Traditional Chinese medicine composition for preventing and treating hepatopathy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating liver diseases as well as a preparation method and application thereof. The traditional Chinese medicine composition comprises ginseng, bighead atractylodes rhizome, poria cocos, liquorice, pinellia ternate and pericarpium citri reticulatae. The traditional Chinese medicine composition disclosed by the invention has an improvement effect on metabolism-related fatty liver diseases, and the treatment effects of the traditional Chinese medicine composition and the metabolism-related fatty liver diseases are almost equivalent compared with those of currently recognized liver protection medicine silibinin.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and in particular to a traditional Chinese medicine composition for preventing and treating liver disease, and a preparation method and application thereof. Background Art

[0002] Metabolic associated fatty liver disease (MAFLD) is a highly prevalent chronic liver disease that begins as benign hepatic steatosis and can progressively progress without intervention. MAFLD represents a spectrum of liver diseases that can progress from simple fatty liver to metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, and hepatocellular carcinoma, and may become the leading cause of end-stage liver disease in the coming decades. Epidemiological studies in my country indicate that approximately one billion people worldwide will be affected by MAFLD in 2020, with the prevalence among adults potentially exceeding 25% to 30%, placing significant strain on healthcare and becoming a global health concern. Furthermore, MAFLD is a risk factor for cardiovascular disease, increasing the mortality rate associated with cardiovascular and cerebrovascular events by 64%.

[0003] Due to its complex pathogenesis, there are currently limited effective treatments for metabolic-related fatty liver disease. Only resmetirom is approved for the treatment of adults with MASH and advanced liver fibrosis, but its long-term use carries the risk of hepatotoxicity. Therefore, the development of related drugs is urgently needed. Currently, most traditional Chinese medicines for the treatment of metabolic-related fatty liver disease focus on clearing heat and removing dampness (such as Longdan Xiegan Pills and Huazhi Rougan Granules), neglecting the core pathogenesis of spleen deficiency. Currently, there is a lack of effective and fast-acting traditional Chinese medicine preparations on the market. Summary of the Invention

[0004] The present invention aims to solve at least one of the above-mentioned technical problems existing in the prior art. To this end, the present invention aims to provide a Chinese medicine composition for preventing and treating liver disease, and its preparation method and application.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is:

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition comprising ginseng, atractylodes macrocephala, poria cocos, liquorice, pinellia tuber, and tangerine peel.

[0007] According to Traditional Chinese Medicine theory, the spleen is responsible for transportation and transformation of water. If the spleen fails to function properly, water and dampness will stagnate and form phlegm. The key to the onset of metabolic-related fatty liver disease lies in the spleen. It is caused by spleen deficiency and dysfunction, and Qi imbalance, which prevents the full utilization of food to transform the body's essence, and instead transforms it into water, dampness, and phlegm. Phlegm and dampness accumulate in the middle burner and turn into heat over time. The combination of phlegm, dampness, and heat ultimately leads to the occurrence of the disease. Based on the Traditional Chinese Medicine theory of "the spleen is responsible for transportation and transformation" and "the spleen is the source of phlegm", the inventor has formulated a spleen-tonifying law and creatively transformed the classic Chinese medicine prescriptions used to treat spleen and stomach deficiency and indigestion into Chinese medicine preparations for the treatment of metabolic-related fatty liver disease.

[0008] In the prescription, Atractylodes macrocephala is the main medicine, ginseng and Poria cocos are the assistant medicines, Pinellia ternata and dried tangerine peel are the adjuvant medicines, and licorice is the guiding medicine.

[0009] Ginseng significantly tonifies the spleen and stomach's Qi, stimulating the transport and transformation process, allowing the proper distribution of dietary essences. Atractylodes macrocephala eliminates dampness and strengthens the spleen, helping it to ascend lucid energy and descend turbidity, eliminating the root causes of dampness and water retention. Licorice root nourishes the middle and harmonizes the other herbs. These three herbs work together to restore the spleen's function of transport and transformation, effectively blocking the pathological link whereby food and water fail to transform into essential essences, leading to the generation of phlegm and dampness. Poria cocos strengthens the spleen and eliminates dampness, providing a pathway for pathogenic factors to dissipate. It not only supports Atractylodes macrocephala in strengthening the spleen, but also acts as a mild diuretic, directly channeling dampness from the middle burner through urination. Pinellia ternata, with its pungent, warm, and intense drying properties, specifically targets phlegm and dampness in the middle burner, dissolving phlegm and turbidity. Tangerine peel regulates Qi and dissipates stagnation, restoring the ascending and descending Qi of the spleen and stomach, and eliminating the vicious cycle of qi stagnation leading to dampness stagnation. The two herbs, when combined, specifically transform established phlegm and dampness. By restoring the transport and transformation function of the middle burner, they disrupt the MAFLD pathogenesis of "spleen deficiency → dampness stagnation → phlegm stagnation → heat and blood stasis," ultimately strengthening the spleen to treat the liver.

[0010] Atractylodes: bitter, sweet, warm, invigorates the spleen and replenishes Qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is the dried rhizome of Atractylodes macrocephala Koldz., a plant of the Asteraceae family.

[0011] Ginseng: sweet, slightly bitter, neutral, greatly replenishes vital energy, restores pulse and strengthens deficiency, nourishes the spleen and lungs, promotes the production of body fluids, and calms the mind. It is the dried root of Panax ginseng CAMey. of the Araliaceae family.

[0012] Poria: sweet, light, flat, diuretic and dampness-eliminating, spleen-strengthening and heart-calming. It is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf.

[0013] Tangerine peel (Citrus reticulata Blanco): Bitter, pungent, and warm, it regulates qi and strengthens the spleen, dispels dampness, and resolves phlegm. It is the dried, mature peel of the Rutaceae plant Citrus reticulata Blanco and its cultivated varieties. Modern pharmacological research indicates that tangerine peel can be used to treat excessive phlegm, spleen deficiency, and qi stagnation. Its components, naringenin, nobiletin, and naringin, can modulate oxidative stress, inflammation, lipid metabolism, and other biological processes through multiple targets and pathways to treat metabolic-related fatty liver disease.

[0014] Pinellia: pungent, warm; toxic, dries dampness and resolves phlegm, relieves adverse reactions and stops vomiting, eliminates lumps and resolves nodules. It is the dried tuber of Pinelliaternata (Thunb.) Breit., a plant of the Araceae family.

[0015] Licorice: sweet, neutral, tonifies the spleen and replenishes qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves urgency and relieves pain, and harmonizes various medicines. It is the dried rhizome and root of Glycyrrhiz uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza gla-bra L. of the legume family.

[0016] In some embodiments of the present invention, the traditional Chinese medicine composition comprises, by weight, 3 to 12 parts of ginseng, 4 to 18 parts of atractylodes macrocephala, 3 to 12 parts of poria, 3 to 12 parts of liquorice, 4 to 18 parts of pinellia, and 3 to 12 parts of tangerine peel.

[0017] In some embodiments of the present invention, the ginseng content that can achieve the purpose of the present invention is 3 to 12 parts by weight, such as 3.0 parts, 3.5 parts, 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, and 12.0 parts.

[0018] In some embodiments of the present invention, the content of Atractylodes macrocephala that can achieve the purpose of the present invention is 4 to 18 parts by weight; such as 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, 12.0 parts, 12.5 parts, 13.0 parts, 13.5 parts, 14.0 parts, 14.5 parts, 15.0 parts, 15.5 parts, 16.0 parts, 16.5 parts, 17.0 parts, 17.5 parts, and 18.0 parts.

[0019] In some embodiments of the present invention, the content of Poria cocos that can achieve the purpose of the present invention is 3 to 12 parts by weight, such as 3.0 parts, 3.5 parts, 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, and 12.0 parts.

[0020] In some embodiments of the present invention, the content of licorice that can achieve the purpose of the present invention is 3 to 12 parts by weight, such as 3.0 parts, 3.5 parts, 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, and 12.0 parts.

[0021] In some embodiments of the present invention, the content of Pinellia ternata that can achieve the purpose of the present invention is 4 to 18 parts by weight; such as 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, 12.0 parts, 12.5 parts, 13.0 parts, 13.5 parts, 14.0 parts, 14.5 parts, 15.0 parts, 15.5 parts, 16.0 parts, 16.5 parts, 17.0 parts, 17.5 parts, and 18.0 parts.

[0022] In some embodiments of the present invention, the content of tangerine peel that can achieve the purpose of the present invention is 3 to 12 parts by weight, such as 3.0 parts, 3.5 parts, 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, and 12.0 parts.

[0023] In some embodiments of the present invention, the traditional Chinese medicine composition comprises, by weight, 3 to 8 parts of ginseng, 4 to 11 parts of atractylodes macrocephala, 3 to 9 parts of poria, 3 to 11 parts of liquorice, 4 to 12 parts of pinellia, and 3 to 9 parts of tangerine peel.

[0024] In some embodiments of the present invention, the traditional Chinese medicine composition is composed of the following components, in parts by weight: 3 to 8 parts of ginseng, 4 to 11 parts of Atractylodes macrocephala, 3 to 9 parts of Poria cocos, 3 to 11 parts of Licorice, 4 to 12 parts of Pinellia ternata, and 3 to 9 parts of Tangerine peel.

[0025] In some embodiments of the present invention, the dosage form of the traditional Chinese medicine composition is an oral preparation.

[0026] In some embodiments of the present invention, the oral preparation includes any one of pills, granules, powders, capsules, tablets, mixtures, decoctions or oral liquids.

[0027] In some embodiments of the present invention, the oral formulation further comprises a pharmaceutically acceptable carrier; the pharmaceutical carrier comprises one or more of a diluent, an excipient, a filler, a binder, a disintegrant, a surfactant and a lubricant.

[0028] The second aspect of the present invention provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0029] The components are mixed, added with water and boiled to prepare the traditional Chinese medicine composition.

[0030] In some embodiments of the present invention, the method for preparing the Chinese medicine composition comprises the following steps:

[0031] Mix the components by weight, add 3 to 10 times the weight of water, soak for 0.5 to 2 hours, boil for 30 to 60 minutes, and pour out the liquid;

[0032] Then add 3 to 10 times the weight of water and boil for 30 to 60 minutes, pour out the medicinal solution, and combine the two medicinal solutions to prepare the traditional Chinese medicine composition.

[0033] The third aspect of the present invention provides a use of the traditional Chinese medicine composition in the preparation of drugs for preventing and treating liver diseases.

[0034] As used herein, "preventing" includes prevention and / or treatment.

[0035] In some embodiments of the present invention, the liver disease comprises at least one of metabolic-associated fatty liver disease, metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, or liver cancer.

[0036] In some embodiments of the present invention, the metabolic-associated fatty liver disease (MAFLD) includes simple non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and its derived liver fibrosis and / or cirrhosis. Simple non-alcoholic fatty liver disease refers to a condition in which there is increased fat in the liver, but little or no inflammation or liver cell damage. Non-alcoholic steatohepatitis (NASH) refers to a disease caused by inflammation due to excessive accumulation of fat in the liver. Although subjects with only non-alcoholic fatty liver disease are usually asymptomatic, the inflammation and liver cell damage caused by NASH may lead to liver fibrosis or scarring, and in severe cases may lead to cirrhosis (advanced scarring) or liver cancer.

[0037] The beneficial effects of the present invention are:

[0038] The traditional Chinese medicine composition of the present invention has an improving effect on metabolism-related fatty liver disease, and compared with the currently recognized liver-protecting drug silibinin, the therapeutic effects of the two are almost equivalent. DETAILED DESCRIPTION

[0039] The present invention is further described in detail below using specific examples. Unless otherwise specified, the raw materials, reagents, and apparatus used in the examples and comparative examples are available from conventional commercial sources or by conventional methods. Unless otherwise specified, all experimental or testing methods are conventional in the art.

[0040] Example 1

[0041] This example prepares a Chinese medicine composition, and the specific process is as follows:

[0042] The Chinese medicine composition of this embodiment includes, by weight, 3 parts of ginseng, 4.5 parts of Atractylodes macrocephala, 3 parts of Poria cocos, 3 parts of Licorice root, 4.5 parts of Pinellia ternata, and 3 parts of dried tangerine peel.

[0043] The preparation method of the Chinese medicine composition comprises the following steps:

[0044] Under normal pressure, all components were soaked in 5 times the volume of distilled water for 0.5 h, decocted for 30-60 min, and filtered to obtain filtrate 1; the decocted medicinal residue was further decocted with 5 times the volume of distilled water for 30 min, filtered to obtain filtrate 2; filtrate 1 and filtrate 2 were combined and finally concentrated to 0.86 g / mL to prepare a traditional Chinese medicine composition.

[0045] Example 2

[0046] This example prepares a Chinese medicine composition, and the specific process is as follows:

[0047] The Chinese medicine composition of the embodiment comprises, by weight, 6 parts of ginseng, 9 parts of atractylodes macrocephala, 6 parts of poria, 9 parts of liquorice, 9 parts of pinellia, and 6 parts of dried tangerine peel.

[0048] The preparation method of the Chinese medicine composition comprises the following steps:

[0049] Under normal pressure, all components were soaked in 5 times the volume of distilled water for 0.5 h, decocted for 30-60 min, and filtered to obtain filtrate 1; the decocted medicinal residue was further decocted with 5 times the volume of distilled water for 30 min, filtered to obtain filtrate 2; filtrate 1 and filtrate 2 were combined and finally concentrated to 1.73 g / mL to prepare a traditional Chinese medicine composition.

[0050] Example 3

[0051] In this example, the Chinese medicine composition prepared in Example 1 and Example 2 was administered to mice with metabolic-related fatty liver disease induced by MCD (methionine choline deficiency). The specific process was as follows:

[0052] 1 Experimental materials:

[0053] 1.1 Experimental Animals: SPF-grade wild-type male C57BL / 6 mice (age: 6-8 weeks, weight: 20 ± 2 g) were provided by Spefoc Biotechnology (Beijing) Co., Ltd. under license number SCXK(Jing)2024-0001 and housed in the animal barrier system of Beijing University of Chinese Medicine under license number SYXK(Jing)2023-0011.

[0054] 1.2 Experimental reagents:

[0055] Modeling feed: MCD feed and MCS feed (methionine and choline supplemented feed) were provided by Keao Xieli (Tianjin) Feed Co., Ltd., license number SCXK (Jin) 2020-0004.

[0056] 1.3 Experimental drugs:

[0057] Positive control drug: Silibinin, provided by Shanghai Yuanye Company, batch number S24053-1g. Silibinin is an antioxidant extracted from milk thistle. It stabilizes liver cell membranes and maintains liver cell integrity, preventing cirrhosis and fatty liver. It is currently the most effective flavonoid discovered in the world for treating liver diseases.

[0058] Experimental drugs (test samples): Chinese medicine compositions prepared in Examples 1 and 2.

[0059] 2 Experimental methods

[0060] 2.1 Adaptive feeding

[0061] From the date of receipt, experimental mice were observed once daily for adaptation to feeding. Observations included: mental state, normal behavior, shiny fur, loose stools, bloodshot eyes, abnormal discharge, perineal discharge, ulceration, and mortality. Healthy animals without abnormalities were included in the formal experiments. Mouse husbandry and environmental conditions: The experimental animal room maintained a room temperature of 20°C to 25°C, a humidity of 40% to 70%, and a 12h / 12h light / dark cycle.

[0062] 2.2 Modeling and drug administration

[0063] After adaptive feeding, mice were randomly divided into a control group, a model group, a low-dose group of the decoction of Example 1, a high-dose group of the decoction of Example 2, and a silibinin positive control group, with 10 mice in each group. Starting from day 0, the control group mice were fed MCS feed, and the mice in the other groups were fed MCD feed. Finally, the samples were collected on day 42 of the experiment. Based on the human-mouse dose conversion, the high-dose group of Example 2 was given the Chinese herbal preparation obtained in Example 2, with a dosage of 8.63g (raw drug) / kg (mouse); the low-dose group of Example 1 was given the Chinese herbal preparation obtained in Example 1, with a dosage of 4.315g (raw drug) / kg (mouse); the silibinin group was given 55mg (drug) / kg (mouse) of silibinin by gavage, and the control and model groups were given distilled water by gavage. All treatments were administered by gavage for 4 weeks, once daily.

[0064] 2.3 Detection indicators

[0065] After the experiment, the NAS scores of the liver pathological sections stained with HE, the relative area of lipid droplets stained with Oil Red O, the fibrosis area stained with Sirius Red, and the levels of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), tumor necrosis factor α (TNF-α), interleukin 1β (IL-1β), interleukin 6 (IL-6), and interleukin 10 (IL-10) of the mice were measured.

[0066] 3 Data processing

[0067] SPSS 20.0 was used for analysis. The comparison among multiple groups was performed by one-way analysis of variance, P < 0.05 was considered statistically different, and P < 0.01 was considered statistically significant.

[0068] 4 Experimental results

[0069] 4.1 Effects on NAS score of liver pathological sections stained with HE, relative area of lipid droplets stained with Oil Red O, and fibrosis area stained with Sirius Red in MCD model mice. The results are shown in Table 1.

[0070] Table 1 Effects of NAS score, Oil Red O relative area and Sirius Red staining fibrosis area on the liver of MCD model mice

[0071] Group NAS score Oil Red O relative area (%) Sirius red stained fibrosis area (%) control group - 0.40±0.33 0.37±0.14 Model Group <![CDATA[7.00±0.63 ** ]]> <![CDATA[23.74±4.78 ** ]]> <![CDATA[3.27±0.20 ** ]]> Silybin group <![CDATA[3.00±0.63 ## ]]> <![CDATA[8.49±2.04 ## ]]> <![CDATA[0.34±0.19 ## ]]> Example 1 Low-dose group <![CDATA[5.00±0.63 ## ]]> <![CDATA[11.98±0.97 ## ]]> <![CDATA[0.66±0.079 ## ]]> Example 2 High-dose group <![CDATA[3.00±0.63 ## ]]> <![CDATA[7.14±0.27 ## ]]> <![CDATA[0.56±0.091 ## ]]>

[0072] Note: Compared with the control group, ** P<0.01; compared with the model group, ## P<0.01.

[0073] The NAS score is a semiquantitative scoring system for liver pathological sections. A NAS score of less than 3 points can exclude MASH, a NAS score of more than 4 points can diagnose MASH, and a score between the two is a possible non-alcoholic fatty liver disease (NAFLD) with MASH.

[0074] As shown in Table 1, compared with the control group, the NAS score of the model group mice was significantly increased, and the relative area of Oil Red O and the area of fibrosis stained by Sirius increased (P < 0.01). Compared with the model group, the NAS score of the mice in the low / high dose groups of the examples decreased after administration, and the relative area of Oil Red O and the area of fibrosis stained by Sirius decreased (P < 0.01). The three indicators of the mice in the silybin group also decreased after administration (P < 0.01). Compared with the silybin group, there was no statistical difference in the NAS score, relative area of Oil Red O and the area of fibrosis stained by Sirius in the low / high dose groups of the examples after administration (P > 0.05). The results showed that the NAS score of the model group mice was greater than 5, Oil Red O staining showed obvious lipid accumulation in the liver, and Sirius red staining showed fibrosis in the liver, which can be determined as MASH. The Chinese medicine composition prepared in Examples 1 and 2 can reduce the level of lipid accumulation and fibrosis in the liver of MASH mice and improve MASH.

[0075] 4.2 Effects on serum AST and ALT levels in MCD model mice. The results are shown in Table 2.

[0076] Table 2 Effects of serum AST and ALT in MCD model mice

[0077] Group AST (IU / L) ALT (IU / L) control group 179.00±30.87 42.33±13.56 Model Group <![CDATA[637.00±119.45 ** ]]> <![CDATA[587.50±135.3 ** <!-- 5 -->]]> Silybin group <![CDATA[414.13±54.29 ## ]]> <![CDATA[337.70±21.70 ## ]]> Example 1 Low-dose group <![CDATA[384.13±58.15 ## ]]> <![CDATA[266.0±55.77 ## ]]> Example 2 High-dose group <![CDATA[342.38±41.41 ## ]]> <![CDATA[225.0±50.03 ##▲ ]]>

[0078] Note: Compared with the control group, ** P<0.01; compared with the model group, ## P<0.01; compared with the silybin group, ▲ P<0.05.

[0079] As shown in Table 2, compared with the control group, the serum AST and ALT levels of the model group mice were significantly increased (P < 0.01); compared with the model group, the serum AST and ALT levels of the low-dose and high-dose groups of the example mice were significantly decreased after administration (P < 0.01), and the serum AST and ALT levels of the silybin group mice were significantly decreased (P < 0.01). Compared with the silybin group, the serum ALT levels of the low-dose and high-dose groups of the test sample mice were lower after administration (P < 0.05). The results showed that the serum liver enzymes (AST and ALT) of the model mice were abnormally elevated, indicating liver damage. After four weeks of administration of the Chinese herbal composition prepared in Examples 1 and 2, the serum liver enzyme levels of the model mice were significantly reduced, and Example 2 was more effective in lowering ALT than silybin.

[0080] 4.3 Effects on serum TNF-α, IL-1β, IL-6, and IL-10 levels in MCD model mice. The results are shown in Table 3.

[0081] Table 3 Effects on serum TNF-α, IL-1β, IL-6 and IL-10 in MCD model mice.

[0082] Group TNF-α (ng / L) IL-1β (ng / L) IL-6 (ng / L) IL-10 (ng / L) control group 631.63±48.03 55.89±5.445 78.15±9.956 1284.00±55.50 Model Group <![CDATA[1188.10±54.95 ** ]]> <![CDATA[115.1±4.809 ** ]]> <![CDATA[139.2±9.711 ** ]]> <![CDATA[618.50±54.03 ** ]]> Silybin group <![CDATA[705.19±48.04 ## ]]> <![CDATA[69.67±4.345 ## ]]> <![CDATA[87.94±9.674 ## ]]> <![CDATA[1128.00±66.69 ## ]]> Example 1 Low-dose group <![CDATA[893.80±44.19 ## ]]> <![CDATA[86.58±4.712 ## ]]> <![CDATA[109.8±10.74 ## ]]> <![CDATA[1029.00±54.57 ## ]]> Example 2 High-dose group <![CDATA[783.10±45.34 ## ]]> <![CDATA[78.64±4.805 ## ]]> <![CDATA[95.12±10.87 ## ]]> <![CDATA[961.40±52.91 ## ]]>

[0083] Note: Compared with the control group, ** P<0.01; compared with the model group, ## P<0.01.

[0084] TNF-α, IL-1β, and IL-6 are pro-inflammatory factors, while IL-10 is an anti-inflammatory factor. As shown in Table 3, compared with the control group, the serum TNF-α, IL-1β, and IL-6 levels of the mice in the model group were increased, while the IL-10 level was decreased (P < 0.01). Compared with the model group, the serum TNF-α, IL-1β, and IL-6 levels of the mice in the low / high dose groups of the examples were also decreased after administration, while the IL-10 level was increased (P < 0.01). The serum TNF-α, IL-1β, and IL-6 levels of the mice in the silibinin group were decreased, while the IL-10 level was increased (P < 0.01). Compared with the silibinin group, there was no statistically significant change in the serum TNF-α, IL-1β, IL-6, and IL-10 levels of the mice in the low / high dose groups of the examples (P > 0.05). The results showed that the serum levels of pro-inflammatory factors in the model group mice were increased, while the levels of anti-inflammatory factors were decreased. After four weeks of taking the finished products prepared in Examples 1 and 2, the inflammation of MAFLD mice was significantly improved, indicating that the Chinese medicine compositions prepared in Examples 1 and 2 can achieve the purpose of improving metabolic-related fatty liver disease by inhibiting the expression of inflammatory factors.

[0085] In summary, the Chinese medicine compositions prepared in Examples 1 and 2 have an improving effect on metabolism-related fatty liver disease, and compared with the currently recognized liver-protecting drug silybin, the therapeutic effects of the two are almost equivalent.

[0086] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be considered as equivalent replacement methods and are included in the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: Including ginseng, Atractylodes macrocephala, Poria cocos, licorice, Pinellia ternata, and tangerine peel.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the traditional Chinese medicine composition comprises 3 to 12 parts of ginseng, 4 to 18 parts of atractylodes macrocephala, 3 to 12 parts of poria, 3 to 12 parts of liquorice, 4 to 18 parts of pinellia, and 3 to 12 parts of tangerine peel.

3. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the traditional Chinese medicine composition comprises 3 to 8 parts of ginseng, 4 to 11 parts of atractylodes macrocephala, 3 to 9 parts of poria, 3 to 11 parts of liquorice, 4 to 12 parts of pinellia, and 3 to 9 parts of tangerine peel.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following components in parts by weight: 3 to 8 parts of ginseng, 4 to 11 parts of atractylodes macrocephala, 3 to 9 parts of poria, 3 to 11 parts of liquorice, 4 to 12 parts of pinellia, and 3 to 9 parts of tangerine peel.

5. The Chinese medicine composition according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is an oral preparation.

6. The Chinese medicine composition according to claim 5, characterized in that: The oral preparation includes any one of pills, granules, powders, capsules, tablets, mixtures, decoctions or oral liquids.

7. The Chinese medicine composition according to claim 1, characterized in that: The oral preparation further includes a pharmaceutically acceptable carrier.

8. A method for preparing the Chinese medicine composition according to any one of claims 1 to 7, comprising the following steps: The components are mixed, added with water and boiled to prepare the traditional Chinese medicine composition.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 7 in the preparation of drugs for preventing and treating liver diseases.

10. The use according to claim 9, characterized in that: The liver disease includes at least one of metabolism-related fatty liver disease, metabolic dysfunction-related steatohepatitis, cirrhosis or liver cancer.