A traditional Chinese medicine composition for preventing and treating diabetes, a preparation method and use thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for preventing and / or treating diabetes, preparation method and purposes.Component includes Astragalus membranaceus, Pueraria, Bupleurum, Ganoderma lucidum, Salvia miltiorrhiza.The water or alcohol extract preparation process of the present application is economical, simple, suitable for industrial large-scale production, and patient is convenient to take.The obtained extract has significant effect of regulating sugar and lipid metabolism, and can be applied to prepare medicine for preventing and treating diabetes.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for preventing and / or treating diabetes, a preparation method and use. BACKGROUND

[0002] Diabetes mellitus is a group of endocrine and metabolic diseases characterized by absolute or relative insulin deficiency in the body, leading to metabolic disorders of fat, protein and carbohydrates in the human body, and further causing chronic damage and functional disorders of organs.

[0003] Nowadays, the treatment of diabetes is mainly based on Western medicine. Western medicine for treating diabetes mainly uses sulfonylureas, biguanides and insulin, etc. Although the hypoglycemic effect is obvious, it can reach the level of regulating metabolic disorders, but the recurrence rate is high, and there are many complications. The disease not only affects the lungs, stomach and kidneys, but also affects the heart, brain, liver and spleen. At present, the treatment of this disease and the prevention and treatment of its complications are quite a problem for modern medicine.

[0004] Diabetes is a chronic and progressive chronic disease with complex pathological changes and many complications. The traditional pathogenesis of diabetes is mainly due to the loss of yin and the dominance of dryness and heat. Yin deficiency is the root and dryness and heat are the symptoms, and the two are causally related. The affected organs are mainly the lungs, stomach and kidneys. Although there is a bias among the three organs, they often affect each other. CN201810522811.6 discloses a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. It discloses the following raw material components by weight: Radix Bupleuri 6-18 parts, Radix Paeoniae Alba 10-20 parts, Radix Astragali 15-45 parts, Radix Puerariae 9-18 parts, Citrus medica 6-15 parts, Fructus Aurantii 3-12 parts, Radix Panacis Quinquefolii 3-12 parts, Fructus Lycii 6-18 parts, Morus alba 9-18 parts, Folium Mori 6-15 parts, Radix Ophiopogonis 6-18 parts, Fructus Corni 6-18 parts, Radix Salviae Miltiorrhizae 9-18 parts and Radix Angelicae Sinensis 6-18 parts. The traditional Chinese medicine is used for treating diabetes, mainly based on the treatment principle of soothing the liver and regulating qi, to achieve the effect of tonifying qi and nourishing yin, and generating fluid to stop thirst.

[0005] Wang Junqi recorded in "Auxiliary Effect of Ganoderma lucidum on Diabetes Patients in the Treatment Process" that Ganoderma lucidum water extract has a hypoglycemic effect on diabetic mice, and Ganoderma lucidum polysaccharide can improve the glucose tolerance of diabetic mice, increase the serum insulin level, and reduce the serum TG and TC levels. Clinical cases of Ganoderma lucidum preparation for treating diabetes are also disclosed.

[0006] With the development of practice, the pathogenesis of diabetes has been updated and supplemented in traditional Chinese medicine. The relationship between "liver and spleen" in traditional Chinese medicine and the occurrence, development and treatment of type II diabetes mellitus has gradually attracted the attention of clinicians, and the balance of qi, blood and body fluid is the key to overcoming diabetes.

[0007] The theoretical basis of treating diabetes by the method of soothing liver and invigorating spleen: The spleen is in charge of transportation and transformation, and can produce blood and control blood. When the spleen is deficient, the production of blood is insufficient, and the water and liquid are deficient and stagnate, which can form pathological product of phlegm and turbidity, and can also hinder the transportation of body fluid, and induce type 2 diabetes. The liver is in charge of dispersion, and has the function of dispersion and discharge, so as to maintain the smoothness of qi movement in the whole body, and to adjust and reach the qi movement. When the liver fails to disperse, the qi movement is not smooth, and the fire is generated, which can burn the yin fluid. The stagnation of liver can not only lead to blood stasis, but also can make the spleen and stomach fail to transport and transform, and the transportation of qi, blood and essence is hindered, which can easily lead to diabetes. Therefore, the disease is mainly located in the spleen and liver, and the deficiency of the spleen and the stagnation of the liver and blood stasis are the main pathogenesis of the disease.

[0008] CN200810055636.0 discloses a traditional Chinese medicine composition for treating liver diseases. The composition is prepared from radix astragali, radix puerariae, radix bupleuri, ganoderma lucidum, red peony root, turtle shell, salvia miltiorrhiza, panax notoginseng, sphenodesma, and phyllanthus urinaria in a certain weight ratio. The traditional Chinese medicine has the effects of tonifying qi, soothing liver, promoting blood circulation and softening hard masses, and is used for treating chronic hepatitis, liver fibrosis and early liver cirrhosis. The new drug is currently under clinical research by Yingke Rui (Zhu Hai) Innovative Medicine Manufacturing Co., Ltd., and belongs to a new traditional Chinese medicine. The present group formula is developed on the basis of the traditional Chinese medicine composition.

[0009] Although modern medical research has reported the hypoglycemic effect of radix astragali, radix puerariae, radix bupleuri, ganoderma lucidum and salvia miltiorrhiza and their extracts, there is no research on the combination of the few medicines for treating diabetes. The present group formula is developed from the perspective of syndrome differentiation and treatment of traditional Chinese medicine, and has significant clinical application value in combination with the current social science medicine. SUMMARY

[0010] The present application aims to provide a traditional Chinese medicine composition for preventing and / or treating diabetes, a preparation method and use thereof. Another object of the present application is to provide a preparation comprising the traditional Chinese medicine composition, which can be used for preventing and / or treating diabetes, especially early diabetes, and improving fat metabolism of diabetes patients. The traditional Chinese medicine composition is realized by the following technical scheme:

[0011] According to one aspect of the present application, a traditional Chinese medicine composition for preventing and / or treating diabetes is provided, which is prepared from the following raw medicinal materials:

[0012] Radix astragali 250-750 parts by weight; radix puerariae 150-450 parts by weight; radix bupleuri 150-450 parts by weight; ganoderma lucidum 75-225 parts by weight; and salvia miltiorrhiza 150-450 parts by weight.

[0013] Preferably, the traditional Chinese medicine composition is prepared from the following raw medicinal materials:

[0014] Radix Astragali 400-600 parts by weight; Pueraria 240-360 parts by weight; Bupleurum 240-360 parts; Ganoderma 120-180 parts by weight; Salvia 240-360 parts by weight.

[0015] Preferably, the traditional Chinese medicine composition is made of the following raw materials:

[0016] Radix Astragali 500 parts by weight; Pueraria 300 parts by weight; Bupleurum 300 parts by weight; Ganoderma 150 parts by weight; Salvia 300 parts by weight.

[0017] According to one aspect of the present application, a preparation method of a traditional Chinese medicine composition for preventing and / or treating diabetes is provided, comprising the following steps: extracting all crude drugs with water to obtain an extract, concentrating the extract, recovering water to obtain a concentrated solution, further concentrating the concentrated solution, drying, and pulverizing to obtain the traditional Chinese medicine composition; the weight of the crude drugs to the volume of the water is 1:8-1:12.

[0018] Preferably, the specific steps for preparing the extract include: decocting or heating refluxing the raw materials for 2-3 times, each time for 0.5-2 hours, to obtain the extract.

[0019] According to another aspect of the present application, a preparation method of a traditional Chinese medicine composition for treating diabetes is provided, comprising the following steps: extracting raw materials Radix Astragali, Pueraria, and Salvia with an aqueous ethanol solution to obtain an extract, concentrating the extract, recovering the solvent to obtain a concentrated solution A; extracting Bupleurum and Ganoderma with water to obtain an extract B, combining the extract B with the concentrated solution A, further concentrating, drying, and pulverizing to obtain the traditional Chinese medicine composition; preferably, the aqueous ethanol solution is 50%-90% aqueous ethanol solution, and the weight of the raw materials to the volume of the solvent is 1:8-1:12.

[0020] Preferably, the specific steps for preparing the extract include: decocting or heating refluxing Radix Astragali, Pueraria, and Salvia with an aqueous ethanol solution for 2-3 times, each time for 0.5-2 hours, to obtain the extract, concentrating the extract, recovering the solvent to obtain a concentrated solution A; decocting or heating refluxing Bupleurum and Ganoderma with water for 2-3 times to obtain the extract B.

[0021] Preferably, the specific steps for preparing the traditional Chinese medicine composition include: further concentrating the concentrated solution at 60-70°C to a relative density of 1.30-1.35 extract, drying, and pulverizing to obtain the traditional Chinese medicine composition.

[0022] The specific steps of the preparation method can be: extracting all raw materials with 8 times the amount of water for 3 times, each time for 1 hour, combining the extracts, recovering water to obtain a concentrated solution, and optionally, further concentrating the concentrated solution at 60°C, drying, and pulverizing to obtain the traditional Chinese medicine composition.

[0023] The specific steps of the preparation method can be as follows: the raw medicinal materials Astragalus, Pueraria and Salvia miltiorrhiza are extracted with 70% ethanol, the weight / volume ratio of the raw medicinal materials to ethanol is 1:8, decoction or heating reflux is performed for 3 times, 1 hour each time, the obtained extract is concentrated, ethanol is recovered, and a concentrated solution is obtained; the Bupleurum and Ganoderma are decocted or heated refluxed for 3 times, 1 hour each time, an extract is obtained, the extract and the concentrated solution are combined, the extract and the concentrated solution are further concentrated at 60°C, dried, and pulverized to obtain the traditional Chinese medicine composition.

[0024] According to another aspect of the present application, a preparation for preventing and / or treating diabetes is provided, which comprises the traditional Chinese medicine composition described above and a pharmaceutically acceptable excipient.

[0025] The pharmaceutically acceptable excipient includes, but is not limited to, one or more of starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, dextrin, magnesium stearate, mannitol, stevioside, etc.

[0026] The preparation steps of the preparation are as follows: the concentrated solution can be directly added with a solvent and an appropriate amount of excipient without further concentration to prepare a liquid preparation, such as an oral liquid.

[0027] The preparation steps of the preparation are as follows: the concentrated solution can be further concentrated into an extract with a relative density of 1.30-1.35, dried, pulverized, and added with a pharmaceutically acceptable excipient to prepare a solid oral preparation, such as tablets, granules, etc.

[0028] The preparation is prepared into any conventional dosage form of traditional Chinese medicine preparation, including but not limited to tablets, granules, tablets, capsules, pills, pellets, soft capsules, oral liquids, dripping pills, dispersible tablets, effervescent tablets, oral liquid preparations, etc.

[0029] In addition, the traditional Chinese medicine composition of the present application can also be prepared by a traditional decoction method.

[0030] According to another aspect of the present application, the use of the traditional Chinese medicine composition for preparing a medicine for preventing and / or treating diabetes is provided.

[0031] According to another aspect of the present application, the use of the traditional Chinese medicine composition for preparing a medicine for improving fat metabolism of diabetes patients is provided. Preferably, the use refers to the use of the traditional Chinese medicine composition for preparing a medicine for improving blood fat or liver fat metabolism of diabetes patients.

[0032] The mechanisms of the drugs in the present application are as follows:

[0033] This formula consists of five herbs: Bupleurum, Astragalus, Kudzu Root, Ganoderma, and Salvia miltiorrhiza. It has the functions of strengthening the spleen, soothing the liver, and promoting blood circulation. Astragalus, sweet and warm, tonifies Qi and nourishes the middle Jiao, especially the spleen Qi. When the spleen Qi functions properly, Qi and blood are generated; when the ascending and descending functions are restored, the distribution of Qi, blood, and essence is normal. Ganoderma also assists Astragalus in tonifying Qi. Bupleurum, pungent, bitter, and slightly cold, soothes the liver, relieves stagnation, regulates the body's Qi, and promotes the liver's function of clearing and dispersing. When Qi flows smoothly, dampness is eliminated, and blood stasis is resolved. Salvia miltiorrhiza, bitter and slightly cold, invigorates blood and removes blood stasis. Kudzu Root, on the one hand, assists in raising Yang Qi and distributing body fluids by stopping diarrhea, and on the other hand, assists Salvia miltiorrhiza in invigorating blood and removing blood stasis. The combined effects of these herbs strengthen the spleen, soothe the liver, and promote blood circulation, making it effective in treating diabetes caused by liver stagnation and spleen deficiency.

[0034] The beneficial effects of this invention are:

[0035] 1. The traditional Chinese medicine composition is used for the prevention and / or treatment of diabetes, mainly based on the principle of soothing the liver and strengthening the spleen, thereby achieving the prevention and treatment of diabetes and preventing the occurrence and development of diabetic complications.

[0036] 2. The water or ethanol extracts of Astragalus membranaceus, Pueraria lobata, Bupleurum chinense, Ganoderma lucidum and Salvia miltiorrhiza of the present invention are all natural ingredients, which are safer and have no obvious side effects. The obtained extracts have significant effects on regulating sugar and lipid metabolism. Moreover, when the extracts are prepared with water or alcohol, the preparation process is economical, simple and suitable for large-scale industrial production, and convenient for patients to take. Attached Figure Description

[0037] Fig. 1 The effect of the traditional Chinese medicine composition of the present invention on oral glucose tolerance (OGTT) in diabetic model mice;

[0038] Fig. 2 The effect of the traditional Chinese medicine composition of the present invention on oral glucose tolerance (AUC) in diabetic model mice;

[0039] Fig. 3 The effect of the traditional Chinese medicine composition of the present invention on insulin tolerance (ITT) in diabetic model mice;

[0040] Fig. 4 The effect of the traditional Chinese medicine composition of the present invention on insulin tolerance (AUC) in diabetic model mice;

[0041] Fig. 5 The effect of the traditional Chinese medicine composition of the present invention on serum lipids in diabetic model mice;

[0042] Fig. 6 The effect of the traditional Chinese medicine composition of the present invention on liver lipids in diabetic model mice. Detailed Implementation

[0043] In order to make the objects, technical solutions and advantages of the present application clearer, the embodiments of the present application will be further described in detail below with reference to the drawings.

[0044] Example 1

[0045] Take dry Radix Astragali 500g, Pueraria 300g, Salvia 300g, extract with 70% ethanol, solid-liquid ratio is 1:8 (i.e. 1100g of decoction pieces are added to 8800ml of ethanol), heat reflux extraction for 3 times, 1 hour each time, filter, combine the filtrate, recover ethanol under reduced pressure, and concentrate the liquid for use; take dry Bupleurum 300g, Ganoderma 150g, extract with water, solid-liquid ratio is 1:8 (i.e. 450g of decoction pieces are added to 3600ml of water), heat reflux extraction for 3 times, 1 hour each time, filter, combine the filtrate with the aforementioned concentrated liquid, concentrate under reduced pressure to a relative density of 1.30-1.35 (60°C) of extract, dry, and crush into dry extract powder. Mix the above dry extract powder and dextrin 100g, granulate, and granules are prepared.

[0046] Example 2

[0047] Take dry Radix Astragali 500g, Pueraria 300g, Bupleurum 300g, Ganoderma 150g, Salvia 300g, extract with water, solid-liquid ratio is 1:8 (i.e. 1550g of decoction pieces are added to 12400ml of water), heat reflux extraction for 3 times, 1 hour each time, filter, combine the filtrate, concentrate under reduced pressure to a relative density of 1.30-1.35 (60°C) of extract, dry, and crush into dry extract powder; mix the above dry extract powder and dextrin 100g, granulate, and granules are prepared.

[0048] Example 3

[0049] Take dry Radix Astragali 500g, Pueraria 300g, Bupleurum 300g, Ganoderma 150g, Salvia 300g, extract with water, solid-liquid ratio is 1:12 (i.e. 1550g of decoction pieces are added to 18600ml of water), heat reflux extraction for 3 times, 1 hour each time, filter, combine the filtrate, concentrate under reduced pressure to a relative density of 1.30-1.35 (70°C) of extract, dry, and crush into dry extract powder; mix the above dry extract powder, dextrin 100g, microcrystalline cellulose 100g, and magnesium stearate 3g, granulate, and tablets are prepared.

[0050] Example 4

[0051] Take dry Radix Astragali 250g, Pueraria 450g, Radix Bupleuri 450g, Ganoderma 75g, Salvia miltiorrhiza 150g, extract with water, solid-liquid ratio is 1:10 (i.e. 1375g decoction pieces add 13750ml volume of water), heated reflux extraction 3 times, 1 hour each time, filter, combine the filtrate, reduce pressure concentration to the relative density of 1.30~1.35 (70℃) of the extract, dry, crush into dry extract powder. The above dry extract powder and dextrin 75g, microcrystalline cellulose 75g, magnesium stearate 2g, mix evenly, granulation, tabletting, tablet is made.

[0052] Example 5

[0053] Take dry Radix Astragali 750g, Pueraria 150g, Radix Bupleuri 150g, Ganoderma 225g, Salvia miltiorrhiza 450g, extract with water, solid-liquid ratio is 1:10 (i.e. 1725g decoction pieces add 17250ml volume of water, heated reflux extraction 3 times, 1 hour each time, filter, combine the filtrate, reduce pressure concentration to the relative density of 1.30~1.35 (65℃) of the extract, dry, crush into dry extract powder. The above dry extract powder and dextrin 130g, mix evenly, granulation, granules are made.

[0054] Example 6

[0055] Experimental study on preventing and / or treating metabolic diseases of model mice of diabetes mellitus by traditional Chinese medicine composition

[0056] To further illustrate the application of the obtained extract in preparing drugs for preventing and treating type II diabetes mellitus, the following animal experiments are carried out by taking Example 1 and Example 2 as examples, the prevention and / or treatment effects of the traditional Chinese medicine composition of the application on diabetes mellitus are studied by taking oral glucose tolerance, insulin tolerance, serum lipids and liver lipids as indexes.

[0057] 1、Test materials

[0058] 1.1 Test drug: take the dry extract powder of Example 1 and Example 2, respectively, and prepare the required concentrations in Table 1 with distilled water.

[0059] 1.2 Control drug: metformin

[0060] 1.3 Animals: male SPF mice, C57BL / 6J, clean level

[0061] 1.4 Streptozotocin (STZ), manufacturer: Sigma Chemical Co

[0062] 2、Experimental animal administration and modeling

[0063] Male SPF grade 6-8 weeks old C57BL / 6J mice 50, body weight 20-22 g. After adaptive feeding for one week, the mice were randomly divided into 7 groups according to body weight (Table 1). The normal control group was fed with ordinary mouse feed, and the model group, metformin group (20 mg / mL), composition water extract low dose group (100 mg / mL), composition water extract high dose group (200 mg / mL), composition alcohol extract low dose group (100 mg / mL), and composition alcohol extract high dose group (200 mg / mL) were fed with high-fat feed and intragastrically administered with the corresponding drugs once a day, with a intragastric dose of 10 mL / kg.

[0064] The composition alcohol extract was prepared according to the method of Example 1, and the composition water extract was prepared according to the method of Example 2.

[0065] After 48 days of prophylactic administration, the mice were intraperitoneally injected with STZ (100 mg / kg.BW; STZ was prepared with 4°C, pH 4.4, 0.1M sterile citric acid buffer, and was prepared on the spot) after fasting for 12-16 hours, and was continuously injected for 5 days. The normal control group was intraperitoneally injected with solvent citric acid buffer. One week after the injection was completed, the mice were fasted for 12 hours, and the blood glucose value was measured and recorded. After the modeling was successful, the mice were fed with ordinary mouse feed, and the administration was continued for 30 days to take blood and sacrifice.

[0066] Table 1 Administration and modeling methods of each group

[0067]

[0068] 3. Test method and results

[0069] 3.1 Effect of the composition on oral glucose tolerance (OGTT) of diabetic model mice

[0070] After the modeling was successful, the blood glucose value of the mice was measured and recorded. Operation: Before the experiment, the mice were fasted for 12-16 hours, and the test was performed according to the requirements of the blood glucose meter (Roche vitality type) and test paper instructions, with fasting blood glucose (FBG) as the blood glucose value at 0 min of OGTT. Subsequently, the mice were intragastrically administered with 2 g / kg glucose solution prepared with normal saline according to body weight, and the blood glucose value was detected by tail blood at 15, 30, 60, 90, and 120 min after the administration of sugar load, and was recorded for plotting. If the blood glucose of the experimental animals significantly increased at each time point after the administration of sugar load, or the area under the curve increased, it indicated abnormal glucose tolerance.

[0071] Table 2 Blood glucose values of mice at each time point of OGTT

[0072]

[0073] Note: #, compared with the normal control group, p<0.05; ##, compared with the normal control group, p<0.01;

[0074] *, compared with the model group, p<0.05; **, compared with the model group, p<0.01.

[0075] Test results: compared with the normal control group, the blood glucose of the model group mice was significantly increased after intragastric administration of glucose, and the highest value appeared at 30-60 min, and then gradually decreased, and tended to be stable after 120 min, the blood glucose value at each corresponding time point was higher than that of the normal control group, and the AUC was significantly higher than that of the normal control group, that is, it showed obvious glucose tolerance abnormality.

[0076] Compared with the model group, the blood glucose value at each time point of the metformin group and the low-dose water extract composition group was significantly reduced, and the effects of the two were comparable. It is suggested that the metformin group and the low-dose water extract composition have a certain preventive effect on glucose tolerance abnormality caused by high-fat diet. Figs. 1-2

[0077] The area under the AUC curve is calculated by the following formula:

[0078] AUC = [(BG0+BG15) x 0.25 / 2] + [(BG15+BG30) x 0.25 / 2] + [(BG30+BG60) x 0.5 / 2] + [(BG60+BG90) x 1 / 2] + [(BG90+BG120) x 1 / 2]

[0079] Continue to give drug for 30 days, after the last administration, the mice of each group are fasted for 12h, blood is taken, and fasting blood glucose (FBG) is measured.

[0080] Table 3 Fasting blood glucose value of mice after modeling

[0081] Table 3 Fasting blood glucose value of mice after modeling

[0082]

[0083]

[0084] Test results: compared with the normal group, the fasting blood glucose of the model group was significantly increased; compared with the model group, the fasting blood glucose of the metformin group was significantly reduced, and the fasting blood glucose of the remaining administration groups had a decreasing trend.

[0085] ​Combined with the fasting blood glucose of Table 2 and Table 3, the fasting blood glucose of the model group mice after the modeling success was 10.47±2.24 mmol / L, and the fasting blood glucose of the low-dose group of the composition water extract mice was 11.82±4.42 mmol / L; after 30 days of administration, the fasting blood glucose of the model group mice was 18.61±3.02 mmol / L, and the fasting blood glucose of the low-dose group of the composition water extract mice was 15.47±2.26 mmol / L; compared with the two groups of data, it is suggested that the traditional Chinese medicine composition can control the blood glucose level of diabetic mice, delay the development of diabetes, and has a certain therapeutic effect on diabetic mice.

[0086] 3.2 Effect of the composition on insulin tolerance test (ITT) of diabetic model mice

[0087] Insulin tolerance test is used to evaluate the insulin sensitivity of type II diabetes patients. Under normal circumstances, the blood glucose will decrease significantly after intraperitoneal injection of insulin, and will gradually recover in 60-90 min; if the regulation function is abnormal, the blood glucose concentration will decrease slowly after intraperitoneal injection of insulin, and cannot recover to the original value in a short time. The insulin sensitivity of the mice after the modeling success was evaluated by insulin tolerance test. The mice were fasted for 4-6 h before the experiment, and the fasting blood glucose of the mice was used as the blood glucose value of ITT 0 min. Then, 0.5 U / kg of insulin was intraperitoneally injected, and the rest of the operation was the same as the glucose tolerance test.

[0088] Supplemental insulin tolerance calculation formula:

[0089] AUC = [(BG0+BG15)×0.25 / 2]+[(BG15+BG30)×0.25 / 2]+[(BG30+BG60)×0.5 / 2]+[(BG60+BG90)×1 / 2]

[0090] Table 4 Blood glucose values of mice at each time point of ITT

[0091]

[0092] Note: #, compared with the normal control group, p<0.05; ##, compared with the normal control group, p<0.01;

[0093] *, compared with the model group, p<0.05; **, compared with the model group, p<0.01.

[0094] Test results: compared with the normal control group, after intraperitoneal injection of insulin, the blood glucose of the model group mice decreased slowly, and the blood glucose values at each corresponding time point were higher than those of the normal control group, and the AUC was significantly higher than that of the normal control group, that is, the insulin resistance was obvious; compared with the model group, the blood glucose values at each time point of each administration group were significantly reduced after intraperitoneal injection of insulin, the insulin sensitivity of each composition administration group was significantly improved, and the AUC was significantly reduced (see Table 4 and Table 5). Figs. 3-4). It is shown that the composition of the present application can effectively improve the insulin sensitivity of the diabetic patients, and the effect is equivalent to that of metformin.

[0095] 3.3 Effect of the composition on serum and liver lipid of the diabetic model mice

[0096] After the last administration, the mice of each group were fasted for 12 h, and the eyeball was taken to collect blood. After standing, the serum was collected by centrifugation, and the content of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in the serum was determined according to the instruction of the kit (manufacturer: Nanjing Jiancheng Biological Engineering Institute).

[0097] Table 5 Content of serum lipid of mice

[0098]

[0099] Note: #, compared with the normal control group, p<0.05; ##, compared with the normal control group, p<0.01;

[0100] *, compared with the model group, p<0.05; **, compared with the model group, p<0.01.

[0101] Test results: compared with the model group, the content of LDL-C in the serum of the low-dose and high-dose water extraction groups and the low-dose and high-dose alcohol extraction groups of the composition was significantly decreased (P<0.05), and the composition had certain improvement effect on the content of TC, TG and HDL-C in the serum, but no obvious difference was found (see Fig. 5 ).

[0102] Table 6 Content of liver lipid of mice

[0103]

[0104]

[0105] Note: #, compared with the normal control group, p<0.05; ##, compared with the normal control group, p<0.01;

[0106] *, compared with the model group, p<0.05; **, compared with the model group, p<0.01.

[0107] Test results: compared with the normal control group, the content of TG, TC and LDL-C in the liver of the diabetic model mice was significantly increased, and the content of HDL-C had a decreasing trend; compared with the model mice, the content of TG in the liver of each administration group was significantly decreased, and the contents of TC, LDL-C and HDL-C had an improvement trend (see Fig. 6 ).

[0108] The results of the above experiments show that the low-dose group of the composition water extract has the most significant effect in preventing the abnormal glucose metabolism of the diabetic mice induced by high-fat diet plus STZ intraperitoneal injection. Both the composition water extract and alcohol extract can effectively reduce the serum LDL-C content and the liver TG, TC and LDL-C content of the diabetic mice, thereby regulating liver lipid metabolism and reducing blood lipids.

[0109] The above has described the present application in detail. The above examples are only used to help understand the method of the present application and its core idea. It should be pointed out that those skilled in the art can make several improvements and modifications to the present application without departing from the principles of the present application, and these improvements and modifications also fall within the protection scope of the claims of the present application.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of diabetes, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 250-750 parts by weight, Pueraria lobata 150-450 parts by weight, Bupleurum chinense 150-450 parts by weight, Ganoderma lucidum 75-225 parts by weight, and Salvia miltiorrhiza 150-450 parts by weight. The method includes the following steps: extracting all raw materials with water to obtain an extract, further concentrating the extract to obtain a concentrate, drying, and pulverizing to obtain the traditional Chinese medicine composition; the weight-to-volume ratio of the raw materials to the water is 1:8 to 1:

12. The specific steps for preparing the extract include: decocting or heating all the raw materials under reflux for 2-3 times, each time for 0.5-2 hours, to obtain the extract; The specific steps for preparing the traditional Chinese medicine composition include: further concentrating the concentrated liquid at 60℃~70℃ to a relative density of 1.30~1.35 extract, drying, and pulverizing to obtain the traditional Chinese medicine composition.

2. The traditional Chinese medicine composition for the prevention and / or treatment of diabetes according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 400-600 parts by weight, Pueraria lobata 240-360 parts by weight, Bupleurum chinense 240-360 parts by weight, Ganoderma lucidum 120-180 parts by weight, and Salvia miltiorrhiza 240-360 parts by weight.

3. The traditional Chinese medicine composition for the prevention and / or treatment of diabetes according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus 500 parts by weight; Pueraria lobata 300 parts by weight; Bupleurum chinense 300 parts by weight; Ganoderma lucidum 150 parts by weight; and Salvia miltiorrhiza 300 parts by weight.

4. A formulation for the prevention and / or treatment of diabetes, said formulation comprising the traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

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

6. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for improving lipid metabolism in diabetic patients.

Images