Traditional Chinese medicine composition for treating obesity as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating obesity. The invention also provides a traditional Chinese medicine extract and a preparation method thereof. The invention further provides a traditional Chinese medicine preparation. The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the traditional Chinese medicine preparation in preparation of medicines for treating obesity. According to the traditional Chinese medicine composition for treating obesity and the preparation method and application of the traditional Chinese medicine composition, the obesity treatment principle of tonifying qi, accumulating qi and removing turbidity is provided, the traditional Chinese medicine composition can obviously reduce the body weight and body fat mass of obese patients, improve the traditional Chinese medicine syndromes of the patients and effectively treat spleen deficiency and dampness accumulation and heat depression non-transforming type overweight / obesity, and meanwhile, the traditional Chinese medicine composition is good in safety and free of toxic and side effects. The traditional Chinese medicine has no influence on liver and kidney of a patient and has no adverse reaction.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating obesity and a preparation method and application thereof. BACKGROUND

[0002] Under the influence of multiple factors such as unhealthy lifestyle, environment and society, the prevalence of obesity is increasing year by year. According to the 2025 World Obesity Map, the global obesity population will be about 1.13 billion by 2030, and the number of overweight / obese adults in China will reach 515 million. As a risk factor for type 2 diabetes, metabolic-related fatty liver disease and cardiovascular disease, overweight / obesity will affect the occurrence and development of related diseases, increase the social and economic burden, and also bring higher mortality and disability rate. Therefore, active intervention and treatment of overweight / obesity are conducive to improving the quality of life of patients, relieving the economic burden, and reducing the incidence and mortality of related diseases.

[0003] At present, lifestyle intervention is still the first choice for the treatment of obesity, but the weight loss effect is poor by this method alone. Drugs such as semaglutide and tirzepatide have obvious weight loss effect and considerable cardiovascular benefits, but some patients still have resistance due to common gastrointestinal reactions such as nausea, vomiting and constipation. Traditional Chinese medicine has good effect in the treatment of obesity due to its unique theoretical system and rich clinical experience. Therefore, it is necessary to study and explore. SUMMARY

[0004] In view of the shortcomings of the prior art described above, the purpose of the present application is to provide a traditional Chinese medicine composition for treating obesity and a preparation method and application thereof. The obesity treatment principle of "benefiting qi, dispersing accumulation and removing turbidity" is proposed, which can significantly reduce the body weight and body fat of obese patients.

[0005] To achieve the above object and other related objects, the first aspect of the present application provides a traditional Chinese medicine composition for treating obesity, which comprises the following raw material components by weight:

[0006] Radix Astragali 20-40 parts by weight;

[0007] Smilax 20-40 parts by weight;

[0008] Giant Knotweed 5-25 parts by weight;

[0009] Alisma 1-20 parts by weight;

[0010] Coptis 1-10 parts by weight;

[0011] Herba Artemisiae Scopariae 5-25 parts by weight;

[0012] Typha Angustifolia Pollen 5-25 parts by weight.

[0013] The second aspect of the present application provides a traditional Chinese medicine extract, which is prepared by extracting the traditional Chinese medicine composition of the first aspect of the present application.

[0014] The third aspect of the present application provides a preparation method of the traditional Chinese medicine extract, which comprises: mixing the components of the traditional Chinese medicine composition of the first aspect of the present application according to the ratio, and then extracting the mixture by water decoction method.

[0015] The fourth aspect of the present application provides a traditional Chinese medicine preparation, which comprises a therapeutically effective amount of the traditional Chinese medicine composition of the first aspect of the present application, or a therapeutically effective amount of the traditional Chinese medicine extract of the second aspect of the present application, and one or more conventional pharmaceutically acceptable adjuvants.

[0016] The fifth aspect of the present application provides the use of the traditional Chinese medicine composition of the first aspect of the present application, the traditional Chinese medicine extract of the second aspect of the present application, or the traditional Chinese medicine preparation of the fourth aspect of the present application in the preparation of a medicament for treating obesity.

[0017] As described above, the present application provides a traditional Chinese medicine composition for treating obesity, and a preparation method and application thereof. In combination with the traditional Chinese medicine theory that "the spleen governs transformation", and the pathological mechanism and characteristic performance of obesity that the adipocyte is dysfunctional and visceral fat is excessively accumulated, the present application proposes the treatment principle of obesity that "benefiting qi, transforming accumulation and removing turbidity". The traditional Chinese medicine composition can significantly reduce the body weight and body fat of the obese patients, improve the TCM syndromes of the patients, and effectively treat the overweight / obesity of the patients with spleen deficiency and dampness accumulation, and heat stagnation and incoordination. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 FIGS. 6A and 6B show the curve graph and comparative bar graph A, B of the reduction of the body weight of the ob / ob obese mice by the traditional Chinese medicine composition of the present application in Test Example 2. FIG. 6A is a curve graph of the change of the body weight of different mice within 6 weeks of treatment, and FIG. 6B is a comparative bar graph of the body weight of different mice after 6 weeks of treatment. In the figures, Model represents the control mouse group, Orlistat represents the mouse group fed with Orlistat, YQHJQZ-L represents the mouse group fed with a low-dose traditional Chinese medicine extract 1*, and YQHJQZ-H represents the mouse group fed with a high-dose traditional Chinese medicine extract 1*. **: p < 0.01; ***: p < 0.001.

[0019] Figure 2A comparative bar chart showing the effect of the traditional Chinese medicine composition of the present application on reducing the weight of the inguinal white adipose tissue of ob / ob obese mice in Test Example 2, which is a comparative bar chart of the weight of the iWAT of mice in different groups after 6 weeks of treatment, wherein iWAT is the inguinal white adipose tissue of mice, ob / ob group is the control mouse group, Orlistat group is the mouse group fed with orlistat, Low group is the mouse group fed with low-dose traditional Chinese medicine extract 1*, and High group is the mouse group fed with high-dose traditional Chinese medicine extract 1*, **: p < 0.01.

[0020] Figure 3 A comparative bar chart showing the effect of the traditional Chinese medicine composition of the present application on reducing the weight of the epididymal white adipose tissue of ob / ob obese mice in Test Example 2, which is a comparative bar chart of the weight of the eWAT of mice in different groups after 6 weeks of treatment, wherein eWAT is the epididymal white adipose tissue of mice, ob / ob group is the control mouse group, Orlistat group is the mouse group fed with orlistat, Low group is the mouse group fed with low-dose traditional Chinese medicine extract 1*, and High group is the mouse group fed with high-dose traditional Chinese medicine extract 1*, **: p < 0.01.

[0021] Figure 4 A comparative bar chart showing the effect of the traditional Chinese medicine composition of the present application on the weight of the brown adipose tissue of ob / ob obese mice in Test Example 2, which is a comparative bar chart of the weight of the BAT of mice in different groups after 6 weeks of treatment, wherein BAT is the brown adipose tissue of mice, ob / ob group is the control mouse group, Orlistat group is the mouse group fed with orlistat, Low group is the mouse group fed with low-dose traditional Chinese medicine extract 1*, and High group is the mouse group fed with high-dose traditional Chinese medicine extract 1*. DETAILED DESCRIPTION

[0022] Before further describing the specific embodiments of the present application, it should be understood that the scope of protection of the present application is not limited to the following specific embodiments; it should also be understood that the terms used in the embodiments of the present application are for the purpose of describing the specific embodiments, and are not intended to limit the scope of protection of the present application. The test methods in the following examples, if not specified, are generally carried out under conventional conditions, or under the conditions recommended by the manufacturers.

[0023] The first aspect of the present application provides a traditional Chinese medicine composition for treating obesity, comprising the following raw material components by weight:

[0024] Radix Astragali 20-40 parts by weight; specifically, 20-25 parts, 25-35 parts, 35-40 parts;

[0025] Radix Pseudostellariae 20-40 parts by weight; specifically, 20-25 parts, 25-35 parts, 35-40 parts;

[0026] Polygonum cuspidatum 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0027] Alisma orientale 1-20 parts by weight; specifically, 1-5 parts, 5-15 parts, 15-20 parts;

[0028] Rhizoma Coptidis 1-10 parts by weight; specifically, 1-4 parts, 4-8 parts, 8-10 parts;

[0029] Herba Artemisiae Scopariae 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts;

[0030] Pollen Typhae 5-25 parts by weight; specifically, 5-10 parts, 10-20 parts, 20-25 parts.

[0031] In the present application, the Astragalus is the dried root of Astragalus membranaceus or Astragalus membranaceus var. mongholicus, and has the effects of tonifying qi and raising yang, consolidating surface and stopping sweating, promoting water excretion and reducing swelling, supporting pus discharge and promoting tissue regeneration.

[0032] In the present application, the Radix Pseudostellariae is the dried rhizome of Smilax glabra, and has the effects of detoxification, dampness elimination and joint lubrication.

[0033] In the present application, the Polygonum cuspidatum is the dried rhizome and root of Polygonum cuspidatum, and has the effects of dampness elimination, heat clearing and detoxification, stasis-removing and pain-relieving, cough relieving and phlegm reducing.

[0034] In the present application, the Alisma orientale is the dried tuber of Alisma orientale, and has the effects of water excretion and dampness elimination.

[0035] In the present application, the Rhizoma Coptidis is the dried rhizome of Coptis chinensis, Coptis deltoidea or Coptis teeta, and has the effects of heat clearing and dampness eliminating, fire purging and detoxification.

[0036] In the present application, the Herba Artemisiae Scopariae is the dried aboveground part of Artemisia scoparia or Artemisia capillaris, and has the effects of dampness-heat clearing, gallbladder-heat clearing and jaundice relieving.

[0037] In the present application, the Pollen Typhae is the dried pollen of Typha angustata, Typha orientalis or the same genus plants, and has the effects of astringency and hemostasis, blood-activating and stasis-removing, diuresis and stranguria relieving.

[0038] The above-mentioned raw medicinal materials (or medicinal materials) used in the present application can be purchased from ordinary medicine stores or Chinese medicinal material sales companies, and their specifications meet the national medicine standards or relevant provisions of Chinese Pharmacopoeia, and are all in the category directory of the original State Health Department.

[0039] The traditional Chinese medicine composition for treating obesity in the application fully follows the principle of syndrome differentiation and treatment of traditional Chinese medicine, combines the traditional Chinese medicine theory that "spleen governs transformation", and the pathological mechanism and characteristic performance of obesity of adipocyte dysfunction and excessive accumulation of visceral fat, takes "benefiting qi, transforming and removing turbidity" as the treatment principle of obesity, wherein, Astragalus root benefits qi and strengthens the spleen, promotes the operation of the middle jiao pivot, helps the spleen to scatter essence, and promotes qi transformation, and is the monarch drug. Smilax ripariana clears heat and removes toxicity, removes dampness and swelling; Giant knotweed removes heat and dampness, resolves stasis and removes mass; Alisma rhizome removes dampness and promotes water excretion; The three drugs are combined to remove dampness, clear heat, transform and remove mass, and disperse fat accumulation, and are the minister drugs. Coptis clears heat and removes dampness; Chinese wormwood removes dampness and resolves heat stagnation; The two drugs help the minister drugs to transform and remove mass, and are the auxiliary drugs. Pulsatilla is a blood system drug and also functions in the qi system, and can clear heat, remove dampness, and remove stasis, and is the minister drug. The combination of the drugs makes the middle jiao pivot smooth, restores qi transformation, removes dampness, heat and blood stasis, and enables essence and substance to be normally generated and distributed, so that the synergistic effect of treating diseases can be achieved, and the state of "spleen deficiency and failure to transform, and fat turbidity accumulation" of obesity can be improved.

[0040] In a preferred embodiment of the application, the traditional Chinese medicine composition comprises the following raw material components by weight:

[0041] Astragalus root 25-35 parts; for example, 25 parts, 30 parts, 35 parts, and preferably 30 parts;

[0042] Smilax ripariana 25-35 parts; for example, 25 parts, 30 parts, 35 parts, and preferably 30 parts;

[0043] Giant knotweed 10-20 parts; for example, 10 parts, 15 parts, 20 parts, and preferably 15 parts;

[0044] Alisma rhizome 5-15 parts; for example, 5 parts, 10 parts, 15 parts, and preferably 10 parts;

[0045] Coptis 4-8 parts; for example, 4 parts, 6 parts, 8 parts, and preferably 6 parts;

[0046] Chinese wormwood 10-20 parts; for example, 10 parts, 15 parts, 20 parts, and preferably 15 parts;

[0047] Pulsatilla 10-20 parts; for example, 10 parts, 15 parts, 20 parts, and preferably 15 parts.

[0048] The second aspect of the application provides a traditional Chinese medicine extract, which is prepared by extracting the traditional Chinese medicine composition described in the first aspect of the application.

[0049] The third aspect of the application provides a preparation method of the traditional Chinese medicine extract, which comprises: mixing the raw material components of the traditional Chinese medicine composition described in the first aspect of the application according to the ratio, and obtaining a mixture, and then extracting the mixture by water decoction method.

[0050] In a preferred embodiment of the present application, the water decoction method comprises: first boiling the mixture after water immersion with strong fire until boiling, then boiling with weak fire, filtering, concentrating the obtained extract, and drying into powder to provide the traditional Chinese medicine extract.

[0051] In a further preferred embodiment of the present application, the water amount added to the mixture is 2-3 cm higher than the top surface of the mixture. According to the water absorption of the medicinal materials, the water amount added is ensured to be 2-3 cm higher than the top surface of the mixture.

[0052] In a further preferred embodiment of the present application, the water immersion time of the mixture is 25-30 minutes.

[0053] In a further preferred embodiment of the present application, the boiling temperature of the strong fire is 150-220℃.

[0054] In a further preferred embodiment of the present application, the boiling temperature of the weak fire is 80-120℃.

[0055] In a further preferred embodiment of the present application, the boiling time of the weak fire is 25-35 minutes.

[0056] In a further preferred embodiment of the present application, the filtering is a conventional filtering mode, such as filter screen filtering, filter cloth filtering, etc., preferably filter screen filtering, which is mainly used for removing impurities and requires no residue of medicinal dregs.

[0057] In a further preferred embodiment of the present application, the mesh number of the filter screen is not less than 100 meshes, preferably 100-120 meshes.

[0058] In a further preferred embodiment of the present application, the concentration is reduced pressure concentration, and the concentration is to 1.0-2.0 g crude drug / 5 mL.

[0059] In a further preferred embodiment of the present application, the drying is spray drying, and the drying conditions are: inlet air temperature is 150-180℃; liquid inlet speed is 400-500 mL / min; atomization pressure is 1.0-1.2 bar; and outlet air temperature is 80-120℃.

[0060] The fourth aspect of the present application provides a traditional Chinese medicine preparation, which comprises a therapeutically effective amount of the traditional Chinese medicine composition provided in the first aspect of the present application, or a therapeutically effective amount of the traditional Chinese medicine extract provided in the second aspect of the present application, and one or more conventional pharmaceutically acceptable adjuvants.

[0061] Pharmaceutically acceptable excipients include, but are not limited to, pharmaceutically acceptable carriers, diluents, fillers, binders, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and other excipients. Therapeutically inert inorganic or organic carriers known to those of skill in the art include, but are not limited to, lactose, corn starch or derivatives thereof, talc, vegetable oils, waxes, fats, polyols such as polyethylene glycols, water, sucrose, ethanol, glycerol, and the like, various preservatives, lubricants, dispersing agents, flavoring agents, humectants, antioxidants, sweeteners, colorants, stabilizers, salts, buffers, and the like, which are employed as needed to facilitate the stability of the formulation or to improve the delivery or bioavailability of the active agent.

[0062] In a preferred embodiment of the present application, the dosage form of the traditional Chinese medicine preparation includes, but is not limited to, tablets, capsules, pills, syrup, granules, powder, paste, dripping pills, suspension or emulsion, preferably granules.

[0063] The traditional Chinese medicine preparation in the above-mentioned various dosage forms can be prepared by conventional methods. The traditional Chinese medicine preparation of the present application can also be used together with other therapeutic agents.

[0064] The therapeutically effective amount in the present application is, based on the total weight of the raw medicinal material, and the specific dosage should also consider the route of administration, patient health status and other factors, which are within the skill of a skilled physician.

[0065] The fifth aspect of the present application provides the use of the traditional Chinese medicine composition provided in the first aspect of the present application, the traditional Chinese medicine extract provided in the second aspect of the present application, or the traditional Chinese medicine preparation provided in the fourth aspect of the present application in the preparation of a medicament for treating obesity.

[0066] In a preferred embodiment of the present application, the syndrome type of obesity is spleen deficiency and dampness accumulation, or heat stagnation and non-elimination syndrome.

[0067] The present application is further described below in conjunction with specific embodiments, which should be understood as merely illustrating the present application and not limiting the scope of protection of the present application.

[0068] The embodiments of the present application are described below by specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the disclosure of the present specification. The present application can also be implemented or applied by other different specific embodiments, and various modifications or changes can be made to the details in the present specification based on different viewpoints and applications without departing from the spirit of the present application.

[0069] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art.

[0070] Unless otherwise specified, the production processes, experimental methods, or testing methods involved in the embodiments and comparative examples of this invention are all conventional methods in the prior art, and their names and / or abbreviations are all conventional names in the art, which are very clear and distinct in the relevant application fields. Those skilled in the art can understand the conventional process steps based on the names and apply the corresponding equipment to implement them according to conventional conditions or conditions recommended by the manufacturer.

[0071] The various instruments, equipment, raw materials, or reagents used in the embodiments of this invention are not subject to any special restrictions on their source; they are all conventional products that can be purchased through legitimate commercial channels and can be prepared according to conventional methods known to those skilled in the art. Unless otherwise specified, the sources of cells, animals, and drugs involved in the embodiments of this invention are all commercially available.

[0072] Example 1

[0073] The raw material components of a traditional Chinese medicine composition for treating obesity were taken as follows: Astragalus membranaceus 30g, Smilax glabra 30g, Polygonum cuspidatum 15g, Alisma plantago-aquatica 10g, Coptis chinensis 6g, Artemisia capillaris 15g, and Typha orientalis 15g, to obtain sample 1# of the traditional Chinese medicine composition.

[0074] Example 2

[0075] The raw material components of a traditional Chinese medicine composition for treating obesity were taken as follows: Astragalus membranaceus 25g, Smilax glabra 35g, Polygonum cuspidatum 10g, Alisma plantago-aquatica 15g, Coptis chinensis 4g, Artemisia capillaris 20g, and Typha orientalis 10g, to obtain sample 2# of the traditional Chinese medicine composition.

[0076] Example 3

[0077] The raw material components of a traditional Chinese medicine composition for treating obesity were taken as follows: Astragalus membranaceus 15g, Smilax glabra 25g, Polygonum cuspidatum 20g, Alisma plantago-aquatica 8g, Coptis chinensis 8g, Artemisia capillaris 12g, and Typha orientalis 18g, to obtain sample 3# of the traditional Chinese medicine composition.

[0078] Example 4

[0079] The traditional Chinese medicine composition sample 1# of Example 1 was mixed according to the proportion, and then the effective components were extracted by water decoction method. Specifically, the mixture was soaked for 28 minutes after adding water to 2.5 cm above the top surface of the mixture, and then boiled by strong fire at 200℃, and then boiled by weak fire at 100℃ for 30 minutes. The mixture was filtered by a 100-mesh filter screen, and the extract was concentrated under reduced pressure to 1.6g crude drug / 5mL. Then, the extract was spray dried into powder to obtain the traditional Chinese medicine extract sample 1*. The spray drying conditions were as follows: the inlet air temperature was 150℃; the liquid inlet speed was 500mL / min; the atomization pressure was 1.2bar; and the outlet air temperature was 90℃.

[0080] Example 5

[0081] The traditional Chinese medicine composition sample 1# of Example 1 was mixed according to the proportion, and then the effective components were extracted by water decoction method. Specifically, the mixture was soaked for 30 minutes after adding water to 3 cm above the top surface of the mixture, and then boiled by strong fire at 180℃, and then boiled by weak fire at 120℃ for 32 minutes. The mixture was filtered by a 120-mesh filter screen, and the extract was concentrated under reduced pressure to 2.0g crude drug / 5mL. Then, the extract was spray dried into powder to obtain the traditional Chinese medicine extract sample 2*. The spray drying conditions were as follows: the inlet air temperature was 180℃; the liquid inlet speed was 400mL / min; the atomization pressure was 1.0bar; and the outlet air temperature was 110℃.

[0082] Test Example 1

[0083] 1. Case selection

[0084] 1.1 Patient information

[0085] Seventy-six patients with spleen deficiency and dampness accumulation and heat stagnation who visited the outpatient and inpatient departments of the Department of Endocrinology of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from May 2024 to December 2024 were randomly divided into a test group and a control group, with 38 patients in each group. This study has been approved by the Ethics Committee of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Ethics Number: 2024-7th-HIRB-039).

[0086] 1.2 Diagnostic criteria

[0087] (1) Western diagnostic criteria:

[0088] Reference: Expert Consensus on Obesity Prevention and Control for Chinese Residents, published by the Obesity Prevention and Control Branch of the Chinese Nutrition Society in 2022 [2] The diagnostic criteria for overweight and obesity were established: according to the body mass index (BMI), overweight was defined as 24.0kg / m 2 ≤BMI<28.0kg / m 2 , and obesity was defined as BMI≥28.0kg / m 2 .

[0089] (2) TCM syndrome type diagnostic criteria:

[0090] (2.1) TCM diagnostic criteria for obesity:

[0091] Reference "Obesity" chapter of "Internal Medicine" (New Century 2nd Edition) is defined as a kind of disease caused by excessive accumulation of body fat due to various reasons, abnormal increase in body weight, and symptoms such as dizziness, fatigue, lazy speech, and shortness of breath.

[0092] (2.2) TCM diagnostic criteria for spleen deficiency and dampness accumulation, heat stagnation and non- transformation syndrome:

[0093] Reference "TCM Clinical Diagnosis and Treatment Terminology Part 2: Syndromes" published by the National Health Commission, main symptoms: head and body are heavy, limbs are sore, abdominal distension, sticky or loose stools, less food, poor appetite, thirst, sticky or bitter mouth, repeated pustules on the edge of the eyelid, like a grain of rice, red, swollen, itchy and painful; tongue and pulse: red tongue, yellow and greasy fur, soft and slippery pulse. 1 main symptom, 2 secondary symptoms or 2 main symptoms, 1 secondary symptom and corresponding tongue and pulse can be diagnosed.

[0094] 1.3 Inclusion criteria

[0095] (1) No gender limit, 18-65 years old at the time of informed consent;

[0096] (2) BMI ≥ 24.0 kg / m 2 ;

[0097] (3) Meet the diagnostic criteria for TCM obesity, spleen deficiency and dampness accumulation, heat stagnation and non- transformation syndrome;

[0098] (4) Within 3 months, reduce weight by less than 5% through lifestyle improvement (according to patient's self- report), body weight change formula = (highest weight in the last 3 months- lowest weight) / highest weight * 100%;

[0099] (5) If the subject has added weight loss, blood sugar lowering, lipid lowering, uric acid lowering drugs within 1 month before enrollment, the subject can be enrolled in the study after 3 months of drug metabolism and weight stabilization. If the subject has used weight loss, blood sugar lowering, lipid lowering, uric acid lowering drugs for more than 3 months before enrollment, the dose is stable and the weight is stable, the subject can be enrolled in the study;

[0100] (6) Fully understand, understand and comply with the requirements of this study and sign the informed consent form.

[0101] 1.4 Exclusion criteria

[0102] (1) Diagnosed as secondary obesity in the past, including but not limited to Cushing's syndrome, hypothalamic obesity, pituitary obesity, hypothyroid obesity, etc.

[0103] (2) Using drugs such as glucocorticoids that obviously cause weight gain, and the drug dose is not fixed;

[0104] (3) Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times the upper limit of the normal range;

[0105] (4) Impaired renal function, defined as serum creatinine ≥ 133 μmol / L (male), serum creatinine ≥ 125 μmol / L (female) or CKD-EPI formula estimated eGFR ≤ 60 ml / min / 1.73m 2 ;

[0106] (5) Pregnant, lactating, planning to get pregnant women or women of childbearing age who do not use adequate contraceptive measures;

[0107] (6) Combined with severe primary diseases of circulatory system, digestive system, respiratory system, nervous system, urogenital system and hematopoietic system, etc;

[0108] (7) Combined with diabetic acute complications such as ketoacidosis, hyperglycemic hyperosmolar state or lactic acidosis;

[0109] (8) Patients with mental illness;

[0110] (9) Known or suspected to be allergic to the test drug, or unable to tolerate known side effects.

[0111] 1.5 Exclusion criteria

[0112] (1) Not cooperating with randomization;

[0113] (2) Poor compliance, not taking the required medication;

[0114] (3) Other conditions considered by the investigator to be excluded.

[0115] 1.6 Termination of study criteria

[0116] (1) Severe adverse reactions occurred during the study;

[0117] (2) Withdrawn voluntarily for any reason during the study;

[0118] (3) Self-use of other drugs during the study affects the observation index.

[0119] 2. Treatment plan

[0120] 2.1 Basic treatment

[0121] Diet, exercise therapy: reference to the 2022 Chinese Nutrition Society Obesity Prevention Branch released "Chinese residents obesity prevention expert consensus", by the nutritionist of Shanghai University of Traditional Chinese Medicine Affiliated the Seventh People's Hospital according to the standard body weight of patients to guide the diet and exercise, the total energy intake of two groups of patients under the premise of control design balanced diet, 1 day total energy (Kcal) = (height-105) *25, keep daily intake of protein energy ratio 20%-25%, fat energy ratio is 20%-30%, carbohydrate energy ratio is 45%-60%; 3-5 times per week moderate intensity exercise (equivalent to 61%-70% of maximum heart rate, maximum heart rate = 220-age), each duration 30-45 minutes.

[0122] 2.2 Treatment method of each group

[0123] Test group: on the basis of basic treatment, give the sample 1* prepared in example 4 of traditional Chinese medicine extract, prepare it into 9g / bag, take 1 bag after breakfast and dinner, take for 12 weeks.

[0124] Control group: on the basis of basic treatment, cooperate with oral placebo, placebo is a granular preparation with similar appearance, taste and specification as sample 1* of traditional Chinese medicine extract prepared in example 4, made with excipient, food colorant, etc., take 1 bag after breakfast and dinner, take for 12 weeks.

[0125] The preparation of granules of test group and control group is strictly in accordance with "Chinese Pharmacopoeia" 2020 edition preparation general 0104 granules, two groups of patients maintain the original drug treatment scheme during the test and follow up once every 4 weeks.

[0126] 3, observation index

[0127] 3.1 efficacy index

[0128] 3.1.1 primary efficacy index

[0129] The change of BMI and body weight relative to baseline before and after treatment, the number of people whose body weight decreased more than 5% and 10% than baseline.

[0130] 3.1.2 secondary efficacy index

[0131] 3.1.2.1 anthropometric index

[0132] The change of waist circumference and hip circumference relative to baseline before and after treatment.

[0133] 3.1.2.2 human composition

[0134] The change of body fat mass, body fat rate, muscle mass, muscle rate, visceral fat area and subcutaneous fat area relative to baseline before and after treatment.

[0135] Note: Muscle rate = muscle mass / body weight*100%; subcutaneous fat area was measured by Omron HDS-2000 fat area detector, and the rest of the indicators were measured by SELVAS Healthcare GAIAKIKO human body composition analyzer.

[0136] 3.1.2.3 Metabolic related indicators

[0137] Blood glucose: fasting plasma glucose (FPG), fasting insulin (FINS), fasting C-peptide (FC-P), glycosylated hemoglobin (HbA1c), homeostasis model assessment of insulin resistance index (HOMA-IR), homeostasis model assessment of beta cell function index (HOMA-beta);

[0138] Blood lipids: total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense low-density lipoprotein (sdLDL), apolipoprotein B (ApoB), apolipoprotein E (ApoE), free fatty acids (FFA);

[0139] Serum uric acid (SUA);

[0140] Blood pressure: systolic blood pressure, diastolic blood pressure;

[0141] Changes in the above metabolic related indicators of patients before and after treatment relative to baseline.

[0142] Note: HOMA-IR = FPG (mmol / L) x FINS (μU / mL) / 22.5; HOMA-beta = [20 x FINS (μIU / mL)] / [FPG (mmol / L) - 3.5]

[0143] 3.1.3 Traditional Chinese medicine efficacy evaluation indicators

[0144] According to the changes of the scores of the main symptoms and secondary symptoms of TCM syndromes before and after treatment, the semi-quantitative grading scoring evaluation method was used, i.e. according to the four grades of none, mild, moderate and severe, the main symptoms were scored as 0, 2, 4 and 6 points, and the secondary symptoms were scored as 0, 1, 2 and 3 points, respectively. The corresponding scores were evaluated before and after treatment. According to the Guiding Principles for the Clinical Study of New Drugs of Traditional Chinese Medicine, the evaluation criteria for the efficacy of traditional Chinese medicine are as follows:

[0145] Marked effect: the TCM clinical symptoms and signs are obviously improved, and the syndrome efficacy rate after treatment is ≥70%;

[0146] Effective: the TCM clinical symptoms and signs are improved, and the syndrome efficacy rate after treatment is ≥30% and <70%;

[0147] No effect: the TCM clinical symptoms and signs are not obviously improved, or even aggravated, and the syndrome efficacy rate after treatment is <30%.

[0148] Note: Syndrome efficacy rate = (total score before treatment - total score after treatment) / total score before treatment * 100%; Overall syndrome efficacy rate = (number of patients with marked effect + number of patients with effect) / total number of patients * 100%.

[0149] 3.2 Safety indicators

[0150] Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DBIL), γ-glutamyl transpeptidase (γ-GT);

[0151] Renal function: blood urea nitrogen (BUN), creatinine (Cr), estimated glomerular filtration rate (eGFR) estimated by CKD-EPI formula;

[0152] Symptoms, time of occurrence and degree of adverse reactions.

[0153] 3.3 Other indicators

[0154] Changes in non-control eating, cognitive restriction eating, emotional eating and total score of the Three factor eating questionnaire (TFEQ-R21) before and after treatment compared with baseline.

[0155] 3.4 Adverse reaction judgment and treatment

[0156] Adverse event severity classification: mild: tolerable by the subject, no impact on intelligence, no special treatment required, no impact on the health of the subject; moderate: difficult for the subject to tolerate, requiring drug withdrawal or special treatment, having a direct impact on the recovery of the subject; severe: endangering the life of the subject, causing death or disability, requiring immediate drug withdrawal or emergency treatment.

[0157] Serious adverse event definition: causing death; threatening life; causing hospitalization or prolonging hospitalization; causing persistent or severe disability / loss of ability; causing congenital abnormalities or birth defects; important medical events (such as those that may affect the subject and may require drugs / surgery to prevent the above results).

[0158] 4. Statistical analysis

[0159] Statistical analysis was performed using SPSS 25.0 software. Measurement data conforming to normal distribution were expressed as mean ± standard deviation [(X ± S)], and t-test was used for comparison between groups; measurement data not conforming to normal distribution were expressed as median and quartile [M(P 25 , P 75 )], and Mann-Whitney U test was used for comparison between groups. For measurement data of pre- and post-treatment differences conforming to normal distribution, paired t-test was used for comparison within groups; for measurement data of pre- and post-treatment differences not conforming to normal distribution, paired design sign rank sum test was used for comparison within groups. Count data were expressed as cases (%) and χ2test was used for comparison between groups, with Bonferroni method for multiple comparisons. P<0.05 was considered to have statistically significant difference.

[0160] 5. Research results

[0161] A total of 77 patients meeting the criteria were included in this study, including 39 cases in the experimental group and 38 cases in the control group. During the experiment, 2 cases in the experimental group were lost to follow-up, 5 cases dropped out, 3 cases in the control group were lost to follow-up, and 4 cases dropped out. The reasons for dropping out were all due to the patients' voluntary withdrawal and failure to take the required medication. One patient in the experimental group was excluded. Finally, 62 patients were included, with 31 cases in the experimental group and 31 cases in the control group.

[0162] 5.1 General data comparison

[0163] 5.1.1 Comparison of gender, age, smoking history, family history between the two groups of patients

[0164] The test group included 31 patients, including 13 males and 18 females, with an average age of (38.23±8.22) years; the control group included 31 patients, including 14 males and 17 females, with an average age of (42.03±11.28) years. There were no statistically significant differences in gender composition, age, history of smoking and drinking, and family history between the two groups (P>0.05), indicating that the data were comparable. See Table 1 below for details.

[0165] Table 1 Comparison of gender, age, history of smoking and drinking, and family history between the two groups

[0166]

[0167]

[0168] 5.1.2 Comparison of previous medical history and concomitant medication between the two groups

[0169] There were no statistically significant differences in previous medical history and concomitant medication between the two groups (P>0.05), indicating that the data were comparable. Among the two groups, the most common comorbidities were hyperlipidemia (74.2%), hyperuricemia (37.1%), hypertension (33.9%), and type 2 diabetes (32.3%); in terms of concomitant medication, the most commonly used drugs were metformin (32.3%), glucagon-like peptide-1 receptor agonist (GLP-1RA) (29.0%), statins (24.2%), angiotensin-converting enzyme inhibitors / angiotensin II receptor antagonists (ACEI / ARB) (21.0%), and calcium channel blockers (CCB) (16.1%). See Table 2 below for details.

[0170] Table 2 Comparison of previous medical history and concomitant medication between the two groups

[0171]

[0172]

[0173] 5.2 Comparison of efficacy indicators

[0174] 5.2.1 Primary efficacy indicators

[0175] 5.2.1.1 Comparison of BMI and body weight between the two groups before and after treatment

[0176] In terms of BMI and body weight, inter-group comparison showed that the body weight of the test group was higher than that of the control group before treatment (P<0.05), and there was no statistical difference in BMI between the two groups, and there was no statistical difference in BMI and body weight of the two groups after treatment (P>0.05); the intra-group comparison showed that the BMI and body weight of the two groups after treatment were lower than those before treatment (P<0.05). The difference before and after treatment showed that the BMI and body weight reduction of the test group were more than those of the control group (P<0.05). See Table 3 below for details.

[0177] Table 3 Comparison of BMI and body weight of patients in the two groups before and after treatment

[0178]

[0179] Note: a Intra-group comparison, P<0.05

[0180] 5.2.1.2 Comparison of the number of patients whose body weight decreased by more than 5% and 10% than baseline after treatment in the two groups

[0181] In terms of the number of patients whose body weight decreased by more than 5% than baseline, χ 2 test showed that the test group was more than the control group (P=0.020); in terms of the number of patients whose body weight decreased by more than 10% than baseline, the corrected χ 2 test showed that there was no statistical difference between the two groups (P>0.05). See Table 4 below for details.

[0182] Table 4 Comparison of the number of patients whose body weight decreased by more than 5% and 10% than baseline after treatment in the two groups

[0183]

[0184] 5.2.2 Secondary efficacy indicators

[0185] 5.2.2.1 Comparison of anthropometric indicators of patients in the two groups before and after treatment

[0186] In terms of anthropometric indicators, inter-group comparison showed that there was no statistical difference in waist circumference and hip circumference of the two groups before and after treatment (P>0.05); intra-group comparison showed that the waist circumference and hip circumference of the two groups after treatment were lower than those before treatment (P<0.05). The difference before and after treatment showed that the waist circumference reduction of the test group was more than that of the control group (P=0.001). See Table 5 below for details.

[0187] Table 5 Comparison of anthropometric indicators of patients in the two groups before and after treatment

[0188]

[0189] Note: a Intra-group comparison, P<0.05

[0190] 5.2.2.2 Comparison of human body composition between the two groups before and after treatment

[0191] In terms of human body composition, the comparison between the groups showed that the body fat mass of the test group was higher than that of the control group before treatment (P<0.05), and there was no statistically significant difference in body fat rate, muscle mass, muscle rate, visceral fat area, and subcutaneous fat area (P>0.05). After treatment, there was no statistically significant difference in each index (P>0.05). The intragroup comparison showed that the body fat mass, body fat rate, muscle mass, and visceral fat area of the test group decreased, and the muscle rate increased compared with before treatment (P<0.05). The muscle mass of the control group decreased compared with before treatment (P<0.05), and there was no statistically significant difference in the remaining indexes (P>0.05). The comparison of the difference before and after treatment showed that the decrease in body fat mass and subcutaneous fat area of the test group was greater than that of the control group (P<0.05), and there was no statistically significant difference in the difference of the remaining indexes (P>0.05). See Tables 6, 7, and 8 below for details.

[0192] Table 6 Comparison of body fat mass and body fat rate between the two groups before and after treatment

[0193]

[0194] Note: a Intragroup comparison, P<0.05

[0195] Table 7 Comparison of muscle mass and muscle rate between the two groups before and after treatment

[0196]

[0197]

[0198] Note: a Intragroup comparison, P<0.05

[0199] Table 8 Comparison of visceral fat area and subcutaneous fat area between the two groups before and after treatment

[0200]

[0201] Note: a Intragroup comparison, P<0.05; due to the partial absence of subcutaneous fat area data before treatment, the number of people included in this index was 25 cases in the test group and 26 cases in the control group.

[0202] 5.2.2.3 Comparison of metabolic-related indexes between the two groups before and after treatment

[0203] 5.2.2.3.1 Comparison of blood glucose indexes between the two groups before and after treatment

[0204] In terms of blood glucose indicators, inter-group comparison showed that there was no statistical difference in FPG, HbA1c, FINS, FC-P, HOMA-IR and HOMA-β between the two groups before treatment (P>0.05), and HOMA-β was higher in the test group than in the control group after treatment (P<0.05); intra-group comparison showed that HbA1c decreased in the test group compared with before treatment (P<0.05), and the rest of the indicators had no statistical difference. Comparison of the difference before and after treatment showed that the decrease of each indicator before and after treatment had no statistical difference in the two groups (P>0.05). See Tables 9, 10 and 11 below for details.

[0205] Table 9 Comparison of FPG and HbA1c before and after treatment in the two groups

[0206]

[0207]

[0208] Note: a Intra-group comparison, P<0.05

[0209] Table 10 Comparison of FINS and FC-P before and after treatment in the two groups

[0210]

[0211] Table 11 Comparison of HOMA-IR and HOMA-β before and after treatment in the two groups

[0212]

[0213] 5.2.2.3.2 Comparison of blood lipid indicators before and after treatment in the two groups

[0214] In terms of blood lipid indicators, inter-group comparison showed that TG and SdLDL were higher in the test group than in the control group before treatment (P<0.05), and there was no statistical difference in TC, HDL-C, LDL-C, FFA, ApoB and ApoE (P>0.05), and there was no statistical difference in each indicator after treatment (P>0.05); intra-group comparison showed that HDL-C and FFA were higher in the test group than before treatment, and ApoE was lower than before treatment (P<0.05), and HDL-C and FFA were higher in the control group than before treatment (P<0.05), and there was no statistical difference in the rest of the indicators in the two groups. Comparison of the difference before and after treatment showed that the decrease of each indicator before and after treatment had no statistical difference in the two groups (P>0.05). See Tables 12, 13, 14 and 15 below for details.

[0215] Table 12 Comparison of TC and TG before and after treatment in the two groups

[0216]

[0217] Table 13 Comparison of HDL-C and LDL-C of two groups of patients before and after treatment

[0218] Note: a Intra-group comparison, P<0.05

[0219] Table 14 Comparison of FFA and SdLDL of two groups of patients before and after treatment

[0220]

[0221] Note: a Intra-group comparison, P<0.05

[0222] Table 15 Comparison of ApoB and ApoE of two groups of patients before and after treatment

[0223]

[0224]

[0225] Note: a Intra-group comparison, P<0.05

[0226] 5.2.2.3.3 Comparison of blood uric acid of two groups of patients before and after treatment

[0227] In terms of blood uric acid, both inter-group comparison and intra-group comparison suggested that there was no statistical difference between before and after treatment of two groups (P>0.05), and the difference before and after treatment was also not statistically different (P>0.05). See Table 16 below for details.

[0228] Table 16 Comparison of SUA of two groups of patients before and after treatment

[0229]

[0230] 5.2.2.3.4 Comparison of blood pressure of two groups of patients before and after treatment

[0231] In terms of blood pressure, inter-group comparison suggested that there was no statistical difference in systolic pressure, diastolic pressure and difference before and after treatment of two groups (P>0.05); intra-group comparison suggested that the systolic pressure and diastolic pressure of the test group after treatment were lower than those before treatment (P<0.05), and the systolic pressure of the control group after treatment had no difference compared with that before treatment, and the diastolic pressure was lower than that before treatment (P<0.05). Comparison of the difference before and after treatment found that the blood pressure of two groups before and after treatment had no statistical difference (P>0.05). See Table 17 below for details.

[0232] Table 17 Comparison of blood pressure of two groups of patients before and after treatment

[0233]

[0234]

[0235] Note: a Intragroup comparison, P<0.05

[0236] 5.2.3 TCM efficacy indicators

[0237] 5.2.3.1 Comparison of TCM syndrome scores between the two groups before and after treatment

[0238] In terms of TCM syndrome scores, the intergroup comparison showed that there was no statistically significant difference in TCM syndrome scores between the two groups before treatment (P>0.05); after treatment, the TCM syndrome scores of the test group were lower than those of the control group (P<0.01). Intragroup comparison showed that the TCM syndrome scores of the two groups decreased after treatment (P<0.05), as shown in Table 18 below.

[0239] Table 18 Comparison of TCM syndrome scores between the two groups before and after treatment

[0240]

[0241] Note: a Intragroup comparison, P<0.05

[0242] 5.2.3.2 Comparison of syndrome efficacy rates between the two groups before and after treatment

[0243] In terms of syndrome efficacy rates, the proportion of patients with marked efficacy in the test group (45.2%) was higher than that in the control group, and the proportion of patients with no efficacy in the test group (12.9%) was lower than that in the control group; the overall effective rate of the test group was 87.1%, and that of the control group was 38.7%, with statistically significant difference (P<0.01). Details are shown in Table 19 below.

[0244] Table 19 Comparison of syndrome efficacy rates between the two groups before and after treatment

[0245]

[0246]

[0247] Note: The total number of effective patients is the sum of the number of patients with marked efficacy and the number of patients with efficacy; Bonferroni method was used for multiple comparisons, and P<0.05 compared with the control group.

[0248] 5.2.4 Comparison of safety indicators

[0249] 5.2.4.1 Comparison of liver function between the two groups before and after treatment

[0250] In terms of liver function, inter-group comparison showed that the test group had higher γ-GT than the control group before treatment (P<0.05), and there was no statistically significant difference after treatment, and there was no statistically significant difference in other indicators before and after treatment (P>0.05); the intra-group comparison showed that the test group had lower γ-GT after treatment than before treatment (P<0.05), and there was no difference in other indicators before and after treatment in the two groups (P>0.05). See Tables 20, 21 and 22 below for details.

[0251] Table 20 Comparison of ALT and AST of patients in the two groups before and after treatment

[0252]

[0253] Table 21 Comparison of ALP and TBIL of patients in the two groups before and after treatment

[0254]

[0255] Table 22 Comparison of DBIL and γ-GT of patients in the two groups before and after treatment

[0256]

[0257]

[0258] Note: a P<0.05 for intra-group comparison

[0259] 5.2.4.2 Comparison of renal function of patients in the two groups before and after treatment

[0260] In terms of renal function, inter-group comparison showed that the test group had lower BUN than the control group, and there was no statistically significant difference in Cr and eGFR, and after treatment, the test group had lower BUN and higher eGFR than the control group, and the difference was statistically significant (P<0.05); the intra-group comparison showed that the test group had lower Cr and higher eGFR than before treatment, and the control group had lower Cr than before treatment (P<0.05), and there was no statistically significant difference in other indicators in the two groups. See Table 23 below for details.

[0261] Table 23 Comparison of BUN, Cr and eGFR of patients in the two groups before and after treatment

[0262]

[0263] Note: a P<0.05 for intra-group comparison

[0264] 5.2.4.3 Adverse reaction symptoms, occurrence time and degree of patients in the two groups

[0265] In terms of adverse reactions, no serious adverse reactions occurred in the test group and the control group. The common adverse symptoms were mainly gastrointestinal discomfort, manifested as hiccup, diarrhea, and acid reflux. The symptoms occurred 2-3 days after starting medication, were mild, and improved spontaneously without special treatment. See Table 24 below for details.

[0266] Table 24 Adverse reactions of patients in the two groups

[0267]

[0268]

[0269] 5.2.4.4 Other indicators

[0270] In terms of appetite scores, the comparison between the two groups showed that there was no statistically significant difference in non-controlled eating, cognitive restriction eating, emotional eating, and total appetite scores before and after treatment (P>0.05). The comparison within the groups showed that the non-controlled eating scores were lower than before treatment, and the cognitive restriction eating scores were higher than before treatment (P<0.05). See Table 25 below for details.

[0271] Table 25 Comparison of appetite scores of patients in the two groups

[0272]

[0273] Note: a Intragroup comparison, P<0.05

[0274] Test Example 2

[0275] 1. Animal experiment design

[0276] Male ob / ob mice were purchased from Janvier Labs (Shanghai, China). Five-week-old male mice (body weight: 20 ± 2 g) were maintained in a standard environment at 22-24 °C, with a 12:12 h light-dark cycle, humidity (65% ± 5%), and free access to standardized food and filtered water ad libitum. After one week of acclimatization, different treatments were given. The mice treated with normal saline were used as the control group, the mice treated with orlistat (30 mg / kg) were used as the positive control group, and the mice treated with low-dose traditional Chinese medicine extract 1 (YQHJQZ-L, 15.73 g / kg) and high-dose traditional Chinese medicine extract 1 (YQHJQZ-H, 62.92 g / kg) were defined as the treatment groups. Each group was administered by gavage. Thirty-two ob / ob male mice were randomly divided into four groups: 1) normal chow diet (NCD) + normal saline group (n = 8); 2) NCD + orlistat (30 mg / kg) group (n = 8); 3) NCD + YQHJQZ low dose (15.73 g / kg) group (n = 8); 4) NCD + YQHJQZ high dose (62.92 g / kg) group (n = 8). The above doses were the doses of orlistat and YQHJQZ dissolved in normal saline. A total of six weeks of treatment, with weekly weighing. After 6 weeks, the mice were fasted overnight, free water was given, and white adipose tissue (WAT) and brown adipose tissue (BAT) were taken after anesthesia, weighed, and recorded.

[0277] 2. Results of the experiment

[0278] 2.1 YQHJQZ reduces the body weight of ob / ob mice

[0279] After feeding ob / ob mice with orlistat and different doses of YQHJQZ, the body weight of mice in the orlistat group and the YQHJQZ group was lower than that of the control group from the second week, and was lower than that of the control group within 6 weeks (see Fig. 1A). After six weeks of treatment, the body weight of mice in the orlistat group and the different doses of YQHJQZ group was significantly lower than that of the model group (see Fig. 1B). Figure 1 Figure 1

[0280] 2.2 YQHJQZ reduces the weight of white adipose tissue in ob / ob mice

[0281] After 6 weeks, the white adipose tissue (WAT) and brown adipose tissue (BAT) of each group of mice were weighed and analyzed. It was found that compared with the model group, the weight of the inguinal white adipose tissue (iWAT) of mice in the orlistat group, the YQHJQZ-L group and the YQHJQZ-H group was significantly reduced (see Fig. 2), and the weight of the epididymal white adipose tissue (eWAT) of mice in the YQHJQZ-H group was significantly reduced compared with the model group (see Fig. 3). Figure 2 Figure 3 ​​​), while the eWAT of the orlistat group and the YQHJQZ-L group had no significant change compared with the model group, and the weight of BAT had no significant difference among the model group, the orlistat group and the YQHJQZ group (see Figure 4 ), which indicated that YQHJQZ did not affect the weight of BAT of ob / ob mice.

[0282] The above description is only the preferred embodiment of the present application, and is not any form and substantial limitation of the present application. It should be pointed out that, for ordinary skilled in the art, without departing from the method of the present application, a number of improvements and supplements can also be made, which should be considered as the protection scope of the present application. For those skilled in the art, without departing from the spirit and scope of the present application, some changes, modifications and equivalent changes made by using the above disclosed technical content are equivalent embodiments of the present application; at the same time, any equivalent changes, modifications and evolution made according to the essential technology of the present application to the above embodiments are still within the scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition, comprising the following raw material components by weight: Astragalus membranaceus 20-40 parts by weight; 20-40 parts by weight of Smilax glabra; Polygonum cuspidatum 5-25 parts by weight; Alisma plantago-aquatica 1-20 parts by weight; Coptis chinensis 1-10 parts by weight; Artemisia capillaris 5-25 parts by weight; 5-25 parts by weight of cattail pollen.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight, the following raw material components: Astragalus membranaceus 25-35 parts; 25-35 parts of Smilax glabra; 10-20 portions of Japanese knotweed; Alisma plantago-aquatica 5-15 parts; Coptis chinensis 4-8 parts; 10-20 portions of Artemisia capillaris; 10-20 parts of cattail pollen.

3. A traditional Chinese medicine extract, prepared by extraction from the traditional Chinese medicine composition according to any one of claims 1-2.

4. A method for preparing a traditional Chinese medicine extract, comprising: According to the formula, each of the raw material components of the traditional Chinese medicine composition according to any one of claims 1-2 is mixed, and the resulting mixture is extracted by decoction with water.

5. The method for preparing the traditional Chinese medicine extract according to claim 4, characterized in that, The water-addition decoction method includes: soaking the mixture in water, first boiling it over high heat, then simmering it over low heat, filtering it, concentrating the obtained extract, and drying it into powder to provide the Chinese herbal extract.

6. The method for preparing the traditional Chinese medicine extract according to claim 5, characterized in that, Includes one or more of the following conditions: A1) The amount of water added to the mixture is 2-3 cm above the top surface of the mixture; A2) The mixture is soaked in water for 25-30 minutes; A3) The boiling temperature of the high heat mentioned is 150-220℃; A4) The simmering temperature over a low flame is 80-120℃; A5) The simmering time over low heat is 25-35 minutes; A6) The filtration described is filter screen filtration; A7) The concentration described is vacuum concentration; The drying described in A8) is spray drying.

7. The method for preparing the traditional Chinese medicine extract according to claim 6, characterized in that, Includes one or more of the following conditions: B1) In item A6, the mesh size of the screen used for filtration is not less than 100 mesh; B2) In item A7, the drug is concentrated under reduced pressure to 1.0-2.0 g crude drug / 5 mL; B3) In item A8, the drying conditions are: air inlet temperature of 150-180℃; liquid inlet rate of 400-500mL / min; The atomization pressure is 1.0-1.2 bar; the outlet air temperature is 80-120℃.

8. A traditional Chinese medicine preparation comprising a therapeutically effective amount of the traditional Chinese medicine composition according to any one of claims 1-2, or a therapeutically effective amount of the traditional Chinese medicine extract according to claim 3, and one or more conventional pharmaceutically acceptable excipients.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-2, the traditional Chinese medicine extract according to claim 3, or the traditional Chinese medicine preparation according to claim 8 in the preparation of a medicament for treating obesity.

10. The use according to claim 9, characterized in that, The obesity pattern described is spleen deficiency with dampness accumulation and unresolved heat stagnation.

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