A traditional Chinese medicine composition for treating diabetes, its preparation method and application

Abstract

The present invention relates to a traditional Chinese medicine composition for treating diabetes, its preparation method and application, and belongs to the technical field of traditional Chinese medicine. Calculated by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 5-15 parts of ginseng, 20-50 parts of astragalus membranaceus, 15-30 parts of rehmannia glutinosa, 3-10 parts of schizandra chinensis, 5-12 parts of aster tataricus, and 5-15 parts of mulberry bark. The applicant has first discovered that Bufei Decoction has a certain therapeutic effect on type II diabetes. Subsequently, based on the existing formula of Bufei Decoction, a large number of experiments on component and dosage screening have been carried out. The experimental results show that after removing the ginseng component and adjusting the dosages of astragalus membranaceus and rehmannia glutinosa, the therapeutic effect on type II diabetes is more significant. Thus, a traditional Chinese medicine composition for treating diabetes with good curative effect and no side effects is obtained, providing a new means for the treatment of diabetes patients and having practical application value.

Description

Technical Field

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

[0002] Diabetes is a common metabolic disease characterized by high blood sugar. Its incidence is related to genetic factors, lifestyle, diet and age. According to the pathological characteristics of patients, diabetes can be divided into two categories: type 1 diabetes and type 2 diabetes; among them, the vast majority of diabetic patients are type 2 diabetes, accounting for more than 90%. Therefore, the prevention and treatment of type 2 diabetes has been a research hotspot in recent years.

[0003] Type 2 diabetes, also known as non-insulin-dependent diabetes or adult-onset diabetes, is characterized by a decrease in insulin secretion and insulin action by pancreatic beta cells, resulting in a persistent increase in blood sugar levels. In the body's high blood sugar environment, large blood vessels, microvessels, nerves, etc. will become diseased, thereby endangering organs such as the heart, kidneys, and eyes, leading to long-term complications such as heart disease, kidney failure, and diabetic retinopathy.

[0004] At present, in addition to insulin, the clinical treatment of type II diabetes uses chemical hypoglycemic drugs such as sulfonylureas and biguanides. However, long-term use can easily cause adverse reactions such as hypoglycemia, skin allergies and digestive discomfort, which bring great side effects to patients. On the other hand, clinical trials have been trying to use plant-based Chinese herbal medicines to treat patients with type II diabetes, such as the emergence of Jiangtangning Capsules and Shenqi Jiangtang Granules, which reduce the adverse reactions of chemical hypoglycemic drugs to patients, reflecting the unique advantages of Chinese medicine, and gradually becoming a mainstream treatment method.

[0005] In view of this, it is very meaningful to provide a Chinese medicine composition for treating diabetes with good efficacy and no side effects. Summary of the invention

[0006] In order to solve the above problems, the present invention provides a Chinese medicine composition for treating diabetes and a preparation method and application thereof.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetes, which is composed of the following raw materials in parts by weight: 5-15 parts of ginseng, 20-50 parts of astragalus, 15-30 parts of rehmannia, 3-10 parts of schisandra, 5-12 parts of aster and 5-15 parts of mulberry bark.

[0008] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 20-50 parts of Astragalus, 15-30 parts of Rehmannia, 3-10 parts of Schisandra, 5-12 parts of Aster and 5-15 parts of Morus alba.

[0009] Further, the weight ratio of the astragalus membranaceus and the rehmannia glutinosa is 1.8:1.

[0010] Further, by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 33.3 parts of astragalus membranaceus, 18.5 parts of rehmannia glutinosa, 5 parts of schizandra chinensis, 7 parts of aster tataricus and 10 parts of mulberry bark.

[0011] Further, the diabetes is type II diabetes.

[0012] In a second aspect, the present invention provides a preparation method of the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and the preparation method includes the following steps:

[0013] Crush each component in the traditional Chinese medicine composition to obtain a mixture.

[0014] Add the mixture into an extraction solvent for reflux extraction, and then filter to obtain an extract.

[0015] Concentrate and dry the extract to obtain the traditional Chinese medicine composition.

[0016] Further, the extraction solvent is composed of 95% ethanol, ethyl acetate and n-hexane with a weight ratio of (10-15):(1-3):(3-5); the weight ratio of the extraction solvent to the total weight of the traditional Chinese medicine composition is (5-10):1.

[0017] Further, the working parameters of the reflux extraction include: the reflux extraction temperature is 85-90 °C, the reflux extraction time is 1-3 hours, and the reflux extraction frequency is 1-3 times.

[0018] In a third aspect, the present invention provides the application of the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and / or the traditional Chinese medicine composition prepared by the preparation method according to any one of the second aspect in the preparation of drugs for treating diabetes.

[0019] In a fourth aspect, the present invention provides a traditional Chinese medicine preparation for treating diabetes, characterized in that the traditional Chinese medicine preparation includes the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and / or the application of the traditional Chinese medicine composition prepared by the preparation method according to any one of the second aspect in the preparation of drugs for treating diabetes.

[0020] The above technical solutions provided by the embodiments of the present invention have at least the following advantages compared with the prior art:

[0021] An embodiment of the present invention provides a traditional Chinese medicine composition for treating diabetes. The applicant has first discovered that Bufei Decoction has a certain therapeutic effect on type II diabetes. Subsequently, based on the existing formula of Bufei Decoction, a large number of experiments on component screening and dosage adjustment were carried out. The experimental results show that after removing the ginseng component and adjusting the dosages of astragalus root and rehmannia root, the therapeutic effect on type II diabetes is more significant. Thus, a traditional Chinese medicine composition for treating diabetes with good curative effect and no side effects is obtained, providing a new means for the treatment of diabetes patients and having practical application value. Detailed implementation manners

[0022] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0023] Unless otherwise specifically stated, all kinds of raw materials, reagents, instruments and equipment used in the present invention can be obtained through market purchase or prepared by existing methods.

[0024] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetes. Calculated by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 5-15 parts of ginseng, 20-50 parts of astragalus root, 15-30 parts of rehmannia root, 3-10 parts of schisandra fruit, 5-12 parts of aster root and 5-15 parts of mulberry bark.

[0025] Bufei Decoction (its prescription composition: 9g of ginseng, 24g of astragalus root, 24g of rehmannia root, 6g of schisandra fruit, 9g of aster root, 9g of mulberry bark.), from "Yong Lei Qian Fang", has the effects of tonifying the lung and replenishing qi, relieving cough and asthma, etc. It is mainly applied to the treatment of lung deficiency with cough and asthma, shortness of breath and spontaneous sweating, weak voice, pale tongue, weak pulse, etc. The applicant has first discovered that Bufei Decoction has a certain therapeutic effect on type II diabetes. Subsequently, based on the existing formula of Bufei Decoction, a large number of experiments on component screening and dosage adjustment were carried out. The experimental results show that after removing the ginseng component and adjusting the dosages of astragalus root and rehmannia root, the therapeutic effect on type II diabetes is more significant. Thus, a traditional Chinese medicine composition for treating diabetes with good curative effect and no side effects is obtained, providing a new means for the treatment of diabetes patients and having practical application value.

[0026] Preferably, calculated by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 20-50 parts of astragalus root, 15-30 parts of rehmannia root, 3-10 parts of schisandra fruit, 5-12 parts of aster root and 5-15 parts of mulberry bark.

[0027] More preferably, by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 27-50 parts of Astragalus membranaceus, 15-27.78 parts of Rehmannia glutinosa, 3-10 parts of Schisandra chinensis, 5-12 parts of Aster tataricus, and 5-15 parts of Morus alba root bark.

[0028] Most preferably, by weight parts, the traditional Chinese medicine composition is composed of the following raw materials: 33.3 parts of Astragalus membranaceus, 18.5 parts of Rehmannia glutinosa, 5 parts of Schisandra chinensis, 7 parts of Aster tataricus, and 10 parts of Morus alba root bark.

[0029] In some specific embodiments, the weight ratio of Astragalus membranaceus to Rehmannia glutinosa is 1.8:1.

[0030] The applicant found through experiments that when the weight ratio of Astragalus membranaceus to Rehmannia glutinosa is controlled at 1.8:1, the obtained traditional Chinese medicine composition has a more significant effect on treating diabetes.

[0031] In some specific embodiments, the diabetes is type II diabetes.

[0032] In a second aspect, based on a general inventive concept, the present invention provides a preparation method of the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and the preparation method includes the following steps:

[0033] Crush each component in the traditional Chinese medicine composition to obtain a mixed material;

[0034] Add the mixed material into an extraction solvent for reflux extraction, and then filter to obtain an extract;

[0035] Concentrate and dry the extract to obtain the traditional Chinese medicine composition.

[0036] The preparation method of the traditional Chinese medicine composition for treating diabetes provided by the present invention adopts the reflux extraction method. By controlling the process parameters of the reflux extraction, not only the full extraction of the medicinal materials is realized and the quality of the obtained traditional Chinese medicine composition is controllable; moreover, the whole operation steps are simple, no additional specific equipment is required, and it is convenient for industrial production.

[0037] In some specific embodiments, there is no specific requirement for the particle size of the mixed material. For example, it can be particulate matter with an average particle size of 2-5 mm, or it can be powder passed through a 100-500 mesh sieve.

[0038] In some specific embodiments, the extraction solvent is composed of 95% ethanol, ethyl acetate, and n-hexane with a weight ratio of (10-15):(1-3):(3-5); the weight ratio of the extraction solvent to the total weight of the traditional Chinese medicine composition is (5-10):1.

[0039] The applicant found through experiments that when the extraction solvent is 95% ethanol, ethyl acetate, and n-hexane with a weight ratio of (10-15):(1-3):(3-5), the polarity of the extraction solvent is appropriate, and the active ingredients of the obtained traditional Chinese medicine composition have a more significant effect on treating diabetes. Preferably, 95% ethanol, ethyl acetate, and n-hexane with a weight ratio of 13:2:4 are used as the extraction solvent.

[0040] In some specific embodiments, the working parameters of the reflux extraction include: the reflux extraction temperature is 85-90°C, the reflux extraction time is 1-3 hours, and the reflux extraction times are 1-3 times.

[0041] In a third aspect, based on a general inventive concept, the present invention provides the use of the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and / or the traditional Chinese medicine composition prepared by the preparation method according to any one of the second aspect in the preparation of a drug for treating diabetes.

[0042] The traditional Chinese medicine composition provided by the present invention has a significant therapeutic effect on type II diabetes, with good curative effect and no side effects, providing a new means for the treatment of diabetes patients and having practical application value.

[0043] In a fourth aspect, the present invention provides a traditional Chinese medicine preparation for treating diabetes, characterized in that the traditional Chinese medicine preparation includes the traditional Chinese medicine composition for treating diabetes according to any one of the first aspect, and / or the use of the traditional Chinese medicine composition prepared by the preparation method according to any one of the second aspect in the preparation of a drug for treating diabetes.

[0044] The traditional Chinese medicine preparation for treating diabetes provided by the present invention is realized based on the traditional Chinese medicine composition according to any one of the first aspect, and thus has at least all the beneficial effects brought by the technical solutions of the above embodiments, which will not be elaborated here one by one.

[0045] In some specific embodiments, the traditional Chinese medicine preparation provided by the embodiments of the present invention further includes pharmaceutical excipients (or pharmaceutically acceptable carriers). The pharmaceutical excipients refer to pharmaceutically acceptable additives other than the main drug in the pharmaceutical preparation, and their types and dosages can be selected according to the technical content disclosed in the prior art and actual needs. Specifically, such as binders, fillers, disintegrants, lubricants in tablets; such as the matrix part in semi-solid preparations such as ointments and creams; such as preservatives, antioxidants, flavoring agents, fragrances, cosolvents, emulsifiers, solubilizers, osmotic pressure regulators, coloring agents, etc. in liquid preparations. For example, the obtained traditional Chinese medicine extract can be ground into powder, mixed with excipients such as sucrose and dextrin to make granules; or the obtained traditional Chinese medicine extract can be ground into powder, simply using distilled water as a binder, mixed evenly to make pills, and dried immediately after making the pills to make water pills.

[0046] In some specific embodiments, the dosage form of the traditional Chinese medicine preparation for treating diabetes is a granule, and its preparation method includes the following process: the obtained traditional Chinese medicine composition (specifically, dry extract powder) is continuously made into granules by means of existing dry granulation methods through processes such as compression, shaping, pulverization, and sizing; or, a suitable wetting agent or binder is added to the obtained traditional Chinese medicine composition to make a soft material and then made into granules by means of existing wet granulation methods.

[0047] It should be noted that for the raw materials involved in the traditional Chinese medicine composition for treating diabetes provided by the present invention, its preparation method and application, if there are no special limitations or specific descriptions, commercially available products can be used or self-made according to existing preparation processes; at the same time, for the process steps and parameters involved in the preparation method of the traditional Chinese medicine composition and the traditional Chinese medicine preparation, if there are no special limitations or specific descriptions, the preparation processes disclosed in the prior art can be used or existing equipment can be adopted, and the details will not be elaborated one by one in this application document.

[0048] The following will further illustrate the present invention in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. For the experimental methods without specific conditions noted in the following embodiments, they are generally determined according to national standards. If there are no corresponding national standards, they are carried out according to general international standards, conventional conditions, or the conditions recommended by the manufacturer.

[0049] Example 1

[0050] This example provides a traditional Chinese medicine composition for treating diabetes (in this example, the weight ratio of astragalus membranaceus and rehmannia glutinosa is 1:1). Calculated by weight parts (each weight part unit is 100 g), the traditional Chinese medicine composition is composed of the following raw materials: 9 parts of ginseng, 24 parts of astragalus membranaceus, 24 parts of rehmannia glutinosa, 6 parts of schisandra chinensis, 9 parts of aster tataricus, and 9 parts of mulberry bark.

[0051] The preparation method of the above-provided traditional Chinese medicine composition includes the following steps:

[0052] Crush each component in the traditional Chinese medicine composition to obtain a mixture;

[0053] Add the mixture to an extraction solvent for reflux extraction, and then filter to obtain an extract;

[0054] Concentrate and dry the extract to obtain the traditional Chinese medicine composition;

[0055] Among them, the extraction solvent is composed of 95% ethanol, ethyl acetate, and n-hexane with a volume ratio of 13:2:4, and the weight ratio of the extraction solvent to the total weight of the traditional Chinese medicine composition is 7:1; the working parameters of the reflux extraction include: the reflux extraction temperature is 88 °C, the reflux extraction time is 1.5 hours, and the reflux extraction frequency is 2 times.

[0056] Example 2

[0057] This example provides a traditional Chinese medicine composition for treating diabetes (in this example, the weight ratio of astragalus membranaceus and rehmannia glutinosa is 1:1). Calculated by weight parts (each weight part unit is 100 g), the traditional Chinese medicine composition is composed of the following raw materials: 24 parts of astragalus membranaceus, 24 parts of rehmannia glutinosa, 6 parts of schisandra chinensis, 9 parts of aster tataricus, and 9 parts of mulberry bark.

[0058] The preparation method of the above-provided traditional Chinese medicine composition is the same as that of Example 1.

[0059] Example 3

[0060] This example provides a traditional Chinese medicine composition for treating diabetes (in this example, the weight ratio of astragalus membranaceus and rehmannia glutinosa is 1.8:1). Calculated by weight parts (each weight part unit is 100 g), the traditional Chinese medicine composition is composed of the following raw materials: 27 parts of astragalus membranaceus, 15 parts of rehmannia glutinosa, 3 parts of schisandra chinensis, 5 parts of aster tataricus, and 5 parts of mulberry bark.

[0061] The preparation method of the above-provided traditional Chinese medicine composition is the same as that of Example 1.

[0062] Example 4

[0063] This example provides a traditional Chinese medicine composition for treating diabetes (in this example, the weight ratio of astragalus membranaceus and rehmannia glutinosa is 1.8:1). Calculated by weight parts (each weight part unit is 100 g), the traditional Chinese medicine composition is composed of the following raw materials: 50 parts of astragalus membranaceus, 27.78 parts of rehmannia glutinosa, 10 parts of schisandra chinensis, 12 parts of aster tataricus, and 15 parts of mulberry bark.

[0064] The preparation method of the above-provided traditional Chinese medicine composition is the same as that of Example 1.

[0065] Example 5

[0066] This example provides a traditional Chinese medicine composition for treating diabetes (in this example, the weight ratio of astragalus membranaceus and rehmannia glutinosa is 1.8:1). Calculated by weight parts (each weight part unit is 100 g), the traditional Chinese medicine composition is composed of the following raw materials: 33.3 parts of astragalus membranaceus, 18.5 parts of rehmannia glutinosa, 5 parts of schisandra chinensis, 7 parts of aster tataricus, and 10 parts of mulberry bark.

[0067] The preparation method of the above-provided traditional Chinese medicine composition is the same as that of Example 1.

[0068] Example 6

[0069] This example provides a traditional Chinese medicine composition for treating diabetes and its preparation method. The difference from Example 5 is only that: the extraction solvent used in the preparation method of the traditional Chinese medicine composition is composed of 95% ethanol and ethyl acetate with a weight ratio of 13:2; the remaining steps and parameters are the same.

[0070] Test Example 1

[0071] This test example uses experimental type II diabetic rats induced by 1 wt% streptozotocin solution (prepared on-site in a 4°C ice bath with streptozotocin at a concentration of 0.1 mol / L and pH 4.4 citrate-citrate buffer) as the animal model to investigate the therapeutic effect of the traditional Chinese medicine compositions obtained in Examples 1-6 on diabetes.

[0072] 1. Experimental subjects: 80 healthy male rats, randomly divided into 8 groups, with 10 rats in each group, and the body weight of each rat was 163.2 - 205.6 g.

[0073] 2. Experimental grouping: Blank control group: Without modeling, without medication, fed with basal diet; Model control group: Modeling, without medication, fed with high-fat and high-sugar diet (12% lard, 18% sucrose, 2% cholesterol, 1% cholate, 5% egg yolk powder, 62% basal diet); Experimental groups: Modeling, medicated, fed with high-fat and high-sugar diet (12% lard, 18% sucrose, 2% cholesterol, 1% cholate, 5% egg yolk powder, 62% basal diet).

[0074] 3. Experimental method: After the blank control group, model control group, and experimental groups were continuously fed with specific diets for 4 weeks, the rats were fasted for 12 h without water deprivation. The modeling groups were intraperitoneally injected with 1% streptozotocin solution at 35 mg / kg; the blank group was injected with 0.1 mol / L citrate-citrate buffer solution (pH 4.4) of the same volume after standard conversion; 72 h after injection, blood was taken from the tail vein to measure blood glucose, and a random blood glucose higher than 16.7 mmol / L was considered successful diabetes modeling; if the standard value was not reached, 1% streptozotocin solution at 30 mg / kg was injected again the next day. After the blood glucose was stabilized, each experimental group was respectively given the traditional Chinese medicine compositions obtained in Examples 1-6, with a dosage of 1.2 g of crude drug / kg, a dosage volume of 10 mL / kg (dissolved in physiological saline in advance), and the administration method was gavage. The blank control group and model control group were both given 0.9 wt% NaCl solution with a volume of 10 mL / kg by gavage. After continuous administration for 4 weeks, after the administration was completed, the rats were fasted for 4 h, blood was taken from the tail vein, and the blood glucose value was measured using a blood glucose meter (expressed as mean ± standard deviation). The test results are shown in Table 1.

[0075] Table 1

[0076] Group Blood glucose before treatment (mmol / L) Blood glucose after treatment (mmol / L) Blank control group 5.5±0.3 5.4±0.2 Model control group 24.4±1.7 25.8±4.1 Example 1 group 23.6±2.3 20.5±3.5 Example 2 group 24.9±1.9 20.1±4.8 Example 3 group 24.7±1.4 18.4±5.0 Example 4 group 23.8±2.6 18.0±4.6 Example 5 group 24.2±2.1 15.3±3.9 Example 6 group 23.9±3.1 19.0±4.2

[0077] As can be seen from Table 1, compared with the model control group, the traditional Chinese medicine compositions provided in the embodiments of the present invention can all reduce the blood glucose value to varying degrees, and the blood glucose reduction effect of the group of Example 5 is the most significant; while there is no significant difference between the blank control group and the model control group before and after treatment. In addition, after the administration was completed, the rats were anesthetized with chloral hydrate, blood was taken from the abdominal aorta, centrifuged, and the contents of total cholesterol (TC) (expressed as mean ± standard deviation) and triglyceride (TG) (expressed as mean ± standard deviation) in the serum were measured using a kit method. The test results also showed a similar pattern to the rat blood glucose measurement results: compared with the model control group, the traditional Chinese medicine compositions provided in the embodiments of the present invention can all reduce the TC and TG values, and the reduction degree of the group of Example 5 is the most obvious.

[0078] Test Example 2

[0079] The traditional Chinese medicine composition obtained in Example 5 was mixed with dextrin in an appropriate proportion (the added weight accounted for 36% of the total weight of the crude drugs of the raw materials) to prepare granules, which were bagged and sealed, with each bag containing 0.3 g. The above-mentioned granules were applied to 81 type II diabetic patients in this hospital, 1 bag each time, orally taken with warm water, 3 times a day in the morning, middle and evening. After continuous use for 1 month, the patients were evaluated for clinical treatment effect indicators. Among them, the observed index parameters included: clinical symptom score, FBG, glycated hemoglobin (HbAlc), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C). The efficacy judgment criteria: Refer to the efficacy criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": Marked effect: The symptom score is reduced by ≥70%, FBG is normal or decreased by more than 40%, HbAlc is normal or decreased by more than 30%, and the improvement of TC, TG, and LDL-C is more than 30% or returns to normal; Effective: The symptom score is reduced by ≥30%, FBG is normal or decreased by more than 20%, HbAlc is normal or decreased by more than 10%, and TC, TG, and LDL-C are improved compared with before treatment, but do not meet the marked effect criteria; Ineffective: There is no change or aggravation of clinical symptoms or less than 30%, and there is no change or increase in laboratory indicators.

[0080] The statistical test results showed that: 64 cases had a marked effect, 11 cases were effective, 6 cases were ineffective, and the total effective rate was 92.6%. At the same time, no adverse reaction phenomena were observed in the patients during and after the treatment.

[0081] In summary, the embodiments of the present invention provide a traditional Chinese medicine composition for treating diabetes, its preparation method and application. The applicant has for the first time discovered that Bufei Decoction has a certain therapeutic effect on type II diabetes. Subsequently, based on the existing formula of Bufei Decoction, a large number of experiments on the screening of components and dosages were carried out. The experimental results show that after removing the ginseng component and adjusting the dosages of astragalus root and rehmannia root, the therapeutic effect on type II diabetes is more significant. Thus, a traditional Chinese medicine composition for treating diabetes with good curative effect and no side effects is obtained, providing a new means for the treatment of diabetes patients and having practical application value.

[0082] The various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be construed as a rigid limitation on the scope of the present invention; therefore, it should be considered that the described range description has specifically disclosed all possible sub-ranges and single values within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, which applies regardless of the range. Additionally, whenever a numerical range is indicated herein, it means including any cited number (fraction or integer) within the indicated range.

[0083] In the description of the specification of the present invention, terms such as "including" and "comprising" mean "including but not limited to". In this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. In this article, "and / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B may represent: A exists alone, A and B exist simultaneously, and B exists alone. Where A and B may be singular or plural.

[0084] The above are only specific embodiments of the present invention, enabling those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for treating diabetes, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20-50 parts of Astragalus membranaceus, 15-30 parts of Rehmannia glutinosa, 3-10 parts of Schisandra chinensis, 5-12 parts of Aster tataricus, and 5-15 parts of Morus alba root bark.

2. The traditional Chinese medicine composition for treating diabetes according to claim 1, wherein The weight ratio of the Astragalus membranaceus to the Rehmannia glutinosa is 1.8:

1.

3. The traditional Chinese medicine composition for treating diabetes according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 33.3 parts of Astragalus membranaceus, 18.5 parts of Rehmannia glutinosa, 5 parts of Schisandra chinensis, 7 parts of Aster tataricus, and 10 parts of Morus alba root bark.

4. The traditional Chinese medicine composition for treating diabetes according to any one of claims 1 to 3, characterized in that, The diabetes is type II diabetes.

5. A method for preparing the traditional Chinese medicine composition for treating diabetes according to any one of claims 1 to 4, characterized in that, The preparation method comprises the following steps: Crush each component in the traditional Chinese medicine composition to obtain a mixed material; Add the mixed material into an extraction solvent for reflux extraction, and then filter to obtain an extract; Concentrate and dry the extract to obtain the traditional Chinese medicine composition.

6. The preparation method of the traditional Chinese medicine composition for treating diabetes according to claim 5, characterized in that, The extraction solvent is composed of 95% ethanol, ethyl acetate, and n-hexane with a weight ratio of (10-15):(1-3):(3-5); the weight ratio of the extraction solvent to the total weight of the traditional Chinese medicine composition is (5-10):

1.

7. The preparation method of the traditional Chinese medicine composition for treating diabetes according to claim 5, characterized in that, The working parameters of the reflux extraction include: the reflux extraction temperature is 85-90°C, the reflux extraction time is 1-3 hours, and the reflux extraction times are 1-3 times.

8. Use of the traditional Chinese medicine composition for treating diabetes according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition for treating diabetes according to any one of claims 5-7 in the preparation of a medicament for treating diabetes.

9. A traditional Chinese medicine preparation for treating diabetes, characterized in that, The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition for treating diabetes according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition for treating diabetes according to any one of claims 5-7.