Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating diabetes

By using traditional Chinese medicine compositions, including sagitta, seaweed, oyster, hawthorn, schisandra, and katyopsis, drugs for preventing and treating diabetes were prepared, which solved the shortcomings of improving pancreatic β-cell function and reducing blood sugar levels in the prior art, and achieved significant blood sugar control and insulin sensitivity improvement.

CN119868443AActive Publication Date: 2025-04-25JIANGSU KANION PHARMA CO LTD
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Patent Information

Application Number
CN202510241786.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-03
Publication Date
2025-04-25
Estimated Expiration
2045-03-03

AI Technical Summary

Technical Problem

The prior art is difficult to effectively prevent and treat diabetes, especially in improving the function of pancreatic β-cells and reducing blood sugar levels.

Method used

The Chinese medicine compositions, including sagitta, seaweed, oyster, hawthorn, sagittata, schisandra and kaminata, were prepared by adding water reflux extraction and concentration, and were used to reduce blood sugar levels and improve pancreatic β-cell function.

Benefits of technology

It significantly reduced the blood sugar level of type 2 diabetes rats, improved the serum insulin level and insulin sensitivity index, effectively alleviated insulin resistance, and improved the function of pancreatic β-cells.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to application of a traditional Chinese medicine composition in preparation of medicine for preventing and treating diabetes. The traditional Chinese medicine composition comprises sedum sarmentosum, seaweed, oyster, hawthorn, herba siegesbeckiae, schisandra chinensis and polygonum cuspidatum. The composition is found to be capable of remarkably reducing the blood sugar level of rats with type 2 diabetes mellitus and increasing the serum insulin level and insulin sensitivity index of the rats. The compound combination medicine for treating diabetes is an existing Chinese patent medicine, medication is safe, and the preparation method is simple, rapid, efficient and easy to operate. The prepared mixture, tablet, capsule, pellet and the like are convenient to carry and take.
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Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to the application of a traditional Chinese medicine composition in the preparation of medicines for preventing and treating diabetes. Background Art

[0002] Diabetes mellitus is a syndrome of a series of metabolic disorders such as protein, fat, water and electrolytes caused by absolute or relative insufficient insulin secretion and reduced sensitivity of target tissue cells to insulin, among which hyperglycemia is the main sign.

[0003] Diabetes is mainly divided into three types: type 1, type 2 and gestational diabetes. The cause is mainly attributed to the combined effects of genetic and environmental factors, including pancreatic islet cell dysfunction leading to decreased insulin secretion, or the body's insensitivity to insulin, or both, which prevents glucose in the blood from being effectively utilized and stored. Some diabetic patients and families have a clustering of the disease.

[0004] The symptoms of diabetes are mainly manifested as "three mores and one less", namely, drinking more, urinating more, eating more and losing weight. In addition, patients with a long course of the disease may develop chronic progressive lesions, functional impairment or even failure of tissues and organs such as the eyes, kidneys, nerves, heart and blood vessels, and may also cause acute and severe metabolic disorders.

[0005] At present, type 1 and type 2 diabetes cannot be completely cured, but since the discovery of medical insulin in 1921, diabetes has been well treated and controlled. At present, the treatment of diabetes is mainly a combination of diet control and hypoglycemic drugs (for type 2 diabetes) or insulin supplementation. In addition, the prognosis of diabetes depends on whether the disease is controlled and whether complications exist. The prevention of diabetes mainly depends on a healthy lifestyle, including a balanced diet, moderate exercise, maintaining a normal weight, and regular physical examinations.

[0006] In recent years, with the deepening of medical research, the treatment plan for diabetes has been constantly evolving. The field of traditional Chinese medicine must also actively intervene in the prevention and treatment of diabetes and develop prescriptions for the symptoms. Summary of the invention

[0007] In view of this, the technical problem to be solved by the present invention is to provide an application of a Chinese medicine composition in the preparation of a medicine for preventing and treating diabetes.

[0008] The invention provides application of a traditional Chinese medicine composition in preparing medicine for preventing and treating diabetes.

[0009] In the present invention, the Chinese medicine composition comprises the following raw materials in parts by weight: 1-1000 parts of Creeping Herb, 1-500 parts of Seaweed, 1-1000 parts of Oyster, 1-500 parts of Crataegus Pinnatifida, 1-1000 parts of Siegesbeckia scabra, 1-500 parts of Schisandra chinensis, and 1-800 parts of Polygonum cuspidatum.

[0010] In the present invention, the prevention and treatment include: lowering blood sugar level and / or improving pancreatic β cell function.

[0011] Blood sugar refers to the glucose concentration in the blood, including fasting blood sugar and postprandial blood sugar, wherein fasting blood sugar refers to the blood sugar value measured by blood sampling before breakfast after overnight fasting, which is usually one of the important indicators for diabetes diagnosis. The results of the embodiments of the present invention show that the administration of the Chinese medicine composition can effectively control blood sugar levels. In some embodiments, the lowering of blood sugar levels is to lower fasting blood sugar levels.

[0012] Pancreatic beta cells, also known as pancreatic B cells, are a type of pancreatic islet cells that maintain blood sugar within a normal range by secreting insulin and regulating insulin sensitivity. When pancreatic beta cell function is impaired or abnormal, it may cause blood sugar to rise or fall, thereby causing related diseases. In some embodiments, improving pancreatic beta cell function includes increasing insulin levels and / or increasing the insulin sensitivity index.

[0013] Abnormal insulin levels are one of the important factors in the occurrence of diabetes. For diabetic patients, understanding and controlling insulin levels is crucial for the treatment and management of the disease. The embodiments of the present invention show that the Chinese medicine composition can significantly promote the secretion of insulin.

[0014] The insulin sensitivity index, also known as the insulin resistance index, is a mathematical model for evaluating the body's insulin resistance. The calculation formula for the index is: fasting insulin (uU / mL) × fasting blood glucose (mmol / L) / 22.5. Under normal circumstances, the human insulin resistance index is less than 2.69. When the value is greater than 2.69, it can be determined as insulin resistance. The embodiments of the present invention show that the Chinese medicine composition can effectively alleviate insulin resistance and improve the body's sensitivity to insulin.

[0015] Diabetes is divided into type 1, type 2 and gestational diabetes. Experiments in the embodiments of the present invention show that the diabetes that the Chinese medicine composition is used to prevent and treat is type 2 diabetes.

[0016] In the embodiment of the present invention, the mass fractions of each component in the traditional Chinese medicine composition are: 923 parts of Creeping Herb, 308 parts of Seaweed, 923 parts of Oyster, 308 parts of Crataegus, C923 parts, 308 parts of Schisandrae Chinensis, and 618 parts of Polygonum Cuspidatum.

[0017] In a specific embodiment, the preparation method of the Chinese medicine composition comprises: adding water to reflux extraction of Siegesbeckia sibiricum, Herba Lysimachiae, Seaweed, Oyster, Hawthorn, Polygonum cuspidatum, and Schisandra chinensis, and concentrating and drying the filtrate. In this embodiment, in the reflux extraction, the mass ratio of water to the Chinese medicine composition is (4-12):1, and the reflux extraction is performed 1-3 times, each time for 1-2 hours, and the density of the extract is 1.25-1.30.

[0018] Preferably, the extraction method comprises: taking Siegesbeckia sibiricum, Herba Lysimachiae, seaweed, oyster, hawthorn, Polygonum cuspidatum and Schisandra chinensis, adding 8 times the amount of water, refluxing and extracting twice, each time for 1.5 hours, filtering, decompressing and concentrating to an extract with a relative density of 1.25 to 1.30 (60±5°C), and then concentrating and drying. The drying adopts belt vacuum drying, and then further comprises the steps of crushing, sieving, adding sucralose and an appropriate amount of cyclodextrin, mixing, and granulating.

[0019] The present invention also provides a medicine for preventing and treating diabetes, which comprises pharmaceutically acceptable excipients and the following raw materials in parts by weight: 1-1000 g of Creeping Peony Root, 1-500 g of Seaweed, 1-1000 g of Oyster, 1-500 g of Hawthorn, 1-1000 g of Siegesbeckia Herba, 1-500 g of Schisandra Chinensis Fruit, and 1-800 g of Polygonum Cuspidatum.

[0020] The dosage form of the drug of the present invention includes but is not limited to decoction, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays and / or injections.

[0021] In some embodiments provided by the present invention, the capsule is a hard capsule or a soft capsule.

[0022] In some embodiments provided herein, the tablet is an oral tablet or an oral tablet.

[0023] Oral tablets refer to tablets for oral administration. Most of the drugs in such tablets are absorbed through the gastrointestinal tract to exert their effects, and some of the drugs in tablets exert their effects locally in the gastrointestinal tract. In some embodiments provided by the present invention, the oral tablets are ordinary compressed tablets, dispersible tablets, effervescent tablets, chewable tablets, coated tablets or sustained-release tablets.

[0024] The pharmaceutically acceptable excipients include one or a mixture of two or more of fruit powder, edible flavors, sweeteners, acidulants, fillers, lubricants, preservatives, suspending agents, edible pigments, diluents, emulsifiers, disintegrants or plasticizers.

[0025] The drugs described in the present invention also include other drugs for treating diabetes, and the other drugs for treating diabetes include: at least one of insulin, metformin, glibenclamide, glipizide, gliclazide, rosiglitazone, pioglitazone, acarbose, voglibose, liraglutide or exenatide.

[0026] In the present invention, in the medicine, the Chinese medicine composition and other therapeutic agents may exist independently of each other or may exist in combination, and the present invention does not limit this.

[0027] Furthermore, the present invention also provides a method for preventing and treating diabetes, which comprises administering the drug of the present invention.

[0028] The administration of the drug includes, but is not limited to, oral administration, spray inhalation, rectal administration, nasal administration, buccal administration, vaginal administration, topical administration. Or non-enteral administration, such as subcutaneous, intravenous, intramuscular, intraperitoneal, intrathecal, intraventricular, intrasternal or intracranial injection or infusion; or administration via an explanted reservoir. Preferably, the administration is oral, intraperitoneal or intravenous.

[0029] In the present invention, when the medicine includes a Chinese medicine composition and other therapeutic agents, two or more medicines can be administered simultaneously or sequentially, and the present invention is not limited to this.

[0030] For example, the Chinese medicine composition in the medicine is administered no longer than 6 hours, preferably no longer than 5 hours, more preferably no longer than 4 hours, even more preferably no longer than 3 hours, more preferably no longer than 2 hours and most preferably no longer than 1 hour before the administration of other therapeutic agents and / or no longer than 6 hours, preferably no longer than 5 hours, more preferably no longer than 4 hours, even more preferably no longer than 3 hours, more preferably no longer than 2 hours and most preferably no longer than 1 hour after the administration of other therapeutic agents.

[0031] In the present invention, when the medicine includes a Chinese medicine composition and other therapeutic agents, the administration frequency of two or more medicines may be the same or different, and the present invention is not limited to this.

[0032] For example, the administration frequency of two or more of the drugs is independently selected from 4 times / day, 3 times / day, 2 times / day or 1 time / day, wherein the administration frequency of the Chinese medicine composition is 4 times / day, 3 times / day, 2 times / day or 1 time / day.

[0033] In the present invention, the medicine includes a Chinese medicine composition, and the dosage is not less than the effective dose. If the medicine includes a Chinese medicine composition and other therapeutic agents, the dosage of the Chinese medicine composition is lower than the effective dose, or not lower than the effective dose; the dosage of other therapeutic agents is lower than the effective dose, or not lower than the effective dose.

[0034] In the present invention, the effective dose includes a "therapeutically effective amount" or a "prophylactically effective amount", which refers to an amount that is sufficient to treat or prevent a patient's disease but low enough to avoid serious side effects (at a reasonable benefit / risk ratio) within the scope of reasonable medical judgment. The preventive or therapeutic effective amount of a drug will vary depending on the specific drug selected (e.g., considering the efficacy, effectiveness and half-life of the drug), the selected route of administration, the disease to be prevented or treated, the severity of the disease to be prevented or treated, the age, size, weight and physical illness of the patient to be prevented or treated, the medical history of the patient to be prevented or treated, the duration of prevention or treatment, the nature of concurrent therapy, the desired preventive or therapeutic effect, and other factors, but can still be routinely determined by those skilled in the art.

[0035] In the present invention, the prevention and treatment includes prevention and / or treatment, which are preventive and therapeutic measures for diabetes. This includes methods for preventing the occurrence of diabetes, the purpose of which is to prevent, slow down (reduce) undesirable physiological changes or lesions in the treated subject, and the beneficial or desired clinical results include but are not limited to avoiding the occurrence of diabetes, alleviating diabetes symptoms, reducing the degree of diabetes, stabilizing the diabetic state (i.e., not worsening), delaying or slowing the progression of diabetes, improving or alleviating the diabetic state, and alleviating (whether partial or complete), whether detectable or undetectable. Subjects in need of treatment include subjects who already have a condition or disease, as well as subjects who are susceptible to a condition or disease or subjects who intend to prevent a condition or disease.

[0036] In the present invention, the object of prevention and treatment is a human or a mammal, and the mammal includes bovines, equines, ovines, porcines, canines, felines, rodents, and primates.

[0037] The Chinese medicine composition of the present invention comprises scutellaria baicalensis, seaweed, oyster, hawthorn, siegetan herb, schisandra chinensis and polygonum cuspidatum. The present invention finds that the composition can significantly reduce the blood sugar level of rats with type 2 diabetes and increase the serum insulin level and insulin sensitivity index of rats. Moreover, the Chinese medicine composition is an existing Chinese patent medicine, which is safe to use and has a simple, fast, efficient and easy-to-operate preparation method. The prepared mixture, tablets, capsules, pellets and the like are easy to carry and convenient to take. DETAILED DESCRIPTION

[0038] The present invention provides the use of a Chinese medicine composition in the preparation of a medicine for preventing and treating diabetes. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0039] The test materials used in the present invention are all common commercial products and can be purchased in the market.

[0040] The invention provides an application of a traditional Chinese medicine composition in preparing a medicine for treating diabetes.

[0041] The Chinese medicine composition comprises: 1-1000 parts of creeping sedge, 1-500 parts of seaweed, 1-1000 parts of oyster, 1-500 parts of hawthorn, 1-1000 parts of siegetineckia, 1-500 parts of schisandra, and 1-800 parts of knotweed. . The use can be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention. The composition of the present invention can be directly ground into powder, or it can be an extract prepared by conventional means in the art. The Chinese medicine used in the composition of the present invention can also be used in the form of direct grinding into powder, extract, or other processed forms.

[0042] Furthermore, the Chinese medicine composition includes: 1-1000 parts of Creeping Jasmine, 1-500 parts of seaweed, 1-1000 parts of oyster, 1-500 parts of hawthorn, 1-1000 parts of Siegesbeckia, 1-500 parts of Schisandra chinensis, and 1-800 parts of Polygonum cuspidatum.

[0043] Furthermore, the Chinese medicine composition comprises: 500-1000 parts of Herba Creepers, 200-400 parts of Seaweed, 500-1000 parts of Oyster, 200-400 parts of Hawthorn, 500-1000 parts of Siegesbeckia, 200-400 parts of Schisandrae Chinensis, 300-700 parts of Polygonum Cuspidatum

[0044] Preferably, the Chinese medicine composition comprises: 700-950 parts of Creeping Jasmine, 200-350 parts of seaweed, 700-950 parts of oysters, 200-350 parts of hawthorn, 700-950 parts of Siegesbeckia, 200-350 parts of Schisandra chinensis, and 500-650 parts of Polygonum cuspidatum.

[0045] Most preferably, the Chinese medicine composition comprises: 923 parts of Siegesbeckia serrata, 923 parts of Creeping Herb, 308 parts of Sargassum, 923 parts of Oyster, 308 parts of Crataegus pinnatifida, 618 parts of Polygonum cuspidatum, and 308 parts of Schisandra chinensis.

[0046] Specifically, the drug for treating diabetes is selected from oral dosage forms, injection dosage forms or external dosage forms.

[0047] Specifically, the drug for treating diabetes is selected from decoctions, tablets, capsules, granules, pills, injections, decoctions, suspensions, dispersants, syrups, suppositories, gels, aerosols, patches, and oral liquids.

[0048] Among them, the composition of the present invention described above can be directly ground into powder by traditional methods, or it can be obtained by conventional means to obtain extracts so as to be made into different dosage forms, obtain better therapeutic effects and be more conducive to the preparation of modern pharmaceutical dosage forms.

[0049] The present invention also provides a method for preparing any of the aforementioned Chinese medicine compositions, the preparation method comprising:

[0050] Add water to reflux extraction of Siegesbeckia scabra, Creeping Herb, seaweed, oyster, hawthorn, Polygonum cuspidatum and Schisandra chinensis, add 8 times the amount of water each time, extract for 1.5 hours, filter, and concentrate the filtrate under reduced pressure at no more than 80°C to an extract with a relative density of 1.25-1.30 (60±5°C), belt vacuum dry, crush and sieve, add sucralose and dextrin and mix well to obtain granules.

[0051] The compound combination medicine for treating diabetes of the present invention can significantly reduce the blood sugar level of rats with type 2 diabetes, and increase the serum insulin level and insulin sensitivity index of rats. Moreover, the preparation method of the compound combination medicine for treating diabetes is simple, rapid, efficient and easy to operate. The prepared mixture, tablets, capsules, micropills and the like are easy to carry and convenient to take.

[0052] The following experiments, if no specific conditions are specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The APIs or excipients, reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight.

[0053] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention. The present invention is further described below in conjunction with the embodiments:

[0054] Example 1 Preparation of Chinese medicine composition

[0055] Seven herbs in total, 923 g of Siegesbeckia scabra, 923 g of Creeping Herb, 308 g of Sargassum, 923 g of Oyster, 308 g of Crataegus pinnatifida, 618 g of Polygonum cuspidatum and 308 g of Schisandra chinensis, were extracted twice with water under reflux, with 8 times the amount of water added each time. The extraction lasted for 1.5 hours and the extract was filtered. The filtrate was concentrated under reduced pressure at a temperature not higher than 80°C to an extract with a relative density of 1.25-1.30 (60±5°C). The extract was dried under belt vacuum, crushed and sieved to obtain a composite intermediate. 2 g of sucralose and an appropriate amount of dextrin were added and mixed to obtain 1000 g of granules.

[0056] Experimental Example 2 Pharmacological Test

[0057] Therapeutic effect of Chinese herbal medicine combination on animal model of type 2 diabetes

[0058] 1. Experimental Materials

[0059] 1.1 Animals

[0060] Wistar, male, SPF grade, 70, 6-8 weeks old, weighing 200±20g, purchased from Sibeifu (Beijing) Biotechnology Co., Ltd.

[0061] Breeding environment: room temperature 20-26°C, relative humidity controlled at 40-70%, animal breeding density 2 per cage.

[0062] 1.2 Drugs

[0063] The Chinese medicine composition prepared in Example 1 was purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; metformin hydrochloride tablets (Shanghai Hengshan Pharmaceutical Co., Ltd., batch number: National Medicine Standard H31021359); streptozotocin (STZ, Sigma, USA, item number: S0130-500MG); sodium citrate (R&D, item number: 3161 / 500G); citric acid (Sinopharm Chemical Reagent Company, item number: XW00779291). Basic feed was purchased from Qinglongshan Animal Breeding Factory; high-sugar and high-fat feed was purchased from (Beijing Boaigang Biotechnology Co., Ltd.).

[0064] 1.3 Instruments

[0065] The Bayankang blood glucose meter (Bayer Healthcare Co., Ltd.) and rat insulin detection kit (batch number SEKR-0033) were purchased from Beijing Solebow Technology Co., Ltd., purified water instrument (Millipore, Germany, model: Milli-Q Plus); animal weight scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: CX-SC-DA).

[0066] 2. Dosage design

[0067] The daily dosage of the Chinese medicine composition is 8.62 g of crude drug / day. According to the body surface area conversion method, the equivalent dose of rats is 8.62 g / 60 kg × 6.25 = 0.899 g of crude drug / kg. According to the 1 / 2:1:2 dosing method, the low dose is 0.450 g of crude drug / kg, the medium dose is 0.899 g of crude drug / kg, and the high dose is 1.798 g of crude drug / kg. Oral administration, 10 ml / kg, once a day.

[0068] Metformin hydrochloride, 0.5g / time, 2 times / day, then the daily dosage is 1g / day, according to the body surface area conversion method, the equivalent dose for rats is 1g / 60kg×6.25=0.104g / kg. Oral administration, 10ml / kg, once a day.

[0069] 3. Experimental Methods

[0070] (1) Animal modeling of type 2 diabetes mellitus (T2DM): Wistar rats were adaptively fed for 7 days, with free access to feed and water, and randomly divided into a modeling group (60 rats) and a normal group (10 rats) according to body weight. The normal group was fed with a basal diet, and the modeling group was fed with a high-sugar and high-fat diet. Both rats were free to eat and drink water for 8 consecutive weeks. After 8 weeks, the rats were fasted but not watered for 12 hours, and venous blood was collected to test blood glucose and insulin levels. The modeling group was given a single intraperitoneal injection of streptozotocin (STZ) 25 mg / kg, which was dissolved in a citric acid buffer solution (pH 4.2-4.5) at a concentration of 2%. The normal group was given an intraperitoneal injection of the same volume of citric acid-sodium citrate buffer, and the levels of fasting blood glucose and serum insulin were tested 72 hours later. The modeling was considered successful when the fasting blood glucose was >16.7 mmol / L.

[0071] (2) Grouping and administration: The rats with successful modeling were randomly divided into a model group, a positive drug group, and a Chinese medicine composition group according to their blood sugar levels, with 12 rats in each group. The normal group was given a basic diet, and the other groups continued to be given a high-sugar and high-fat diet. The normal group and the model group were given purified water by gavage; the positive drug group was given metformin hydrochloride by gavage; the high, medium, and low dose groups of the Chinese medicine composition were given the corresponding doses of crude drugs.

[0072] (3) Measurement of related indicators: After 8 weeks of administration, all rats were fasted but not watered for 12 h, and blood was collected from the tail vein. Fasting blood glucose (FBG) was measured using a blood glucose meter; serum insulin levels (FINS) were measured using enzyme-linked immunosorbent assay (ELISA), and the insulin sensitivity index (ISI) was calculated using the formula ISI = ln[1 / (FINS × FBG)].

[0073] 4. Statistical methods

[0074] The statistical software package Graphpad prism 8 was used for statistics, and the experimental data were expressed as mean ± standard deviation. The t test was used for comparison between two groups, and one-way ANOVA was used for comparison between multiple groups. P < 0.05 indicated that the data were statistically significant.

[0075] 5. Experimental Results

[0076] 5.1 Effects on FBG levels in T2DM rats

[0077] Compared with the normal group, the FBG level of the model group rats was significantly increased (P<0.001), indicating that the model was successfully established. On this basis, after STZ treatment, their blood glucose level was significantly higher than that of the normal group (P<0.001); after 8 weeks of administration, compared with the model group, the blood glucose levels of the positive drug group and the high and medium dose groups of the Chinese medicine combination were significantly decreased (P<0.001, P<0.001, P<0.01). The results are shown in Table 1.

[0078] Table 1 Effects on FBG in T2DM rats

[0079]

[0080] Note: Compared with the normal group, ###P<0.001; compared with the model group, **P<0.01, ***P<0.001.

[0081] 5.2 Effects on insulin levels in model rats and comparison of ISI

[0082] Compared with the normal group, the insulin level of the model group rats before STZ injection increased, with a very significant difference (P<0.001). After STZ treatment, the insulin level was significantly lower than that before STZ treatment, basically the same as the normal group, indicating that the model was successfully replicated. After 8 weeks of administration, compared with the model group, the insulin level of the positive drug group, the high and medium dose groups of the Chinese medicine combination increased significantly (P<0.01, P<0.01, P<0.05); the ISI value of the positive drug group and the high dose group of the Chinese medicine combination increased significantly (P<0.001, P<0.01), the results are shown in Table 2.

[0083] Table 2 Effects on FINS and ISI in T2DM rats

[0084]

[0085] Note: Compared with the normal group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0086] 6. Experimental conclusion

[0087] The Chinese medicine composition of 1.798 crude drug / kg and 0.899 crude drug / kg can significantly reduce the FBG of rats with type 2 diabetes, indicating that the drug can effectively control blood sugar levels. After administration, the FINS level increased, which may be due to the drug improving the function of pancreatic β cells and promoting insulin secretion; the ISI value increased significantly, indicating that the body's sensitivity to insulin has improved and the drug can effectively alleviate insulin resistance. The experiment shows that the Chinese medicine composition has a certain therapeutic effect on type 2 diabetes.

[0088] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Application of Chinese medicine composition in the preparation of medicine for preventing and treating diabetes; The Chinese medicine composition comprises the following raw materials in parts by weight: 1-1000 parts of Creeping Herb, 1-500 parts of seaweed, 1-1000 parts of oyster, 1-500 parts of hawthorn, 1-1000 parts of Siegesbeckia, 1-500 parts of Schisandra chinensis, and 1-800 parts of Polygonum cuspidatum.

2. The use according to claim 1, characterized in that: The prevention and treatment include: lowering blood sugar level and / or improving pancreatic β cell function.

3. The use according to claim 2, characterized in that: The lowering of blood sugar level refers to lowering fasting blood sugar level.

4. The use according to claim 2, characterized in that: The improving pancreatic β cell function includes increasing insulin level and / or increasing insulin sensitivity index.

5. The use according to any one of claims 1 to 4, characterized in that: The diabetes is type 2 diabetes.

6. The use according to any one of claims 1 to 5, characterized in that: The preparation method of the traditional Chinese medicine composition comprises: adding water to extract schisandra chinensis, scutellaria baicalensis, seaweed, oyster, hawthorn, knotweed and schisandra chinensis, adding 5-10 times the mass of water each time, extracting for 2-4 hours, filtering, concentrating the filtrate under reduced pressure at a temperature not higher than 80° C. to an extract with a relative density of 1.25-1.30 (60±5° C.), and then concentrating and drying.

7. The use according to claim 67, characterized in that In the reflux extraction, reflux extraction was performed twice, each time for 1.5 hours.

8. A drug for preventing and treating diabetes, comprising pharmaceutically acceptable excipients and the following raw materials in parts by weight: 1-1000 parts of Creeping Peony, 1-500 parts of seaweed, 1-1000 parts of oyster, 1-500 parts of hawthorn, 1-1000 parts of Siegesbeckia, 1-500 parts of Schisandrae Chinensis, and 1-800 parts of Polygonum cuspidatum.

9. The drug according to claim 8, characterized in that Other drugs for treating diabetes are also included, and the other drugs for treating diabetes include: at least one of insulin, metformin, glibenclamide, glipizide, gliclazide, rosiglitazone, pioglitazone, acarbose, voglibose, liraglutide or exenatide.

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