Traditional Chinese medicine composition with effects of preventing or treating fatty liver related to metabolic dysfunction and losing weight

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with the effects of preventing or treating metabolic dysfunction related fatty liver and losing weight, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-20 parts of fructus cannabis, 1-20 parts of lily, 1-20 parts of radix curcumae, 1-20 parts of rhizoma alismatis, 1-20 parts of herba lycopi, 1-20 parts of bunge cherry seed and 1-20 parts of herba cistanche. The invention also relates to a preparation method of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in preparation of medicines for preventing or treating fatty liver related to metabolic dysfunction and reducing weight. The traditional Chinese medicine composition has the effects of soothing the liver, removing food retention, reducing phlegm, clearing damp, invigorating the spleen and tonifying the kidney. Animal experiment results show that the traditional Chinese medicine composition has remarkable prevention and treatment effects on fatty liver related to metabolic dysfunction and obesity. Therefore, the traditional Chinese medicine composition has high clinical application value.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition having the functions of preventing or treating fatty liver associated with metabolic dysfunction and losing weight. Background Art

[0002] Metabolic dysfunction associated fatty liver disease (MAFLD) is a hepatic manifestation syndrome of metabolic liver disease and has become one of the most common chronic liver diseases in the world. MAFLD was formerly known as non-alcoholic fatty liver disease (NAFLD), but NAFLD does not fully define the meaning of the disease, so relevant experts have agreed to name NAFLD as MAFLD. According to the definition of the World Health Organization (WHO), a person with a body mass index ≥30 kg / m 2 Considered to be obese, it is estimated that more than 13% of the world's population (>600 million people) are diagnosed with MAFLD, especially in children and adolescents. 80-90% of obese patients and 70-80% of patients with type 2 diabetes usually suffer from MAFLD. MAFLD covers a range of diseases including simple fatty liver, non-alcoholic steatohepatitis, and can further develop into liver fibrosis and cirrhosis, and even lead to hepatocellular carcinoma.

[0003] At present, the commonly used drugs are silybin, ursodeoxycholic acid, polyene phosphatidylcholine, reduced glutathione, bicyclol, bifendate, etc., which have a certain effect on the treatment of MAFLD, but the application of a single drug has certain limitations and the benefits are limited. MAFLD belongs to the "liver addiction", "accumulation", "flank pain" and so on in traditional Chinese medicine. The main location of this disease is in the liver and spleen. The main pathogenesis of this disease is spleen dysfunction, liver depression and qi stagnation or liver and spleen disorder caused by improper diet, improper work and rest, and emotional disorders. The disease affects the kidneys for a long time, which can cause kidney essence loss and kidney water dysfunction. The pathological products of MAFLD are mostly phlegm, dampness, blood stasis, heat, etc., which is a disease mixed with deficiency and excess.

[0004] Chinese patent CN115869358B discloses a Chinese medicine composition for treating non-alcoholic fatty liver disease, which is made of the following raw materials in parts by weight: 5-25 parts of raw astragalus, 3-15 parts of atractylodes, 3-15 parts of polygonum cuspidatum, 3-15 parts of radix scutellariae, 3-15 parts of radix scutellariae, and 2-10 parts of tangerine peel. In the prescription, raw astragalus invigorates qi and strengthens the spleen, and spleen qi is strong and water and dampness are eliminated, which is the main medicine; the minister is atractylodes to dry dampness and strengthen the spleen, and polygonum cuspidatum to eliminate dampness and eliminate phlegm, and the combined use strengthens the effect of strengthening the spleen and eliminating phlegm; the auxiliary is radix scutellariae to clear heat and promote diuresis, and radix scutellariae promotes blood circulation and removes blood stasis, promotes diuresis and reduces swelling, and the combined use strengthens the effect of clearing heat and promoting diuresis; tangerine peel strengthens the spleen and dries dampness, and has the effect of regulating qi and resolving phlegm as the guiding medicine. The combination of all the medicines has the effects of strengthening the spleen and eliminating phlegm, clearing heat and promoting diuresis, making the spleen qi strong, damp heat and clearing, and phlegm and dampness are reduced and cured.

[0005] Chinese patent application CN202410610057.7 (previously applied by the inventor) discloses a Chinese medicine composition for preventing or treating fatty liver disease, which is made of the following raw materials by weight: 5-30 parts of Atractylodes, 5-30 parts of Cyperus rotundus, 5-30 parts of Cuscuta, 5-30 parts of Rubus, 5-30 parts of Lycium barbarum, 5-30 parts of Viscum, 5-30 parts of Fried Dipsacus, 5-30 parts of Eucommia ulmoides, 5-30 parts of Salvia miltiorrhiza, and 5-30 parts of Chuanxiong. This prescription treats the disease from the perspective of the spleen, with the main principles of soothing the liver and promoting gallbladder, resolving phlegm and removing blood stasis, and strengthening the spleen and kidney, and plays a role in preventing and treating fatty liver disease.

[0006] As mentioned above, most obese patients are usually accompanied by MAFLD. Therefore, if a Chinese medicine composition that has the effects of preventing and treating MAFLD and losing weight can be developed, it will definitely bring greater benefits to such patients. Summary of the invention

[0007] The purpose of the present invention is to overcome the deficiencies of the prior art, and to screen out a Chinese medicine composition having the effects of preventing and treating MAFLD and losing weight, as well as a preparation method and use thereof, through a large number of experimental screenings, combined with clinical experience, and using the theory of syndrome differentiation and treatment.

[0008] In order to achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition having the effects of preventing or treating fatty liver associated with metabolic dysfunction and losing weight. The traditional Chinese medicine composition is made of the following raw materials, in parts by weight: 1-20 parts of hemp seed, 1-20 parts of lily, 1-20 parts of curcuma, 1-20 parts of oriental water chestnut, 1-20 parts of zedoaria, 1-20 parts of prunes, 1-20 parts of Prunus mume seeds, and 1-20 parts of Cistanche deserticola.

[0010] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials, by weight: 5-15 parts of hemp seed, 1-10 parts of lily, 1-10 parts of curcuma, 1-10 parts of oriental water chestnut, 1-10 parts of zedoaria, 1-10 parts of prunes, 1-10 parts of Prunus mume seeds, and 1-10 parts of Cistanche deserticola.

[0011] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials, by weight: 9 parts of hemp seed, 6 parts of lily, 6 parts of curcuma, 6 parts of oriental water plantain, 6 parts of zedoaria, 6 parts of prunes, 6 parts of prunes, and 6 parts of cistanche.

[0012] In the second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect, the preparation method comprising the following steps: crushing hemp seed, lily, curcuma, oriental water chestnut, angelica sinensis, Prunus mume seed, and Cistanche deserticola, boiling them with water, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0013] As an optional manner, in the above preparation method, the decoction is performed twice, and after the first decoction for 1-3 hours, a primary filtrate is obtained by filtering, the filter residue is further decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering, and the primary filtrate and the secondary filtrate are combined.

[0014] As an optional manner, in the above preparation method, the decoction time for the first decoction and the second decoction are both 2 hours, and the water used for the first decoction and the second decoction are both distilled water; preferably, the concentration is reduced pressure concentration.

[0015] In the third aspect, the present invention provides the use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in the preparation of a drug having the effects of preventing or treating fatty liver associated with metabolic dysfunction and losing weight.

[0016] As an alternative, in the above use, the metabolic dysfunction-related fatty liver is non-alcoholic fatty liver disease.

[0017] As an optional mode, in the above-mentioned use, the non-alcoholic fatty liver disease is selected from one or more of the following: simple fatty liver, polycystic ovary syndrome combined with fatty liver, non-alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis or hepatocellular carcinoma.

[0018] Preferably, the non-alcoholic fatty liver disease is non-alcoholic steatohepatitis.

[0019] As an optional mode, in the above-mentioned use, the medicine has the effects of soothing the liver and eliminating accumulation, resolving phlegm and removing dampness, and strengthening the spleen and kidney.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The Chinese medicine composition of the present invention has the effects of soothing the liver and eliminating stagnation, resolving phlegm and removing dampness, and strengthening the spleen and kidney. Animal experimental results show that the Chinese medicine composition of the present invention has a significant preventive and therapeutic effect on fatty liver and obesity related to metabolic dysfunction. Therefore, the Chinese medicine composition of the present invention has a high clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 :The effect of Hemp Seed and Lily Decoction on the body weight of mice with fatty liver. Compared with the control group, **** P<0.0001; compared with the model group, #### P < 0.0001, ▲▲▲▲ P < 0.0001, ◆◆◆◆ P<0.0001.

[0023] Figure 2 :The effect of Hemp Seed and Lily Decoction on the weight of liver and adipose tissue in mice with fatty liver. Among them, (A) liver weight, compared with the control group, **** P<0.0001; compared with the model group *** P<0.001; (B) Inguinal fat weight, compared with the control group, **** P<0.0001; compared with the model group **** P<0.0001; (C) Epididymal fat weight, compared with the control group, **** P<0.0001; compared with the model group *** P<0.001.

[0024] Figure 3 :The effect of Hemp Seed and Lily Decoction on serum biochemical indexes in mice with fatty liver. Among them, (A) serum alanine aminotransferase level, compared with the control group, *** P<0.001; compared with the model group **** P<0.0001; (B) Serum aspartate aminotransferase level, compared with the control group, ** P<0.01; compared with the model group * P<0.05; (C) Serum total cholesterol level, compared with the control group, **** P<0.0001; compared with the model group ** P<0.01.

[0025] Figure 4 :The effect of Hemp Seed and Lily Decoction on triglyceride content in liver tissue of mice with fatty liver. Compared with the control group, **** P<0.0001; compared with the model group * P<0.05, ** P<0.01.

[0026] Figure 5:Effects of Ma Ren Bai He Tang on pathological changes of liver tissue in mice with fatty liver (×100). Among them, (A) normal control group; (B) fatty liver model group; (C) Ma Ren Bai He Tang group; (D) Huang Qi Bai He Tang group; (E) metformin group.

[0027] Figure 6 :The effect of Ma Ren Bai He Tang on liver changes in mice with fatty liver. Among them, (A) normal control group; (B) fatty liver model group; (C) Ma Ren Bai He Tang group; (D) Huang Qi Bai He Tang group; (E) metformin group.

[0028] Figure 7 :Effects of Ma Ren Bai He Tang on pathological changes of adipose tissue in mice with fatty liver (×100). Among them, (A) normal control group; (B) fatty liver model group; (C) Ma Ren Bai He Tang group; (D) Huang Qi Bai He Tang group. DETAILED DESCRIPTION

[0029] The formula analysis and treatment principles of the Chinese medicine composition of the present invention are as follows:

[0030] Fatty liver belongs to the category of "liver disorder" and "accumulation" in traditional Chinese medicine. The disease is located in the liver and is closely related to the spleen, lungs and kidneys. "Nanjing" records that "the accumulation of liver is called fat qi". If the liver fails to release, it will lead to the spleen's failure to transport and transform, and the lungs, spleen and kidneys will be dysfunctional, affecting the distribution of body fluids, producing pathological products such as phlegm and blood stasis, which will accumulate in the liver and cause spleen and kidney deficiency over time.

[0031] Pathogenesis: liver qi stagnation, phlegm-dampness obstruction, spleen and kidney deficiency.

[0032] Treatment principle: Soothe the liver and eliminate accumulation, resolve phlegm and remove dampness, strengthen the spleen and benefit the kidneys.

[0033] Analysis of the formula of each medicinal flavor in the prescription: In the prescription of Hemp Seed and Lily Decoction, Hemp Seed belongs to the spleen, stomach, and large intestine meridians, has a sweet taste and a neutral nature, is rich in fat and moist, moisturizes the intestines and promotes bowel movements, nourishes and replenishes deficiency, promotes diuresis and reduces swelling, thereby eliminating accumulation and stagnation. Lily belongs to the heart and lung meridians, has a sweet taste and a cold nature, nourishes yin and moistens the lungs, clears the heart and calms the mind, and can also nourish the liver, replenish qi and promote qi, nourish the body and eliminate evil. Cistanche belongs to the kidney and large intestine meridians, has a sweet and salty taste, is warm in nature, moisturizes and lubricates the intestines, and nourishes the kidney and replenishes essence. Prunus mume belongs to the spleen, large intestine, and small intestine meridians, has a neutral nature, has a pungent, bitter, and sweet taste, moisturizes and lubricates the intestines, and promotes diuresis. Alisma orientalis belongs to the kidney and bladder meridians, has a sweet and light taste, is cold in nature, promotes diuresis and eliminates dampness, removes turbidity and reduces fat, and relieves heat. Ze Lan belongs to the liver and spleen meridians, has a bitter and pungent taste, is warm in nature, promotes blood circulation and regulates menstruation, removes blood stasis and eliminates carbuncle, promotes diuresis and reduces swelling. Curcuma belongs to the liver, heart and lung meridians, tastes pungent and bitter, is cold in nature, promotes qi and relieves depression, promotes blood circulation and relieves pain, clears the heart and cools the blood, and promotes bile and relieves jaundice. The synergistic effect of the various medicines can fully exert the therapeutic effects of soothing the liver and eliminating accumulation, resolving phlegm and removing dampness, strengthening the spleen and benefiting the kidneys, and promoting the flow of qi in the three burners, removing stagnation, and relieving various symptoms.

[0034] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0035] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0036] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0037] Example 1: Animal Experiment Part

[0038] 1. Experimental Materials

[0039] 1.1 Experimental animals

[0040] 40 C57BL / 6N male mice, weighing 22-24 g, SPF grade, were purchased from Zhejiang Weitonglihua Experimental Animal Technology Co., Ltd., with animal license number SCXK(Zhe)-2024-0001.

[0041] All animals were kept in a shielded animal room with constant temperature and humidity, 12 h of light and 12 h of dark each day, and were fed standard feed and had free access to drinking water.

[0042] 1.2 Animal feed

[0043] High-fat diet (D12108C) was purchased from Research Diets, Inc., USA, and contained 40% fat and 1.25% cholesterol.

[0044] 1.3 Drug preparation

[0045] (1) Hemp Seed and Lily Decoction (the Chinese medicine composition of the present invention): 9g of hemp seed, 6g of lily, 6g of turmeric, 6g of oriental rhizome, 6g of zedoaria, 6g of lily, 6g of prunes, 6g of prunes, 6g of cistanche deserticola, a total of 45g.

[0046] (2) Astragalus and Lily Decoction (comparative Chinese medicine composition): Astragalus 9g, Lily 6g, Curcuma 6g, Alisma 6g, Eupatorium 6g, Ophiopogon 6g, Cistanche 6g, totaling 45g.

[0047] 1.4 Decoction scheme

[0048] First, take 5 packets of the above prescription (a total of 225g), add 1500mL of distilled water and soak for 2h, boil it in a medicine pot over high heat, then simmer for 2h on low heat, filter out liquid A, add 1000mL of distilled water, boil it in the same way as above, filter out liquid B, mix liquid A and liquid B, concentrate it to 100mL using a rotary evaporator to obtain a Chinese medicine concentrate with a concentration of 2.25g / mL, and refrigerate it in a 4℃ refrigerator for later use.

[0049] 1.5 Animal grouping and intervention

[0050] After one week of adaptive feeding, SPF C57BL / 6N mice were divided into 5 groups according to body weight, namely, 10 normal control group, 10 fatty liver model group, 12 Maren Baihe Decoction group (45g / kg / d), 12 Huangqi Baihe Decoction group (45g / kg / d), and 12 metformin (200mg / kg / d) positive drug group. The normal control group was fed with ordinary feed, and the other groups were fed with high-fat feed. After 12 weeks of intervention, the mice were fasted for 12h, and the blood was taken and then killed by spinal dislocation. Liver tissue, inguinal fat tissue, epididymal fat tissue, small intestinal tissue and fecal samples were obtained by dissection. After the blood was allowed to stand, the serum was separated by centrifugation (3,500rpm, 4℃, 10min) and stored in a -80℃ refrigerator. Part of the liver tissue was fixed in 4% paraformaldehyde solution for 48h for morphological observation; the remaining liver tissue samples were quickly frozen in liquid nitrogen and stored at -80℃ for subsequent index determination.

[0051] 2. Results and Analysis

[0052] 2.1 Effect of Maren Baihe Decoction on Body Weight of Mice with Fatty Liver

[0053] like Figure 1 As shown, compared with the normal diet control group, the weight of mice treated with high-fat diet (HFD) increased significantly, and significant differences began to appear in the sixth week; the weight gain trend of mice in the Maren Baihe Decoction group slowed down significantly after treatment, and compared with the model group, significant differences began to appear in the sixth week; the weight gain trend of mice in the Huangqi Baihe Decoction group also slowed down significantly after treatment, and significant differences began to appear in the sixth week; the body weight reduction effect of the Maren Baihe Decoction group was significantly better than that of the Huangqi Baihe Decoction group.

[0054] 2.2 Effect of Maren Baihe Decoction on the Weight of Liver and Adipose Tissue in Fatty Liver Mice

[0055] Compared with the normal control group, the liver weight, inguinal fat weight and epididymal fat weight of the mice in the fatty liver model group increased significantly. After treatment, the liver weight and epididymal fat weight of the mice in the Maren Baihe Decoction group decreased, and the inguinal fat weight decreased significantly; the liver weight and inguinal fat weight of the mice in the Huangqi Baihe Decoction group decreased significantly, and the epididymal fat weight did not decrease significantly. However, the effect of Maren Baihe Decoction was significantly better than that of Huangqi Baihe Decoction ( Figure 2 ).

[0056] 2.3 Effect of Hemp Seed and Lily Decoction on Serum Biochemical Indexes in Fatty Liver Mice

[0057] Compared with the normal control group, the levels of ALT, AST and T-CHO in the serum of mice in the fatty liver model group were significantly increased. After treatment, both the Maren Baihe Decoction group and the Huangqi Baihe Decoction group could significantly reduce the above indicators, but the Maren Baihe Decoction was more effective than the Huangqi Baihe Decoction ( Figure 3 ).

[0058] 2.4 Effect of Hemp Seed and Lily Decoction on Hepatic Lipids in Fatty Liver Mice

[0059] like Figure 4 As shown, compared with the normal control group, the triglyceride level in the liver of mice in the fatty liver model group was significantly increased. After treatment, the triglyceride levels in the liver of mice in the Ma Ren Bai Lily Decoction group and the Huang Qi Bai Lily Decoction group were significantly decreased.

[0060] 2.5 Effect of Maren Baihe Decoction on Pathological Changes of Liver Tissue in Mice with Fatty Liver

[0061] like Figure 5 As shown in the figure, the liver cells in the normal control group had perfect morphology and orderly arrangement; the mice in the model group developed fatty degeneration and balloon-like fatty degeneration, liver cell damage and necrosis, inflammatory cell infiltration, and a large number of fat vacuoles. The Ma Ren Bai He Tang group significantly improved the above pathological changes, the fat vacuoles were significantly reduced, and the therapeutic effect was significant; compared with the model group, the fat vacuoles in the Huang Qi Bai He Tang group were reduced, and there was a certain degree of therapeutic effect, but the therapeutic effect of the Ma Ren Bai He Tang group was more significant than that of the Huang Qi Bai He Tang group.

[0062] 2.6 Effect of Hemp Seed and Lily Decoction on the Appearance of the Liver in Fatty Liver Mice

[0063] like Figure 6 As shown, the livers of mice in the normal control group were normal in size, bright red in color, and soft in texture; compared with the normal control group, the livers of the model group were significantly enlarged, light yellow in color, and brittle in texture, and the liver surface had an oily luster and granularity visible to the naked eye; compared with the model group, the liver color of mice in the Ma Ren Bai He Tang group was close to that of the normal control group, the liver volume was reduced, and the appearance of fatty degeneration was improved; the liver size of mice in the Huang Qi Bai He Tang group was also reduced, but the color was yellow, the surface had an oily luster, and the texture was granular; this shows that both Ma Ren Bai He Tang and Huang Qi Bai He Tang have therapeutic effects, and Ma Ren Bai He Tang has a better therapeutic effect.

[0064] 2.7 Effect of Maren Baihe Decoction on Pathological Changes of Adipose Tissue in Mice with Fatty Liver

[0065] like Figure 7As shown in the figure, compared with the normal control group, the size of epididymal fat and inguinal fat cells in the model group was significantly enlarged, while both Ma Ren Bai Li Decoction and Huang Qi Bai Li Decoction had a significant improvement on the size and morphology of fat cells, but the improvement effect of Ma Ren Bai Li Decoction was more significant than that of Huang Qi Bai Li Decoction.

[0066] Example 2: Representative clinical case section

[0067] Case 1:

[0068] Name: Fang Gender: Female Age: 36 years old.

[0069] Initial visit:

[0070] Chief complaint: Physical examination revealed fatty liver for one year.

[0071] Current medical history: The patient reported that physical examination revealed fatty liver, current weight 69kg, fatigue, heavy limbs, lack of exercise, sweating, good appetite, adequate sleep, good urination, sometimes dry stool, twice a day, menstrual cycle 30 days, normal quantity and color.

[0072] Past medical history: denied history of hypertension, heart disease, diabetes, etc., denied history of infectious diseases such as hepatitis and tuberculosis, denied history of drug or food allergies, denied history of blood transfusion during trauma surgery, denied history of smoking or drinking.

[0073] Family history: There are no patients with similar diseases in the family.

[0074] TCM diagnosis by observation, smell and palpation: clear mind, mental fatigue, gloomy complexion, fat body. Pale and fat tongue, greasy white fur, deep and slippery pulse.

[0075] Physical examination: Lung and heart auscultation were normal. Abdomen was soft, no tenderness, no rebound pain, liver and spleen were not below the ribs, no lower limb edema. Height: 159cm, Weight: 69kg, BMI: 27.29kg / m 2 , waist circumference: 92cm.

[0076] Auxiliary examination: cholesterol 3.99mmol / L; triglyceride 0.94mmol / L; low-density lipoprotein 2.1mmol / L; high-density lipoprotein 1.35mmol / L.

[0077] Initial diagnosis:

[0078] TCM diagnosis: fatty liver, phlegm-dampness obstruction syndrome.

[0079] Treatment principles for the first stage: Strengthen the spleen and regulate Qi, resolve phlegm and eliminate dampness.

[0080] The first phase of Chinese medicine formula: by weight, 9 parts of hemp seeds, 6 parts of lily, 6 parts of Cistanche deserticola, 6 parts of Prunus mume seeds, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0081] This patient has phlegm-dampness obstruction syndrome, so the treatment should focus on strengthening the spleen and regulating qi, resolving phlegm and removing dampness. Taking into account the mixture of deficiency and excess, and cold and heat, hemp seed, lily, and Prunus mume seed should be used heavily.

[0082] Directions: One dose per day, taken warm after meals in the morning and evening.

[0083] Care: Eat a balanced diet, eat light food, eat less rich and greasy food, and reduce the intake of sweets and ice drinks; exercise moderately, exercise regularly, and persevere, mainly with resistance exercise. Adjust your work and rest schedule.

[0084] Follow-up visit:

[0085] After taking the Chinese medicine decoction given during the initial visit for 28 days, a follow-up visit was conducted.

[0086] Chief complaint: Medical history is the same as before.

[0087] Current medical history: After taking one course of treatment, the patient's spirits improved, limb heaviness was relieved, fatigue and sweating were significantly improved, bowel movements increased, weight loss of 5kg, occasional fatigue and irritability symptoms, urination was normal, appetite and sleep were good.

[0088] Chinese medicine diagnosis by observation, auscultation and palpation: obese body, clear mind, pale complexion, pale tongue, greasy white tongue coating, deep pulse.

[0089] Physical examination: Generally good, no abnormalities in auscultation of the lungs and heart. Soft abdomen, no tenderness, no rebound pain, liver and spleen not below the ribs, no edema in the lower limbs. Height: 159cm, Weight: 64kg, BMI: 25.32kg / m 2 , waist circumference: 86cm.

[0090] The second stage of treatment principles: Strengthen the spleen and stomach, soothe the liver and regulate qi, resolve phlegm and eliminate dampness.

[0091] The second stage Chinese medicine formula: 9 parts of hemp seed, 6 parts of lily, 6 parts of Cistanche deserticola, 6 parts of Prunus mume, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0092] For this patient, a young woman, the treatment should focus on strengthening the spleen and nourishing the liver. The edema symptoms can be improved and the dosage of Prunus mume can be reduced.

[0093] Directions: One dose per day, taken warm after meals in the morning and evening.

[0094] Care: Eat a balanced diet, eat light food, eat less rich and greasy food, and reduce the intake of sweets and ice drinks; exercise moderately, exercise regularly, and persevere, mainly with resistance exercise. Adjust your work and rest schedule.

[0095] After the second phase (28 days) of treatment, the patient reported that his mental state had improved, his limb heaviness had improved significantly, his bowel movements were normal, his weight had dropped to 62 kg, his abdominal circumference had dropped to 84 cm, and his BMI was 24.52 kg / m2 . Auxiliary examination: cholesterol 3.75mmol / L; triglyceride 0.59mmol / L; low-density lipoprotein 1.95mmol / L; high-density lipoprotein 1.66mmol / L. Case 2:

[0096] Name: Cao Gender: Female Age: 46 years old.

[0097] Initial visit:

[0098] Chief complaint: Fatty liver was found for more than 1 year.

[0099] Current medical history: fatty liver was found more than 1 year ago, liver function was normal, easy to get sleepy, lack of energy, weak limbs, edema in the face when getting up in the morning, occasional abdominal distension, normal appetite, irregular bowel movements, sometimes dry and sometimes loose, no difference in urine, difficulty falling asleep, shallow sleep and easy awakening. Menstrual cycle is still regular, slightly darker in color, less than before, with a small amount of blood clots.

[0100] Past medical history: denied history of hypertension, heart disease, diabetes, etc., denied history of infectious diseases such as hepatitis and tuberculosis, denied history of drug or food allergies, denied history of blood transfusion during trauma surgery, denied history of smoking or drinking.

[0101] Family history: There is no history of genetic diseases in the family.

[0102] TCM diagnosis by observation, auscultation and palpation: clear mind, lack of energy, dull complexion, obese body. Pale and dark tongue, slightly greasy white fur, deep and fine pulse.

[0103] Physical examination: No abnormalities were found in auscultation of the heart and lungs. The abdomen was distended, soft to the touch, no tenderness, no rebound pain, liver and spleen were not palpated below the ribs, and there was no limb edema. Height: 160cm, Weight: 71kg, BMI: 27.73kg / m 2 , waist circumference: 92cm.

[0104] Auxiliary examination: cholesterol 4.36mmol / L; triglycerides 1.8mmol / L; low-density lipoprotein 2.72mmol / L; high-density lipoprotein 1.02mmol / L.

[0105] Initial diagnosis:

[0106] TCM diagnosis: fatty liver and spleen and kidney yang deficiency syndrome.

[0107] Treatment principles for the first stage: tonify Qi and strengthen the spleen, benefit the kidney and warm the Yang, resolve phlegm and eliminate turbidity.

[0108] The Chinese medicine formula for the first stage: 9 parts of hemp seed, 6 parts of lily, 6 parts of Cistanche deserticola, 6 parts of Prunus mume, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0109] The patient suffers from spleen and kidney yang deficiency as the root cause and phlegm and turbidity obstruction as the symptoms. The root is deficient and the symptoms are more severe. The treatment requires strengthening the spleen and kidney, replenishing fire and earth, resolving phlegm and eliminating turbidity. Therefore, seed kernel drugs are used to slow down the bowel movement, resolve phlegm and eliminate turbidity, while at the same time, warming yang and consolidating the root, and supporting the positive energy.

[0110] Directions: One dose per day, taken warm after meals in the morning and evening.

[0111] Care: Eat a balanced diet, eat less rich and greasy food, and reduce the intake of sweets and cold drinks; exercise regularly and persevere, focusing on resistance exercise.

[0112] Follow-up visit:

[0113] After taking the Chinese herbal decoction given during the initial visit for 28 days, a follow-up visit was conducted.

[0114] Chief complaint: Medical history is the same as before.

[0115] Current medical history: The patient has lost weight, his waist circumference has shrunk, he feels more energetic, facial edema has decreased, abdominal distension has improved, limbs no longer feel heavy, he has 2-3 slightly loose bowel movements per day, he feels relaxed after defecation, his appetite is good, he sleeps a little faster, but still sleeps lightly and has many dreams.

[0116] Chinese medicine diagnosis: clear mind, pale complexion, fat body. Pale and fat tongue with teeth marks on the edges, white fur, deep and fine pulse.

[0117] Physical examination: No abnormalities were found in auscultation of the heart and lungs. The abdomen was distended, soft to the touch, no tenderness, no rebound pain, liver and spleen were not palpated below the ribs, and there was no limb edema. Height: 160cm, Weight: 64kg, BMI: 25kg / m 2 , waist circumference: 84cm.

[0118] Auxiliary examination: cholesterol 4.53mmol / L; triglycerides 1.17mmol / L; low-density lipoprotein 2.79mmol / L; high-density lipoprotein 1.11mmol / L.

[0119] The second stage of treatment principles: Strengthen the spleen and eliminate dampness, benefit the kidney and warm the yang, resolve phlegm and eliminate turbidity.

[0120] The second phase of Chinese medicine formula: 9 parts of hemp seed, 6 parts of lily, 6 parts of Cistanche, 6 parts of Prunus mume, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0121] The patient is a perimenopausal woman, and the pathogenesis is characterized by deficiency of the root cause and excess of the symptoms. At this stage, the treatment should take into account both the root cause and the symptoms. The treatment method is the same as before, still using seed-based drugs to slow down the bowel movement, resolve phlegm and eliminate turbidity, while at the same time not forgetting to warm the yang and strengthen the foundation, and support the positive energy.

[0122] Directions: One dose per day, taken warm after meals in the morning and evening.

[0123] Maintenance: Eat a balanced diet, eat less rich and greasy food, and reduce the intake of sweets and cold drinks; exercise regularly and persevere, focusing on resistance exercise.

[0124] Case 3:

[0125] Name: Cao XX Gender: Female Age: 30 years old.

[0126] Initial visit:

[0127] Chief complaint: Physical examination revealed fatty liver for more than 3 months.

[0128] Current medical history: Physical examination revealed fatty liver for more than 3 months, with occasional fatigue, heaviness of limbs, less movement, no obvious abdominal distension, no sticky mouth, good appetite, bowel movement once a day, not smooth, sometimes dry and sometimes loose, no difference in urine, sleep late, good sleep quality. Recently, menstruation is regular, color is good, not much, with a small amount of blood clots.

[0129] Past medical history: history of polycystic ovary. Denied history of hypertension, heart disease, diabetes, infectious diseases such as hepatitis and tuberculosis, drug and food allergies, trauma surgery and blood transfusion, smoking and drinking.

[0130] Family history: There is no history of genetic diseases in the family.

[0131] Chinese medicine diagnosis by observation, smell and palpation: clear mind, less spirit, pale complexion, fat body. Pale and fat tongue with teeth marks on the edges, thick and greasy white fur, deep and smooth pulse.

[0132] Physical examination: No abnormalities were found in auscultation of the heart and lungs. The abdomen was distended, soft to the touch, no tenderness, no rebound pain, liver and spleen were not palpated below the ribs, and there was no limb edema. Height: 163cm, Weight: 80kg, BMI: 30.11kg / m 2 , waist circumference: 101cm.

[0133] Auxiliary examination: cholesterol 5.12mmol / L; triglycerides 1.35mmol / L; low-density lipoprotein 3.31mmol / L; high-density lipoprotein 1.65mmol / L.

[0134] Initial diagnosis:

[0135] TCM diagnosis: fatty liver with phlegm blocking and qi stagnation syndrome.

[0136] The first stage of treatment principles: regulating Qi, clearing the bowels, removing phlegm and reducing turbidity.

[0137] The Chinese medicine formula for the first stage: 9 parts of hemp seed, 6 parts of lily, 6 parts of Cistanche deserticola, 6 parts of Prunus mume, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0138] The patient has phlegm blocking qi and stagnant intestinal qi, so the treatment should be to regulate qi and clear the intestinal tract, remove phlegm and reduce turbidity. The pathogenesis is a combination of deficiency and excess, with excess being the main cause. Therefore, laxatives are used as the main treatment, supplemented by qi-regulating and dampness-removing drugs, so that phlegm and dampness can be eliminated through defecation and urination, and qi can flow smoothly.

[0139] Directions: One dose per day, taken warm after meals in the morning and evening.

[0140] Care: Eat a balanced diet, eat less rich and greasy food, and reduce the intake of sweets and cold drinks; exercise regularly and persevere, focusing on resistance exercise.

[0141] Follow-up visit:

[0142] After taking the Chinese herbal decoction given during the initial visit for 28 days, a follow-up visit was conducted.

[0143] Chief complaint: Medical history is the same as before.

[0144] Current medical history: The patient reported on follow-up that his weight had dropped by 8 kg after taking the medicine, his abdominal circumference had been significantly reduced, his fatigue had improved, his abdominal circumference had been reduced, his bowel movements were smooth, twice a day, his urine was normal, and his sleep was normal.

[0145] TCM diagnosis: clear mind, good spirit, pale complexion, fat body. Pale and fat tongue with teeth marks on the edges, thinning greasy coating, deep and smooth pulse.

[0146] Physical examination: No abnormalities were found in auscultation of the heart and lungs. The abdomen was distended, soft to the touch, no tenderness, no rebound pain, liver and spleen were not palpated below the ribs, and there was no limb edema. Height: 163cm, Weight: 72kg, BMI: 27.10kg / m 2 , waist circumference: 91cm.

[0147] Auxiliary examination: cholesterol 4.22mmol / L; triglycerides 0.59mmol / L; low-density lipoprotein 2.39mmol / L; high-density lipoprotein 1.6mmol / L.

[0148] The second stage of treatment principles: regulating Qi, clearing the bowels, removing phlegm and reducing turbidity.

[0149] The second stage Chinese medicine formula: 9 parts of hemp seed, 6 parts of lily, 6 parts of Cistanche deserticola, 6 parts of Prunus mume, 6 parts of Alisma orientalis, 6 parts of Zedoariae rhizome, and 6 parts of Curcuma aromatica.

[0150] The patient's phlegm and dampness were gradually eliminated, and the Qi flow was gradually unblocked, but there was still blockage, and the fundamental pathogenesis had not changed. The treatment should be the same as before, regulating Qi and clearing the bowels, removing phlegm and lowering turbidity. Therefore, the treatment should be mainly based on laxatives, supplemented by Qi-regulating and dampness-removing drugs, so that the phlegm and dampness can be eliminated through defecation and urination, and the Qi can flow smoothly.

[0151] Directions: One dose per day, taken warm after meals in the morning and evening.

[0152] Care: Eat a balanced diet, eat less rich and greasy food, and reduce the intake of sweets and cold drinks; exercise regularly and persevere, focusing on resistance exercise.

[0153] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for preventing or treating fatty liver associated with metabolic dysfunction and losing weight, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials by weight: 1-20 parts of hemp seeds, 1-20 parts of lilies, 1-20 parts of turmeric, 1-20 parts of oriental rhizome, 1-20 parts of zedoaria, 1-20 parts of prunes, 1-20 parts of prunes seeds and 1-20 parts of cistanche deserticola.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials by weight: 5-15 parts of hemp seeds, 1-10 parts of lily, 1-10 parts of turmeric, 1-10 parts of oriental rhizome, 1-10 parts of zedoaria, 1-10 parts of prunes, 1-10 parts of prunes seeds and 1-10 parts of cistanche deserticola.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 9 parts of hemp seeds, 6 parts of lily, 6 parts of curcuma, 6 parts of oriental water plantain, 6 parts of zedoaria, 6 parts of prunes, 6 parts of prunes seeds, and 6 parts of cistanche.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: crushing hemp seed, lily, turmeric, oriental rhizome, zedoaria, prunes, and cistanche deserticola, adding water for decoction, mixing filtrate, and concentrating to obtain concentrated solution.

5. The preparation method according to claim 4, characterized in that: The decoction is performed twice. After the first decoction for 1-3 hours, a primary filtrate is obtained by filtering. The filter residue is then decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

6. The preparation method according to claim 5, characterized in that: The decoction time for the first decoction and the second decoction are both 2 hours, and the water used for the first decoction and the second decoction are both distilled water; preferably, the concentration is reduced pressure concentration.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6 in the preparation of a medicament for preventing or treating fatty liver associated with metabolic dysfunction and for reducing weight.

8. The use according to claim 7, characterized in that: The metabolic dysfunction-associated fatty liver is non-alcoholic fatty liver disease.

9. The use according to claim 8, characterized in that: The non-alcoholic fatty liver disease is selected from one or more of the following: simple fatty liver, polycystic ovary syndrome combined with fatty liver, non-alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis or hepatocellular carcinoma.

10. The use according to claim 7, characterized in that: The medicine has the effects of soothing the liver and eliminating accumulation, resolving phlegm and removing dampness, and strengthening the spleen and kidney.

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