Application of Traditional Chinese Medicine Compositions in the Preparation of Drugs for the Prevention and Treatment of Diabetes

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and more particularly to the application of TCM compositions in the preparation of drugs for the prevention and treatment of diabetes. The TCM composition of this invention includes *Sedum sarmentosum*, seaweed, oyster shell, hawthorn, *Siegesbeckia orientalis*, *Schisandra chinensis*, and *Polygonum cuspidatum*. This invention has found that this composition can significantly reduce blood glucose levels in type 2 diabetic rats and increase serum insulin levels and insulin sensitivity index in rats. Moreover, the compound combination drug for treating diabetes is an existing TCM preparation, safe to use, and its preparation method is simple, rapid, efficient, and easy to operate. The prepared mixtures, tablets, capsules, and micro-pills are easy to carry and convenient to take.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to the application of traditional Chinese medicine compositions in the preparation of drugs for the prevention and treatment of diabetes. Background Technology

[0002] Diabetes mellitus is a syndrome caused by absolute or relative insulin deficiency and decreased sensitivity of target tissue cells to insulin, resulting in a series of metabolic disorders involving proteins, fats, water, and electrolytes, with hyperglycemia as the main characteristic.

[0003] Diabetes is mainly classified into three types: type 1, type 2, and gestational diabetes. The causes are primarily attributed to the combined effects of genetic and environmental factors, including decreased insulin secretion due to pancreatic islet cell dysfunction, or insensitivity to insulin, or both, resulting in the ineffective utilization and storage of glucose in the blood. Some diabetic patients and their families exhibit disease clustering.

[0004] The main symptoms of diabetes are "the three highs and one low," namely, excessive thirst, excessive urination, excessive hunger, and weight loss. In addition, patients with a long course of the disease may develop chronic progressive lesions, functional decline, or even failure of tissues and organs such as the eyes, kidneys, nerves, heart, and blood vessels, and may also experience acute severe metabolic disorders.

[0005] Currently, 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. Current treatment for diabetes mainly involves dietary control combined with hypoglycemic drugs (for type 2 diabetes) or insulin supplementation. Furthermore, the prognosis of diabetes depends on disease control and the presence of complications. Prevention of diabetes primarily relies on a healthy lifestyle, including a balanced diet, moderate exercise, maintaining a normal weight, and regular checkups.

[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 should also actively participate in the prevention and treatment of diabetes and develop prescriptions that are appropriate 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 the application of traditional Chinese medicine composition in the preparation of drugs for the prevention and treatment of diabetes.

[0008] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for the prevention and treatment of diabetes.

[0009] In this invention, the raw materials of the traditional Chinese medicine composition are as follows in parts by weight: 1-1000 parts of Sedum sarmentosum, 1-500 parts of Sargassum, 1-1000 parts of Oyster shell, 1-500 parts of Crataegus pinnatifida, 1-1000 parts of Siegesbeckia orientalis, 1-500 parts of Schisandra chinensis, and 1-800 parts of Polygonum cuspidatum.

[0010] In this invention, the prevention and treatment include: reducing blood glucose levels and / or improving pancreatic β-cell function.

[0011] Blood glucose refers to the concentration of glucose in the blood, including fasting blood glucose and postprandial blood glucose. Fasting blood glucose is the blood glucose level measured after an overnight fast, before breakfast, and is usually one of the important indicators for diagnosing diabetes. The results of the embodiments of this invention show that administering the aforementioned traditional Chinese medicine composition can effectively control blood glucose levels. In some embodiments, the reduction of blood glucose levels refers to reducing fasting blood glucose levels.

[0012] Pancreatic beta cells, also known as pancreatic β cells, are a type of pancreatic cell that maintains blood glucose within a normal range by secreting insulin and regulating insulin sensitivity. When pancreatic beta cell function is impaired or abnormal, it can lead to elevated or decreased blood glucose levels, potentially causing related diseases. In some embodiments, improving pancreatic beta cell function includes increasing insulin levels and / or improving the insulin sensitivity index.

[0013] Abnormal insulin levels are a significant contributing factor to the development of diabetes. Understanding and controlling insulin levels is crucial for the treatment and management of diabetes in patients. Embodiments of this invention demonstrate that the traditional Chinese medicine composition can significantly promote insulin secretion.

[0014] The insulin sensitivity index, also known as the insulin resistance index, is a mathematical model for assessing the degree of insulin resistance in the body. The formula for calculating this index is: fasting insulin (uU / mL) × fasting blood glucose (mmol / L) / 22.5. Under normal circumstances, the insulin resistance index in humans is less than 2.69; a value greater than 2.69 indicates insulin resistance. The embodiments of this invention demonstrate that the traditional Chinese medicine composition can effectively alleviate insulin resistance and improve the body's sensitivity to insulin.

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

[0016] In this embodiment of the invention, the mass fractions of each component in the traditional Chinese medicine composition are as follows: 923 parts of Sedum sarmentosum, 308 parts of Sargassum, 923 parts of Oyster shell, 308 parts of Crataegus pinnatifida, 923 parts of C, 308 parts of Schisandra chinensis, and 618 parts of Polygonum cuspidatum.

[0017] In a specific embodiment, the preparation method of the traditional Chinese medicine composition includes: extracting Siegesbeckia orientalis, Sedum sarmentosum, Sargassum, Ostrea gigas, Crataegus pinnatifida, Polygonum cuspidatum, and Schisandra chinensis by reflux with water, and concentrating and drying the filtrate. In this embodiment, the mass ratio of water to the traditional Chinese medicine composition in the reflux extraction is (4-12):1, 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] As a preferred method, the extraction method includes: taking Siegesbeckia orientalis, Sedum sarmentosum, seaweed, oyster shell, hawthorn, Polygonum cuspidatum, and Schisandra chinensis, adding 8 times the amount of water, reflux extraction twice, 1.5 hours each time, filtering, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 (60±5℃), and then concentrating and drying. The drying is carried out using a belt vacuum dryer, and the process also includes pulverizing, sieving, adding sucralose and an appropriate amount of cyclodextrin, mixing, and granulating.

[0019] The present invention also provides a drug for the prevention and treatment of diabetes, comprising pharmaceutically acceptable excipients and the following raw materials in parts by weight: 1-1000g of Sedum sarmentosum, 1-500g of Sargassum, 1-1000g of Oyster shell, 1-500g of Crataegus pinnatifida, 1-1000g of Siegesbeckia orientalis, 1-500g of Schisandra chinensis, and 1-800g of Polygonum cuspidatum.

[0020] The dosage forms of the drugs described in this invention include, but are not limited to, decoctions, 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 by the present invention, the tablet is an oral tablet or a dental tablet.

[0023] Oral tablets refer to tablets intended for oral administration. Most of these tablets contain drugs that are absorbed through the gastrointestinal tract to exert their effects, while some contain drugs that exert their effects locally within the gastrointestinal tract. In some embodiments provided by this 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 more of the following: fruit powder, flavoring, sweetener, acidulant, filler, lubricant, preservative, suspending agent, food coloring, diluent, emulsifier, disintegrant, or plasticizer.

[0025] The medicament described in this invention also includes other medicaments for treating diabetes, including at least one of insulin, metformin, glibenclamide, glipizide, gliclazide, rosiglitazone, pioglitazone, acarbose, voglibose, liraglutide, or exenatide.

[0026] In this invention, the traditional Chinese medicine composition and other therapeutic agents in the drug can exist independently or in combination, and this invention does not limit this.

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

[0028] The administration methods of the drug include, but are not limited to, oral, spray inhalation, rectal, nasal, buccal, vaginal, and topical administration. Alternatively, it may be administered via non-enteric routes, such as subcutaneous, intravenous, intramuscular, intraperitoneal, intrathecal, intraventricular, intrasternal, or intracranial injection or infusion; or via an external implantation device. Preferably, the administration method is oral, intraperitoneal, or intravenous administration.

[0029] In this invention, when the drug includes a traditional Chinese medicine composition and other therapeutic agents, two or more drugs may be administered simultaneously or sequentially, and this invention does not limit this.

[0030] For example, the traditional Chinese medicine composition in the drug is applied no longer than 6 hours before the application of other therapeutic agents, 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 and / or no longer than 6 hours after the application of other therapeutic agents, 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.

[0031] In this invention, when the drug includes a traditional Chinese medicine composition and other therapeutic agents, the dosing frequencies of two or more drugs may be the same or different, and this invention does not limit this.

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

[0033] In this invention, the drug comprises a traditional Chinese medicine composition, and the dosage is not less than the effective dose. If the drug comprises a traditional Chinese medicine composition and other therapeutic agents, the dosage of the traditional Chinese medicine composition is either less than or not less than the effective dose; the dosage of the other therapeutic agents is either less than or not less than the effective dose.

[0034] In this invention, the effective dose includes a "therapeutic effective dose" or a "preventive effective dose," which refers to an amount sufficient, within reasonable medical judgment, to treat or prevent a patient's disease while avoiding serious side effects with a sufficiently low risk-benefit ratio. The preventive or therapeutic effective dose of a drug will vary depending on factors such as the specific drug chosen (e.g., considering the drug's potency, effectiveness, and half-life), the chosen route of administration, the disease being prevented or treated, the severity of the disease being prevented or treated, the patient's age, size, weight, and physical condition, the patient's medical history, the duration of prevention or treatment, the nature of concurrent therapies, and the desired preventive or therapeutic effect, but can still be routinely determined by those skilled in the art.

[0035] In this invention, the prevention and treatment encompasses prevention and / or treatment, specifically measures for the prevention and treatment of diabetes. This includes methods for preventing the onset of diabetes, the purpose of which is to prevent, slow down (reduce) undesirable physiological changes or lesions in the treated subject. Beneficial or desired clinical outcomes include, but are not limited to, avoiding the onset of diabetes, alleviating diabetes symptoms, reducing the severity of diabetes, stabilizing the diabetes state (i.e., not worsening), delaying or slowing the progression of diabetes, improving or mitigating the diabetes state, and achieving remission (whether partial or complete remission), whether detectable or undetectable. Subjects requiring treatment include those already suffering from the condition or disease, those susceptible to the condition or disease, or those intending to prevent the condition or disease.

[0036] In this invention, the target of prevention and control is a human or mammal, including bovines, equines, sheep, pigs, canines, felines, rodents, and primates.

[0037] The traditional Chinese medicine composition of this invention includes Sedum sarmentosum, Sargassum, Oyster shell, Crataegus pinnatifida, Siegesbeckia orientalis, Schisandra chinensis, and Polygonum cuspidatum. This invention has found that this composition can significantly reduce blood glucose levels in type 2 diabetic rats and increase serum insulin levels and insulin sensitivity index. Furthermore, this traditional Chinese medicine composition is an existing prepared Chinese medicine, safe to use, and its preparation method is simple, rapid, efficient, and easy to operate. The prepared mixture, tablets, capsules, and micro-pellets are easy to carry and convenient to take. Detailed Implementation

[0038] This invention provides the application of traditional Chinese medicine compositions in the preparation of drugs for the prevention and treatment of diabetes. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired results. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

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

[0040] This invention proposes the application of a traditional Chinese medicine composition in the preparation of drugs for treating diabetes.

[0041] The herbal composition comprises: 1-1000 parts of *Sedum sarmentosum*, 1-500 parts of *Sargassum fusiforme*, 1-1000 parts of oyster shell, 1-500 parts of hawthorn, 1-1000 parts of *Siegesbeckia orientalis*, 1-500 parts of *Schisandra chinensis*, and 1-800 parts of *Polygonum cuspidatum*. The use of the herbal composition can be any method 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 obtained by conventional means in the art. The herbal medicines used in the composition of the present invention can also be used by directly grinding into powder, extracting, or other processed forms.

[0042] Furthermore, the traditional Chinese medicine composition includes: 1-1000 parts of Sedum sarmentosum, 1-500 parts of Sargassum, 1-1000 parts of Oyster shell, 1-500 parts of Crataegus pinnatifida, 1-1000 parts of Siegesbeckia orientalis, 1-500 parts of Schisandra chinensis, and 1-800 parts of Polygonum cuspidatum.

[0043] Further, the traditional Chinese medicine composition comprises: 500-1000 parts of Sedum sarmentosum, 200-400 parts of Sargassum, 500-1000 parts of Oyster shell, 200-400 parts of Crataegus pinnatifida, 500-1000 parts of Siegesbeckia orientalis, 200-400 parts of Schisandra chinensis, and 300-700 parts of Polygonum cuspidatum.

[0044] Preferably, the traditional Chinese medicine composition comprises: 700-950 parts of Sedum sarmentosum, 200-350 parts of Sargassum, 700-950 parts of Ostrea gigas, 200-350 parts of Crataegus pinnatifida, 700-950 parts of Siegesbeckia orientalis, 200-350 parts of Schisandra chinensis, and 500-650 parts of Polygonum cuspidatum.

[0045] Most preferably, the traditional Chinese medicine composition includes: 923 parts of Siegesbeckia orientalis, 923 parts of Sedum sarmentosum, 308 parts of Sargassum, 923 parts of Ostrea gigas, 308 parts of Crataegus pinnatifida, 618 parts of Polygonum cuspidatum, and 308 parts of Schisandra chinensis.

[0046] Specifically, the diabetes treatment drug is selected from oral dosage forms, injectable dosage forms, or topical dosage forms.

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

[0048] The composition of the present invention described above can be made by directly grinding the ingredients into powder using traditional methods, or by obtaining extracts through conventional means, so as to prepare different dosage forms, achieve better therapeutic effects, and be more conducive to the preparation of modern pharmaceutical dosage forms.

[0049] This invention also proposes a method for preparing any of the aforementioned traditional Chinese medicine compositions, wherein the preparation method is as follows:

[0050] Siegesbeckia orientalis, Sedum sarmentosum, seaweed, oyster shell, hawthorn, Polygonum cuspidatum, and Schisandra chinensis were extracted by reflux with water, adding 8 times the amount of water each time, and extracting for 1.5 hours. The extract was filtered, and the filtrate was concentrated under reduced pressure at no higher than 80℃ to obtain an extract with a relative density of 1.25-1.30 (60±5℃). The extract was then dried under vacuum using a belt dryer, pulverized, sieved, and mixed with sucralose and dextrin to obtain granules.

[0051] The compound drug for treating diabetes of this invention can significantly reduce blood glucose levels in type 2 diabetic rats and increase serum insulin levels and insulin sensitivity index. Furthermore, the preparation method of the compound drug for treating diabetes is simple, rapid, efficient, and easy to operate. The prepared mixtures, tablets, capsules, and microcapsules are easy to carry and convenient to take.

[0052] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. Active pharmaceutical ingredients (APIs) or excipients, as well as reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The invention is further illustrated below with reference to embodiments:

[0054] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0055] Seven medicinal herbs, including 923g of Siegesbeckia orientalis, 923g of Sedum sarmentosum, 308g of Sargassum, 923g of Ostrea gigas, 308g of Crataegus pinnatifida, 618g of Polygonum cuspidatum, and 308g of Schisandra chinensis, were extracted twice by reflux with water, adding 8 times the amount of water each time, for 1.5 hours each time. The extract was filtered, and the filtrate was concentrated under reduced pressure at no higher than 80℃ to obtain an extract with a relative density of 1.25-1.30 (60±5℃). The extract was then dried under vacuum using a belt dryer, pulverized, and sieved to obtain an intermediate of the composition. 2g of sucralose and an appropriate amount of dextrin were added, mixed well, and 1000g of granules were obtained.

[0056] Experimental Example 2: Pharmacological Test

[0057] Therapeutic effects of traditional Chinese medicine composition on animal models of type 2 diabetes

[0058] 1. Experimental Materials

[0059] 1.1 Animals

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

[0061] Rearing environment: Room temperature 20-26℃, relative humidity controlled at 40-70%, animal stocking density 2 animals / cage.

[0062] 1.2 Drugs

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

[0064] 1.3 Instruments

[0065] The Bayer Glucose Meter (Bayer Healthcare Co., Ltd.), the Rat Insulin Assay Kit (batch number SEKR-0033) were purchased from Beijing Solarbio Technology Co., Ltd., the Purified Water Instrument (Milli-Q Plus, Germany) and the Animal Weight Scale (CX-SC-DA, Shanghai Xiangchuan Electronic Weighing Instrument Co., Ltd.) were purchased from Beijing Solarbio Technology Co., Ltd.

[0066] 2. Dosage design

[0067] The daily dosage of the traditional Chinese medicine composition is 8.62g of crude drug / day. Based on the body surface area calculation method, the equivalent dose for rats is 8.62g / 60kg × 6.25 = 0.899g of crude drug / kg. Following a 1 / 2:1:2 dosing regimen, the low dose is 0.450g of crude drug / kg, the medium dose is 0.899g of crude drug / kg, and the high dose is 1.798g of crude drug / kg. Administered by gavage, 10ml / kg, once daily.

[0068] Metformin hydrochloride, 0.5g / dose, twice a day, therefore the daily dose is 1g / day. Based on the body surface area calculation method, the equivalent dose for rats is 1g / 60kg × 6.25 = 0.104g / kg. Administer by gavage, 10ml / kg, once daily.

[0069] 3. Experimental Methods

[0070] (1) Animal modeling of type 2 diabetes mellitus (T2DM): Wistar rats were acclimatized for 7 days with free access to food and water, and randomly divided into a modeling group (60 rats) and a normal group (10 rats) according to their body weight. The normal group was fed a basal diet, while the modeling group was fed a high-sugar, high-fat diet. Both groups had free access to food and water for 8 weeks. After 8 weeks, the rats were fasted but allowed free access to water for 12 hours, and venous blood was collected to measure blood glucose and insulin levels. The modeling group received a single intraperitoneal injection of streptozotocin (STZ) 25 mg / kg, dissolved in citrate buffer (pH 4.2–4.5) at a concentration of 2%. The normal group received an intraperitoneal injection of the same volume of citrate-sodium citrate buffer. Fasting blood glucose and serum insulin levels were measured 72 hours later. A fasting blood glucose level >16.7 mmol / L was considered a successful model.

[0071] (2) Grouping and administration: Rats that successfully developed the model were randomly divided into a model group, a positive drug group, and various dosage groups of the traditional Chinese medicine composition according to their blood glucose levels, with 12 rats in each group. The normal group was given a basal diet, while the other groups continued to be given a high-sugar, 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; and the high, medium, and low dosage groups of the traditional Chinese medicine composition were given the corresponding doses of raw herbs.

[0072] (3) Measurement of relevant indicators: After 8 weeks of drug administration, all rats were fasted but allowed to drink water for 12 hours, and fasting tail vein blood was collected. Fasting blood glucose (FBG) was measured using a blood glucose meter; serum insulin level (FINS) was measured using enzyme-linked immunosorbent assay (ELISA), and insulin sensitivity index (ISI) was calculated using the formula ISI = ln[1 / (FINS×FBG)].

[0073] 4. Statistical Methods

[0074] Statistical analysis was performed using the Graphpad Prism 8 software package. Experimental data are expressed as mean ± standard deviation. The t-test is used to compare two groups, and one-way ANOVA is used to compare multiple groups. P < 0.05 indicates that the data is 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 in the model group rats was significantly increased (P<0.001), indicating successful model establishment. Following this, after STZ treatment, their blood glucose levels were significantly higher than those in the normal group (P<0.001). After 8 weeks of administration, compared with the model group, the blood glucose levels in the positive control group, the high-dose group, and the medium-dose group of the traditional 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 of FBG on 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 rats in the model group was significantly higher before STZ injection (P<0.001). After STZ treatment, their insulin level was significantly lower than before STZ treatment, basically the same as that of the normal group, indicating that the model was successfully replicated. After 8 weeks of administration, compared with the model group, the insulin levels of the positive drug group, the high-dose group and the medium-dose group of the traditional Chinese medicine composition were significantly increased (P<0.01, P<0.01, P<0.05); the ISI values ​​of the positive drug group and the high-dose group of the traditional Chinese medicine composition were significantly increased (P<0.001, P<0.01). The results are shown in Table 2.

[0083] Table 2 Effects of FINS and ISI on 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 Conclusions

[0087] The traditional Chinese medicine composition at concentrations of 1.798 g / kg and 0.899 g / kg significantly reduced fasting blood glucose (FBG) in type 2 diabetic rats, indicating that the drug can effectively control blood glucose levels. After administration, the fecal insulin (FINS) level increased, possibly due to the drug improving pancreatic β-cell function and promoting insulin secretion; the insulin resistance index (ISI) showed a significant increase, indicating improved insulin sensitivity and that the drug can effectively alleviate insulin resistance. The experiment demonstrates that the traditional Chinese medicine composition has a certain therapeutic effect on type 2 diabetes.

[0088] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating diabetes, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 700-950 parts of Sedum sarmentosum, 200-350 parts of Sargassum, 700-950 parts of Oyster shell, 200-350 parts of Crataegus pinnatifida, 700-950 parts of Siegesbeckia orientalis, 200-350 parts of Schisandra chinensis, and 500-650 parts of Polygonum cuspidatum.

2. The application according to claim 1, characterized in that, The diabetes mentioned is type 2 diabetes.

3. The application according to claim 1 or 2, characterized in that, The preparation method of the traditional Chinese medicine composition includes: extracting Siegesbeckia orientalis, Sedum sarmentosum, Sargassum, Ostrea gigas, Crataegus pinnatifida, Polygonum cuspidatum, and Schisandra chinensis by reflux with water, adding 5-10 times the weight of water each time, extracting for 2-4 hours, filtering, concentrating the filtrate under reduced pressure at no higher than 80℃ to an extract with a relative density of 1.25-1.30 at 60±5℃, and then concentrating and drying.

4. The application according to claim 3, characterized in that, In the reflux extraction, reflux extraction is performed twice, each time for 1.5 hours.

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