A traditional Chinese medicine composition for treating non-alcoholic fatty liver and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease (NAFLD). The composition is made from the following raw materials in parts by weight: 12 parts turmeric extract, 9 parts rhubarb extract, 10 parts atractylodes macrocephala extract, 10 parts gynostemma pentaphyllum extract, 10 parts kudzu root extract, 10 parts lotus leaf extract, 10 parts alisma plantago-aquatica extract, 10 parts salvia miltiorrhiza extract, 15 parts polygonum cuspidatum extract, 10 parts silkworm extract, 3 parts leech extract, 10 parts malachite extract, and 6 parts licorice extract; as well as its preparation method and uses. This composition can effectively alleviate the clinical symptoms of NAFLD patients, improve liver function, reduce the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and triglycerides (TG), total cholesterol (TC), and low-density lipoprotein (LDL-C) in the blood, and increase the level of high-density lipoprotein (HDL-C), effectively improving blood lipids and alleviating the protracted disease progression towards recovery.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and its preparation method. Background Technology

[0002] Nonalcoholic fatty liver disease (NAFLD) often presents with no obvious symptoms in its early stages and progresses slowly. However, it requires a long treatment course and is prone to becoming chronic. Treatment is relatively complex, and if not controlled in time, it can eventually lead to liver fibrosis, cirrhosis, and even hepatocellular carcinoma.

[0003] The pathogenesis of non-alcoholic fatty liver disease (NAFLD) remains unclear. Current clinical views largely suggest that its occurrence is based on the "second-hit" theory, involving insulin resistance, leptin resistance, oxidative stress, endoplasmic reticulum stress, gut microbiota, and autophagy. No ideal method for the prevention and treatment of NAFLD has yet been found. Modern medicine advocates for dietary control, increased exercise, and medication. Currently, there are no specific drugs for drug treatment; most treatments utilize insulin sensitizers, lipid-lowering agents, and hepatoprotective drugs, primarily targeting insulin resistance, oxidative stress, inflammation, and fibrosis. Summary of the Invention

[0004] The first objective of this invention is to solve the above-mentioned problems by providing a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, which has a good therapeutic effect on non-alcoholic fatty liver disease and no obvious side effects.

[0005] The second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition.

[0006] A third objective of this invention is to provide the use of the above-mentioned traditional Chinese medicine composition.

[0007] The objective of this invention is specifically achieved through the following technical solutions:

[0008] A traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, said composition being made from raw materials comprising the following parts by weight:

[0009] Turmeric extract 12 parts, rhubarb extract 9 parts, atractylodes macrocephala extract 10 parts, gynostemma pentaphyllum extract 10 parts, kudzu root extract 10 parts, lotus leaf extract 10 parts, alisma plantago-aquatica extract 10 parts, salvia miltiorrhiza extract 10 parts, polygonum cuspidatum extract 15 parts, silkworm extract 10 parts, leech extract 3 parts, malachite extract 10 parts, licorice extract 6 parts.

[0010] The above-mentioned traditional Chinese medicine composition is prepared by mixing turmeric extract, rhubarb extract, atractylodes macrocephala extract, gynostemma pentaphyllum extract, kudzu root extract, lotus leaf extract, alisma plantago-aquatica extract, salvia miltiorrhiza extract, polygonum cuspidatum extract, silkworm extract, leech extract, malachite extract, and licorice extract.

[0011] The application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating non-alcoholic fatty liver disease.

[0012] This invention relates to a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, comprising: turmeric and rhubarb, which are bitter and cold in nature, promoting qi circulation, relieving depression, and clearing the bowels and removing blood stasis; atractylodes macrocephala and gynostemma pentaphyllum, which invigorate qi, strengthen the spleen, resolve phlegm, and lower lipids; kudzu root, lotus leaf, and alisma, which promote the upward movement of clear qi and the downward movement of turbid qi, and regulate blood lipids; salvia miltiorrhiza and polygonum cuspidatum, which nourish blood, promote blood circulation, and eliminate phlegm and toxins; silkworm pupae and leeches, which dispel wind, resolve phlegm, remove blood stasis, and eliminate masses; malachite, which clears phlegm, promotes digestion, softens hardness, and eliminates masses; and licorice, which harmonizes the middle jiao, detoxifies, and effectively regulates the effects of other herbs. The compatibility characteristics of this invention's formulation are: silkworm pupae, kudzu root, and lotus leaf promote the upward movement of clear yang, while turmeric, rhubarb, and malachite lower the downward movement of turbid yin. The formula promotes the flow of qi and blood, harmonizing internal and external energies. Leeches break up blood stasis and resolve masses without harming qi and yin, while malachite effectively clears phlegm and promotes digestion. When these two herbs are combined, they treat both phlegm and blood stasis. Together with Atractylodes macrocephala and Gynostemma pentaphyllum, the formula synergistically strengthens qi and spleen. This formula combines qi-regulating and stagnation-relieving, blood-nourishing and blood-activating, phlegm-clearing and lipid-lowering, bowel-clearing and blood-stasis-resolving, and ascending of clear qi and descending of turbid qi into one, achieving the effects of strengthening the spleen, resolving phlegm, activating blood, and removing lipids.

[0013] The present invention has the following beneficial effects:

[0014] The traditional Chinese medicine composition for treating non-alcoholic fatty liver disease provided by this invention is a safe and effective treatment formula that can effectively alleviate the clinical symptoms of patients with non-alcoholic fatty liver disease, improve liver function, reduce the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), as well as triglycerides (TG), total cholesterol (TC), and low-density lipoprotein (LDL-C) in blood lipids, and increase the level of high-density lipoprotein (HDL-C). It effectively improves blood lipids, alleviates the protracted nature of the disease and promotes its recovery, thereby improving the quality of life of patients. It is a new treatment option for patients with non-alcoholic fatty liver disease. Detailed Implementation

[0015] The preferred embodiments of the present invention are described below. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0016] The extracts of each Chinese herbal medicine in the examples are manufactured by Jiangyin Tianjiang Pharmaceutical Co., Ltd. They are granular new formula single-herb Chinese herbal medicines made from single traditional Chinese herbal medicine slices as raw materials through processes such as water extraction, separation, concentration, drying, granulation, and packaging, for use in clinical prescriptions of traditional Chinese medicine.

[0017] Example 1

[0018] A traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, each dose consisting of the following granular traditional Chinese medicine extracts:

[0019] Turmeric extract 12g, rhubarb extract 9g, silkworm extract 10g, gynostemma pentaphyllum extract 10g, atractylodes macrocephala extract 10g, kudzu root extract 10g, lotus leaf extract 10g, alisma plantago-aquatica extract 10g, salvia miltiorrhiza extract 10g, polygonum cuspidatum extract 15g, leech extract 3g, malachite extract 10g, licorice extract 6g.

[0020] Mixing the various Chinese herbal granules yields Erhuang Quzhi Granules, a type of Chinese herbal granule preparation that requires no decoction.

[0021] Clinical trials

[0022] Subjects: All subjects included were patients diagnosed with non-alcoholic fatty liver disease from the clinic of the National Famous Traditional Chinese Medicine Practitioner Yuan Jinqi Inheritance Studio and the liver disease clinic of the First Affiliated Hospital of Shihezi University School of Medicine from September 2018 to November 2019. A total of 110 patients were randomly divided into a treatment group and a treatment group, with 55 patients in each group.

[0023] Treatment methods: The basic treatment consisted of diet control, appropriate exercise, weight loss, and vitamin E supplementation. Patients in the treatment group took Erhuang Quzhi Granules orally, one dose daily, mixed with 300ml of warm water and divided into two portions, taken in the morning and evening. Patients in the control group received polyene phosphatidylcholine capsules orally, two capsules three times daily. The treatment duration for both groups was three months.

[0024] Evaluation criteria: (1) Cured: Liver function and blood lipid indicators are normal, liver ultrasound shows that fatty liver has disappeared, and clinical symptoms and signs have disappeared; (2) Significantly effective: Symptoms and signs have basically disappeared, liver function and blood lipid are basically normal, and liver ultrasound shows that the fatty liver disease grade has decreased by 2 levels (from severe to mild); (3) Effective: Clinical symptoms and signs, liver function and blood lipid have improved, and ultrasound shows no significant change in fatty liver; (4) Ineffective: Symptoms and signs have not improved, and liver function, blood lipid and liver ultrasound have no significant changes.

[0025] Clinical treatment results: No adverse reactions occurred in either group after the course of treatment.

[0026] In the treatment group, 27 cases were cured, 14 cases showed significant improvement, 9 cases showed improvement, and 5 cases showed no improvement, with a total effective rate of 90.90%. In the control group, 15 cases were cured, 12 cases showed significant improvement, 9 cases showed improvement, and 19 cases showed no improvement, with a total effective rate of 65.45%. The clinical efficacy of the two groups was statistically significant (P<0.05), with the treatment group being superior to the control group.

[0027] After treatment, the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), triglycerides (TG), total cholesterol (TC), and low-density lipoprotein (LDL-C) in the treatment group were significantly lower than those in the control group, while high-density lipoprotein (HDL-C) was significantly higher (P<0.05).

[0028] Comparison of liver function changes before and after treatment in two clinical trial groups

[0029] Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT); * indicates comparison with pre- and post-treatment levels, P < 0.05; △ indicates comparison between the two groups and post-treatment levels, P < 0.05, the same applies below.

[0030]

[0031] Triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C)

[0032] In a study of 55 patients with non-alcoholic fatty liver disease treated with the Erhuang Quzhi Granules of this invention, and compared with 55 patients treated with the control drug polyene phosphatidylcholine capsules, the efficacy of Erhuang Quzhi Granules was superior to that of polyene phosphatidylcholine capsules in terms of liver function, blood lipids, and total effective rate.

[0033] Traditional Chinese medicine emphasizes holistic and dialectical treatment. The herbal composition (Erhuang Quzhi Granules) for treating non-alcoholic fatty liver disease (NAFLD) of this invention is based on traditional Chinese medicine theory combined with modern pharmacological research. This formula is a self-formulated and effective prescription accumulated by the inventor through years of clinical practice. It is comprehensively formulated, integrating qi-regulating and stagnation-relieving, blood-nourishing and blood-activating, phlegm-resolving and lipid-lowering, bowel-clearing and blood-stasis-removing, and clearing the upper and lower turbid qi into a single action, achieving the effects of strengthening the spleen, resolving phlegm, activating blood, and removing lipids. Clinical studies have shown that it can significantly improve the symptoms of patients with NAFLD, effectively alleviate the condition, and can be widely used in clinical practice.

[0034] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, characterized in that, The traditional Chinese medicine composition is made from the following parts by weight of granular traditional Chinese medicine extract: Turmeric extract 12 parts, rhubarb extract 9 parts, atractylodes macrocephala extract 10 parts, gynostemma pentaphyllum extract 10 parts, kudzu root extract 10 parts, lotus leaf extract 10 parts, alisma plantago-aquatica extract 10 parts, salvia miltiorrhiza extract 10 parts, polygonum cuspidatum extract 15 parts, silkworm extract 10 parts, leech extract 3 parts, malachite extract 10 parts, licorice extract 6 parts.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The extracts are obtained by mixing turmeric extract, rhubarb extract, atractylodes macrocephala extract, gynostemma pentaphyllum extract, kudzu root extract, lotus leaf extract, alisma plantago-aquatica extract, salvia miltiorrhiza extract, polygonum cuspidatum extract, silkworm extract, leech extract, malachite extract, and licorice extract.

3. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating non-alcoholic fatty liver disease.

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