A Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects, and its preparation method and application

Abstract

The present invention provides a Chinese medicine composition with weight loss, blood sugar and lipid lowering effects. Compared with the prior art, the Chinese medicine composition provided by the present invention uses coptis chinensis and pinellia tuber as the main ingredients, coptis chinensis is bitter and cold, clears heat, dries dampness, reduces blood sugar, clears heart fire and relieves stomach heat, pinellia tuber is pungent, opens and descends bitterly, relieves depression and dissipates knots, and helps rhubarb to relieve depression. Rhubarb and raw hawthorn are used as ministers, rhubarb removes dampness, heat and turbidity from the five internal organs, relieves depression, relieves heat and clears the bowels, raw hawthorn digests food and strengthens the spleen, eliminates blood stasis and reduces fat, and eliminates the accumulation of greasy meat; tangerine peel, radish seeds and red yeast rice are used as adjuvant drugs, tangerine peel regulates qi and relieves depression, dries dampness and resolves phlegm, radish seeds digest food and eliminates bloating, lowers qi and removes phlegm, red yeast rice reduces fat and resolves turbidity, activates blood circulation and unblocks meridians, and strengthens the spleen and digests food. The combination of multiple drugs takes all aspects into consideration and intervenes and regulates all pathological links in the early stages of obese diabetes; the components are compatible with each other, so that the obtained Chinese medicine composition has the effects of relieving depression and heat, eliminating internal fullness, promoting blood circulation and reducing turbidity, lowering blood lipids and losing weight, and it is highly safe and has no side effects.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicines, and in particular relates to a Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects, and a preparation method and application thereof. Background Art

[0002] Prediabetes is considered a sub-healthy state, mostly accompanied by obesity, and is an important risk factor for the development of diabetes. Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) refer to conditions in which blood glucose levels rise above the normal range and below the diagnostic threshold for diabetes. The cumulative incidence of progression to type 2 diabetes five years after a diagnosis of IGT or IFG is estimated to be 26% and 50%, respectively. On December 6, 2021, the International Diabetes Federation (IDF) released the "Global Diabetes Atlas 2021 (10th Edition)" on its official website. According to the report, China (54.5 million), the United States (37.4 million) and Indonesia (29.1 million) are the populations with the largest number of impaired glucose tolerance (IGT) among people aged 20 to 79.

[0003] A large number of studies have shown that there is a close association between obesity and prediabetes. First, obesity is an important predictor of prediabetes. Obese people are often accompanied by an abnormal increase in adipose tissue in the body, especially abdominal obesity, which is more significantly related to prediabetes. Abdominal obesity is closely related to insulin resistance, which is one of the main pathophysiological bases of prediabetes. Secondly, obesity has an adverse effect on pancreatic islet function, thereby increasing the risk of prediabetes. In the obese state, fatty acids released by adipocytes and cytokines secreted by adipose tissue interfere with the function of pancreatic islet cells and lead to a decrease in the response of pancreatic cells to glucose. This impaired pancreatic function is one of the key steps in the development of prediabetes. In addition, obesity is closely related to inflammatory response and metabolic disorders, which are also important links in the occurrence of prediabetes. Obesity leads to enhanced inflammatory response in adipose tissue, which in turn releases a variety of proinflammatory cytokines, such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), which can interfere with insulin signaling and further aggravate the damage of pancreatic islet function.

[0004] The earliest record of obesity in traditional Chinese medicine can be found in Huangdi Neijing. For example, Suwen Tongping Xushilun Pian describes obesity as "fat nobleman". Lingshu Weiqidangchang Pian classifies obesity according to the amount of Qi and blood in the human skin and flesh, and divides it into three types: "fat, fat, and meat". Obese prediabetes can be classified as "spleen disease" in traditional Chinese medicine. Suwen Qibinglun said: "Fat makes people hot inside, and sweet makes people full, so their qi overflows and turns into thirst". If the prediabetes stage of obesity-"spleen disease" cannot be effectively controlled, it will develop into type 2 diabetes-"thinness" discussed in ancient times. If the thirst lasts for a long time and changes into various symptoms, it will be classified as the late complication stage. Therefore, it can be said that "spleen disease"-thinness-thinness complications are the natural development process of obese diabetes. Recently, it is believed that obesity is an important basis for metabolic syndrome, and central obesity participates in the formation and development of metabolic syndrome by affecting insulin sensitivity. The early stage of metabolic syndrome is characterized by overweight and obesity, followed by a series of metabolic diseases, such as hypertension, hyperuricemia, etc., which ultimately lead to a variety of complications, such as cardiovascular and cerebrovascular diseases, retinopathy, neuropathy, renal failure, etc. Among them, cardiovascular and cerebrovascular diseases are the main ones, such as coronary heart disease, cerebral infarction, etc., that is, the three stages of obesity development are: obesity-metabolic syndrome-cardiovascular and cerebrovascular diseases.

[0005] Advocating early screening, early intervention, and early treatment of prediabetes is in line with the TCM concept of "preventing disease before it occurs". Preventing the occurrence of prediabetes (IGT) during the obesity stage, actively intervening in IGT, and preventing the onset of type 2 diabetes are manifestations of TCM's idea of ​​preventing chronic diseases before they occur.

[0006] There are not many Chinese patent medicines for the treatment of obesity and prediabetes on the market. Some of the existing drugs only treat the symptoms and not the root cause. Some use expensive ingredients. Some are discontinued during use due to uncertain efficacy.

[0007] The Chinese patent with publication number CN102885918A discloses a Chinese medicine preparation for weight loss, which is prepared from the following Chinese medicine raw materials: raw rhubarb, turmeric, raw hawthorn, red yeast rice, red tangerine peel, sophora flavescens, atractylodes, scutellaria baicalensis, plantago seed, cassia seed, and can effectively control body weight. However, the Chinese medicine composition has no hypoglycemic effect.

[0008] The Chinese patent with publication number CN103520314A discloses a lipid-lowering Chinese medicine preparation, which is prepared from seven Chinese medicines: hawthorn, schisandra, coptis, gynostemma, rhubarb, red yeast rice, and safflower, and can effectively reduce blood lipids. However, the Chinese medicine combination has no effect on reducing body weight and blood sugar.

[0009] The Chinese patent with publication number CN106110092A discloses a Chinese medicine preparation for treating simple obesity, which is composed of coptis root, rhubarb, litchi seed, lotus leaf, gynostemma pentaphyllum, hawthorn, Shenqu, malt, radish seed, cassia seed, fructus aurantii, magnolia bark, tangerine peel, pinellia tuber, oriental rhizome, senna leaf, coix seed, tuckahoe and atractylodes macrocephala, and can be instilled into the Chinese medicine for treating simple obesity through the rectum of Chinese medicine. However, the Chinese medicine composition has no effect of lowering blood sugar, lowering blood lipids and improving metabolism. Summary of the invention

[0010] In view of this, the technical problem to be solved by the present invention is to provide a Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects, and a preparation method and application thereof.

[0011] The present invention provides a Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects, comprising:

[0012]

[0013] According to the present invention, the content of the coptis root in the traditional Chinese medicine composition is preferably 8 to 15 parts by weight, more preferably 8 to 12 parts by weight, and even more preferably 10 parts by weight. Coptis root is a heat-clearing medicine, the dry rhizome of the ranunculaceae plants coptis root, triangular leaf coptis root or cloud lian, which contains berberine, coptis pine, jatrorrhizine, palmatine, palmitine, africanine, magnoline, epiberberine and other isoquinoline alkaloids, and also contains components such as phellodendron, phellodendron lactone, ferulic acid, chlorogenic acid, etc., which has the effects of clearing away heat and dampness, purging fire and detoxifying.

[0014] According to the present invention, the content of the pinellia in the traditional Chinese medicine composition is preferably 8 to 15 parts by weight, more preferably 8 to 12 parts by weight, and even more preferably 10 parts by weight. Pinellia is the dried tuber of the Araceae plant Pinellia, which mainly contains volatile oils: anethole, citral, 1-octene, β-elemene, etc., and has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and eliminating lumps and dispersing nodules.

[0015] According to the present invention, the content of rhubarb in the traditional Chinese medicine composition is preferably 2 to 5 parts by weight, more preferably 3 to 4 parts by weight. Rhubarb is a purgative, which is the dried root and rhizome of Rheum palmatum, Rheum tangutum or Rheum officinale of the Polygonaceae family. It contains anthraquinone derivatives, tannins, organic acids, estrogen-like substances and other ingredients, and has the functions of purgation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and removing dampness and jaundice.

[0016] According to the present invention, the content of the dried tangerine peel in the Chinese medicine composition is preferably 8 to 25 parts by weight, more preferably 10 to 20 parts by weight, more preferably 13 to 16 parts by weight, and most preferably 15 parts by weight. Dried tangerine peel is the dried and mature peel of the Rutaceae plant tangerine and its cultivars, and has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0017] According to the present invention, the content of the radish seeds in the traditional Chinese medicine composition is preferably 8 to 25 parts by weight, more preferably 10 to 20 parts by weight, more preferably 13 to 16 parts by weight, and most preferably 15 parts by weight. Radish seeds are the dried mature seeds of the cruciferous plant radish, mainly containing fatty acids, volatile oils and other ingredients, and have the effects of digesting food, eliminating bloating, and reducing qi and resolving phlegm.

[0018] According to the present invention, the content of the red yeast rice in the traditional Chinese medicine composition is preferably 3 to 12 parts by weight, more preferably 5 to 10 parts by weight, more preferably 5 to 8 parts by weight, and most preferably 5 parts by weight. Red yeast rice is a red yeast rice made by parasitizing the mycelium of the Aspergillus fungus Monascus purpureus Went. on polished rice, and has the effects of strengthening the spleen and promoting digestion, promoting blood circulation and removing blood stasis.

[0019] According to the present invention, the content of the raw hawthorn in the traditional Chinese medicine composition is preferably 8 to 25 parts by weight, more preferably 10 to 20 parts by weight, more preferably 13 to 16 parts by weight, and most preferably 15 parts by weight. Raw hawthorn is the dried mature fruit of the plant Crataegus pin,natiida Bge.var.majorN.E.Br. or Crataegus pin.nati fida Bge. of the Rosaceae family. The fruit is harvested when it matures in autumn, sliced, and dried to obtain the raw hawthorn, which has the effects of promoting digestion and strengthening the stomach, promoting qi and dispersing blood stasis, and removing turbidity and reducing lipids.

[0020] Preferably, the Chinese medicine composition comprises:

[0021]

[0022] Further, preferably, including:

[0023]

[0024] The Chinese medicine composition provided by the present invention is a pure Chinese medicine compound medicine with definite efficacy, safety, convenience, small side effects and low price. The Chinese medicine composition can reduce blood sugar, fat prediabetes, reduce weight, improve blood lipids, and protect liver function. In traditional Chinese medicine theory, the Chinese medicine composition provided by the present invention is aimed at obese prediabetes manifested by "stagnation of heat". The fullness in the middle for a long time is often depressed and turns into heat, so the fullness in the middle is more critical for prediabetes. The so-called fullness in the middle, for modern people, is mainly due to "food depression" caused by excessive nutrient intake, which leads to stagnation of qi, blood, phlegm, dampness, heat, etc., and finally the fullness of qi overflows and turns into thirst.

[0025] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects, comprising:

[0026] The Chinese medicinal composition is obtained by mixing coptis root, pinellia tuber, rhubarb, tangerine peel, radish seed, red yeast rice and raw hawthorn.

[0027] The present invention has no special limitation on the preparation method, and the above components can be mixed according to a method well known to those skilled in the art; in the present invention, it is preferred that the above components are first ground into fine powders, and then mixed according to proportions to obtain a Chinese medicine composition with weight loss, blood sugar and lipid lowering effects.

[0028] The animal experiment results of the present invention show that the therapeutic effect of the Chinese medicine composition on obesity and hyperglycemia symptoms is significantly better than the case of using any of the raw materials alone. It can effectively treat obesity and prediabetes, improve sugar and lipid metabolism, and prevent diabetes transformation, and has broad application prospects.

[0029] Based on the above results, the present invention also provides a Chinese medicine preparation, including the above-mentioned Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects.

[0030] Preferably, it also includes pharmaceutically acceptable excipients.

[0031] The present invention has no particular limitation on the dosage form of the Chinese medicine preparation, which may be a decoction, granules, capsules, tablets, etc.

[0032] The method for preparing the Chinese medicine preparation can be prepared according to methods well known to those skilled in the art, and there is no special limitation. Taking granules as an example, the preparation can be carried out according to the following steps: prepare granules from coptis root, pinellia tuber, rhubarb, dried orange peel, radish seed, red yeast rice and raw hawthorn according to conventional processes, and then mix them to obtain mixed granules; boil red yeast rice with water, filter it, and mix the filtrate with the mixed granules to obtain; or,

[0033] Mix coptis root, pinellia tuber, rhubarb, tangerine peel, radish seed and raw hawthorn and prepare into granules according to conventional process; boil red yeast rice with water and filter, mix the filtrate with granules to obtain; or,

[0034] The method comprises mixing coptis root, pinellia tuber, rhubarb, tangerine peel, radish seed, raw hawthorn and red yeast rice and extracting the mixture according to a conventional extraction method or extracting the mixture according to a conventional extraction method and then mixing the mixture, filtering the mixture, collecting the filtrate, concentrating, drying and granulating the mixture to obtain the product.

[0035] Furthermore, the conventional process of preparing the granules by conventional process includes extraction, filtration, concentration, drying and granulation. The Chinese medicine preparation provided by the present invention has the effects of reducing blood sugar and weight, eliminating fat and reducing turbidity.

[0036] The present invention also provides a use of a Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects in the preparation of a drug for treating and / or preventing obesity.

[0037] The present invention also provides a use of a Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects in the preparation of a blood sugar-lowering drug.

[0038] The present invention provides a Chinese medicine composition with weight loss, blood sugar and lipid lowering effects, comprising: 5-20 parts by weight of coptis root; 5-20 parts by weight of pinellia tuber; 1.5-6 parts by weight of rhubarb; 6-30 parts by weight of dried orange peel; 6-30 parts by weight of radish seeds; 3-15 parts by weight of red yeast rice; and 6-30 parts by weight of raw hawthorn. Compared with the prior art, the Chinese medicine composition provided by the present invention is composed of a variety of Chinese herbal medicines including coptis root, pinellia tuber, rhubarb, dried orange peel, radish seeds, red yeast rice, and raw hawthorn. Coptis root and pinellia tuber are used as the main ingredients in the prescription. Coptis root is bitter and cold, clears heat, dries dampness, reduces blood sugar, clears heart fire and relieves stomach heat. Pinellia tuber is pungent, bitter and descends, relieves depression and disperses stagnation, and helps rhubarb to eliminate depression. Rhubarb and raw hawthorn are used as the ministers. Rhubarb removes dampness, heat and turbidity from the five internal organs, eliminates depression, relieves heat and clears the bowels. Raw hawthorn can digest food and strengthen the spleen, eliminate blood stasis and reduce fat, and eliminate the accumulation of greasy meat. Tangerine peel, radish seeds and red yeast rice are used as adjuvants. Tangerine peel regulates qi and relieves depression, dries dampness and resolves phlegm. Radish seeds can digest food and eliminate bloating, lower qi and eliminate phlegm. Red yeast rice can reduce fat and resolve turbidity, activate blood circulation and dredge meridians, and invigorate the spleen and digest food. Multiple drugs are compatible, all-round considerations are taken, and all pathological links of obese diabetes pre-diabetes are intervened and regulated. The components are compatible with each other, so that the obtained traditional Chinese medicine composition has the effects of eliminating depression and clearing heat, eliminating internal fullness, activating blood circulation and reducing turbidity, reducing fat and losing weight, and is highly safe and has no side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 This is a statistical result diagram of the body weight of mice after administration of the drug in Example 1 of the present invention;

[0040] Figure 2 This is a curve diagram of the weight change over time of mice after administration of the drug in Example 1 of the present invention;

[0041] Figure 3 This is a statistical result diagram of blood glucose in mice after administration of the drug in Example 1 of the present invention;

[0042] Figure 4 This is a graph showing changes in blood sugar over time in mice after administration of the drug in Example 1 of the present invention;

[0043] Figure 5 This is a photo of the body circumference of mice after 11 weeks of drug administration in Example 1 of the present invention;

[0044] Figure 6 This is a bar graph showing the changes in body circumference of mice after 11 weeks of drug administration in Example 1 of the present invention;

[0045] Figure 7 This is a statistical graph of fasting insulin and HOMA-IR in mice after 11 weeks of drug administration in Example 1 of the present invention;

[0046] Figure 8The graphs of glucose tolerance of mice after 10 weeks of administration and insulin tolerance after 11 weeks of administration in Example 1 of the present invention are as follows:

[0047] Fig. 9 This is a graph showing the test results of serum biochemical indicators of mice after 11 weeks of drug administration in Example 1 of the present invention;

[0048] Fig.10 This is a graph showing the fat volume detection results of mice after 11 weeks of drug administration in Example 1 of the present invention;

[0049] Fig.11 This is a Masson staining image of white adipose tissue after 11 weeks of administration in Example 1 of the present invention;

[0050] Fig.12 This is a Masson staining image of beige adipose tissue after 11 weeks of administration in Example 1 of the present invention;

[0051] Fig.13 This is the HE staining image of mouse liver pathology after 11 weeks of drug administration. DETAILED DESCRIPTION

[0052] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0053] Example 1

[0054] The prescription for relieving depression and reducing weight is composed of 10g of Coptis chinensis, 10g of Pinellia ternata, 3g of Rhubarb, 15g of Tangerine Peel, 15g of Radish Seed, 6g of Red Yeast Rice, and 15g of Raw Hawthorn.

[0055] Grind coptis root, pinellia tuber, rhubarb, tangerine peel, radish seed, red yeast rice and raw hawthorn into powder respectively, and then mix them according to the above amounts to obtain a traditional Chinese medicine composition with the effects of reducing weight, lowering blood sugar and lowering blood lipids, which is recorded as the depression-relieving and weight-loss prescription.

[0056] The mixed Chinese medicine composition powder is extracted with water according to conventional processes, filtered, and concentrated by rotary evaporation to obtain an extract;

[0057] The extract is spray-dried and then granulated by dry method to obtain Xiaoyu Jianzhong Fang granules.

[0058] Experimental animals: 50 healthy male C57BL / 6J mice, SPF grade, 5 weeks old, provided by Jiangsu Jicui Yaokang Biotechnology Co., Ltd., and raised in Beijing Institute of Traditional Chinese Medicine. The breeding environment is a clean animal room, the indoor temperature is controlled at 22℃~25℃, the humidity is 55±5%, 12 / 12 hours light-dark cycle (lighting time 7:00-19:00), free access to food and drinking water. Adaptive feeding for one week.

[0059] Model establishment: 10 mice were randomly selected as the blank control group, and the rest of the mice were the modeling group. The blank control group was fed with a standard diet, and the modeling group was fed with a 60% high-fat diet (D12492, Open Source Diet). The modeling group was fed with a high-fat diet for 6 weeks. The model was successfully established when the body weight of the mice was 20% higher than normal and the average fasting blood glucose level after fasting for 6 hours was higher than 10.7mmol / L, and there was a significant difference compared with the blank control group.

[0060] Grouping and administration: After the model was successfully established, the modeling group was randomly divided into a model group, a control group, a western medicine group, and a Xiaoyu Jianzhong group according to the random number table method, with 10 mice in each group; based on the weight of the Chinese medicine composition, the drug administration group was converted according to the equivalent dose of animals and humans (9.1:1), the dose of Xiaoyu Jianzhong for humans was 1.23 g / kg / d, and the dose of Xiaoyu Jianzhong for mice was 11.23 g / kg / d. The Xiaoyu Jianzhong granules obtained in Example 1 were diluted with distilled water. The western medicine group was metformin hydrochloride 100 mg / kg / d, diluted with distilled water. Continuous gavage for 11 weeks. Animal experiments strictly followed the ethical requirements of the "Regulations on the Management of Experimental Animals of Beijing Institute of Traditional Chinese Medicine" and the "Regulations on the Management of Experimental Animals" of the State Science and Technology Commission, and were approved by the Animal Protection and Use Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (Ethics Approval Number: IACUC-GAMH-2022-004).

[0061] Experimental results:

[0062] Table 1 shows the statistical results of the body weight of mice after administration. Figure 1 This is the statistical result of the weight of mice after drug administration. Figure 2 The graph is a curve of the weight change of mice after administration. Table 1 shows that the Xiaoyu weight-reducing prescription can effectively reduce the weight of mice and has a significant therapeutic effect (n=10, X±SEM).

[0063] Table 1 Body weight of mice after administration

[0064] Group Dosing Week 0 3 weeks of medication 6 weeks of medication 8 weeks of treatment 11 weeks of medication Model Group <![CDATA[32.2±3.17 ** ]]> <![CDATA[36.19±4.72 *** ]]> <![CDATA[41.92±5.65 **** ]]> <![CDATA[45.56±5.39 **** ]]> <![CDATA[45.68±3.59 **** ]]> Western medicine group 32.62±2.95 36.38±3.84 39.19±4.82 42.02±5.53 44.01±5.81 Depression-relief and weight-loss group 32.07±3.2 33.83±3.72 <![CDATA[33.72±3.61 ### ]]> <![CDATA[37.3±4.87 ### ]]> <![CDATA[37.34±5.56 ## ]]> Control group 26.42±1.48 29.34±3.27 28.13±1.71 29.96±1.94 29.13±1.73

[0065] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0066] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001, ###P<0.0001.

[0067] Table 2 shows the statistical results of blood glucose in mice after administration. Figure 3 This is the statistical result of blood glucose after drug administration in mice. Figure 4 The graph is a graph showing the change of blood sugar over time after administration to mice. Table 2 shows that the Xiaoyu Jianzhong Recipe can effectively reduce the weight of mice and has a significant therapeutic effect (n=10, X±SEM).

[0068] Table 2 Blood glucose of mice after administration

[0069] Group Dosing Week 0 3 weeks of medication 6 weeks of medication 8 weeks of treatment Model Group <![CDATA[10.84±1.76 ** ]]> <![CDATA[10.75±1.64 ** ]]> <![CDATA[11.53±2.26 *** ]]> <![CDATA[11.7±1.04 *** ]]> Western medicine group 11.01±1.13 10.39±1.4 10.83±2.09 9.28±1.42 Depression-relief and weight-loss group 10.5±1.4 <![CDATA[8.89±0.95 ## ]]> <![CDATA[8.31±0.81 # ]]> <![CDATA[9.17±1.6 # ]]> Control group 8.73±1.28 8.98±0.95 7.31±0.95 8.52±1.06

[0070] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0071] The statistical results of the body circumference of mice after 11 weeks of drug administration are shown in Figure 2. Figure 5 This is a photo of the body circumference of mice after 11 weeks of drug administration. Figure 6 The bar graph is a graph showing the changes in the body circumference of mice after 11 weeks of administration. Table 3 shows that the Xiaoyu Jianwei Recipe can reduce the waist circumference of mice and has a significant therapeutic effect in reducing the Lee's index (n=10, X±SEM).

[0072] Table 3 Body circumference of mice after administration

[0073]

[0074] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0075] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0076] Table 4 shows the statistical results of fasting insulin and HOMA-IR in mice after drug administration. Figure 7 The fasting insulin and HOMA-IR statistical graphs of mice after 11 weeks of administration. Table 4 shows that the Xiaoyu Jianzhong recipe can effectively alleviate the insulin resistance of obese mice and has a significant therapeutic effect (n=7, X±SEM).

[0077] Table 4 Fasting insulin and HOMA-IR in mice after administration

[0078] Group Fasting insulin (ng / mL) HOMA-IR Model Group <![CDATA[1.59±0.446 **** ]]> <![CDATA[0.1±0.03 ** ]]> Depression-relief and weight-loss group <![CDATA[0.77±0.39 ## ]]> <![CDATA[0.01±0.01 # ]]> Control group 0.38±0.34 0.01±0.01

[0079] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0080] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0081] Table 5 shows the changes in glucose tolerance over time in mice after administration. Figure 8 The graphs are the changes of glucose tolerance of mice after 10 weeks of administration and insulin tolerance after 11 weeks of administration. Table 5 shows that Xiaoyu Jianwei Fang can effectively restore glucose tolerance of obese mice (n=10, X±SEM).

[0082] Table 5 Changes of glucose tolerance in mice over time

[0083]

[0084] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0085] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0086] Table 6 shows the changes in insulin tolerance of mice over time. It can be seen from Table 6 that the Xiaoyu Jianzhong recipe can effectively restore the insulin tolerance of obese mice and has a significant therapeutic effect (n=7, X±SEM).

[0087] Table 6 Changes of insulin tolerance in mice over time

[0088]

[0089] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0090] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0091] Table 7 shows the results of serum biochemical indexes of mice after 11 weeks of administration. Fig. 9 The figure is the test result of serum biochemical indexes of mice after 11 weeks of administration. Table 7 shows that Xiaoyu Jianzhong Fang can effectively improve the serum biochemical indexes of obese mice (n=10, X±SEM). This shows that Xiaoyu Jianzhong Fang can reduce fasting blood sugar, improve liver function, and reduce blood lipids.

[0092] Table 7 Serum biochemical parameters of mice

[0093] Group GLU (mmol / L) ALT (mmol / L) CHOL(mmol / L) LDLC(mmol / L) Model Group <![CDATA[9.41±1.85 *** ]]> <![CDATA[120.72±66.51 ** ]]> <![CDATA[6.28±1.3 **** ]]> <![CDATA[1.73±0.44 **** ]]> Control group 5.61±1.08 29.38±7.65 3.08±0.32 0.59±0.07 Depression-relief and weight-loss group 9±1.94 61.27±30.61 5.01±1.13 <![CDATA[1.26±0.36 # ]]> Western medicine group 9.88±2.58 97.95±76.71 5.85±1.4 1.64±0.5

[0094] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0095] Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0096] Table 8 shows the fat volume of mice detected by MicroCT after 11 weeks of administration. Fig.10 The figure is the result of the fat volume test of mice after 11 weeks of administration. Table 8 shows that the Xiaoyu weight-reducing recipe can effectively reduce the fat volume of obese mice (n=6, X±SEM).

[0097] Table 8 Fat volume of mice

[0098]

[0099] Note: Compared with the control group, * P<0.05, ** P<0.01, *** P<0.001.

[0100] Compared with the model group, # P<0.05, ## P<0.01, ### P<0.001.

[0101] Table 9 shows the results of the mouse fat cell area detection. Fig.11 This is the Masson staining image of white adipose tissue after 11 weeks of administration. Fig.12 The beige adipose tissue Masson staining after 11 weeks of administration, where A is the control group, B is the model group, and C is the Xiaoyu weight-reducing prescription group. The Masson staining of adipose tissue showed that the Xiaoyu weight-reducing prescription could effectively reduce the area of ​​white adipocytes and beige adipocytes in obese mice (n=6, X±SEM).

[0102] Table 9 Mouse adipocyte area

[0103] Group White fat (um3) Beige fat (um3) Model Group <![CDATA[4629.8±960.6 **** ]]> <![CDATA[3577.57±1371.47 ** ]]> Control group 1029.33±343.08 1193.78±614.04 Depression-relief and weight-loss group <![CDATA[2700.4±871.2 ## ]]> <![CDATA[1799.97±949.49 # ]]>

[0104] Note: Compared with the control group, * P<0.05, ** P<0.01, *** P<0.001.

[0105] Compared with the model group, # P<0.05, ## P<0.01, ### P<0.001.

[0106] Fig.13 The following are HE staining images of mouse liver pathology after 11 weeks of drug administration, where A is the control group, B is the model group, C is the Western medicine group, and D is the Xiaoyu Jianzhong prescription group. Fig.13It can be seen that the Xiaoyu Jianzhong recipe can effectively reduce the fat vacuolar degeneration of liver tissue in the model group.

[0107] From the above results, it can be seen that the Chinese medicine composition provided by the present invention is a targeted prescription created for the "stagnant heat" state of obese prediabetic patients, and can give play to the multi-target and multi-effect mechanism of traditional Chinese medicine. It can not only target and lower blood sugar, reduce weight, and improve blood lipids, but also can comprehensively adjust the "stagnant heat" state of obese prediabetic patients without obvious side effects and adverse reactions. With the advantage of state-target synchronization, it is of great benefit to achieving stable and lasting weight and blood sugar control, treating prediabetes, and effectively preventing diabetes conversion.

[0108] The above descriptions are only preferred embodiments of the present invention. It should be pointed out that professionals in this technical field can implement various modifications to these embodiments without departing from the technical principles of the present invention, and these modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition having weight-reducing, blood sugar-lowering and lipid-lowering effects, It is characterized in that It is composed of the following components: 8-15 parts by weight of Coptis chinensis; 8-15 parts by weight of Pinellia tuber; 2-5 parts by weight of rhubarb; Tangerine peel 10-20 parts by weight; 10-20 parts by weight of radish seeds; Red yeast rice 5-10 parts by weight; 10-20 parts by weight of raw hawthorn.

2. The Chinese medicine composition according to claim 1, characterized in that: It is composed of the following components: 10 parts by weight of Coptis chinensis; 10 parts by weight of pinellia tuber; 3 parts by weight of rhubarb; Tangerine peel 15 parts by weight; 15 parts by weight of Radish Seed; 5 parts by weight of red yeast rice; 15 parts by weight of raw hawthorn.

3. A method for preparing the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects according to claim 1, characterized in that: include: The Chinese medicinal composition is obtained by mixing coptis root, pinellia tuber, rhubarb, tangerine peel, radish seed, red yeast rice and raw hawthorn.

4. A Chinese medicine preparation, made from the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects according to any one of claims 1 to 2 or the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects prepared by the preparation method according to claim 3.

5. The Chinese medicine preparation according to claim 4, characterized in that: Pharmaceutically acceptable excipients are also included.

6. Use of the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects as described in any one of claims 1 to 2 or the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects prepared by the preparation method according to claim 3 in the preparation of drugs for treating and / or preventing obesity.

7. Use of the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects as described in any one of claims 1 to 2 or the Chinese medicine composition with weight-reducing, blood sugar-lowering and lipid-lowering effects prepared by the preparation method according to claim 3 in the preparation of hypoglycemic drugs.

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