Traditional Chinese medicine composition for treating fatty liver disease and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating fatty liver diseases and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The main component of the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of radix bupleuri, 6 parts of rhizoma cimicifugae, 15 parts of rhizoma atractylodis (fried with honey and bran), 15 parts of radix astragali, 12 parts of pericarpium citri reticulatae, 30 parts of pollen typhae (raw), 30 parts of hawthorn (raw), 30 parts of oyster (calcined) and 9 parts of radix aucklandiae. The deposition of lipid in the liver is obviously reduced, the liver inflammation is relieved, and the liver function is protected.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and more particularly to a traditional Chinese medicine composition for treating fatty liver disease and a preparation method thereof. BACKGROUND

[0002] Fatty liver disease is mainly divided into two categories, namely alcoholic fatty liver and non-alcoholic fatty liver, and non-alcoholic fatty liver has been renamed metabolic associated fatty liver disease internationally, which is referred to as metabolic associated fatty liver disease hereinafter.

[0003] Alcoholic fatty liver disease (AFLD) is a liver damage disease caused by long-term and large-dose intake of alcohol, and is one of the most common alcoholic liver diseases (ALD). Its incidence accounts for about 90% of alcoholic liver diseases, and the pathological feature is that the lipid accumulation in liver cells exceeds 5% of the liver wet weight. With the improvement and change of people's living standards and lifestyle, the incidence of the disease has increased year by year. AFLD can develop from alcoholic fatty liver (AFL) to alcoholic steatohepatitis (ASH) characterized by liver inflammation. Chronic ASH eventually leads to fibrosis and cirrhosis, and in some cases, it leads to hepatocellular carcinoma (HCC). In addition, severe ASH (with or without cirrhosis) can lead to alcoholic hepatitis, which is an acute clinical manifestation of alcoholic liver disease, and is associated with liver failure and high mortality. Modern medicine has made great breakthroughs in the etiology and pathology of AFLD, and the pathogenesis of the disease mainly includes liver steatosis, oxidative stress, acetaldehyde-mediated toxicity, and cytokine and chemokine-induced inflammation, etc. The treatment strategy of western medicine is biased towards alcohol abstinence as the first priority, and the remaining drugs are still in clinical trials, or have not been widely used due to drug side effects.

[0004] Metabolic associated fatty liver disease (MAFLD) is a chronic progressive liver disease characterized by liver steatosis combined with metabolic abnormalities, and the disease progression mainly includes simple liver steatosis, steatohepatitis (MASH), MASH-related cirrhosis, and hepatocellular carcinoma (HCC), etc. Along with the disease progression, there are also many complications such as metabolic syndrome, hypertension, diabetes, and cardiovascular disease. Complications are not only one of the main risk factors of MAFLD, but also associated with the increase of all-cause mortality of MAFLD, which poses a great threat to human health.

[0005] The pathogenesis of MAFLD is complex, and the multiple parallel hit hypothesis proposed by Tilg and Moschen is widely accepted. MAFLD is caused by the parallel action of various factors, including lipid metabolism interruption, lipotoxicity, changes in cytokines and adipokines, oxidative stress, endoplasmic reticulum (ER) stress, mitochondrial dysfunction, intestinal-derived endotoxins and genetic susceptibility. The treatment strategy is to improve lifestyle, improve insulin resistance, treat metabolic syndrome and type 2 diabetes, and liver transplantation surgery.

[0006] Regardless of AFLD or MAFLD, there is no specific drug and perfect treatment plan in the world except resmetirom approved by FDA in 2024, and the initial disease symptoms are not obvious, which depends on physical examination (ultrasound examination, transient elastography, magnetic resonance imaging (MRI), serum biomarker measurement and liver biopsy histology) for diagnosis. The development of the disease and complications seriously endanger human health, and the current situation is in urgent need of clinical drugs for treating fatty liver.

[0007] Therefore, it is an urgent problem for those skilled in the art to provide an effective therapeutic drug for the treatment of fatty liver. SUMMARY

[0008] Therefore, the present application provides a traditional Chinese medicine composition for treating fatty liver disease and a preparation method thereof.

[0009] In order to achieve the above purpose, the technical scheme adopted by the present application is as follows:

[0010] A traditional Chinese medicine composition for treating fatty liver disease, characterized in that the main components of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Radix Bupleuri 12 parts, Radix Anemonis Preparata 6 parts, Atractylodes Rhizome (fried with honey and bran) 15 parts, Astragalus Root 15 parts, Pericarpium Citri Reticulatae 12 parts, Typha Angustifolia Pollen (raw) 30 parts, Crataegus Pinnatifida Bge. (raw) 30 parts, Ostrea Gigas Thunb. (calcined) 30 parts and Saussurea Lappa Clarke 9 parts.

[0011] There is no clear name of fatty liver in traditional Chinese medicine. According to its etiology and clinical symptoms, the disease can be attributed to the category of 'Pi Man', 'Ji Ju', 'Fei Qi', 'Tanzhuo', 'Ganzhuo' and other disease syndromes. The etiology of fatty liver in traditional Chinese medicine is mostly due to improper diet, long-term sitting and emotional depression of patients, and the disease is located in the liver, also related to the spleen and kidney. The total pathogenesis is based on spleen deficiency, and the main pathological factors are phlegm, dampness, heat and blood stasis. The research group believes that fatty liver is a disease mainly involving the spleen and multiple organs, and the spleen deficiency runs through the whole process of the development of fatty liver. In the early stage of the disease, the spleen fails to transport and the lung and Sanjiao fail to govern, resulting in the accumulation of water and dampness, so the disease is mainly manifested as liver stagnation and spleen deficiency and internal retention of dampness. If the dampness and turbidity are converted into heat for a long time, phlegm and fluid can be further formed, and the long-term accumulation of phlegm and fluid can easily form blood stasis, so the disease is mainly manifested as damp-heat accumulation and phlegm and blood stasis in the middle and late stages. Therefore, the treatment should be based on the spleen, combined with the methods of soothing the liver and promoting qi, clearing heat and removing dampness, drying dampness and resolving phlegm, and promoting blood circulation to remove blood stasis. The spleen is used to regulate the liver, resolve pathological products and maintain the health of the human body. Based on the above-mentioned traditional Chinese medicine theory, the research group believes that MAFLD is mainly caused by spleen deficiency, internal accumulation of dampness and heat, and finally leads to phlegm, dampness and blood stasis. AFLD is caused by long-term heavy drinking, internal accumulation of dampness and heat, leading to liver and spleen imbalance and poor blood circulation.

[0012] The traditional Chinese medicine composition in the present application is based on Tiaozhong Yiqi Decoction, and the pathogenesis of fatty liver is based on tonifying qi and invigorating the spleen and resolving phlegm and removing blood stasis.

[0013] Radix Astragali is used as the monarch drug, and can enter the spleen and invigorate the spleen and replenish qi, so that the clear qi can be raised and the water and dampness can be transported, which fundamentally improves the transport disorder of water, dampness and phlegm caused by spleen deficiency, and is the root of the disease mechanism.

[0014] Atractylodes can dry dampness and remove turbidity of the spleen and stomach, and Pericarpium Citri Reticulatae can regulate qi, invigorate the spleen, dry dampness and resolve phlegm, and the two can assist the monarch drug to enhance the function of invigorating the spleen, removing dampness, regulating qi and harmonizing the center, and restore the function of ascending and descending of the spleen and stomach. Radix Paeoniae Alba and Fructus Crataegi can activate blood and resolve stasis, and can also activate blood and resolve stasis, and can eliminate the accumulation of fat, turbidity and stasis in the liver. The two are used as the ministerial drug according to the pathogenesis of phlegm and blood stasis of fatty liver.

[0015] Radix Angelicae Pubescentis and Radix Bupleuri can clear and disperse, and assist Radix Astragali to raise the clear yang of the spleen and stomach, and assist Atractylodes and Pericarpium Citri Reticulatae to regulate the qi of the spleen and stomach, and raise the clear and descend the turbid. Oyster Shell can soften and resolve stasis, and can also astringe and contract, and prevent the further excretion of fat turbidity. Radix Aucklandiae can regulate qi and relieve pain, regulate the center and remove stagnation, so that the blood circulation and phlegm elimination can be achieved, and the two are used as the assistant drug.

[0016] The whole prescription can tonify without stagnation, resolve without damage, and ascend and descend simultaneously, so that the qi and blood can be treated together, the main and secondary symptoms can be considered, and the core pathogenesis of fatty liver, that is, the spleen deficiency is the main and phlegm, dampness and blood stasis are the secondary, is closely related.

[0017] As a preferred technical solution, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable excipient.

[0018] As a preferred technical solution, the dosage form of the traditional Chinese medicine composition is powder, granules, capsules, tablets, mixture or oral liquid.

[0019] Another object of the present application is to provide a preparation method of the traditional Chinese medicine composition for treating fatty liver disease, comprising the following steps:

[0020] (1) Herbal medicine soaking: Put the herbal medicine into a pot, add ten times the amount of water at room temperature, and soak for 30 minutes;

[0021] (2) Decoction: First decoction: Puhuang needs to be decocted, boil on high heat and then slow decoction on low heat, decoct for 40 minutes, and pour out;

[0022] Second decoction: Add half the amount of hot water of the first decoction, boil on high heat and then slow decoction on low heat for 30 minutes, and pour out;

[0023] Combine the two times of medicinal liquid into one dose of medicinal liquid.

[0024] Another object of the present application is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating fatty liver disease.

[0025] Beneficial effects: Compared with the prior art, the present application provides a traditional Chinese medicine composition for treating fatty liver disease, which has a significant improvement effect on fatty liver disease (including metabolic-related fatty liver disease and alcoholic liver disease), significantly reduces the deposition of lipids in the liver, reduces liver inflammation, and protects liver function. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only embodiments of the present application, and those skilled in the art can obtain other drawings according to the provided drawings without creative labor.

[0027] Figure 1 Oil red O staining results of liver pathological sections of mice in effect example 1 of the present application.

[0028] Figure 2 Liver supernatant lipid results of mice in effect example 1 of the present application.

[0029] Figure 3 HE staining results of liver pathological sections of mice in effect example 1 of the present application.

[0030] Figure 4 Serum AST and liver supernatant ALT results of mice in effect example 1 of the present application.

[0031] Figure 5The CAP value detection result before medication for typical case 1 of effect example 2 of the present application.

[0032] Figure 6 The CAP value detection result after medication for typical case 1 of effect example 2 of the present application.

[0033] Figure 7 The CAP value detection result before medication for typical case 2 of effect example 2 of the present application.

[0034] Figure 8 The CAP value detection result after medication for typical case 2 of effect example 2 of the present application.

[0035] Figure 9 The CAP value detection result before medication for typical case 1 of effect example 3 of the present application.

[0036] Figure 10 The CAP value detection result after medication for typical case 1 of effect example 3 of the present application.

[0037] Figure 11 The CAP value detection result before medication for typical case 2 of effect example 3 of the present application.

[0038] Figure 12 The CAP value detection result after medication for typical case 2 of effect example 3 of the present application. DETAILED DESCRIPTION

[0039] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the protection scope of the present application.

[0040] The present application discloses a traditional Chinese medicine composition for treating fatty liver disease and a preparation method thereof. The raw materials used in the present application are commercially available, and their sources are not specifically limited (for example, they can be purchased from Wujiang Shanghai Caitiongtang Chinese Medicine Herbal Pieces Co., Ltd.). The methods involved are conventional methods unless otherwise specified, and will not be described one by one here.

[0041] Example 1

[0042] Traditional Chinese medicine composition for treating fatty liver disease (Tiaozhong Yigan Decoction)

[0043] Take 12 parts of Radix Bupleuri, 6 parts of Radix Coptidis, 15 parts of honey and bran-fried Atractylodes Rhizome, 15 parts of Radix Astragali, 12 parts of Pericarpium Citri Reticulatae, 30 parts of raw Pulsatilla, 30 parts of raw Hawthorn, 30 parts of calcined Concha Molluscorum, and 9 parts of Radix Aucklandiae.

[0044] Preparation method:

[0045] (1) Medicine soaking: Put the medicine into the pot, add ten times the amount of normal temperature water, soak for 30 min;

[0046] (2) Decoction: First decoction: Puhuang needs to be decocted, boil on high heat, then turn to low heat, decoct for 40 min, pour out;

[0047] Second decoction: Add half of the first decoction water, boil on high heat, then turn to low heat, 30 min, pour out;

[0048] Combine the two times of medicine liquid into one dose, take twice a day, half an hour after breakfast and dinner.

[0049] Example 1 Metabolic-related fatty liver animal experiment

[0050] 1. Experimental animals and feed:

[0051] 30 C57BL / 6J male mice (6 weeks old) were provided by the Experimental Animal Center of the Second Military Medical University. They were raised in the SPF level animal experiment center, with 12 hours of day-night alternation every day, constant temperature of 18-20℃, and free access to food and water. All mice were adaptively fed for one week and adapted to the living environment before the experiment.

[0052] The normal diet group of SPF level experimental mice was maintained on feed provided by the Experimental Animal Center.

[0053] CDAA feed (Choline deficient amino acid-defined diet), referred to as CDAA feed (purchased from Nantong Tiaolofei Feed Technology Co., Ltd.

[0054] CSAA feed (Choline sufficient amino acid-defined diet), purchased from Nantong Tiaolofei Feed Technology Co., Ltd.

[0055] The feed was given at a rate of 3g per mouse per day, and new feed was replaced every day to prevent the feed from becoming soft and affecting the mice's eating.

[0056] 2. Grouping and modeling administration:

[0057] The combined medicine liquid obtained in Example 1 was concentrated to obtain a low-dose Tiaozhong Yigan Decoction water decoction containing 0.826g / mL of crude drug, and a high-dose Tiaozhong Yigan Decoction water decoction containing 2.478g / mL of crude drug.

[0058] The 30 C57BL / 6J mice were numbered after weighing, and recorded. Then the mice were randomly divided into 5 groups, A. normal diet group; B. CSAA modeling group; C. CDAA modeling group; D. low dose of TZYGT group (TZYGT-L) group; E. high dose of TZYGT group (TZYGT-H) group. Each group of 6, there was no significant difference in the body weight of mice in each group before the experiment.

[0059] ① Normal diet group: SPF grade experimental mouse maintenance feed, given sterile drinking water gavage (0.5ml / kg / d);

[0060] ② CSAA group: CSAA feed, given sterile drinking water gavage (0.5ml / kg / d);

[0061] ③ CDAA modeling group: CDAA feed, given sterile drinking water gavage (0.5ml / kg / d);

[0062] ④ Low dose of TZYGT group (TZYGT-L) group: CDAA feed, given low concentration of TZYGT decoction gavage (0.5ml / kg / d);

[0063] ⑤ High dose of TZYGT group (TZYGT-H) group: CDAA feed, given high concentration of TZYGT decoction gavage (0.5ml / kg / d);

[0064] ⑥ Administration once a day, for 16 weeks. Animals in each group were housed in separate cages. Body weight was recorded every week.

[0065] 3, Index detection

[0066] Specimen collection: after the last administration, fasting without water for 12h, after anesthesia with 3% sodium pentobarbital (40mg / kg), weighing, taking blood from the eye socket, placing in blood collection tube, 4℃ for 4h, then centrifuged at 4℃ low speed 1500g for 15min, taking the upper serum, placing in-80℃ refrigerator for preservation, for serum biochemical detection.

[0067] The mouse liver was separated, weighed and the appearance and color of the liver were observed. The left outer lobe of the mouse liver was cut and placed in 12% neutral formaldehyde solution for 48h fixation before pathological detection. Part of the liver was extracted with ethanol and PBS to obtain liver supernatant for subsequent biochemical detection, and the rest of the liver was stored in-80℃ refrigerator for subsequent experiments.

[0068] 4, Results:

[0069] (1) Effect on lipid deposition in liver

[0070] As shown in the accompanying Figure 1As shown, the CDAA group of mice exhibited significant homogeneous and large-area lipid deposition, while the normal group showed no lipid droplets, indicating successful establishment of the mouse fatty liver model. Oil Red O staining results of mouse liver pathological sections confirmed that the Tiaozhong Yigan Decoction of this invention can reduce lipid deposition in the liver of a mouse model of metabolic-related fatty liver. Specifically, the normal diet group showed normal liver tissue staining with Oil Red O without lipid droplet deposition; the CSAA model group showed significant inflammatory changes in liver tissue; the CDAA model group showed significant lipid droplet deposition and vacuolar changes in liver tissue; the low-dose Tiaozhong Yigan Decoction treatment group showed a significant reduction in lipid droplet deposition and vacuolar changes; and the high-dose Tiaozhong Yigan Decoction treatment group also showed a significant reduction in both lipid droplet deposition and vacuolar changes.

[0071] As attached Figure 2 As shown, the results of liver supernatant blood lipids in mice confirmed that the Tiaozhong Yigan Decoction of the present invention can reduce lipid deposition in the liver of a mouse model of metabolic-associated fatty liver. Specifically, both the high- and low-dose groups of Tiaozhong Yigan Decoction showed significantly lower lipid levels compared to the CDAA model group, indicating that Tiaozhong Yigan Decoction has a significant ameliorative effect on lipid deposition in the liver of a MAFLD mouse model.

[0072] (2) Effects on liver inflammation

[0073] As attached Figure 3 As shown, HE (hematoxylin-eosin) staining results of mouse liver pathological sections confirmed that the Tiaozhong Yigan Decoction of the present invention can alleviate liver inflammation and protect liver function in MAFLD model mice. Specifically, HE staining of normal liver tissue was observed in the normal diet group; inflammatory changes were observed in liver tissue in the CSAA model group; significant vacuolar changes and liver inflammation were observed in the CDAA model group; liver inflammation and vacuolar changes were reduced in the low-dose Tiaozhong Yigan Decoction treatment group; and liver inflammation and vacuolar changes were also reduced in both the high-dose and low-dose Tiaozhong Yigan Decoction treatment groups.

[0074] As attached Figure 4 As shown, the results of serum AST (Aspartate Aminotransferase, AST) and liver supernatant ALT (Alanine Aminotransferase, ALT) in mice showed that both the low-dose group and the model group exhibited statistically significant decreases. The results of serum and liver supernatant AKP (Alkaline Phosphatase, AKP) in mice showed that both the high- and low-dose groups decreased significantly after treatment compared to the model group.

[0075] The above results indicate that the Tiaozhong Yigan Decoction of the present invention has the effect of improving liver inflammation and protecting liver function in patients with MAFLD.

[0076] Example 2: MAFLD Clinical Trial

[0077] 1. Volunteer source

[0078] Volunteers were selected from 17 patients with metabolic-related fatty liver who were examined at the First Affiliated Hospital of Navy Military Medical University from May 2024 to March 2025.

[0079] 2. Diagnostic criteria:

[0080] Fatty liver diagnostic criteria:

[0081] Refer to the "Prevention and Treatment Guidelines for Metabolic-related (Non-alcoholic) Fatty Liver Disease (2024 Edition)" and "Chinese Medicine Diagnosis and Treatment Guidelines for Non-alcoholic Fatty Liver Disease"

[0082] Non-invasive quantitative diagnosis of fatty liver by detecting controlled attenuation parameter (CAP). It can measure the fat content of the liver. When the fatty change is ≤10%, the CAP value is ≤238db / m, which is normal liver. When 11%≤fatty change<34%, 238<CAP value≤259db / m, which is mild fatty liver. When 34%≤fatty change<67%, 259<CAP value≤292db / m, which is moderate fatty liver. When fatty change≧67%, CAP value>292db / m, which is severe fatty liver. The CAP values of the volunteers included in this experiment were all severe fatty liver.

[0083] 3. Treatment method

[0084] The medicine obtained by the method of Example 1 of the present application is used for water decoction and treatment for 30 days, 1 dose per day, taken 2 times in 2 times, and liver shear wave elastography examination is performed before and after treatment. The intervention duration is 3 months.

[0085] 4. Efficacy evaluation criteria

[0086] Cure (fatty liver disappears), effective (fatty liver is reduced), ineffective (fatty liver has no change or is aggravated), and the total effective rate=(cure number+effective number) / total number of people.

[0087] 5. Treatment results

[0088] 3 cases were cured, 14 cases were effective, and the total effective rate was 100%. The data of the volunteers collected this time were all severe fatty liver patients, and the CAP values before and after treatment are shown in the following table:

[0089] Table 2

[0090]

[0091] 6. Typical cases:

[0092] Use case 1: Mr. Jin, male, 45 years old.

[0093] Physical examination showed obesity, red tongue with thick white and greasy fur, and slippery pulse. B-ultrasound confirmed severe fatty liver. The CAP value detected by FibroScan at the first visit was 349 db / m (see Appendix Figure 5 ). After treatment, the patient was reexamined and the CAP value detected by transient liver elastography B-ultrasound was 210 db / m (see Appendix Figure 6 ).

[0094] Use case 2: Mr. Huang, male, 36 years old.

[0095] Obesity, pale tongue with white and greasy fur, and slippery pulse. B-ultrasound confirmed severe fatty liver. Laboratory tests showed blood lipid indicators: total cholesterol 5.7 mmol / L, triglycerides 1.5 mmol / L, and low-density lipoprotein cholesterol 3.0 mmol / L. The CAP value detected by FibroScan at the first visit was 360 db / m (see Appendix Figure 7 ). After treatment, the patient was reexamined and the CAP value detected by transient liver elastography B-ultrasound was 237 db / m (see Appendix Figure 8 ).

[0096] Effect example 3 AFD clinical experiment

[0097] 1. Volunteer source

[0098] Volunteers were selected from 13 patients with alcoholic fatty liver who were examined at the First Affiliated Hospital of the Navy Military Medical University from June 2024 to April 2025.

[0099] 2. Diagnostic criteria:

[0100] Fatty liver diagnostic criteria:

[0101] Refer to "Guidelines for Prevention and Treatment of Alcoholic Liver Disease (2018 Updated Edition)"

[0102] Non-invasive quantitative diagnosis of fatty liver was performed by detecting the controlled attenuation parameter (CAP). It can measure the fat content of the liver. When the fatty change is ≤10%, the CAP value is ≤238 db / m, which is normal liver; when 11%≤fatty change<34%, 238<CAP value≤259 db / m, which is mild fatty liver; when 34%≤fatty change<67%, 259<CAP value≤292 db / m, which is moderate fatty liver; when fatty change≧67%, CAP value>292 db / m, which is severe fatty liver. The CAP values of the volunteers included in this experiment were all severe fatty liver.

[0103] 3. Treatment method

[0104] The medicine obtained by the embodiment 1 of the present application is water-decocted and taken for 30 days, 1 dose per day, taken twice in 2 times, and the liver shear wave elastography is performed before and after treatment. The intervention lasts for 3 months.

[0105] 4. Therapeutic effect evaluation standard

[0106] Cure (fatty liver disappears), effective (fatty liver reduces), ineffective (fatty liver has no change or aggravation), and total effective rate = (cure number + effective number) / total number.

[0107] 5. Treatment result

[0108] 3 cases are cured, 10 cases are effective, and the total effective rate is 100%. The data of the volunteers collected this time are all severe fatty liver patients, and the CAP values before and after treatment are shown in the following table:

[0109] Table 2

[0110]

[0111]

[0112] 6. Typical case:

[0113] Use case 1: Zhang, male, 48 years old.

[0114] Right costal pain for 3 months, and body and eyes yellow for 1 week. Drinking history: drinking white wine (52°) about 250ml (half catty) per day. Last for 15 years, and the drinking amount increases in the past 5 years. The face is yellow and yellow like smoke, the eyes are yellow, the right costal burning pain, the abdominal distension is full and refuses to press, the mouth is bitter and sticky, the appetite is poor and the nausea is poor, the urine is yellow and red like strong tea, the stool is sticky and smelly, the body is not hot, the fatigue is weak. The tongue is red, the tongue is yellow and thick, and the tongue edge is blood point; the pulse is stringy and slippery.

[0115] The liver parenchyma is diffusely thickened, and the fatty attenuation value (CAP) is 308dB / m (see attached Figure 9 ); the CAP value is 225dB / m after 1 month of treatment (see attached Figure 10 ).

[0116] Use case 2: Liu, male, 56 years old.

[0117] Abdominal distension and loose stool for 2 years, aggravated with lower limb edema for 1 month. Drinking history: 4-5 bottles of beer (about 1600-2000ml) per day, and high white wine 3 times a week (about 150ml each time). Beer drinking lasts for 20 years, and mixed drinking history lasts for 10 years. The face is yellow and yellow, the eyelids are edematous, and the lip color is pale. The tongue is pale and obese, the edge tooth mark is obvious, the tongue is white and slippery. The pulse is slow and weak. The costal pain is hidden, the abdominal distension is severe after eating; the appetite is poor, the cold limbs are cold; the stool is thin and 3-4 times a day, the urine is clear and long; the lower limbs are pitting edema.

[0118] The liver was enlarged, and the CAP value before treatment was 311 dB / m (see attached Figure 11 ), and the CAP value after 1 month of treatment was 225 dB / m (see attached Figure 12 ).

[0119] The various embodiments described in this specification are presented for the purpose of illustration and description. Each of the embodiments highlights a different aspect of the disclosure, and the embodiments are presented separately for ease of understanding. However, it will be apparent to those of ordinary skill in the art that the various embodiments can be combined in different ways, and that the embodiments can be combined with other embodiments disclosed herein without departing from the scope of the disclosure.

[0120] The above description of disclosed embodiments is intended to be illustrative, and not restrictive. Many embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the disclosure should, therefore, be determined not with reference to the above description, but instead with reference to the appended claims, along with their full scope of equivalents.

Claims

1. A traditional Chinese medicine composition for treating fatty liver disease, characterized in that, The main components of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Bupleurum 12 parts, Cimicifuga 6 parts, Atractylodes (fried with honey and bran) 15 parts, Astragalus 15 parts, Tangerine Peel 12 parts, Typhae Pollen (raw) 30 parts, Crataegus (raw) 30 parts, Oyster Shell (calcined) 30 parts, and Saussurea 9 parts.

2. The traditional Chinese medicine composition for treating fatty liver disease according to claim 1, characterized in that, The traditional Chinese medicine composition further comprises a pharmaceutically acceptable excipient.

3. The traditional Chinese medicine composition for treating fatty liver disease according to claim 2, characterized in that, The dosage form of the traditional Chinese medicine composition is powder, granules, capsules, tablets, mixture, or oral liquid.

4. The preparation method of the traditional Chinese medicine composition for treating fatty liver disease according to claim 1, characterized in that, The method comprises the following steps: (1) soaking of medicinal materials: medicinal materials are put into a pot, ten times the amount of water at room temperature is added, and soaked for 30 min; (2) decoction: first decoction: Typhae Pollen needs to be decocted in a bag, boiled with a large fire and then slowly decocted with a small fire, decocted for 40 min, and poured out; second decoction: half the amount of hot water of the first decoction is added, boiled with a large fire and then slowly decocted for 30 min, and poured out; the two times of medicinal liquid are combined as one dose of medicinal liquid.

5. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating fatty liver disease.

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