阅读说明：本技术 一种治疗糖尿病的组合物及其用途 (Composition for treating diabetes and application thereof ) 是由 仝小林 于 2019-08-26 设计创作，主要内容包括：本发明提供了一种治疗糖尿病的组合物及其用途,本发明还提供了包括该组合物的治疗糖尿病的药物,该组合物包括如下组分：葛根素、黄芩苷、小檗碱、芍药甙、芒果苷和人参皂苷Rb1,本发明的单体化合物组成的组合物,糖尿病的预防及治疗效果好,且该组合物组成明确,与常规中药复方制剂相比,更加便于实现有效的质量控制和标准化,克服现有技术中治疗糖尿病的中药制剂成分复杂不明确,难以实现有效的质量控制和标准化的缺陷。(The invention provides a composition for treating diabetes and application thereof, and also provides a medicament for treating diabetes, which comprises the following components: puerarin, baicalin, berberine, paeoniflorin, mangiferin and ginsenoside Rb1, the composition formed by the monomeric compound of the invention has good prevention and treatment effects on diabetes, and the composition has definite composition, is more convenient to realize effective quality control and standardization compared with the conventional Chinese medicinal compound preparation, and overcomes the defects that the traditional Chinese medicinal preparation for treating diabetes in the prior art has complex and undefined components and is difficult to realize effective quality control and standardization.)

1. A composition for treating diabetes, comprising the following components: puerarin, baicalin, berberine, paeoniflorin, mangiferin and ginsenoside Rb 1.

2. The composition for treating diabetes according to claim 1, characterized by comprising the following components in parts by weight: 15-20 parts of puerarin, 310 parts of baicalin 290-.

3. The composition for treating diabetes according to claim 2, characterized by comprising the following components in parts by weight: 18.6 parts of puerarin, 301.8 parts of baicalin, 1080 parts of berberine, 178.65 parts of paeoniflorin, 42.75 parts of mangiferin and 130.96 parts of ginsenoside Rb130.

4. A medicament for treating diabetes, comprising the composition for treating diabetes according to any one of claims 1 to 3.

5. The medicament for treating diabetes according to claim 4, wherein conventional auxiliary materials are added into the composition for treating diabetes, and the composition is prepared into clinically acceptable dosage forms according to a conventional process.

6. Use of the composition for treating diabetes according to any one of claims 1 to 3 in the preparation of a medicament for treating diabetes.

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a composition for treating diabetes and application thereof.

Background

The 8 th edition of the global diabetes map report published by the international diabetes union (IDF) shows that about 4.25 billion adults in 2017 suffer from diabetes globally, and with the current trend of development, it is predicted that by 2045, the global diabetic patients may reach 6.29 billion. In China, the number of diabetics reaches 1.144 hundred million, and the first people live in the world.

Diabetes is a series of metabolic disorder syndromes of sugar, protein, fat, water, electrolyte and the like caused by hypofunction of pancreatic islets of the body, insulin resistance and the like caused by various pathogenic factors such as genetic factors, immune dysfunction, microbial infection, mental factors and the like, and is clinically characterized by hyperglycemia, and typical cases can show polyuria, polydipsia, polyphagia, emaciation and the like. In addition, diabetes may also cause complications such as infection, heart disease, cerebrovascular disease, renal failure, and binocular blindness. The medicine for treating diabetes mainly takes oral hypoglycemic medicine and insulin as main materials at present, and the commonly used oral hypoglycemic medicine comprises biguanides, sulfonylureas, alpha-glucosidase inhibitors, thiazolidinedione oral hypoglycemic medicine, carbamoylmethyl benzenesulfonic acid derivatives and the like, and treats diabetes by correcting sugar metabolism disorder, promoting islet function recovery, improving insulin resistance and the like. However, the drugs need to be added gradually after long-term use, and most of the drugs have adverse reactions with different degrees.

The history of traditional Chinese medicine for preventing and treating diabetes is long, and a large amount of evidence of the medicine proves that the traditional Chinese medicine has a curative effect on preventing and treating diabetes in recent years. Wherein, the Gegenqinlian decoction belongs to one of the classic ancient prescriptions of the traditional Chinese medicine, is originated from the Shanghai Han Lun, differentiation of the syndromes of the taiyang and treatment of the middle-sixth syndrome, and comprises the following components: half jin of kudzu root, two times of roasted liquorice, three or two times of baical skullcap root and three or two times of golden thread. The formula mainly has the effects of clearing heat, removing toxicity and relieving interior heat, and also has the effects of expelling exterior and clearing interior, and is used as an agent for relieving exterior and interior simultaneously, and is used for treating the syndrome of heat descending and interior heat caused by the invasion of exterior pathogenic factors by the sun.

At present, most of traditional Chinese medicine preparations for treating diabetes are prepared by taking traditional Chinese medicinal materials as raw materials through methods such as water decoction and the like, and because active ingredients in the traditional Chinese medicinal materials are complex, it is difficult to determine which active substances really have better diabetes treatment effects, so that effective quality control and standardization are difficult to realize.

Disclosure of Invention

Therefore, the technical problem to be solved by the invention is to overcome the defects that the traditional Chinese medicine preparation for treating diabetes in the prior art has complex and undefined components and is difficult to realize effective quality control and standardization, thereby providing a composition for treating diabetes, which has definite substance composition, can realize effective quality control and standardization and has good diabetes treatment effect, and the application thereof.

Therefore, the invention provides a composition for treating diabetes, which comprises the following components: puerarin, baicalin, berberine, paeoniflorin, mangiferin and ginsenoside Rb 1.

The composition for treating diabetes comprises the following components in parts by weight: 15-20 parts of puerarin, 310 parts of baicalin 290-.

The composition for treating diabetes comprises the following components in parts by weight: 18.6 parts of puerarin, 301.8 parts of baicalin, 1080 parts of berberine, 178.65 parts of paeoniflorin, 42.75 parts of mangiferin and 130.96 parts of ginsenoside Rb130.

The invention provides a medicine for treating diabetes, which comprises the composition for treating diabetes.

The medicine for treating diabetes is prepared by adding conventional auxiliary materials into the composition for treating diabetes and preparing a clinically acceptable preparation according to a conventional process.

The composition for treating diabetes mellitus is applied to the preparation of the medicine for treating diabetes mellitus.

The technical scheme of the invention has the following advantages:

1. the invention provides a composition for treating diabetes, which comprises the following components: puerarin, baicalin, berberine, paeoniflorin, mangiferin and ginsenoside Rb1, because the active ingredients in the traditional Chinese medicinal materials are complex, the same medicinal material often comprises a plurality of active ingredients, and it is difficult to determine which active substances really have better diabetes treatment effect, so that effective quality control and standardization are difficult to realize.

2. The invention provides a composition for treating diabetes, which comprises the following components in parts by weight: 15-20 parts of puerarin, 310 parts of baicalin 290-.

3. The medicine for treating diabetes provided by the invention comprises the composition for treating diabetes, and because the active ingredients in the traditional Chinese medicinal materials are complex, the same medicinal material often comprises a plurality of active ingredients, and it is difficult to determine which active substances really have better diabetes treatment effect, so that effective quality control and standardization are difficult to realize.

4. The composition for treating diabetes provided by the invention is used for preparing the medicine for treating diabetes, and the dosage of the composition can be more accurately controlled due to the definite composition, so that the effective quality control and standardization are realized, and the better treatment effect of diabetes can be achieved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a graph showing the results of the measurement of the effect of the composition on the body weight gain of mice induced by high fat in the experimental examples of the present invention;

FIG. 2 is a graph showing the results of examining the influence of the composition on the body-to-fat ratio of high-fat-induced mice in the experimental examples of the present invention;

FIG. 3 is a graph showing the results of testing the effect of the composition on fasting plasma glucose induced by high fat in the experimental examples of the present invention;

FIG. 4 is a result of examining the influence of the composition on high fat-induced glucose tolerance in mice in experimental examples of the present invention;

FIG. 5 shows the results of examining the effects of the composition on TC and LDL-C in mice induced by high fat in the experimental examples of the present invention.

Detailed Description

The raw materials referred to in the following examples were purchased from Shanghai-derived leaf Biotech, Inc., and the types and purities of the raw materials were as follows: puerarin, S30646, purity greater than or equal to 98%; baicalin, S30647, purity more than or equal to 90%; mangiferin, S26694, with a purity of 95% or more; berberine S27357 with purity more than or equal to 95%; paeoniflorin, S31585, with purity not less than 98%; ginsenoside Rb1 and S26692, the purity is more than or equal to 90 percent.

Example 1

The present embodiment provides a composition for treating diabetes, comprising: 18.6mg of puerarin, 301.8mg of baicalin, 1080mg of berberine, 178.65mg of paeoniflorin, 42.75mg of mangiferin and 130.96mg of ginsenoside Rb130.

The embodiment also provides a medicament for treating diabetes, which comprises the composition for treating diabetes, and the preparation method of the medicament comprises the steps of weighing 18.6mg of puerarin, 301.8mg of baicalin, 1080mg of berberine, 178.65mg of paeoniflorin, 42.75mg of mangiferin and Rb130.96mg of ginsenoside, uniformly mixing, and dissolving in 50ml of sterile drinking water to obtain the medicament.

Example 2

The present embodiment provides a composition for treating diabetes, comprising: 15mg of puerarin, 310mg of baicalin, 1060mg of berberine, 185mg of paeoniflorin, 35mg of mangiferin and Rb125 mg.

The embodiment also provides a medicament for treating diabetes, which comprises the composition for treating diabetes, and the preparation method of the medicament comprises the steps of weighing 15mg of puerarin, 310mg of baicalin, 1060mg of berberine, 185mg of paeoniflorin, 35mg of mangiferin and Rb125mg, uniformly mixing, and dissolving in 50ml of sterile drinking water to obtain the medicament.

Example 3

The embodiment provides a composition for treating diabetes, which comprises 20mg of puerarin, 290mg of baicalin, 1100mg of berberine, 165mg of paeoniflorin, 50mg of mangiferin and 135mg of ginsenoside.

The embodiment also provides a medicament for treating diabetes, which comprises the composition for treating diabetes, and the preparation method of the medicament comprises the steps of weighing 20mg of puerarin, 290mg of baicalin, 1100mg of berberine, 165mg of paeoniflorin, 50mg of mangiferin and Rb135mg, uniformly mixing, and dissolving in 50ml of sterile drinking water to obtain the medicament.

Examples of the experiments

1. Experimental protocol

Healthy male C57BL/6J mice, 7 weeks old, were purchased from the model animal research institute of Nanjing university. Mice were raised in single cages under Specific Pathogen Free (SPF) conditions and fed on standard chow. The ambient temperature is controlled at 22-25 deg.C, humidity is 55 + -5%, and the light and dark cycle is 12/12 hr (light time is 7:00-19:00) to obtain food and drinking water freely.

Healthy male C57BL/6J mice were taken 36 and randomly divided into 4 groups of 9 mice each.

The specific grouping is as follows:

(1) blank control group (hereinafter blank control): feeding with common feed, and perfusing with equal volume of sterile drinking water once a day.

(2) Group of high fat models (hereinafter referred to as high fat models): feeding high fat feed, and perfusing stomach with equal volume of sterile drinking water once a day.

(3) Positive control group (hereinafter referred to as positive control): feeding high fat feed, and intragastrically administering 250mg/kg/d metformin once daily.

(4) Composition group (hereinafter referred to as composition): high-fat diet was fed and gavage was performed once daily with the diabetes-treating drug prepared in example 1.

2. Detection of each index and results

The experiment adopts a preventive administration mode, after C57BL/6J mice of 7 weeks old are bred adaptively for one week, the other groups are given 60% high fat diet and are simultaneously given medicine intervention (according to the administration mode in the grouping information) except a blank group at the age of 8 weeks, the mice are gavaged with a volume of 0.1mL/10g, high fat induction is still carried out in the administration process, and the administration period is 12 weeks. During which the following respective tests are carried out:

the following analysis of each index was performed by comparing the differences between different groups of samples using univariate statistical testing. For normally distributed data, ANOVA (multiple panel test) and Student's t-test (two panel test) were used for analysis; for data with non-normal distributions, analysis was performed using Kruskal-Wallis H-test (multiple-panel test) and Mann-Whitney U-test (two-panel test).

2.1 weight detection

The weight of the mice was weighed with an electronic weighing scale and recorded for 1 time/week with a fixed weighing time. The results of the weight measurements are shown in table 1 and fig. 1. In the figure, ND represents a blank control group, HFD represents a high-fat model group, AMC represents a composition group, and MET represents a positive control group.

Table 1. effect of the composition of the present invention on body weight gain in mice induced by high fat (n ═ 9, x ± s) (unit: g)

Note: compared with the blank control group, the composition of the composition,^##p is less than 0.01; p <0.05, P <0.01 compared to the high fat model group.

TABLE 1

Note: compared with the blank control group, the composition of the composition,^##p is less than 0.01; p <0.05, P <0.01 compared to the high fat model group.

The basal body weight of each group of mice at 0 week is basically consistent, and the body weight of the mice shows a continuous growth state along with the increase of time; wherein the mice in the high-fat model group grow at the fastest speed, and the difference from 3 weeks is statistically significant (compared with a blank control group, p is less than 0.01); the weight growth rate of mice in the administration group is relatively slower than that of mice in the high-fat model group, and the composition has a certain inhibiting effect on the weight growth of the mice induced by high fat.

2.2 body-to-fat ratio measurement

After the administration, the body-to-fat ratio was measured by bone densitometer (PIXImus 2, GE Lunar). The results are shown in Table 2 and FIG. 2. In the figure, ND represents a blank control group, HFD represents a high-fat model group, AMC represents a composition group, and MET represents a positive control group.

Table 2. effect of the composition of the present invention on body fat ratio of high fat-induced mice (n ═ 6, x ± s) (unit:%)

Group of	Blank control	High fat model	Composition comprising a metal oxide and a metal oxide	Positive control
					Body fat ratio	15.3±1.6	44.2±3.7##	32.5±5.3**	28.5±3.2**

Note: compared with the blank control group, the composition of the composition,^##p is less than 0.01; with high fatModel group comparisons, P < 0.01.

After 12 weeks of different diets and drug treatment, the body-to-fat ratio of mice in the high-fat model group was significantly higher than that of mice in the blank control group (p < 0.01). The intervention of the composition and a positive control medicament metformin obviously slows down the increase of body fat of mice caused by high fat diet induction (p < 0.01).

2.3 fasting blood glucose assay

Fasting Blood Glucose (FBG) was measured by a handheld glucometer (Byajie 2 nd 1455, Bayer Germany), with fixed measurement time, fasting for 6h, 1 time/2 weeks before measurement, and no drug administration on the day of blood glucose measurement. The results are shown in Table 3 and FIG. 3. In the figure, ND represents a blank control group, HFD represents a high-fat model group, AMC represents a composition group, and MET represents a positive control group.

TABLE 3 Effect of the composition of the present invention on the high fat-induced increase in fasting plasma glucose in mice (n ═ 9, x. + -.s) (unit: mmol/L)

Note: compared with the blank control group, the composition of the composition,^#P＜0.05，^##p is less than 0.01; p <0.05, P <0.01 compared to the high fat model group.

The basal fasting blood glucose of 0 week of each group of mice is basically consistent, and the fasting blood glucose of the mice in the high-fat model group is gradually increased along with the increase of time, particularly the fasting blood glucose is rapidly increased after 4 weeks, and the difference from 2 weeks has statistical significance (compared with a blank control group, p is less than 0.01); the fasting blood glucose increase rate of mice in the administration group is relatively slower than that of mice in the high-fat model group, the difference of the composition of the invention from the intervention to the 2 nd week has statistical significance (compared with the control group of the high-fat model, p is less than 0.01), and the composition has a certain inhibiting effect on the fasting blood glucose increase of the mice induced by high fat.

2.4 sugar metabolism index detection

Continuously administering the medicine to the last week for Oral Glucose Tolerance Test (OGTT), fasting the mice for 6h, taking out the mice to a test bed, and starting the test after adapting to the environment for 5-10 min. Injecting 20% glucose into abdominal cavity at a dose of 1g/kg, collecting blood at tail tip for 0min, 15min, 30min, 60min and 120min, measuring blood glucose with a handheld glucometer, and calculating area under blood glucose-time curve (AUC).

The results are shown in Table 4 and FIG. 4. In the figure, ND represents a blank control group, HFD represents a high-fat model group, AMC represents a composition group, and MET represents a positive control group.

Table 4. effect of the composition of the present invention on high fat induced glucose tolerance in mice (n ═ 6, x ± s)

Note: compared with the blank control group, the composition of the composition,^##p is less than 0.01; p <0.05, P <0.01 compared to the high fat model group.

According to the OGTT test result, compared with a blank control group, the blood sugar value of the mice in the high-fat model group is obviously increased (p is less than 0.01); compared with a high-fat model group, the composition provided by the invention remarkably reduces the blood sugar value of mice at 0min and 120min after sugar administration (p < 0.05).

The area under the curve of each administration group is obviously lower than that under the curve of a high fat induction group (p is less than 0.01), which shows that the composition can inhibit the rise of blood sugar caused by oral glucose and enhance the tolerance of the mouse body to sugar. The results indicate that the composition has a good regulating effect on high fat induced mouse glucose tolerance.

2.5 Biochemical detection of blood

The mouse is anesthetized by carbon dioxide, whole blood is collected by cardiac puncture, the mouse is kept still in a 1.5mL centrifuge tube for about 2 hours, serum is separated after centrifugation, and the content of Total Cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the serum is detected on a full-automatic biochemical analyzer (7020, Hitachi). The measurements are shown in Table 5 and FIG. 5. In the figure, ND represents a blank control group, HFD represents a high-fat model group, AMC represents a composition group, and MET represents a positive control group.

TABLE 5 Effect of the composition of the present invention on high fat-induced serum TC and LDL-C in mice (n ═ 6, x. + -.s) (unit: mmol/L)

Group of	Blank control	High fat model	Composition comprising a metal oxide and a metal oxide	Positive control
					TC	2.72±0.18	5.57±0.32##	3.99±0.18**	4.25±0.08**
LDL-C	0.36±0.03	1.46±0.19##	0.65±0.07*	0.69±0.04*

Note: compared with the blank control group, # # P is less than 0.01; p <0.05, P <0.01 compared to the high fat model group.

After 12 weeks of different diets and drug treatment, compared with a blank control group, the serum TC and LDL-C levels of the mice of the high-fat model group are obviously increased (p is less than 0.01); after the treatment of the composition and a positive control medicament, namely metformin, the TC and LDL-C levels in the serum of a mouse are obviously reduced (p is less than 0.05, and p is less than 0.01).

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.