A traditional Chinese medicine composition for treating obesity and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating obesity and application. The traditional Chinese medicine composition comprises 4-8 parts of pericarpium citri reticulatae, 4-8 parts of fructus mume, 8-12 parts of dendrobium, 8-12 parts of lablab albumus, 13-17 parts of malt, 4-8 parts of hawthorn, 13-17 parts of buzhaye, and 1-5 parts of stevia rebaudiana. The traditional Chinese medicine composition has the following advantages: good curative effect on blood lipid abnormality, impaired glucose tolerance, especially fat metabolism abnormality caused by obesity, and can obviously improve the clinical symptoms of the obese patients; the traditional Chinese medicine composition has the effects of invigorating the spleen and eliminating fat, has no obvious damage to liver function, and has a protection function, and therefore, the safety is high. Therefore, the traditional Chinese medicine composition can be used for treating obesity.

Description

TECHNICAL FIELD

[0001] The present application relates to a traditional Chinese medicine composition solid beverage, in particular to a traditional Chinese medicine composition for treating obesity and application. BACKGROUND

[0002] Obesity is a chronic, recurrent and progressive disease. According to the 2024 World Obesity Report, there were 2.2 billion overweight or obese adults in 2020, accounting for 42% of the global population, and this proportion will exceed 54% in 2035. A cross-sectional real-world study of 15.8 million adults in China in 2023 showed that 34.8% of people were overweight and 14.1% were obese. According to the latest estimates of the 2024 Global Burden of Disease Study, 42 million deaths and 1.6 billion disability-adjusted life years globally each year are caused by the four non-communicable diseases of cancer, coronary heart disease, stroke and diabetes. Each of the above diseases is related to and exacerbated by overweight and obesity, and obesity has become a global public health challenge. Long-term weight management can use drug therapy as an adjunct in addition to low-calorie diet and increased physical activity. Clinical applications show that long-term use of weight loss drugs is necessary in long-term weight management, but the currently FDA-approved drugs have contraindications and adverse reactions, and their drug safety is a concern during the long period of use. For example, many studies have reported some side effects related to conventional therapy: gastrointestinal diseases caused by glucagon-like peptide analogue injection, and frequent gastrointestinal reactions caused by gastrointestinal lipase inhibitors. Efforts to find safe weight loss methods and drugs are still a medical problem in the world today. SUMMARY

[0003] The primary purpose of the present application is to overcome the shortcomings and deficiencies of the prior art and provide a traditional Chinese medicine composition for treating obesity.

[0004] Another purpose of the present application is to provide the use of the above-mentioned traditional Chinese medicine composition for treating obesity.

[0005] The purpose of the present application is achieved by the following technical solution: a traditional Chinese medicine composition for treating obesity, comprising the following components in parts by mass: 4-8 parts of pericarpium citri reticulatae, 4-8 parts of fructus mume, 8-12 parts of dendrobium, 8-12 parts of lablab albumus, 13-17 parts of malt, 4-8 parts of hawthorn, 13-17 parts of buzhaye, and 1-5 parts of stevia rebaudiana; preferably comprising the following components in parts by mass: 5-7 parts of pericarpium citri reticulatae, 5-7 parts of fructus mume, 9-11 parts of dendrobium, 9-11 parts of lablab albumus, 14-16 parts of malt, 5-7 parts of hawthorn, 14-16 parts of buzhaye, and 2-4 parts of stevia rebaudiana; more preferably comprising the following components in parts by mass: 6 parts of pericarpium citri reticulatae, 6 parts of fructus mume, 10 parts of dendrobium, 10 parts of lablab albumus, 15 parts of malt, 6 parts of hawthorn, 15 parts of buzhaye, and 3 parts of stevia rebaudiana.

[0006] The obesity is preferably simple obesity.

[0007] The malt is preferably roasted malt.

[0008] The Chinese medicine composition for treating obesity is used for preparing a preparation for treating obesity.

[0009] A preparation for treating obesity is prepared by the following steps: extracting the Chinese medicine composition for treating obesity, and preparing the desired dosage form from the obtained extract.

[0010] The extraction includes water extraction and supercritical extraction.

[0011] The water extraction is preferably as follows: soaking the Chinese medicine composition for treating obesity with water, then decocting, separating the solid from the liquid, obtaining the medicinal liquid and medicinal residue, repeatedly decocting the medicinal residue for 0 times or more, combining the obtained medicinal liquids to obtain the extract, and repeatedly decocting is for better extraction of the effective components of the Chinese medicine composition for treating obesity.

[0012] The amount of water is preferably calculated according to the ratio of the Chinese medicine composition for treating obesity: water = 1:2-1:15 (g:mL); more preferably according to the ratio of the Chinese medicine composition for treating obesity: water = 1:2-4 (g:mL).

[0013] The decocting time is preferably 30-60 min; more preferably 30-40 min.

[0014] The amount of water in the repeated decocting is preferably calculated according to the ratio of the Chinese medicine composition for treating obesity: water = 1:2-1:15 (g:mL); more preferably according to the ratio of the Chinese medicine composition for treating obesity: water = 1:2-4 (g:mL).

[0015] The repeated decocting time is preferably 30-60 min; more preferably 30-40 min.

[0016] The number of times of repeated decocting is preferably 1-3; more preferably 2.

[0017] The dosage form is preferably decoction, pill, powder, paste, pill, granule, oral liquid, capsule, tablet, injection.

[0018] The preparation includes ordinary preparation, sustained-release preparation, controlled-release preparation, targeted preparation, and microparticle drug delivery system.

[0019] The obesity is preferably simple obesity.

[0020] The method for using the preparation for treating obesity comprises the following steps: taking twice a day, taking again after six hours, and taking an appropriate amount of exercise one hour after taking the medicine, with a little sweat.

[0021] So far, the treatment of obese patients includes oral weight loss drugs (orlistat) and semeglu peptide injection, lidolu peptide injection, single drug treatment and combination therapy, and various obese people need to take medicine every day. The safety of long-term use of various weight loss drugs is a concern, especially the more obvious gastrointestinal reactions. The present application aims to expand the unique advantages of traditional Chinese medicine in the treatment of obesity in terms of lipid-lowering, low side effects, long-term safety and other aspects. Traditional Chinese medicine believes that the pathogenesis of obesity is mainly due to the deficiency of yangqi and excessive phlegm-dampness, and the disease is mainly located in the spleen and stomach. When the transportation and transformation function of the spleen and stomach is out of balance, it leads to problems in water metabolism, and then forms phlegm-dampness, and the blockage of phlegm-dampness leads to obesity. The inventor believes that the pathogenic factors of modern obesity are mainly due to the retention of exogenous pathogens, the accumulation of internal heat, the excessive consumption of fatty and sweet food, the lack of exercise, the excessive worry and thinking, the phlegm-dampness, blood stasis, emotional damage, internal disorder of qi, improper diet, and imbalance of the spleen and stomach; or the body is deficient, unable to expel pathogens, and the deficiency is caused by the excess, every time the body is affected by external pathogens, the body is in a state of imbalance, and the obesity is formed. According to the above pathogenesis, the inventor innovatively establishes the treatment method of "eliminating phlegm and dampness, and invigorating the spleen and food", and creates the Chenpi Jianpi Quqian Decoction. The decoction is composed of 4-8 parts of pericarpium citri reticulatae, 4-8 parts of prunus mume, 8-12 parts of dendrobium, 8-12 parts of lablab albumus, 13-17 parts of hordeum vulgare, 4-8 parts of crataegus pinnatifida, 13-17 parts of buzhaye, and 1-5 parts of stevia rebaudiana. The amount of pericarpium citri reticulatae in the decoction plays an important role in promoting qi, invigorating the spleen, and eliminating phlegm, so it is identified as the monarch drug. It and other drugs are combined to play the effects of eliminating phlegm and dampness and invigorating the spleen and food.

[0022] The three more and one less symptoms of modern obese patients are often not obvious, because the positive qi has not appeared obvious deficiency, and the four evils of phlegm, heat, wind and drink invade the human body without immediate disease, but are latent in the meridians, channels, five zang organs and six fu organs (mostly latent in the lung, spleen and kidney). The pericarpium citri reticulatae enters the lung and spleen meridians, clears and nourishes lung yin, is suitable for the latent syndrome of slight damage of lung yin, restores the function of lung by nourishing lung, and the lung meridian is unobstructed, so that the latent evils have no place to hide; the lung governs the skin and hair, so that the latent evils can be resolved. At the same time, it has the effects of benefiting the stomach and generating saliva, restores the function of the postnatal spleen and stomach, and removes the source of phlegm and drink, so as to play the role of clearing the source and strengthening the spleen to remove food. The dendrobium nobile benefits qi and strengthens the spleen, and can remove water and calm the heart, and can better restore the function of the spleen and stomach by combining with pericarpium citri reticulatae, and at the same time, it can remove water and wet from the body, and play the role of removing latent drink by clearing the source and strengthening the spleen. The lablab seed enters the lung, spleen and kidney meridians, and can deeply search and remove the latent wind in the channels. Phlegm and heat are the two factors (inducing factors) that easily induce latent evils and cause many symptoms in obesity. The prunus mume in the prescription can remove fire and detoxify, clear heat and dampness, and can remove the inducing factors of latent heat. Wind is the long of a hundred diseases, and often combines with dampness and heat evils to enter the channels. The lablab seed can remove the evils of wind, drink and heat, and can make the three evils disperse and excrete, and can be removed from the channels. At the same time, it is combined with pericarpium citri reticulatae to resolve latent evils. The resolving method is one of the important principles of latent evils, and the malt and sweet leaf chrysanthemum are warm and sweet, and can regulate the collaterals, and can regulate the ying and wei, and can remove the three evils of wind, drink and heat, and can resolve latent wind, latent phlegm, latent drink and latent heat. The hawthorn and buzhaye can clear heat and resolve phlegm, and can strengthen the spleen and remove food, and can remove the inducing factors of latent phlegm. The eight medicines together play the role of clearing the source and removing phlegm and dampness, so as to play the role of clearing and nourishing the lung, spleen and kidney, resolving latent evils in nothing, and removing the inducing factors of latent evils. At the same time, the obese mouse model is constructed by feeding high-fat feed, and the treatment effect of the prescription and the prepared prescription on obesity is investigated, and the experimental results show that the prescription can effectively reduce the body weight and fat content of high-fat fed mice, reduce the blood lipid level of obese mice, and improve the fatty liver disease of obesity.

[0023] The present application has the following advantages and effects compared with the prior art:

[0024] (1) The present application is the first to find that the pericarpium citri reticulatae spleen-qi-removing phlegm prescription has good curative effect on blood lipid abnormalities, impaired glucose tolerance, especially abnormal fat metabolism caused by obesity, and can significantly improve the clinical symptoms of obese patients.

[0025] (2) The pericarpium citri reticulatae spleen-qi-removing phlegm prescription provided by the present application has the effect of strengthening the spleen and removing fat, and has no obvious damage to liver function, and has a protective effect, so it is relatively safe.

[0026] (3) The pericarpium citri reticulatae spleen-qi-removing phlegm prescription provided by the present application mainly uses medicinal materials that are homologous to food, and pericarpium citri reticulatae itself has the effect of regulating qi and strengthening the spleen, and compared with western medicine weight loss drugs (such as semeglutide, orlistat, etc.), it has lower gastrointestinal adverse reactions, and can be taken for a long time, and has a broad application prospect in the field of obesity treatment.

[0027] (4) The Chenpi weight loss recipe provided by the application has better effect than other recipes, and has good performance in obesity treatment and effect maintenance.

[0028] (5) The preparation method provided by the application is made by decocting raw materials with water, and has the advantages of adapting to TCM syndrome differentiation and treatment, adding or subtracting according to symptoms, fast absorption, strong effect and long-term use without decline. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 is the body weight result graph of each group of mice at the 12th week after drug intervention; among them, ** represents p<0.01 compared with the model group; *** represents p<0.001 compared with the model group, and *** represents p<0.01 compared with the model group.

[0030] Figure 2 is the cholesterol (TC) level result graph of each group of mice at the 12th week after drug intervention; among them, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0031] Figure 3 is the low-density lipoprotein (LDL-C) level result graph of each group of mice at the 12th week after drug intervention; among them, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0032] Figure 4 is the alanine aminotransferase (ALT) level result graph of each group of mice at the 12th week after drug intervention; among them, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0033] Figure 5 is the aspartate aminotransferase (AST) level result graph of each group of mice at the 12th week after drug intervention; among them, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0034] Figure 6 is the creatinine (Cr) level result graph of each group of mice at the 12th week after drug intervention; among them, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0035] Figure 7Figure is the urea nitrogen (BUN) level result chart of each group of mice after 12 weeks of drug intervention; wherein, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0036] Figure 8 Figure is the white fat content chart of each group of mice after 12 weeks of drug intervention; wherein, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0037] Figure 9 Figure is the white fat index chart of each group of mice after 12 weeks of drug intervention; wherein, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0038] Figure 10 Figure is the liver HE staining morphology chart of each group of mice after 12 weeks of drug intervention.

[0039] Figure 11 Figure is the NAFLD score chart of each group of mice after 12 weeks of drug intervention; wherein, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group.

[0040] Figure 12 Figure is the epididymal white fat HE staining morphology chart of each group of mice after 12 weeks of drug intervention.

[0041] Figure 13 Figure is the epididymal white fat diameter statistical chart of each group of mice after 12 weeks of drug intervention; wherein, * represents p<0.05 compared with the model group, ** represents p<0.01 compared with the model group, and *** represents p<0.01 compared with the model group. DETAILED DESCRIPTION

[0042] The application will be further described in detail below in conjunction with the embodiments and the accompanying drawings, but the embodiments of the application are not limited thereto.

[0043] Example 1 Chenpi Jianpi Qu-tan Prescription for Obesity Prevention Pharmacodynamic Experiment of High-fat Diet Induced Mice

[0044] The high-fat diet-fed obesity model is a classic obesity model, which is simple, easy to form, high in fat content, and stable in weight gain. The main symptoms are high body weight, high fat content, and metabolic disorder, which is similar to the formation of human obesity in terms of etiology and pathological process. Therefore, the high-fat diet-induced obesity model can be used as an experimental obesity model. In this example, high-fat diet-induced obesity was used as an experimental disease model to investigate whether Chenpi Jianpi Qutan Decoction can delay the progression of obesity and evaluate the weight loss effect of Chenpi Jianpi Qutan Decoction by formulating the prescription and dose effect.

[0045] 1. Experimental materials

[0046] (1) Experimental animals

[0047] Forty-eight clean male C57BL / 6J mice, weighing 18±4 g, were purchased from Zhuhai Baisitong Biotechnology Co., Ltd. (License No. SCXK (Guangdong) 2020-0051). After 1 week of adaptive feeding, they were fed with high-fat diet (D124912) for 12 weeks, and at the same time, gavage administration was started. The experimental mice were raised in a barrier environment at the Animal Experiment Center of Guangzhou University of Chinese Medicine, and the experimental operation steps were carried out in accordance with the guidelines developed by the Animal Experiment Center of Guangzhou University of Chinese Medicine.

[0048] (2) Drug grouping

[0049] According to the source of the prescription, A group (Fructus Mume 7g, Dendrobium 11g, White Kidney Bean 11g, Fried Malt 16g, Hawthorn 7g, Buzha Leaf 16g, Sweet Leaf Chrysanthemum 3g) lacks the monarch drug "Cortex Citri Reticulatae", B group (Cortex Citri Reticulatae 8g, Fructus Mume 8g, White Kidney Bean 12g, Fried Malt 16g, Hawthorn 7g, Buzha Leaf 16g, Sweet Leaf Chrysanthemum 4g) lacks the ministerial drug "Dendrobium", and C group (Cortex Citri Reticulatae 6g, Fructus Mume 6g, Dendrobium 10g, White Kidney Bean 10g, Fried Malt 15g, Hawthorn 6g, Buzha Leaf 15g, Sweet Leaf Chrysanthemum 3g) is formulated according to the therapeutic principle of "eliminating phlegm and dampness, and invigorating the spleen and digesting food". All the above medicinal materials were purchased from Xingyuan Chun.

[0050] 2. Experimental methods

[0051] (1) Preparation of traditional Chinese medicine prescription

[0052] 1) Take the chopped traditional Chinese medicine decoction pieces of A and B groups, add water according to the solid-liquid ratio of 1:3 (g / mL), and decoct for 30-40 min to obtain the medicinal liquid and dregs. Repeat the step of adding water to decoct the dregs twice. After combining the medicinal liquids, filter and concentrate to 0.153 g / mL.

[0053] 2) Take the traditional Chinese medicine decoction pieces of C group according to step 1), filter and concentrate the medicinal liquid to 0.306 g / mL of crude drug amount, and then perform gradient half-dilution to obtain 0.153 g / mL (medium-dose medicinal liquid) and 0.0765 g / mL (low-dose medicinal liquid).

[0054] (2) Animal model establishment

[0055] All C57BL / 6J mice were adaptively fed for one week, and then randomly divided into 8 groups according to body weight, 6 mice in each group; except for 6 mice in the control group, the other groups were fed with high-fat diet for 12 weeks.

[0056] (3) Experimental grouping and administration

[0057] Select 6 mice in the control group (normal weight mice with regular feeding), and randomly divide the remaining 42 mice into model group, positive drug (orlistat) group, A group, B group, low-dose C group, medium-dose C group, and high-dose C group, 6 mice in each group. During the administration period, the mice were fed with high-fat diet. The control group was not intervened, and the model group was given the same amount of normal saline by gavage, and the other groups were given corresponding drug intervention (12.42 mL -1 ·kg -1 ·d -1 , wherein the positive drug group: orlistat 75 mg -1 ·kg -1 ·d -1 ; the A group is equivalent to 1.90 g -1 ·kg -1 ·d -1 of crude drug; the B group is equivalent to 1.90 g -1 ·kg -1 ·d -1 of crude drug; the C group: the low-dose group is equivalent to 0.95 g -1 ·kg -1 ·d -1 of crude drug, the medium-dose group is equivalent to 1.90 g -1 ·kg -1 ·d -1 of crude drug, and the high-dose group is equivalent to 3.80 g -1 ·kg -1 ·d -1 of crude drug. Continuous administration for 12 weeks, once a day.

[0058] (4) Detection method

[0059] 1) General observation

[0060] The general state of the mice, including the mental state of the mice, food intake, water intake, urine output, feces output, body weight, body hair, and activity. After administration, the general symptoms were observed continuously, and whether the animals had abnormal symptoms was observed.

[0061] 2) Determination of serum biochemical indicators

[0062] After the drug intervention ended, blood was collected from mice to obtain serum. The levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), liver function indicators alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and kidney function indicators creatinine (Cr) and blood urea nitrogen (BUN) in the upper serum were measured.

[0063] 3) Determination of white fat content

[0064] After the drug intervention ended, the mice were anesthetized and sacrificed. The inguinal white adipose tissue (iWAT), epididymal white adipose tissue (eWAT), and perirenal white adipose tissue (pWAT) were weighed and statistically analyzed.

[0065] 4) Staining of pathological sections

[0066] After the mice were sacrificed, portions of liver and epididymal adipose tissue were harvested, fixed, dehydrated, and embedded in paraformaldehyde. Tissue sections were then prepared and stained with hematoxylin and eosin (HE). Randomly selected fields of view from HE-stained liver sections were used to assess the non-alcoholic fatty liver disease (NAFLD) score of the mouse liver. The total NAFLD score ranged from 0 to 12, with higher numbers indicating more severe fatty degeneration. The diameter of adipocytes was measured based on HE staining of the epididymal adipose tissue.

[0067] (5) Statistical methods

[0068] Animal experiments were performed using a two-independent-samples t-test, with P < 0.05 indicating statistical significance.

[0069] 3. Results

[0070] (1) General observation

[0071] Throughout the experiment, the control group mice moved freely, ate and drank normally, had bright eyes, glossy fur, and a reddish, shiny tail. Their weight gradually increased, and their urine and fecal output were normal. They showed no signs of emaciation or abdominal distension and were in good spirits. The model group mice showed significantly increased food intake, water intake, and urine output. They began to exhibit fluffy, erect, disheveled, and dull fur, preferred to lie down and were less active, and experienced varying degrees of hair loss and weight gain. As shown in Table 1, after 12 weeks of drug administration, compared to the model group, the mice in each group had the same food intake, increased water intake, gradually improved spirits, and decreased weight. Figure 1As shown, after 12 weeks of high-fat diet feeding, the body weight of mice in the model group increased significantly. Compared with the model group, the body weight of mice in the high-dose and medium-dose groups of Formula C decreased significantly after administration (p<0.001). The low-dose groups of Formula B and Formula C, compared with the metformin group, showed significantly lower body weight (p<0.05), while Formula A showed the lowest efficacy. This indicates that Formula B and Formula C can effectively improve obesity caused by high-fat diet feeding, and the role of the principal ingredient, tangerine peel, is indispensable. Furthermore, Formula C showed better efficacy and a clear dose-response effect.

[0072] Table 1. Effects of Chenpi Jianpi Qiutan Formula and its proposed formula on diet and body weight in mice.

[0073]

[0074] (2) Blood lipid levels

[0075] The four lipid profiles include total cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL), and are commonly used to assess an individual's lipid metabolism levels. (See Table 2.) Figure 2 and Figure 3 As shown, the Chenpi Jianpi Qutan formula significantly prevented the increase of total cholesterol and low-density lipoprotein levels in mice fed a high-fat diet, and the efficacy was better at higher doses (p<0.001). From the results of each group, formula B reduced low-density lipoprotein levels in mice fed a high-fat diet, but neither formula A nor formula B improved total cholesterol levels (p>0.05), suggesting that the Chenpi Jianpi Qutan formula significantly improved lipid metabolism and was superior to the proposed formulas.

[0076] Table 2. Effects of the Chenpi Jianpi Qiutan Formula and its proposed formula on the levels of four lipid parameters in mice.

[0077]

[0078] (3) Influence of liver and kidney function indicators

[0079] See Table 3. Figures 4-7 The results of liver and kidney function indicators in mice showed that the Chenpi Jianpi Qutan Decoction and its proposed formulas A and B could reduce the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in mice fed a high-fat diet (p<0.05). This indicates that the Chinese herbs in the Chenpi Jianpi Qutan Decoction have a good liver-protective effect and can improve fatty liver lesions caused by lipid metabolism disorders. The changes in creatinine and blood urea nitrogen levels were not statistically different (p>0.05), indicating that the Chenpi Jianpi Qutan Decoction has high safety and no effect on kidney function.

[0080] Table 3. Effects of the Chenpi Jianpi Qiutan Formula and its proposed formula on liver and kidney function in mice.

[0081]

[0082] (4) White fat content

[0083] The white fat content in vivo of mice after 12 weeks of administration is shown in Table 4, Figures 8-9 The results show that the white fat content in the inguinal white fat, epididymal white fat and perirenal white fat of mice in the Chenpi Jianpi Qutan Decoction group and the Formulated Formula B group was maintained at a low level compared with the model group (p<0.05); the statistical results of the total white fat content and the white fat index of mice showed that the Chenpi Jianpi Qutan Decoction could significantly reduce the white fat content of high-fat diet mice, and there was a dose effect; the white fat content and the white fat index of mice in the Formulated Formula A group had no statistical difference compared with the model group (p>0.05), while the white fat content and the white fat index of mice in the Formulated Formula B group decreased (p<0.05). The results show that the Chenpi Jianpi Qutan Decoction and the Formulated Formula B can both reduce the white fat content of high-fat diet mice, and the effect of the Chenpi Jianpi Qutan Decoction is more significant (p<0.001).

[0084] Table 4 Effect of the Chenpi Jianpi Qutan Decoction and its Formulated Formula on the fat tissue content of mice

[0085]

[0086]

[0087] (5) Nonalcoholic fatty liver-like lesions and adipocyte morphology

[0088] 1) NAFLD score

[0089] Nonalcoholic fatty liver disease (NAFLD) is a metabolic stress-induced liver injury closely related to insulin resistance, and is a common complication in obese patients. After administration, the effect of nonalcoholic fatty liver-like lesions in mice in each group is shown in Table 5 and Figure 10 The results show that the liver of the model group mice showed obvious fat infiltration, and a large number of hepatocyte ballooning degeneration and parenchymal steatosis were observed under the microscope. As shown in Table 5 and Figure 11 The NAFLD score of the model group mice also increased significantly. However, compared with the model group, the medium dose group and the high dose group of the Chenpi Jianpi Qutan Decoction significantly improved the liver steatosis and reduced the NAFLD score (p<0.05). However, the Formulated Formula A and B could not improve the fatty liver-like lesions of high-fat diet mice, and the NAFLD score had no statistical difference (p>0.05).

[0090] Table 5 Effect of the Chenpi Jianpi Qutan Decoction and its Formulated Formula on the nonalcoholic fatty liver-like lesions of mice

[0091]

[0092] 2) fat cell diameter

[0093] Fat cells, which are the main component of adipose tissue, are specialized in storing fat as energy, and the degree of obesity depends on the size of the fat droplets in each fat cell. After feeding the mice for 12 weeks, the diameter of the epididymal white fat of each group of mice was detected, and the results of HE staining are shown in FIG. 2. The fat cell diameter of the model group with high-fat diet was significantly increased, indicating that a large amount of lipid droplets was contained in the cells. Figure 12 Figure 13 The analysis results show that, compared with the model group, the fat cell diameter of the mice in the Chenpi Jianpi Qutan prescription and the proposed prescription B group is significantly reduced (p<0.05), while the fat cells of the mice in the proposed prescription A group do not have statistical difference (p<0.05).

[0094] Table 6 Effect of Chenpi Jianpi Qutan prescription and its proposed prescription on fat cell diameter of mice

[0095]

[0096]

[0097] 4. Conclusion

[0098] From the experimental results, it can be seen that the high-fat diet mouse model has obvious weight gain, blood lipid abnormalities, liver fat-like lesions and other symptoms, and the quality of life of the mice is significantly decreased. Chenpi Jianpi Qutan prescription can improve the body weight, blood lipid abnormalities, non-alcoholic fatty liver-like lesions and hypertrophy of fat cells of high-fat diet mice, and its efficacy is better than that of the related proposed prescription. In addition, Chenpi Jianpi Qutan prescription has a significant dose effect, and the efficacy of the high-dose group is significantly higher than that of the low-dose group.

[0099] The results show that: Chenpi Jianpi Qutan prescription water extract can improve the body weight, blood lipid abnormalities, non-alcoholic fatty liver-like lesions and hypertrophy of fat cells of high-fat diet mice, and has a certain protective effect on liver, which provides a basis for Chenpi Jianpi Qutan prescription in the treatment of obesity, and Chenpi Jianpi Qutan prescription is expected to develop into a new generation of drugs for the treatment of obesity.

[0100] Conclusion: After years of exploration, the inventors found that Chenpi Jianpi Qutan prescription has potential value in the treatment of obesity. The inventors selected simple obesity with a very high incidence for animal experiment research. The research results suggest that Chenpi Jianpi Qutan prescription water extract has reliable curative effect in the treatment of high-fat diet obese mice, and has the characteristics of high safety, which is worthy of further drug research and development.

[0101] ​The above embodiments are the preferred embodiments of the present application, but the embodiments of the present application are not limited to the above embodiments, and any changes, modifications, substitutions, combinations, simplifications, etc. made without departing from the spirit and principles of the present application should be equivalent replacement manners and should be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating obesity, characterized in that It is composed of the following ingredients in parts by mass: Chenpi 4-8 parts, Wumei 4-8 parts, Shihua 8-12 parts, Baibian Dou 8-12 parts, Maiya 13-17 parts, Shanzha 4-8 parts, Busheye 13-17 parts, Tianyeku 1-5 parts.

2. The traditional Chinese medicine composition for treating obesity according to claim 1, characterized in that It is composed of the following ingredients in parts by mass: Chenpi 5-7 parts, Wumei 5-7 parts, Shihua 9-11 parts, Baibian Dou 9-11 parts, Maiya 14-16 parts, Shanzha 5-7 parts, Busheye 14-16 parts, Tianyeku 2-4 parts. 3.The traditional Chinese medicine composition for treating obesity according to claim 1 or 2, characterized in that: The obesity is simple obesity. The Maiya is fried Maiya. 4.The use of the traditional Chinese medicine composition for treating obesity according to any one of claims 1-3 in the preparation of a preparation for treating obesity.

5. A formulation for the treatment of obesity, characterized in that The preparation is prepared by the following steps: extracting the traditional Chinese medicine composition for treating obesity according to any one of claims 1-3, and preparing the desired dosage form from the obtained extract.

6. The preparation for use in the treatment of obesity according to claim 5, characterized in that: The extraction is water extraction or supercritical extraction. 7.The preparation for treating obesity according to claim 6, characterized in that: The water extraction is performed by the following steps: soaking the traditional Chinese medicine composition for treating obesity in water, then decocting, separating the solid and the liquid, obtaining the medicinal liquid and the medicinal residue, repeatedly decocting the medicinal residue for 0 times or more, and combining the obtained medicinal liquids to obtain the extract. 8.The preparation for treating obesity according to claim 7, characterized in that: The amount of water is calculated according to the ratio of the traditional Chinese medicine composition for treating obesity to water 1:2-1:15 (g:mL) ; The decocting time is 30-60 min; The amount of water in the repeated decocting is calculated according to the ratio of the traditional Chinese medicine composition for treating obesity to water 1:2-1:15 (g:mL) ; The repeated decocting time is 30-60 min; The number of repeated decocting is 1-3 times. 9.The preparation for treating obesity according to claim 5, characterized in that: The dosage form is a decoction, a pill, a powder, a paste, a pill, a granule, a capsule or a tablet.

10. The formulation for the treatment of obesity according to claim 5, characterized in that: The preparation is selected from a general preparation, a sustained-release preparation, a controlled-release preparation, a targeted preparation or a micro-particle drug delivery system.

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