Traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver diseases or metabolic syndromes

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver diseases or metabolic syndromes. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 5-50 parts of sweet wormwood, 3-30 parts of scutellaria baicalensis, 5-50 parts of dandelion, 4-60 parts of platycodon grandiflorum, 5-50 parts of fructus aurantii, 3-80 parts of rhizoma pinelliae preparata, 3-70 parts of fructus amomi, 10-80 parts of stir-fried Chinese yam, 5-80 parts of poria cocos and 3-100 parts of raw coix seeds. The traditional Chinese medicine composition for preventing and treating the metabolism-related fatty liver diseases or the metabolic syndromes is simple in formula, proper in compatibility and mild in medicine property, is used for preventing and treating the metabolism-related fatty liver diseases or the metabolic syndromes, is used for improving liver fatty degeneration and inflammation, blood uric acid, blood fat, blood sugar and blood pressure, assisting weight loss and the like, and is safe to use and remarkable in curative effect.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome, belonging to the technical field of traditional Chinese medicine. Background Art

[0002] Metabolic dysfunction-associated fatty liver disease (MAFLD), also known as non-alcoholic fatty liver disease, is a chronic, progressive liver disease caused by overnutrition and insulin resistance in genetically susceptible individuals. MAFLD represents a manifestation of systemic metabolic dysfunction affecting the liver, characterized by the presence of at least one clinical manifestation of metabolic syndrome (MetS) in addition to hepatic steatosis. Metabolic syndrome, like MAFLD, is a cluster of metabolically interrelated risk factors. Like MAFLD, MAFLD is based on systemic metabolic disturbances and insulin resistance, characterized by a cluster of abdominal obesity, dysglycemia, dyslipidemia, and hypertension. The pathogenesis and clinical manifestations overlap significantly. Currently, over one billion people worldwide suffer from MAFLD, with a prevalence of 31.1% in China. MAFLD has become the most common chronic liver disease in my country. Epidemiological surveys show that the prevalence of MAFLD in the general adult population ranges from 6.3% to 45.0%. This indicates that MAFLD and MetS are increasingly becoming global public health concerns that threaten human health. This disease is a chronic, metabolic disease that often requires long-term treatment. Currently, there is no specific drug for MAFLD and MetS, and existing options cannot meet the needs of patients.

[0003] Guidelines such as the "Guidelines for the Prevention and Treatment of Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition)" published by the Chinese Society of Hepatology and the "Expert Consensus on Health Education for the Prevention and Control of Metabolic Syndrome in Adults" published by the Chinese Society of Health Management propose that lifestyle modifications, such as caloric restriction, dietary adjustments, and exercise therapy, are the cornerstone of treatment for MAFLD and MetS. These measures, however, are at odds with the current reality of increased work pressure and sedentary lifestyles, and patients often struggle to maintain long-term adherence. Studies have shown that 85% of patients who successfully achieve phased weight loss regain their initial weight within two years. Western medications designed to improve metabolic function carry the risk of adverse drug reactions and complications. For example, 5-10% of patients experience mild liver biochemical abnormalities during treatment with the lipid-lowering drug fenofibrate, which may lead to hepatocyte proliferation and hepatomegaly. Other fibrates also increase the risk of liver tumors. Asymptomatic, isolated elevations in serum ALT levels are common with statin use. Metformin is often associated with adverse events such as gastrointestinal side effects and lactic acidosis, and may also cause kidney damage and worsen kidney disease.

[0004] Chinese invention patent application CN 118903344 A discloses a composition, a traditional Chinese medicine, a preparation method thereof, and its application in treating hepatitis. The invention comprises Artemisia capillaris, Gardenia jasminoides, Rhubarb (wine-processed), Bupleurum chinense, Schisandra chinensis, Curcuma aromatica, Curcuma longa, Alisma orientalis, Eupatorium fortunei, and Cyperus rotundus. The composition contains rhubarb, which can easily lead to adverse reactions such as abdominal pain and diarrhea. Components such as rhein and emodin in rhubarb are potential material bases for causing colonic melanosis, and there is a risk of liver and kidney damage, so long-term use is not recommended.

[0005] Chinese invention patent application CN 118001349 A discloses a new Chinese medicine composition for preventing and treating metabolic syndrome, as well as its preparation method and application. The Chinese medicine composition includes Poria cocos, Citrus aurantium, Pinellia ternata, Allium macrostemon, Citrus aurantium, Apricot kernel, Platycodon grandiflorum, Viscum album, Polyporus umbellatus, Coix seed, Earthworm, and Licorice root. The formula contains insect drugs such as earthworm, whose animal protein and polypeptide components may increase the risk of allergies. Moreover, the price of medicinal earthworm has gradually increased in recent years, and the quality of medicinal materials has also declined significantly, which may affect overall acceptance and efficacy. These problems hinder long-term use by patients and may affect efficacy. Therefore, there is an urgent need for a drug that is effective in treating metabolic-related fatty liver disease, has a mild and common taste, is easy to prepare, and is safe to use, to improve metabolic disorders such as hepatic steatosis, blood sugar, blood lipids, and uric acid in MAFLD and MetS. Summary of the Invention

[0006] In view of the above-mentioned prior art, the present invention provides a traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome.

[0007] The present invention is achieved through the following technical solutions:

[0008] A traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome is composed of or prepared from the following raw materials in parts by weight: 5-50 parts of Artemisia annua, 3-30 parts of Scutellaria baicalensis, 5-50 parts of Taraxacum mongolicum, 4-60 parts of Platycodon grandiflorum, 5-50 parts of Citrus aurantium, 3-80 parts of Pinellia ternata, 3-70 parts of Amomum villosum, 10-80 parts of stir-fried Chinese yam, 5-80 parts of Poria cocos, and 3-100 parts of raw Coix seeds.

[0009] Furthermore, it is composed of or prepared from the following raw materials in parts by weight: 8-20 parts of Artemisia annua, 10-20 parts of Scutellaria baicalensis, 10-15 parts of Taraxacum mongolicum, 4-15 parts of Platycodon grandiflorum, 5-15 parts of Citrus aurantium, 3-12 parts of Pinellia ternata, 3-18 parts of Amomum villosum, 10-30 parts of stir-fried Chinese yam, 5-20 parts of Poria cocos, and 10-30 parts of raw Coix seed. Preferably, it is composed of or prepared from the following raw materials in parts by weight: 10 parts of Artemisia annua, 10 parts of Scutellaria baicalensis, 10 parts of Taraxacum mongolicum, 10 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 9 parts of Pinellia ternata, 10 parts of Amomum villosum, 15 parts of stir-fried Chinese yam, 15 parts of Poria cocos, and 30 parts of raw Coix seed.

[0010] The dosage form of the Chinese medicine composition can be various common dosage forms, such as decoctions, extracts, granules, tablets, capsules, powders, pills, oral liquids, powders, tea substitutes, lotions, pastes, pills, tablets, lozenges, gels, kojis, dropping pills, ultrafine powders, colloids, etc., preferably decoctions and granules.

[0011] The preparation method of the traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome is as follows: mixing and crushing the raw materials to obtain the composition; or: mixing the traditional Chinese medicine granules or decoction pieces of the raw materials to obtain the composition; or: mixing the raw materials and conventionally decocting the composition. Furthermore, the specific method of decocting can be: mixing the raw materials, soaking them in 10 times the amount of water for 30 minutes, decocting them for 20 minutes, filtering out the medicinal liquid, adding 10 times the amount of water to the medicinal residue, decocting them for 15 minutes, filtering out the medicinal liquid; and combining the two medicinal liquids to obtain the composition.

[0012] The use of the traditional Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome in the preparation of medicines or health foods, wherein the medicines or health foods are used to prevent and treat metabolism-related fatty liver disease or metabolic syndrome, wherein the metabolism-related fatty liver disease or metabolic syndrome comprises one or more of the following characteristics: the presence of liver fat accumulation with or without elevated transaminase, overweight or obesity, increased arterial blood pressure, abnormal blood sugar, increased blood triglycerides, abnormal blood cholesterol, decreased blood high-density lipoprotein cholesterol, increased blood low-density lipoprotein cholesterol, and increased blood uric acid.

[0013] The patients with metabolic-related fatty liver disease or metabolic syndrome include patients with metabolic-related fatty liver disease or metabolic syndrome of spleen deficiency, damp-heat or phlegm-dampness type, and are manifested by one or more of fullness or pain in the ribs, abdominal distension, stomach fullness, bad breath, dry mouth, sticky mouth, flushed face, oily face, sticky and difficult stools, yellow urine, yellow secretions (sweat, phlegm, mucus, vaginal discharge, etc.), fatigue, general fatigue, depression, skin eczema, difficulty in swallowing, brain fog, joint pain, etc.

[0014] The present invention summarizes the core pathogenesis of this disease with "triple burner damp-heat", emphasizes the characteristics of MAFLD and MetS that occur in multiple parts of the body and dynamically evolve, takes the method of eliminating and purging as the basic idea of disease treatment, and proposes the Chinese medicine composition of the present invention. In the Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome of the present invention (named as Artemisia annua by the present invention as Artemisia scutellariae Fat-Removing Recipe), Artemisia annua tastes bitter and pungent, is cold in nature, enters the liver and gallbladder meridians, has a fragrant aroma, obtains the energy of Shaoyang spring wood, can clear Shaoyang stagnant heat, and can also dispel filth, so as to benefit triple burner dampness and turbidity; Scutellaria baicalensis tastes bitter and cold in nature, enters the lung, gallbladder, spleen, large intestine, small intestine meridians, is good at clearing damp heat, and is compatible with Artemisia annua, taking the meaning of Chaihu and Qin, can reconcile and regulate the Shaoyang pivot, and at the same time does not have the pungent and dry nature of Chaihu. Dandelion tastes bitter and sweet, is cold in nature, and enters the liver and stomach meridians. Zhu Danxi's "Compendium of Materia Medica" says it can "disperse stagnant qi." Zhu Liangchun, a master of traditional Chinese medicine, believes that "dandelion flowers bloom very early, and it gets the qi of Shaoyang in early spring, so it has a strong growth-promoting nature." Therefore, it can help Artemisia and Scutellaria to relieve the qi stagnation of Shaoyang. Although dandelion is a heat-clearing and detoxifying product, it "inherits the nature of neutralization of heaven and earth" and has a mild medicinal property. It can clear the liver and stomach heat without damaging the body. The stem tastes bitter, pungent, and flat, and is ascending and dispersing in nature. It enters the lung meridian and can promote the flow of qi, open and lift the lung qi to regulate the water channel. The bitter, pungent, sour, and slightly cold taste of the Citrus aurantium is entered the spleen and stomach meridians. It rises and falls with Platycodon grandiflorum, and can dredge the qi of the triple burner. You Yi wrote in "Jinkui Yi": "Sadness and worry cause liver qi to be depressed, and Citrus aurantium can clear the qi of the triple burner." Citrus aurantium can promote the removal of dampness and turbidity in the liver and triple burner by promoting the flow of qi. Pinellia and Amomum villosum are pungent and warm, can move and disperse, can open dampness and depression, wake up the spleen, regulate qi and harmonize the stomach, and are combined with Scutellaria baicalensis and Pueraria lobata to clear dampness and turbidity in the liver and triple burner. The combination of pungent herbs and bitter herbs can dissipate qi and resolve stagnation in the middle burner. Platycodon grandiflorum and Citrus aurantium are combined to promote upward flow and promote the flow of qi in the three burners. MAFLD and MetS are chronic metabolic diseases. Spleen and stomach weakness and dysfunctional transport and transformation are both the cause of damp-heat and the inevitable result of its deep accumulation. Therefore, stir-fried Chinese yam is combined with sweet and mild herbs such as Poria cocos and raw Coix seed to provide balanced support and mild penetration, supporting the spleen's healthy transport and dissolving damp-heat. Poria cocos and Coix seed can also guide damp-heat through urination, providing a path for the pathogenic factors to dissipate. The entire formula clears dampness and heat, harmonizes qi and fluid, and addresses the Shaoyang and triple burners. This can relieve qi stagnation in the Shaoyang and triple burners, dispelling pathogenic heat, phlegm, dampness, and fat turbidity, all of which together address the core pathogenesis of metabolic-related fatty liver disease and metabolic syndrome. Among them, the combination of Artemisia annua and Scutellaria baicalensis cannot be replaced by the combination of Bupleurum chinense and Scutellaria baicalensis, which is commonly used to reconcile Shaoyang, because Artemisia annua obtains the spring-born energy of Shaoyang and is cold in nature, bitter and pungent in taste. Although Bupleurum chinense helps to expel the evil energy of Shaoyang, it is pungent and dry, and its ability to clear away stagnant heat and damp heat is not as good as Artemisia annua. If they are replaced, the effect on the pathogenesis of damp-heat stagnation in Shaoyang will not be strong, which will affect the clearing and clearing effect of this Chinese medicine composition on the damp-heat pathological products of Shaoyang.

[0015] The present invention provides a traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, featuring a streamlined formula and appropriate compatibility. The raw materials used are all readily available and commonly used clinical Chinese medicines. Seven of the herbs (70%), including dandelion, platycodon grandiflorum, fructus aurantii, amomum villosum, yam, poria cocos, and coix seed, are listed in the Chinese catalog of medicinal and edible herbs. These herbs exhibit mild properties, good safety, and have demonstrated no significant adverse reactions in long-term clinical use. The composition is suitable for early-stage, long-term use by patients with metabolic-related fatty liver disease and metabolic syndrome.

[0016] Clinical studies have demonstrated that the traditional Chinese medicine composition of the present invention, for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, is safe and has significant efficacy compared to lifestyle adjustments such as diet and exercise alone, as recommended by clinical guidelines. In particular, it can improve liver steatosis and inflammation, serum uric acid, blood lipids, blood sugar, blood pressure, and assist in weight loss. Furthermore, in representative cases, the traditional Chinese medicine composition of the present invention significantly improved patients' weight, body fat, and liver inflammation indicators such as serum transaminase, triglyceride, and glucose levels. These effects cannot be achieved in a short period of time with lifestyle adjustments alone. Animal experimental results also support this conclusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 : Schematic diagram of the pathological sections of liver tissues stained by HE in each group of mice (200x light microscope), where C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. DETAILED DESCRIPTION

[0018] The present invention will be further described below in conjunction with the examples. However, the scope of the present invention is not limited to the following examples. Those skilled in the art will appreciate that various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention.

[0019] Unless otherwise specified, the instruments, reagents, and materials used in the following examples are all conventional instruments, reagents, and materials available in the prior art and can be obtained through regular commercial channels. The experimental methods and detection methods used in the following examples are all conventional experimental methods and detection methods available in the prior art, unless otherwise specified.

[0020] Example 1 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0021] It is made from the following raw materials: 10 grams of Artemisia annua, 10 grams of Scutellaria baicalensis, 10 grams of Taraxacum mongolicum, 10 grams of Platycodon grandiflorum, 10 grams of Citrus aurantium, 9 grams of Pinellia ternata, 10 grams of Amomum villosum, 15 grams of fried yam, 15 grams of Poria cocos, and 30 grams of raw Coix seed.

[0022] During preparation, the raw materials are mixed, 10 times the amount (weight multiple, the same below) of water is added, soaked for 30 minutes, decocted for 20 minutes, the medicinal liquid is filtered out, 10 times the amount of water is added to the residue, decocted for 15 minutes, and the medicinal liquid is filtered out; the two medicinal liquids are combined (about 400 mL) to obtain the product.

[0023] When taking, divide it into 2 portions and take them half an hour after breakfast and dinner respectively.

[0024] Example 2 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0025] The medicine is composed of the following raw materials in parts by weight: 10 parts of Artemisia annua, 15 parts of Scutellaria baicalensis, 12 parts of Taraxacum mongolicum, 6 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 12 parts of Pinellia ternata, 18 parts of Amomum villosum, 20 parts of stir-fried Chinese yam, 20 parts of Poria cocos, and 30 parts of raw Coix seeds.

[0026] During preparation, the Chinese medicine formula granules of various raw materials are mixed to obtain the product, which can be taken by mixing with boiled water.

[0027] Example 3 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0028] The medicine is composed of the following raw materials in parts by weight: 8 parts of Artemisia annua, 10 parts of Scutellaria baicalensis, 5 parts of Taraxacum mongolicum, 4 parts of Platycodon grandiflorum, 5 parts of Citrus aurantium, 3 parts of Pinellia ternata, 3 parts of Amomum villosum, 10 parts of stir-fried Chinese yam, 5 parts of Poria cocos, and 10 parts of raw Coix seeds.

[0029] During preparation, the Chinese herbal medicine slices of various raw materials are mixed to prepare Chinese herbal medicine slice preparation, which can be brewed with boiled water and drunk when taken.

[0030] Example 4 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0031] The medicine is composed of the following raw materials in parts by weight: 12 parts of Artemisia annua, 10 parts of Scutellaria baicalensis, 10 parts of Taraxacum mongolicum, 9 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 9 parts of Pinellia ternata, 12 parts of Amomum villosum, 20 parts of stir-fried Chinese yam, 10 parts of Poria cocos, and 20 parts of raw Coix seeds.

[0032] During preparation, the raw materials are mixed and crushed to obtain the product.

[0033] Example 5 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0034] The medicine is prepared from the following raw materials in parts by weight: 15 parts of Artemisia annua, 12 parts of Scutellaria baicalensis, 12 parts of Taraxacum mongolicum, 15 parts of Platycodon grandiflorum, 15 parts of Citrus aurantium, 9 parts of Pinellia ternata, 6 parts of Amomum villosum, 15 parts of stir-fried Chinese yam, 20 parts of Poria cocos, and 15 parts of raw Coix seeds.

[0035] The preparation method is the same as that of Example 1.

[0036] Example 6 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0037] The medicine is prepared from the following raw materials in parts by weight: 20 parts of Artemisia annua, 20 parts of Scutellaria baicalensis, 15 parts of Taraxacum mongolicum, 9 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 12 parts of Pinellia ternata, 15 parts of Amomum villosum, 30 parts of stir-fried Chinese yam, 20 parts of Poria cocos, and 30 parts of raw Coix seeds.

[0038] The preparation method is the same as that of Example 1.

[0039] Example 7 Traditional Chinese Medicine Composition for Preventing and Treating Metabolism-Related Fatty Liver Disease or Metabolic Syndrome

[0040] The medicine is prepared from the following raw materials in parts by weight: 20 parts of Artemisia annua, 20 parts of Scutellaria baicalensis, 15 parts of Taraxacum mongolicum, 9 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 12 parts of Pinellia ternata, 15 parts of Amomum villosum, 30 parts of stir-fried Chinese yam, 20 parts of Poria cocos, and 30 parts of raw Coix seeds.

[0041] The preparation method is the same as that of Example 1.

[0042] Animal experiment: Haoqin Xiaozhi recipe intervenes in high-fat diet-induced MAFLD / MetS mice

[0043] 1 Experimental Materials

[0044] 1.1 Experimental animals

[0045] Sixty SPF-grade C57BL / 6J male mice, 6 weeks old, weighing 18-22 g, were provided by Beijing Weilihua Laboratory Animal Technology Co., Ltd., production license number SCXK(Beijing)2023-0011, and laboratory animal quality certificate number: No. 110011241100542483. The experimental animals were housed in a Class III cleanroom and provided with sterile mouse chow and sterile, filtered tap water, with ad libitum access to feed and water. The room temperature was controlled at 21-25°C, relative humidity at 50%-70%, and a 12-h light-dark cycle. This experiment was approved by the Medical and Laboratory Animal Care Committee of Beijing University of Chinese Medicine, ethics approval number: BUCM-2024010201-1001.

[0046] 1.2 Animal feed

[0047] The feeds used in this study were high-fat feed D12492 with 60% fat energy supply and control feed D12450B with 10% fat energy supply, both provided by Beijing Keao Xieli Feed Co., Ltd.

[0048] 1.3 Experimental equipment and reagents

[0049] As shown in Table 1.

[0050] Table 1 Main instruments

[0051]

[0052]

[0053] 1.4 Experimental drugs and preparation

[0054] The dosages of Chinese herbal medicine and positive drugs required for the experiment were calculated according to the conversion method given in the book "Pharmacological Experimental Methodology" edited by Professor Xu Shuyun. Based on an adult weight of 60 kg, the dosage conversion factor between a standard adult and a mouse is 9.1.

[0055] Preparation of Traditional Chinese Medicine: Three different doses of the Artemisia Scutellariae Fat-Reducing Recipe of the present invention (i.e., the traditional Chinese medicine composition of Example 1) were used: low, medium, and high doses of 9.7825 g / kg / d, 19.565 g / kg / d, and 39.13 g / kg / d, respectively (equivalent to the dose of Example 1, half the dose, and twice the dose). The total amount of traditional Chinese medicine required for the experiment was decocted at once, concentrated to the dose required for the high-dose group, cooled, and stored in a -80°C refrigerator. After equilibration to room temperature, the medium and low doses were then graded diluted with physiological saline.

[0056] Positive drug preparation: Fenofibrate capsules were used as the positive drug at a dose of 30.33 mg / kg. Prepare the positive drug immediately before use. Dissolve the appropriate amount of drug in a suitable proportion of normal saline solution and store in a refrigerator at 4°C until use.

[0057] 2 Methods

[0058] 2.1 Grouping and modeling

[0059] After one week of adaptive feeding, 60 mice were randomly divided into two groups at a 5:1 ratio. The control group (C) consisted of 10 mice, fed a diet containing 10% fat for 16 weeks. The high-fat diet group consisted of 50 mice, fed a high-fat diet containing 60% fat for 8 weeks. After this period, the high-fat diet group was randomly divided into five groups of 10 mice each: the model group (M group), the low-dose Chinese medicine group (HQ-L), the medium-dose Chinese medicine group (HQ-M), the high-dose Chinese medicine group (HQ-H), and the fenofibrate group (F). The high-fat diet was continued for another 8 weeks, for a total of 16 weeks.

[0060] 2.2 Intervention

[0061] From the 9th week onwards, mice in each group were given drug intervention (specific grouping and intervention methods are shown in Table 2) by gavage once a day for 8 consecutive weeks.

[0062] Table 2 Animal modeling and intervention

[0063]

[0064]

[0065] 2.3 Specimen collection and preservation methods

[0066] The animals were fed for 16 weeks. At the end of the 16th week, they were fasted for 12 hours but not water, and were sampled. They were weighed before sampling and anesthetized with an intraperitoneal injection of 3% sodium pentobarbital (0.1 ml / 10 g). The dosage was adjusted according to the anesthesia situation.

[0067] (1) Serum collection: Mice were anesthetized for 3-5 minutes. When the depth of anesthesia was reached, the eyeballs were removed and blood was collected. The blood was placed in a 2 ml EP tube and allowed to stand at room temperature to allow the serum to fully precipitate. The tube was centrifuged at 3500 rpm / min for 10 minutes, and the upper layer of serum was collected. The serum was stored at -80°C.

[0068] (2) Obtain mouse liver tissue: Fix the mouse on the dissecting table, disinfect the abdomen with 75% ethanol, and use forceps to pick up the mouse's abdominal skin. Make a V-shaped incision, cut the skin, abdominal muscles and peritoneum layer by layer, fully expose the mouse liver, and separate the thin membrane connecting the liver and other tissues starting from the subxiphoid ligament. Peel the liver from the surrounding tissues and remove it completely, avoiding scratching the liver. Rinse with saline and dry the water. Weigh it with a precision balance, and lay it flat for photography. After removing the gallbladder, divide the liver tissue on ice bricks. Take the same part of the left lobe of the liver and use 4% formaldehyde solution (the ratio of the amount of fixative to the volume of the tissue block is 20:1). The remaining part is divided into 4 2ml cryovials, quickly frozen in liquid nitrogen and stored at -80℃.

[0069] 2.4 Observation indicators and methods

[0070] (1) General condition: ① General condition of mice: observe the general condition of mice, such as coat color, activity, defecation, and water intake; ② Liver weight and liver index: liver weight is measured at the time of sampling. Liver index = fresh weight of liver tissue / mouse body weight × 100%.

[0071] (2) Liver tissue pathology: The liver tissue was fixed and embedded in paraffin, and HE staining was performed to observe the pathological conditions of the mouse liver tissue.

[0072] (3) Mouse liver and serum testing: Detect mouse serum ALT, AST, GLU, HDL-C, LDL-C, INS, liver tissue and serum TC, TG, and perform the tests in sequence according to the instructions of the corresponding kit.

[0073] 3 Results

[0074] 3.1 General Condition of Mice

[0075] In the later stages of the experiment, mice in Group C were in good spirits, active, with shiny, smooth fur and black, spindle-shaped stools. Mice in Group M were obese, listless, less active, and huddled together. Their fur was greasy and matted, and their stools were soft, gray, thickened, or sticky. Their bedding was damp and foul-smelling. All groups receiving Chinese medicine showed improvements in obesity, spirits, and fur. Thickening and sticky stools were slightly less severe, with more frequent bowel movements compared to Groups C and M. Their bedding was damp. Mice in Group F showed improvements in obesity, spirits, and fur. Their bedding was slightly damp and foul-smelling compared to Group N.

[0076] The liver tissues of the mice were weighed and the liver index was calculated. The results are shown in Table 3. The results showed that compared with group C, the liver weight of group M was significantly increased (P < 0.01). The liver weight of mice in all Chinese medicine groups was reduced compared with group M, but the difference was not statistically significant (P > 0.05). Compared with group M, the liver index of mice in groups HQ-L and HQ-H was significantly reduced (P < 0.05 or P < 0.01). In addition, it was found that after treatment with the positive drug fenofibrate, the liver weight and liver index of mice were increased compared with groups C and M, and the difference was statistically significant (P < 0.01).

[0077] Table 3 Comparison of liver weight and liver index in mice (n=10)

[0078]

[0079] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ Compared with group M, P < 0.05, △△ , P<0.01.

[0080] 3.2 Mouse liver histopathology

[0081] HE-stained liver tissue pathological sections Figure 1 As shown in the figure, the hepatocytes in group C mice were structurally intact with clear outlines, and the hepatic cords were arranged in a radial pattern. Compared to group C, the hepatocytes in group M were arranged irregularly, with disordered hepatic cords. The hepatocytes were swollen, the tissue loosened, and some cellular structures disappeared. Numerous fat vacuoles were scattered within the cells, some of which merged into large round vacuoles. The nuclei were marginalized, and scattered inflammatory infiltrates were present, consistent with the liver pathology of metabolic-related fatty liver disease. Among the 10 liver tissue samples submitted to the model group, eight mice showed obvious fat vacuoles under the microscope after HE staining, suggesting that the high-fat diet led to hepatic lipid deposition. The model was successfully established, with an estimated success rate of approximately 80%. The hepatic cords in mice in all treatment groups were arranged more regularly than in the model group, with less ballooning of hepatocytes, improved number and size of lipid droplets, and less inflammatory infiltration.

[0082] 3.3 Mouse liver lipids and inflammation-related indicators

[0083] (1) TG and TC levels in mouse liver tissue

[0084] The results of liver lipid profile testing in mice are shown in Table 4. The results showed that liver TG and TC levels in mice in group M were significantly higher than those in group C (P < 0.01), indicating that a high-fat diet induced lipid accumulation in the mice's livers. Compared with group M, liver TG and TC levels were significantly lower in mice receiving all doses of TCM and the positive drug group (P < 0.01), indicating improved liver lipid accumulation. TCM improved liver TG and TC levels in obese mice in a dose-dependent manner.

[0085] Table 4 TG and TC levels in mouse liver tissue (n=6)

[0086]

[0087] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ Compared with group M, P < 0.05, △△ , P<0.01.

[0088] (2) ALT and AST levels in mouse serum

[0089] Table 5 shows the results of the mouse serum liver enzyme levels (ALT and AST). The results showed that serum ALT and AST levels in mice in group M were significantly higher than those in group C (P < 0.01), indicating that the high-fat diet caused liver dysfunction and liver damage in mice. Compared with group M, serum ALT and AST levels in mice at all doses of TCM and in the positive drug groups were significantly lower (P < 0.01 or P < 0.05), indicating that TCM and positive drug treatment improved liver function in mice. The improvement in serum ALT and AST levels in obese mice was dose-dependent.

[0090] Table 5 ALT and AST levels in mouse serum (n=6)

[0091]

[0092] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ Compared with group M, P < 0.05, △△ , P<0.01.

[0093] 3.4 Levels of serum lipids and glucose metabolism in mice

[0094] (1) Serum TG and TC levels in mice

[0095] The results of the test for serum TG and TC levels in mice are shown in Table 6. The results showed that the serum TG and TC levels of mice in group M were significantly higher than those in group C (P < 0.01), indicating that the high-fat diet induced abnormalities in the metabolism of serum triglycerides and cholesterol in mice. Compared with group M, the serum TG levels of mice in the medium- and high-dose groups of Chinese medicine and the positive drug group were significantly reduced (P < 0.01). The serum TG levels of mice in the low-dose group of Chinese medicine showed a downward trend, but there was no statistically significant difference compared with the model group (P > 0.05). The serum TC levels of mice in the Chinese medicine at all doses and the positive drug group were significantly reduced (P < 0.01), indicating that the treatment with Chinese medicine and positive drugs improved the liver function of mice. The improvement of serum TG and TC levels in obese mice by Chinese medicine was dose-dependent.

[0096] Table 6 Serum TG and TC levels in mice (n=6)

[0097]

[0098] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ indicates P < 0.05 compared with group M, △△ , P<0.01.

[0099] (2) Mouse serum HDL-C and LDL-C levels

[0100] The results of the test for serum HDL-C and LDL-C levels in mice are shown in Table 7. The results showed that the serum TG and TC levels of mice in group M were significantly higher than those in group C (P < 0.01), indicating that the high-fat diet induced abnormalities in serum apolipoprotein metabolism in mice. Compared with group M, the serum HDL-C levels of mice in the medium- and high-dose TCM groups and the positive drug group were significantly reduced (P < 0.01). The serum HDL-C levels of mice in the low-dose TCM group showed a downward trend, but there was no statistically significant difference compared with the model group (P > 0.05). The serum LDL-C levels of mice in the TCM at all doses and the positive drug group were significantly reduced (P < 0.01), indicating that TCM and positive drug treatment improved the liver function of mice. TCM showed a dose-dependent improvement in the serum HDL-C and LDL-C levels of obese mice.

[0101] Table 7 Serum HDL-C and LDL-C levels in mice (n=5-6)

[0102]

[0103] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ Compared with group M, P < 0.05, △△ , P<0.01.

[0104] (3) GLU, INS, and HOMA-IR levels in mice

[0105] Serum GLU and INS levels in mice were measured, and the HOMA-IR index was calculated. The results are shown in Table 8. The results showed that serum GLU, INS, and the calculated HOMA-IR index in mice in group M were significantly higher than those in group C (P < 0.01), indicating that the high-fat diet induced abnormal circulating glucose metabolism in mice and the presence of insulin resistance. Serum GLU and INS levels were significantly reduced in mice treated with various doses of TCM and the positive drug group (P < 0.01), indicating that TCM and positive drug treatment improved glucose and insulin metabolism in mice. Compared with group M, the HOMA-IR index in mice treated with the medium and high doses of TCM and the positive drug group was significantly reduced (P < 0.01). The serum HOMA-IR index in mice treated with the low dose of TCM showed a downward trend, but the difference was not statistically significant compared with the model group (P > 0.05). TCM showed a dose-dependent effect on the improvement of serum GLU, INS, and HOMA-IR in obese mice.

[0106] Table 8 Serum GLU, INS, and HOMA-IR levels in mice (n=6)

[0107]

[0108] Note: C: control group; M: model group; HQ-L: low-dose Haoqin Xiaozhi Fang group; HQ-M: medium-dose Haoqin Xiaozhi Fang group; HQ-H: high-dose Haoqin Xiaozhi Fang group; F: fenofibrate group. * indicates P < 0.05 compared with group C, **, P < 0.01; △ Compared with group M, P < 0.05, △△ , P<0.01.

[0109] 4 Conclusion

[0110] In this study, a high-fat diet was used to successfully induce a MAFLD / MetS mouse model. The model mice showed hepatic steatosis and inflammation, as well as metabolic disorders such as abnormal blood lipids, blood sugar, and insulin resistance, which are consistent with the characteristics of metabolic-related fatty liver disease and metabolic syndrome.

[0111] The Artemisia Sinensis Fat-Reducing Recipe improves general condition, liver indexes, hepatic steatosis, and inflammatory pathology in a high-fat diet-induced MAFLD / MetS mouse model, reducing liver tissue lipid levels such as TC and TG. It also improves serum transaminase markers (ALT, AST), lipid profiles (TC, TG, HDL-C, LDL-C), blood glucose levels, and insulin resistance (GLU, INS, HOMA-IR). Its therapeutic efficacy is comparable to that of the guideline-recommended lipid-lowering drug fenofibrate. However, based on liver index results, traditional Chinese medicine treatment avoids the hepatomegaly and proliferation effects caused by fenofibrate, resulting in liver sizes closer to those of normal mice, thus reducing the risk of medication use.

[0112] Clinical data: Study on the efficacy and safety of Haoqin Xiaozhi prescription in the intervention of metabolic-related fatty liver disease

[0113] This study aimed to determine the efficacy and safety of the Haoqin Xiaozhi formula in the clinical treatment of patients with metabolic-related fatty liver disease of the damp-heat accumulation type. The clinical efficacy and safety of the Haoqin Xiaozhi formula were observed by administering it in combination with lifestyle intervention or alone.

[0114] 1 Research subjects

[0115] 1.1 Patient Recruitment: This study was conducted at Xiyuan Hospital, China Academy of Chinese Medical Sciences, from July 2024 to January 2025. Participants were informed of and participated in the study through in-clinic recruitment or recruitment posters. This study is registered with the Chinese Clinical Trial Registry (ID: ChiCTR2400086661) and approved by the Medical Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (Approval No.: 2024XLA118-1&2). All participants voluntarily signed informed consent.

[0116] 1.2 Inclusion and exclusion standards

[0117] 1.2.1 Inclusion criteria: ① Meet the diagnostic criteria for metabolic-related fatty liver disease; ② Meet the TCM diagnosis of damp-heat accumulation syndrome for metabolic-related fatty liver disease; ③ BMI < 35 kg / m 2 ; ④Age 18 to 65 years old, no gender restrictions; ⑤Voluntarily sign the informed consent form.

[0118] 1.2.2 Exclusion criteria: ① Serum ALT, AST, ALP, or GGT > 1.5 upper limit of normal (ULN), total bilirubin (TBil) > 21 μmol / L; ② Concomitant liver disease requiring other causal treatment measures, such as alcoholic liver disease, viral liver disease, drug-induced liver disease, total parenteral nutrition, Wilson's disease, or autoimmune liver disease; ③ Advanced liver fibrosis, cirrhosis, or primary liver cancer diagnosed by imaging, or liver stiffness (LSM) ≥ 12 kPa; ④ Concomitant acute or chronic gastrointestinal diseases (including diarrhea, gastrointestinal infection, inflammatory bowel disease), malignant tumors, severe renal insufficiency, cardiovascular disease, or other serious systemic diseases requiring concomitant medication; ⑤ Current or recent use of medications for liver disease, blood sugar, or lipid metabolism, or current participation in other clinical trials; ⑥ Use of weight-loss medications or participation in weight-loss programs within the past 4 weeks; ⑦ Hypersensitivity to study drugs; ⑧ Pregnancy, breastfeeding, or pregnancy planning; ⑨ Poor expected compliance.

[0119] 2 Grouping and intervention methods

[0120] 2.1 Random Methods

[0121] The block randomization method was adopted, with each group consisting of 6 random numbers. SPSS25.0 software was used to generate a random number table. The patients were numbered and grouped by researchers who were not involved in the trial. The group and treatment plan corresponding to each number were placed separately in sealed and opaque envelopes. The envelopes were opened according to the order of patients' visits, and the patients were assigned to the control group and the traditional Chinese medicine group.

[0122] 2.2 Intervention methods

[0123] The control group received lifestyle adjustments recommended by the guidelines, while the traditional Chinese medicine group received the Haoqin Xiaozhi prescription in addition to lifestyle adjustments. Both groups underwent intervention for 12 weeks.

[0124] 2.2.1 Lifestyle adjustment suggestions

[0125] According to the "Guidelines for the Prevention and Treatment of Metabolic (Non-alcoholic) Fatty Liver Disease (2024 Edition)", basic treatment should focus on changing unhealthy lifestyles. Adjustments will be made based on the subjects' diet and exercise habits over the past four weeks. Patients are advised to use a health management app to record their diet and exercise daily, and their lifestyle adjustments will be recorded during each visit.

[0126] 2.2.2 How to take the Artemisia Scutellariae Fat-Reducing Formula

[0127] The Haoqin Xiaozhi recipe (i.e., the Chinese medicine composition of Example 1) has a volume of about 400 mL, which is divided into two portions and taken half an hour after breakfast and dinner, respectively, for a total of 12 weeks.

[0128] 3 Observation indicators and observation nodes

[0129] 3.1 Observation indicators

[0130] (1) Main efficacy indicator: controlled attenuation parameter (CAP).

[0131] (2) Secondary efficacy indicators: ① Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transferase (GGT), alkaline phosphatase (ALP); ② Blood lipids: total cholesterol (TC), triglycerides (TG), blood uric acid (UA), blood pressure, etc.

[0132] 3.2 Observation Node

[0133] After enrollment, the subjects were followed up for 12 weeks. The following information was collected during each visit:

[0134] (1) Week 0: basic information of subjects, safety indicators, all efficacy evaluation indicators, and concomitant medications;

[0135] (2) Week 12: All efficacy evaluation indicators, safety indicators, concomitant medications, and adverse events.

[0136] 3.3 Statistical analysis

[0137] SPSS 25.0 software was used for data processing and statistical analysis. Continuous data were expressed as mean ± standard deviation and median (upper and lower quartiles), and frequency was used for quantitative data. For data that conformed to a normal distribution, independent sample t-tests or t'-tests were used for intergroup comparisons, and paired t-tests or t'-tests were used for intragroup comparisons. For data that did not conform to a normal distribution, nonparametric tests such as the Mann-Whitney U test and the Wilcoxon signed-rank test were used. Enumeration data were analyzed using the chi-square test or Fisher's exact test. All statistical tests were two-sided, with an α level of 0.05. Differences were considered statistically significant when P < 0.05. Baseline and post-treatment values were analyzed using independent sample t-tests or Mann-Whitney tests. At the same time, in order to address the factors that may affect the judgment of efficacy during the trial, analysis of covariance (ANCOVA) was used to compare the differences between the groups at the end of the study, with the post-treatment value as the dependent variable, the group as the fixed factor, and the baseline value as the covariate. In some indicators, the covariate was increased by the difference in weight before and after the corresponding period, and the Bonferroni correction was used to adjust for multiple test errors.

[0138] 4 Research results

[0139] 4.1 Research Completion Status

[0140] A total of 78 subjects underwent randomization, including one in the control group who did not receive the assigned intervention. During follow-up, six subjects withdrew from the study due to reasons such as relocation, loss to follow-up, or unplanned pregnancy (three at week 4, one at week 8, and two at week 12). A total of 71 subjects (36 in the TCM group and 35 in the control group) completed the 12-week follow-up. Statistical analysis was performed on the 74 subjects (37 in the TCM group and 37 in the control group) who underwent the randomization protocol (including one at week 8 and two at week 12) and had one follow-up visit.

[0141] 4.2 Comparison of CAP between groups before and after 12 weeks of intervention

[0142] Independent sample t-tests (or Mann-Whitney tests) and covariance analyses were used to analyze CAP values and their changes at different visit points between the groups. The results are shown in Table 9. The results showed that CAP values were comparable between the groups at baseline (P>0.05). During the subsequent follow-up visits at weeks 4, 8, and 12, the mean CAP values in the control and TCM groups continued to decrease. The difference in CAP values between each treatment visit point and the pre-treatment value (week 0) continued to accumulate with the extension of treatment time, indicating that both groups achieved a certain therapeutic effect and further confirmed their good compliance with the regimen. Comparisons between the groups at weeks 4, 8, and 12 showed that the TCM group had a greater decrease in CAP values at each stage than the control group, and the difference was statistically significant (P<0.01).

[0143] Table 9 Comparison of CAP values among subjects at each visit node

[0144]

[0145] Note: ①P 1 To express the difference between groups based on t test, P 2 The data represent the differences between the groups after correction for the confounding factors of baseline level and weight change using ANCOVA. Bonferroni correction was used to adjust for multiple testing errors. ②* indicates a statistically significant difference compared with the control group, P < 0.05, and ** indicates a statistically significant difference compared with the control group, P < 0.01.

[0146] 4.3 Liver inflammation and fibrosis-related indicators between groups after 12 weeks of intervention

[0147] Independent sample t-tests and covariance analysis were used to analyze liver inflammation and fibrosis-related indicators and their changes between groups. The results are shown in Table 10. The results showed that the levels of liver inflammation and fibrosis-related indicators were comparable between the groups at baseline (P>0.05). After 12 weeks of intervention, the median or mean levels of ALT, AST, GGT, and LSM in the control and TCM groups showed varying degrees of reduction. After adjusting for baseline confounding factors through covariance analysis, the results showed that the TCM group was superior to the control group in reducing ALP levels, and the difference was statistically significant (P<0.05).

[0148] Table 10 Comparison of liver inflammation-related indicators among subjects (n=74)

[0149]

[0150] Note: ①P 1 indicates the difference between the groups before treatment, P 2 To express the difference between the groups after treatment, P 3 Figures represent between-group differences after adjusting for baseline confounding factors using ANCOVA, with Bonferroni correction used to adjust for multiple testing errors. ②* indicates a statistically significant difference compared with the control group, P < 0.05; ** indicates a statistically significant difference compared with the control group, P < 0.01. ③ The measured data in this table were analyzed using the Mann-Whitney test for ALT and AST, and the remaining data were analyzed using independent sample t-tests.

[0151] 4.4 Metabolic-related indicators between groups after 12 weeks of intervention

[0152] Independent sample t-tests (or Mann-Whitney tests) and covariance analysis were used to analyze metabolic-related indicators between groups. The results are shown in Table 11. The results showed that the levels of metabolic-related indicators were comparable at baseline (P>0.05). After 12 weeks of intervention, the median or mean levels of serum TC, TG, and UA in the control and TCM groups showed varying degrees of reduction. In addition, blood pressure levels in the TCM group decreased after treatment compared with pre-treatment, which was not seen in the control group. After adjusting for baseline confounding factors through covariance analysis, the results showed that the TCM group was superior to the control group in reducing serum UA and blood pressure levels, and the differences were statistically significant (P<0.05).

[0153] Table 11 Comparison of metabolic-related indicators among subjects (n=74)

[0154]

[0155] Note: ①P 1 indicates the difference between the groups before treatment, P 2 To express the difference between the groups after treatment, P 3Figures represent between-group differences after adjusting for baseline confounding factors using ANCOVA, with Bonferroni correction used to adjust for multiple testing errors. ②* indicates a statistically significant difference compared with the control group, P < 0.05; ** indicates a statistically significant difference compared with the control group, P < 0.01. ③ The measured data in this table were analyzed using the Mann-Whitney test for TC and TG, and the remaining data were analyzed using independent sample t-tests.

[0156] 5 Conclusion

[0157] Weight loss based on lifestyle adjustments is the basic treatment for metabolic-related fatty liver disease and metabolic syndrome stipulated in clinical guidelines. Compared with this treatment, the traditional Chinese medicine composition Artemisia and Scutellaria fat-reducing prescription proposed in this study has advantages and is safe to use. It can better improve patients' liver fat content (CAP value), liver inflammation index (ALP), and metabolic-related indicators such as blood uric acid (UA) and blood pressure.

[0158] Typical Case 1

[0159] Chen, male, 30 years old, weight 80.5 kg, BMI: 25.4 kg / m 2 , slightly overweight, biochemical examination on September 5, 2024: ALT: 48.6U / L, blood uric acid: 426μmol / L, low-density lipoprotein: 3.18mmol / L; CAP: 301dB / m on September 22, visceral fat area 82cm 2 , waist circumference 93.1cm. From September 22, 2024, the patient took the Artemisia Scutellariae Fat-Reducing Recipe (i.e., the Chinese medicine composition of Example 1) for 12 weeks, 1 dose per day, twice a day, morning and evening, and was advised to adjust his lifestyle. After the patient took the medicine on time and in the prescribed amount for 12 weeks, the examination results on December 13, 2024 were as follows: weight 74.6kg, BMI: 23.5kg / m 2 Biochemistry: ALT: 18.6U / L, serum uric acid: 365μmol / L, low-density lipoprotein: 2.93mmol / L; CAP: 256dB / m, visceral fat area 75cm 2 , waist circumference 88.4cm, all indicators improved.

[0160] For comparison, the patient with the same gender, age, weight, and biochemical index levels as Zhu Moumou is as follows: Zhu Moumou, male, 27 years old, weight 82.4kg, BMI: 23.6kg / m 2 , weight critical. Biochemical examination on June 29, 2024: ALT: 42.6U / L, blood uric acid: 447μmol / L, low-density lipoprotein: 3.32mmol / L; CAP: 290dB / m on July 27, 2024, visceral fat area 71cm 2, waist circumference 89.8cm. From July 27, 2024, the patient was advised to adjust his lifestyle by exercising regularly and controlling his diet. The examination results on December 13, 2024 were as follows: weight 83.7kg, BMI: 23.9kg / m 2 Biochemistry: ALT: 60.3U / L, serum uric acid: 375μmol / L, low-density lipoprotein: 4.23mmol / L; CAP: 279dB / m, visceral fat area 73cm 2 , waist circumference 91.7cm.

[0161] Summary: This case study summarizes the changes in indicators of two young male patients with metabolic-related fatty liver disease and metabolic syndrome at normal and borderline overweight weight levels. The results show that after 12 weeks of using the drug of this invention, Chen Moumou's weight, visceral fat area, and waist circumference decreased, and hepatic steatosis improved. At the same time, blood biochemical liver function, uric acid, and low-density lipoprotein levels also improved. Zhu Moumou, on the other hand, only followed lifestyle adjustments, and only his hepatic steatosis values and uric acid levels improved compared to before. His weight did not change much compared to before, and his abdominal circumference and visceral fat area increased slightly compared to before. His liver function and low-density lipoprotein levels also fluctuated. This shows that for slightly overweight men around 30 years old, Chinese medicine treatment is more effective than ordinary lifestyle adjustments in improving hepatic steatosis, liver function, metabolic-related serum and body measurement treatments, and is more conducive to the steady improvement of the patient's condition.

[0162] Typical Case 2

[0163] Wang, female, 32 years old, weight 87.1 kg, BMI: 34 kg / m 2 Obesity, after cholecystectomy, biochemical examination on August 24, 2024: ALT: 59.3U / L, blood uric acid: 366μmol / L; CAP: 309dB / m, LSM: 6.6kPa, visceral fat area 118cm 2 , waist circumference 95.8cm. From August 24, 2024, the patient took the Artemisia Scutellariae Fat-Reducing Decoction (i.e., the Chinese medicine composition of Example 1) for 12 weeks, 1 dose per day, twice a day, morning and evening, and was advised to adjust his lifestyle. After the patient took the medicine on time and in the prescribed amount for 12 weeks, the examination results on November 22, 2024 were as follows: weight 78.6kg, BMI: 30.7kg / m 2 Biochemistry: ALT: 23.3U / L, serum uric acid: 269μmol / L; CAP: 213dB / m, LSM: 4.3kPa, visceral fat area: 104cm 2The patient's health indicators improved across the board. Although still classified as obese, all clinical indicators were within normal ranges, and fatty liver disease had resolved. Two months after discontinuation of medication, the patient's CAP was 211 dB / m, LSM was 4.1 kPa, and hepatic steatosis and hardness remained within normal levels.

[0164] For comparison, the patient with the same gender, age, weight, and biochemical index levels as Yang Moumou is as follows: Yang Moumou, female, 39 years old, weight 85.9 kg, BMI: 32.3 kg / m 2 , obesity. Biochemical examination on September 7, 2024: ALT: 55U / L, GGT: 52.9U / L, blood uric acid: 356μmol / L, low-density lipoprotein: 3.4mmol / L, triglyceride 2.11mmol / L; CAP: 327dB / m, LSM: 5.8kPa, visceral fat area 117cm 2 , waist circumference 94.7cm. From September 7, 2024, the patient was advised to adjust his lifestyle by exercising regularly and controlling his diet. The examination results on December 13, 2024 were as follows: weight 82.4kg, BMI: 31kg / m 2 Biochemistry: ALT: 34.4U / L, serum uric acid: 349μmol / L, triglyceride 2.19mmol / L; CAP: 324dB / m, LSM: 4.8kPa, visceral fat area 116cm 2 , waist circumference 92.8cm.

[0165] Summary: This case study summarizes the changes in indicators in two obese, young female patients with metabolic-related fatty liver disease and metabolic syndrome. The results show that Wang, who used the drug of this invention for 12 weeks, experienced a decrease in weight, visceral fat area, and waist circumference, and improved hepatic steatosis. Meanwhile, liver function and uric acid levels improved, and fatty liver was cured. Two months after stopping the drug, the hepatic steatosis values remained normal. Yang, who followed the same lifestyle adjustments without the use of traditional Chinese medicine, achieved some weight loss (3.5 kg) and a significant improvement in ALT levels compared to before treatment. However, no significant benefit was seen in indicators reflecting visceral fat, such as hepatic steatosis, abdominal circumference, and visceral fat area. Blood uric acid and triglyceride levels remained roughly the same as before treatment. This suggests that traditional Chinese medicine treatment can assist with, and even amplify, the patient's weight loss effect. Compared with the weight loss effect of lifestyle adjustments alone, it improves hepatic steatosis, weight, visceral fat area, waist circumference, and other aspects more effectively and rapidly. It also helps stabilize liver function and uric acid levels, and is more conducive to the steady improvement of the patient's condition.

[0166] Typical Case 3

[0167] Huo Moumou, female, 52 years old, weight 67.2kg, BMI: 25.6kg / m2 , overweight; biochemical examination on August 24, 2024: ALT: 68.9U / L, AST: 47.5U / L, GGT: 55.25U / L, blood uric acid: 437μmol / L, TG: 2mmol / L, fasting blood glucose: 7.07mmol / L, glycosylated hemoglobin: 7.20; CAP: 277dB / m, LSM: 7.7kPa, visceral fat area 107cm 2 , waist circumference 95.8cm. From August 26, 2024, the patient took the Artemisia Scutellariae Fat-Reducing Decoction (i.e., the Chinese medicine composition of Example 1) for 12 weeks, 1 dose per day, twice a day, morning and evening, and was advised to adjust his lifestyle. After the patient took the medicine on time and in the prescribed amount for 12 weeks, the examination results on November 23, 2024 were as follows: weight 64.8kg, BMI: 24.7kg / m 2 Biochemistry: ALT: 24 U / L, AST: 22.7 U / L, GGT: 16.36 U / L, serum uric acid: 342 μmol / L, TG: 1.37 mmol / L, fasting blood glucose: 5.71 mmol / L, glycosylated hemoglobin: 6.6; CAP: 254 dB / m, LSM: 6.6 kPa, visceral fat area: 93 cm 2 The patient's weight, body fat, serum liver function, blood lipids, blood sugar, uric acid and other abnormal indicators have all improved, and liver fat degeneration and elasticity have also improved.

[0168] For comparison, the patient with the same age, weight, and biochemical index level as the patient is as follows: Hua, male, 50 years old, weight 65.2 kg, BMI: 24.2 kg / m 2 , weight is marginally normal. Biochemical examination on July 26, 2024: ALT: 36.7U / L, serum uric acid: 449μmol / L, triglycerides 1.24mmol / L, CAP: 302dB / m, LSM: 4.6kPa, visceral fat area 122cm 2 , waist circumference 87.1cm. From July 26, 2024, the patient was advised to adjust his lifestyle by exercising regularly and controlling his diet. The examination results on October 12, 2024 were as follows: weight 64.9kg, BMI: 24.1kg / m 2 Biochemistry: ALT: 43.2U / L, serum uric acid: 414μmol / L, triglyceride 1.81mmol / L; CAP: 292dB / m, LSM: 4.8kPa, visceral fat area 126cm 2 , waist circumference 87.6cm.

[0169] Summary: This case summarizes the changes in indicators of two middle-aged, overweight patients with metabolic-related fatty liver disease and metabolic syndrome. The results show that after using the drug of the present invention for 12 weeks, the patient Huo's weight, body fat, serum liver function, blood lipids, blood sugar, uric acid and other abnormal indicators have been comprehensively improved, and the liver fatty degeneration and elasticity value have improved, and the condition has been alleviated. Yang followed the same lifestyle adjustment and did not use Chinese medicine in combination. Although he achieved a certain weight loss effect (0.3kg), his blood uric acid and CAP levels improved slightly, his ALT and triglyceride levels fluctuated compared with before, but no obvious benefit was seen in abdominal circumference, visceral fat area and other indicators reflecting visceral fat. It is suggested that for middle-aged, overweight patients with fatty liver, the use of this patented Chinese medicine composition is more effective in improving liver fatty degeneration, weight, visceral fat area, waist circumference, blood lipids, blood sugar, blood uric acid, liver function and other aspects compared with the weight loss effect of simple lifestyle adjustment, and is more conducive to the steady improvement of the patient's condition.

[0170] The above examples are provided to those skilled in the art to fully disclose and describe how to implement and use the claimed embodiments, rather than to limit the scope of the disclosure herein. Modifications that are obvious to those skilled in the art will fall within the scope of the appended claims.

Claims

1. A Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, characterized in that: The medicine is composed of or prepared from the following raw materials in parts by weight: 5-50 parts of Artemisia annua, 3-30 parts of Scutellaria baicalensis, 5-50 parts of Taraxacum mongolicum, 4-60 parts of Platycodon grandiflorum, 5-50 parts of Citrus aurantium, 3-80 parts of Pinellia ternata, 3-70 parts of Amomum villosum, 10-80 parts of stir-fried Chinese yam, 5-80 parts of Poria cocos, and 3-100 parts of raw Coix seeds.

2. The Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome according to claim 1, characterized in that: The medicine is composed of or prepared from the following raw materials in parts by weight: 8-20 parts of Artemisia annua, 10-20 parts of Scutellaria baicalensis, 10-15 parts of Taraxacum mongolicum, 4-15 parts of Platycodon grandiflorum, 5-15 parts of Citrus aurantium, 3-12 parts of Pinellia ternata, 3-18 parts of Amomum villosum, 10-30 parts of stir-fried Chinese yam, 5-20 parts of Poria cocos, and 10-30 parts of raw Coix seeds.

3. The Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome according to claim 2, characterized in that: The medicine is composed of or prepared from the following raw materials in parts by weight: 10 parts of Artemisia annua, 10 parts of Scutellaria baicalensis, 10 parts of Taraxacum mongolicum, 10 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, 9 parts of Pinellia ternata, 10 parts of Amomum villosum, 15 parts of stir-fried Chinese yam, 15 parts of Poria cocos, and 30 parts of raw Coix seeds.

4. The Chinese medicine composition for preventing and treating metabolism-related fatty liver disease or metabolic syndrome according to claims 1 to 3, characterized in that: The dosage form of the Chinese medicine composition is selected from decoction, extract, granule, tablet, capsule, powder, pill, oral liquid, powder, tea substitute, lotion, paste, pill, tablet, lozenge, gel, koji, dripping pill, ultrafine powder or colloid.

5. Use of a traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome in the preparation of medicines or health foods, characterized in that: The medicine or health food is used to prevent and treat metabolism-related fatty liver disease or metabolic syndrome, which includes one or more of the following characteristics: liver fat accumulation with or without elevated transaminase, overweight or obesity, increased arterial blood pressure, abnormal blood sugar, increased blood triglycerides, abnormal blood cholesterol, decreased blood high-density lipoprotein cholesterol, increased blood low-density lipoprotein, and increased blood uric acid.

6. A method for preparing a traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, comprising using the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The raw materials are mixed and crushed to obtain the product.

7. A method for preparing a traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, comprising using the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The Chinese medicine formula granules or Chinese medicine pieces of each raw material medicine are mixed to obtain the product.

8. A method for preparing a traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome, comprising using the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: Mix all the raw materials and boil them to obtain the product.

9. The method for preparing the traditional Chinese medicine composition for preventing and treating metabolic-related fatty liver disease or metabolic syndrome according to claim 8, characterized in that: Mix the raw materials, add 10 times the amount of water, soak for 30 minutes, boil for 20 minutes, filter out the liquid medicine, add 10 times the amount of water to the residue, boil for 15 minutes, filter out the liquid medicine; combine the two liquid medicines to obtain the product.

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