong, angelica, scutellaria, forsythia, liquorice, atractylodes, and immature bitter orange. Chinese patent document CN108324913A discloses a Chinese medicine composition for treating obesity: talc, atractylodes, platycodon, peony, scutellaria, gypsum, liquorice, angelica, fangfeng, ephedra, chuanxiong, gardenia, forsythia, jingjie, ginger, raw rhubarb, mirabilite, magnolia bark, immature bitter orange. However, there is no report on the Chinese medicine composition for treating MAFLD of the present invention. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition and application for treating MAFLD in view of the deficiencies in the prior art. The present invention starts from the idea of ​​eliminating the upper, middle and lower three burners separately, summarizes the pathogenesis of MAFLD as "damp-heat stagnation, three burners obstruction", and the whole prescription plays the effect of clearing the upper, middle and lower parts of the body and eliminating damp-heat separately. The present invention treats MAFLD, can significantly improve the patient's intrahepatic fat deposition (MRI-PDFF), CAP value, BMI, TG, FINS, HbA1c, HOMA-IR level, and can effectively prevent and treat MAFLD.

[0007] The purpose of the present invention can be achieved by the following technical solutions:

[0008] The first aspect of the present invention provides a Chinese medicine composition, characterized in that the composition comprises the following components and contents by weight:

[0009]

[0010] Furthermore, the composition comprises the following components and contents by weight:

[0011]

[0012] Furthermore, the composition comprises the following components and contents by weight:

[0013]

[0014]

[0015] The second aspect of the present invention provides an application of a Chinese medicine composition, including using the Chinese medicine composition to prepare a medicine, a health product or a tea for preventing and treating metabolism-related fatty liver disease.

[0016] Furthermore, the medicine is an oral preparation.

[0017] Furthermore, the oral preparation is selected from at least one of tablets or capsules.

[0018] Furthermore, the oral preparation is selected from at least one of an oral liquid or a syrup.

[0019] Furthermore, the oral preparation is a granule.

[0020] Furthermore, the oral preparation is a pill.

[0021] Furthermore, the medicine is a decoction, and its preparation method includes: mixing ephedra, gypsum, white peony root, talc, rhubarb, forsythia, kudzu root and water, decocting and filtering to obtain a filtrate, which is the decoction of the traditional Chinese medicine composition.

[0022] Compared with the prior art, the present invention has the following characteristics:

[0023] The onset of MAFLD is mainly related to liver failure to release, spleen failure to function properly, phlegm-dampness accumulation, and blood stasis. Therefore, the present invention summarizes the pathogenesis of MAFLD as "mutual binding of phlegm, dampness, turbidity, stasis, and heat, and imbalance of qi and blood". The treatment mainly starts from the liver, spleen, and kidney, clears liver dampness and heat, improves the qi of the internal organs, and reduces phlegm, stasis, dampness, and turbidity. The effect of the syndrome differentiation treatment of Longhu Fenxiao Fang in the present invention on the changes in related indicators such as glucose and lipid metabolism, liver fat content, and insulin resistance in MAFLD patients, Longhu Fenxiao Fang has obvious clinical efficacy in treating MAFLD, providing a new idea for the treatment of MAFLD. DETAILED DESCRIPTION

[0024] The present invention is described in detail below in conjunction with specific embodiments. This embodiment is implemented based on the technical solution of the present invention, and provides a detailed implementation method and a specific operation process, but the protection scope of the present invention is not limited to the following embodiments.

[0025] The following are more detailed implementation cases, which further illustrate the technical solutions of the present invention and the technical effects that can be obtained.

[0026] In the following examples, unless otherwise specified, raw materials, reagents or processing techniques are all conventional commercial products or conventional processing techniques in the art.

[0027] Example:

[0028] 1. Experimental Subjects

[0029] Patients with MAFLD admitted to the outpatient and inpatient departments of Shanghai Hospital of Traditional Chinese Medicine from August 2023 to May 2024 were selected as the research subjects and divided into an observation group and a control group according to the random number table method, including 10 cases in the control group and 32 cases in the treatment group. There was no significant difference in the general information of the two groups of patients (P>0.05), and they were comparable.

[0030] Table 1 Comparison of general data of two groups of MAFLD patients

[0031]

[0032] Inclusion criteria

[0033] (1) Meet the relevant Western medical diagnostic criteria in the "International Expert Consensus on the New Definition of Metabolic-Associated Fatty Liver Disease (2020)" and be diagnosed with MAFLD by imaging; (2) Aged 18-75 years, regardless of gender; (3) Have not received relevant treatment within the past month.

[0034] Exclusion criteria

[0035] (1) Patients with other serious digestive system diseases, cardiovascular and cerebrovascular diseases, respiratory system diseases, urinary system diseases, blood system diseases, autoimmune diseases, nervous system diseases, etc.; (2) Severe liver function damage (transaminase exceeds 10 times the upper limit of normal value, with or without bilirubin exceeding 2 times the upper limit of normal value); (3) Patients with abnormal thyroid function, malignant tumors and other diseases that affect blood sugar and blood lipids; (4) Pregnant or lactating women; (5) Patients with mental illness or cognitive impairment are excluded.

[0036] 2. Treatment methods:

[0037] The control group was given conventional treatment, and the patients were adjusted in diet, followed a low-sugar and low-fat diet, and exercised appropriately to control their body weight. The observation group was given Longhu Fenxiao Fang plus or minus treatment on the basis of the control group. The prescription was: 15g of ephedra; 15g of gypsum; 9g of mint; 30g of talc; 30g of raw rhubarb; 15g of forsythia; 15g of kudzu root. One dose per day, add appropriate amount of water to the above medicine, decoct and filter it conventionally, and take it warm twice a day in the morning and evening for 12 weeks.

[0038] 3. Observation indicators:

[0039] 1) Liver fat content

[0040] The two groups of patients were examined by 3.0T magnetic resonance imaging before treatment and 12 weeks after treatment.

[0041] 2) Controlled Attenuation Parameter (CAP)

[0042] FibroScan was used to detect the two groups of patients before treatment and after 12 weeks of treatment.

[0043] 3) Weight, body mass index (BMI), waist circumference, hip circumference, waist-to-hip ratio

[0044] The body weight, body mass index (BMI), waist circumference, hip circumference and waist-to-hip ratio of the two groups of patients were measured before and after treatment during follow-up.

[0045] 4) Biochemical indicators

[0046] Fasting venous blood was drawn from the subjects, and the biochemical indices of the two groups were tested before and after treatment. (1) Liver function indices: alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP); (2) Renal function indices: creatinine (Cr), uric acid (UA); (3) Blood glucose metabolism indices: fasting glucose (FBG), glycosylated hemoglobin (HbA1c), fasting insulin (FINS), insulin resistance index (HOMA-IR) = FBG × FINS / 22.5; (4) Blood lipid metabolism indices: total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL).

[0047] 5) Statistical methods

[0048] SPSS 26.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (x ± s), variance analysis was used for inter-group comparison, and t-test was used for intra-group comparison. P < 0.05 was considered statistically significant.

[0049] IV. Results

[0050] 4.1 Comparison of changes in weight, BMI, waist circumference, hip circumference, and waist-to-hip ratio in MAFLD patients before and after treatment

[0051] Before treatment, there was no significant difference in weight, BMI, waist circumference, hip circumference, and waist-to-hip ratio between the two groups (P>0.05). After 12 weeks of treatment, the weight, BMI, waist circumference, and waist-to-hip ratio of the treatment group were lower than those before treatment (P<0.05), and lower than those of the control group at the same time point (P<0.05), as shown in Table 2.

[0052] Table 2 Comparison of changes in weight, BMI, waist circumference, hip circumference, and waist-to-hip ratio in patients with MAFLD before and after treatment

[0053]

[0054]

[0055] 4.2 Comparison of changes in liver fat content percentage and CAP value before and after treatment in MAFLD patients

[0056] Before treatment, there was no significant difference in the percentage of liver fat content and CAP value between the two groups (P>0.05). After 12 weeks of treatment, the percentage of liver fat content and CAP value in the treatment group were lower than those before treatment (P<0.05), and the liver fat content in the treatment group was lower than that in the control group at the same time point (P<0.05), as shown in Table 3.

[0057] Table 3 Comparison of changes in liver fat content percentage and CAP value in MAFLD patients before and after treatment

[0058]

[0059] 4.3 Comparison of serum ALT, AST, ALP, and GGT in MAFLD patients before and after treatment

[0060] Before treatment, there was no significant difference in ALT, ALP and GGT between the two groups (P>0.05). After treatment, ALT, ALP and GGT in the treatment group were lower than those before treatment (P<0.05), and GGT in the observation group was lower than that in the control group at the same time point (P<0.05), as shown in Table 4.

[0061] Table 4 Comparison of serum ALT, AST, ALP and GGT in patients with MAFLD before and after treatment

[0062]

[0063] 4.4 Comparison of changes in serum TC, TG, HDL, and LDL in patients with MAFLD before and after treatment

[0064] Before treatment, there was no significant difference in TC, TG, HDL, and LDL between the two groups (P>0.05). After 12 weeks of treatment, TG in the observation group was lower than that before treatment (P<0.05), as shown in Table 5.

[0065] Table 5 Comparison of serum TC, TG, HDL and LDL in patients with MAFLD before and after treatment

[0066]

[0067]

[0068] 4.6 Comparison of changes in FBG, FINS, HbA1c, HOMA-IR, Cr, and UA in patients with MAFLD before and after treatment

[0069] Before treatment, there was no significant difference in FBG, FINS, HbA1c, HOMA-IR, Cr, and UA between the two groups (P>0.05). After 12 weeks of treatment, FINS, HbA1c, HOMA-IR, and Cr in the treatment group were lower than those before treatment (P<0.05), as shown in Table 6.

[0070] Table 6 Comparison of FBG, FINS, HbA1c, HOMA-IR, Cr, and UA in patients with MAFLD before and after treatment

[0071]

[0072]

[0073] 4.7 Comparison of the reduction of various indicators in MAFLD patients before and after treatment

[0074] After treatment, the decreases in body weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, waist-to-hip ratio, liver fat content, ALT, GGT, FBG, HbA1c, HOMA-IR, and UA in the treatment group were greater than those in the control group (P < 0.05), as shown in Table 7.

[0075] Table 7 Comparison of the reduction of various indicators in patients with MAFLD

[0076]

[0077]

[0078] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The composition comprises the following components and contents by weight:

2. The Chinese medicine composition according to claim 1, characterized in that: The composition comprises the following components and contents by weight:

3. The Chinese medicine composition according to claim 2, characterized in that: The composition comprises the following components and contents by weight:

4. A use of the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is used for preparing medicines, health products or tea drinks for preventing and treating metabolism-related fatty liver disease.

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

6. The use of the Chinese medicine composition according to claim 5, characterized in that: The oral preparation is selected from at least one of tablets or capsules.

7. The use of the Chinese medicine composition according to claim 5, characterized in that: The oral preparation is selected from at least one of an oral liquid or a syrup.

8. The use of the Chinese medicine composition according to claim 5, characterized in that: The oral preparation is a granule.

9. The use of the Chinese medicine composition according to claim 5, characterized in that: The oral preparation is a pill.

10. The use of the Chinese medicine composition according to claim 4, characterized in that: The medicine is a decoction. The preparation method of the water decoction comprises: mixing ephedra, gypsum, white peony root, talc, rhubarb, forsythia, kudzu root and water, decocting and filtering to obtain a filtrate, which is the water decoction of the traditional Chinese medicine composition.

Images