Traditional Chinese medicine formula for treating non-alcoholic fatty liver disease

Through a traditional Chinese medicine formula containing Salvia miltiorrhiza, Tulipa, Citrus aurantium, Panax notoginseng and other medicinal materials, the existing drugs for treating non-alcoholic fatty liver disease have limited effects and major side effects, and the effects of improving liver function, reducing blood lipids and losing weight have been achieved without obvious adverse reactions.

CN119733029APending Publication Date: 2025-04-01长沙市中医医院(长沙市第八医院)
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Patent Information

Application Number
CN202411971118.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-30
Publication Date
2025-04-01

AI Technical Summary

Technical Problem

The current drugs for the treatment of non-alcoholic fatty liver disease are limited in effect and are often accompanied by side effects, such as stomach discomfort, abdominal discomfort and allergies.

Method used

A Chinese medicine formula is adopted, including salvia miltiorrhiza, turmeric aurora, Panax notoginseng, hawthorn, atractylodes macrocephala, poria cocos, lotus leaves, Bupleurum, prince ginseng, albicans and cassia seeds, through synergistic effects, relieve liver depression, strengthen spleen and dampness, promote blood circulation and remove blood stasis, clear heat and detoxify, improve liver function, reduce liver fat deposition and relieve clinical symptoms.

Benefits of technology

This Chinese medicine formula can effectively improve the liver function of patients with non-alcoholic fatty liver disease, reduce blood lipid levels, and lose weight, and no obvious adverse reactions are seen, reflecting the unique advantages of traditional Chinese medicine in the treatment of non-alcoholic fatty liver disease.

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Abstract

The invention discloses a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease. The traditional Chinese medicine formula is prepared from the following raw material medicines in parts by weight: 10-15 parts of salvia miltiorrhiza, 10-15 parts of radix curcumae, 10-15 parts of immature bitter orange, 5-10 parts of pseudo-ginseng, 10-13 parts of hawthorn, 15-20 parts of bighead atractylodes rhizome, 15-20 parts of poria cocos, 10-15 parts of lotus leaf, 10-15 parts of radix bupleuri, 15-20 parts of radix pseudostellariae, 5-9 parts of rhizoma alismatis and 10-15 parts of semen cassiae. The formula can effectively improve the fatty degeneration degree of the liver of a patient with the non-alcoholic fatty liver disease, reduce the blood fat level and reduce the body weight, and has no obvious adverse reaction.
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Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine formulas, and in particular to a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease. Background Art

[0002] Non-alcoholic fatty liver disease (NAFLD) is one of the common chronic liver diseases characterized by diffuse macrovesicular steatosis of hepatocytes, excluding those caused by alcohol and other clear liver-damaging factors. It seriously endangers people's health and may develop into liver fibrosis and cirrhosis. Currently, non-alcoholic fatty liver disease is closely related to obesity and metabolic syndrome. Oral silybin is usually used to promote the recovery of abnormal liver function in fatty liver, but the effect is limited, and patients often experience side effects such as stomach discomfort, abdominal discomfort, and allergies. Traditional Chinese medicine has the characteristics of few side effects and definite clinical efficacy in the prevention and treatment of non-alcoholic fatty liver disease. Summary of the invention

[0003] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease. The composition adopts the synergistic effect of various traditional Chinese medicine ingredients, has the effects of soothing the liver and relieving depression, strengthening the spleen and removing dampness, promoting blood circulation and removing blood stasis, clearing away heat and detoxifying, etc., can effectively improve the liver function of patients with non-alcoholic fatty liver disease, reduce liver fat deposition, and alleviate the clinical symptoms.

[0004] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0005] A traditional Chinese medicine formula for treating non-alcoholic fatty liver disease is prepared from the following raw materials in parts by weight: 10-15 parts of salvia miltiorrhiza, 10-15 parts of curcuma, 10-15 parts of immature bitter orange, 5-10 parts of notoginseng, 10-13 parts of hawthorn, 15-20 parts of atractylodes, 15-20 parts of poria, 10-15 parts of lotus leaf, 10-15 parts of bupleurum, 15-20 parts of pseudostellaria, 5-9 parts of oriental rhizome, and 10-15 parts of cassia seed.

[0006] Furthermore, the weight proportions of the raw materials in the Chinese medicine formula are: 10 parts of Salvia miltiorrhiza, 10 parts of Curcuma aromatica, 10 parts of Citrus aurantium, 5 parts of Panax notoginseng, 10 parts of Crataegus pinnatifida, 15 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 10 parts of Lotus leaf, 10 parts of Bupleurum chinense, 15 parts of Pseudostellaria pseudoginseng, 6 parts of Alismatis orientalis, and 10 parts of Cassia seed.

[0007] Furthermore, the preparation method of the decoction of the traditional Chinese medicine formula is:

[0008] S1. Accurately weigh the above Chinese medicines according to the proportions and mix them evenly;

[0009] S2. Add appropriate amount of water and soak for 30 minutes to allow the herbs to fully absorb water. The amount of water added should be 2 to 3 cm above the herbs.

[0010] S3, the first step is to use the hot and cold fire to alternately decoct, keep the low heat for 15 minutes after the first boiling, pour it out, and filter the liquid medicine; add appropriate amount of water to the residue, and use the hot and cold fire to alternately decoct for the second time, keep the low heat for 10 to 15 minutes after the first boiling, and combine the two liquid medicines;

[0011] S4. Add appropriate amount of honey or flavoring agent to the combined liquid medicine to make it into a decoction bag for patients to take.

[0012] Furthermore, a decoction bag prepared from a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease is taken by the patient once in the morning and once in the afternoon.

[0013] Furthermore, a dosage form of a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease is a capsule or an oral solution.

[0014] In the above technical solution, the technical effects and advantages provided by the present invention are:

[0015] The invention has a formula based on traditional Chinese medicine theory and combined with the research results of modern pharmacology. Chinese herbal medicines with clear liver protection, lipid-lowering and weight-loss effects are carefully selected, and a multi-target and multi-pathway comprehensive therapeutic effect is achieved through scientific formulation. Preclinical and preliminary clinical trials show that the formula can effectively improve the degree of liver fatty degeneration, lower blood lipid levels, and reduce body weight in patients with non-alcoholic fatty liver disease, and no obvious adverse reactions are observed, which reflects the unique advantages of traditional Chinese medicine in the treatment of non-alcoholic fatty liver disease. Compared with the existing traditional Chinese medicine formula for the treatment of non-alcoholic fatty liver disease, the medicine composition and proportion of the decoction prepared by the invention are more obvious, especially the introduction of medicinal materials such as Jishi and Panax notoginseng enhances the blood circulation and blood stasis removal and liver protection functions of the formula, thereby improving the therapeutic effect. DETAILED DESCRIPTION

[0016] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is further described in detail below.

[0017] Example 1

[0018] A Chinese medicine formula for treating non-alcoholic fatty liver disease, the Chinese medicine formula is prepared from the following raw materials in parts by weight: 10-15 parts of salvia miltiorrhiza, 10-15 parts of curcuma, 10-15 parts of immature bitter orange, 5-10 parts of notoginseng, 10-13 parts of hawthorn, 15-20 parts of atractylodes, 15-20 parts of poria, 10-15 parts of lotus leaf, 10-15 parts of bupleurum, 15-20 parts of pseudoginseng, 5-9 parts of oriental rhizome, and 10-15 parts of cassia seed;

[0019] The effects of each Chinese medicine in this formula are as follows:

[0020] Danshen: promotes blood circulation and removes blood stasis, relieves menstruation and relieves pain, clears the heart and relieves restlessness, cools blood and eliminates carbuncle; helps improve blood circulation in the liver and relieves symptoms of liver stasis;

[0021] Curcuma: promotes blood circulation and relieves pain, promotes qi and relieves depression, clears the heart and cools the blood, promotes bile secretion and relieves liver depression and qi stagnation;

[0022] Zhishi: can break up qi and eliminate stagnation, resolve phlegm and relieve abdominal distension; can regulate gastrointestinal function, promote digestion and reduce fat accumulation.

[0023] Panax notoginseng: Disperses blood stasis and stops bleeding, reduces swelling and relieves pain; can improve liver microcirculation and protect liver cells.

[0024] Hawthorn: helps digestion, eliminates stagnation, promotes qi and relieves blood stasis; helps digest fat and lowers blood lipids.

[0025] Atractylodes: Strengthens the spleen and replenishes Qi, expels dampness and promotes diuresis; enhances spleen and stomach function and promotes water metabolism.

[0026] Poria: promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind; has a diuretic effect and expel moisture from the body.

[0027] Lotus leaf: clears away heat and dampness, promotes the flow of clear yang, cools blood and stops bleeding; can clear away heat and dampness, and relieve dampness and heat in the liver.

[0028] Bupleurum: harmonizes the exterior and interior, soothes the liver and relieves depression, raises yang and lifts the sunken; regulates the liver's qi and relieves symptoms of liver depression.

[0029] Radix Pseudostellariae: replenishes Qi and strengthens the spleen, produces body fluid and moistens the lungs; improves the body's immunity and strengthens physical fitness.

[0030] Alisma: promotes diuresis, eliminates dampness, and relieves heat; promotes the discharge of excess water from the body.

[0031] Cassia seed: clears away heat and improves eyesight, moistens the intestines and promotes bowel movements; clears the liver and improves eyesight, lowers blood lipids.

[0032] The weight proportions of the raw materials of the Chinese medicine formula are: 10 parts of salvia miltiorrhiza, 10 parts of curcuma, 10 parts of immature bitter orange, 5 parts of notoginseng, 10 parts of hawthorn, 15 parts of atractylodes, 15 parts of poria, 10 parts of lotus leaf, 10 parts of bupleurum, 15 parts of pseudostellaria, 6 parts of oriental water plantain, and 10 parts of cassia seed.

[0033] The decoction preparation method of the Chinese medicine formula is:

[0034] S1. Accurately weigh the above Chinese medicines according to the proportions and mix them evenly;

[0035] S2. Add appropriate amount of water and soak for 30 minutes to allow the herbs to fully absorb water. The amount of water added should be 2 to 3 cm above the herbs.

[0036] S3, the first step is to use the hot and cold fire to alternately decoct, keep the low heat for 15 minutes after the first boiling, pour it out, and filter the liquid medicine; add appropriate amount of water to the residue, and use the hot and cold fire to alternately decoct for the second time, keep the low heat for 10 to 15 minutes after the first boiling, and combine the two liquid medicines;

[0037] S4. Add appropriate amount of honey or flavoring agent to the combined medicinal liquid to season it, and make it into a decoction medicine bag for easy administration by patients.

[0038] A decoction medicine bag prepared from a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease is taken by patients once in the morning and once in the afternoon.

[0039] A dosage form of the traditional Chinese medicine formula for treating non-alcoholic fatty liver disease is a capsule or oral liquid.

[0040] By summarizing 223 reports on the prevention and treatment of fatty liver with traditional Chinese medicine in major domestic traditional Chinese medicine journals from 1997 to 2002 in these 15 years, the usage frequency of traditional Chinese medicines was statistically analyzed; the results showed that the four traditional Chinese medicines with the highest occurrence frequencies were Hawthorn Fruit, Oriental Waterplantain Rhizome, Red Sage Root, and Bupleurum Root (occurrence frequency > 75%); followed by Fleeceflower Root, Curcuma Root Tuber, Pinellia Tuber, Dried Tangerine Peel, Poria, White Peony Root, Cassia Seed, Giant Knotweed Rhizome, Rhubarb, Licorice Root (occurrence frequency > 45%); and then Atractylodes Macrocephala Rhizome, Capillary Wormwood Herb, Red Peony Root, Chinese Angelica Root, Chinese Wolfberry Fruit, Bitter Orange, Cyperus Rotundus Rhizome, Codonopsis Pilosula Root, Turmeric Root Tuber, Astragalus Root, Polygonatum Rhizome, Cassia Seed, Radish Seed, Lotus Leaf (occurrence frequency > 25%); (Reference: Ye Fang, Zhao Wenxia. Current Research Status of Traditional Chinese Medicine on Non-alcoholic Fatty Liver [J]. Chinese Journal of Integrated Traditional and Western Medicine on Digestion, 2003, 11(1): 60 - 62); and the present invention has optimized the drug composition and ratio, and the prepared decoction has more significant medicinal effects; especially by introducing medicinal materials such as Immature Bitter Orange, Notoginseng Root, and Poria, the blood circulation promoting and stasis removing effect of the formula and the protective function for the liver are enhanced, thereby improving the treatment effect.

[0041] Example 2

[0042] The first group of patients with non-alcoholic fatty liver disease took the decoction prepared from this traditional Chinese medicine formula; the second group of patients with non-alcoholic fatty liver disease took Silybin; after treatment, the liver function indexes of the two groups of patients were significantly improved compared with those before treatment, and the observation group (the first group) was significantly better than the control group (the second group), and the difference was statistically significant (P < 0.05), as shown in Table 1;

[0043]

[0044]

[0045] Table 1 Comparison of liver function indexes of two groups of patients before and after treatment

[0046] Note: Comparison between the two groups before treatment: P > 0.05; * Comparison with before treatment, P < 0.05; △ Comparison with the control group, P < 0.05; ☆ Comparison between the control group after treatment and before treatment, P > 0.05.

[0047] The B-ultrasound conditions of the two groups of patients improved significantly compared with those before treatment. The observation group was significantly better than the control group, and the difference was statistically significant (P < 0.05), as shown in Table 2.

[0048]

[0049] Table 2 Comparison of B-ultrasound conditions between the two groups before and after treatment

[0050] Note: When comparing the two groups before treatment: P > 0.05; * compared with before treatment, P < 0.05; △ compared with the control group, P < 0.05; ☆ After treatment, the comparison between the control group and before treatment showed P > 0.05.

[0051] When comparing the clinical efficacy of the two groups of patients, the total effective rate of the control group was 66.7%, and the total effective rate of the observation group was 84.4%. The difference was statistically significant (P < 0.05), as shown in Table 3.

[0052]

[0053] Table 3 Comparison of clinical efficacy between the two groups before and after treatment

[0054] Note: Compared with the control group, *P < 0.05.

[0055] Only some exemplary embodiments of the present invention have been described above by way of illustration. Without doubt, for those of ordinary skill in the art, the described embodiments can be modified in various different ways without departing from the spirit and scope of the present invention. Therefore, the description is illustrative in nature and should not be construed as a limitation on the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine formula for treating non-alcoholic fatty liver disease, characterized in that: The Chinese medicine formula is prepared from the following raw materials in parts by weight: 10-15 parts of salvia miltiorrhiza, 10-15 parts of curcuma, 10-15 parts of immature bitter orange, 5-10 parts of notoginseng, 10-13 parts of hawthorn, 15-20 parts of atractylodes, 15-20 parts of poria, 10-15 parts of lotus leaf, 10-15 parts of bupleurum, 15-20 parts of pseudoginseng, 5-9 parts of oriental rhizome, and 10-15 parts of cassia seed.

2. A Chinese medicine formula for treating non-alcoholic fatty liver disease according to claim 1, characterized in that: The weight proportions of the raw materials of the Chinese medicine formula are: 10 parts of salvia miltiorrhiza, 10 parts of curcuma, 10 parts of immature bitter orange, 5 parts of notoginseng, 10 parts of hawthorn, 15 parts of atractylodes, 15 parts of poria, 10 parts of lotus leaf, 10 parts of bupleurum, 15 parts of pseudostellaria, 6 parts of oriental water plantain, and 10 parts of cassia seed.

3. A Chinese medicine formula for treating non-alcoholic fatty liver disease according to claim 2, characterized in that: The decoction preparation method of the Chinese medicine formula is: S1. Weigh the above Chinese medicines accurately according to the proportions and mix them evenly; S2. Add appropriate amount of water and soak for 30 minutes to allow the herbs to fully absorb water. The amount of water added should be 2 to 3 cm above the herbs. S3, the first step is to use the hot and cold fire to alternately decoct, keep the low heat for 15 minutes after the first boiling, pour it out, and filter the liquid medicine; add appropriate amount of water to the residue, and use the hot and cold fire to alternately decoct for the second time, keep the low heat for 10 to 15 minutes after the first boiling, and combine the two liquid medicines; S4. Add appropriate amount of honey or flavoring agent to the combined liquid medicine to make it into a decoction bag for patients to take.

4. A decoction bag prepared from a traditional Chinese medicine formula for treating non-alcoholic fatty liver disease according to claim 3, which is taken once in the morning and once in the afternoon by the patient.

5. The Chinese medicine formula for treating non-alcoholic fatty liver disease according to claim 1 is in the form of capsules or oral liquids.