CN110585329A

CN110585329A - Pharmaceutical composition with blood sugar reducing effect and preparation method and application thereof

Info

Publication number: CN110585329A
Application number: CN201810603430.0A
Authority: CN
Inventors: 严伟
Original assignee: Chengdu Hui Tong Tang Technology Co Ltd
Current assignee: Chengdu Hui Tong Tang Technology Co Ltd
Priority date: 2018-06-12
Filing date: 2018-06-12
Publication date: 2019-12-20

Abstract

The invention provides a pharmaceutical composition with the efficacy of reducing blood sugar, which is a preparation prepared from the following raw materials in parts by weight: 10-30 parts of ginseng, 80-120 parts of astragalus membranaceus, 80-120 parts of Chinese yam, 50-70 parts of rehmannia, 30-50 parts of rhizoma anemarrhenae and 50-70 parts of radix scrophulariae. The pharmaceutical composition has the function of reducing blood sugar and has wide market application prospect.

Description

Pharmaceutical composition with blood sugar reducing effect and preparation method and application thereof

Technical Field

The invention relates to a pharmaceutical composition with the efficacy of reducing blood sugar, a preparation method and application thereof.

Background

Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by a defect in insulin secretion or an impaired biological action, or both. Hyperglycemia occurring in the long term of diabetes results in chronic damage to, and dysfunction of, various tissues, particularly the eyes, kidneys, heart, blood vessels, nerves.

Diabetes is divided into type 1 and type 2 diabetes, and causes type 1 and type 2 diabetes with complex etiology including genetic factors and environmental factors. At present, no method for radically treating diabetes exists, but the diabetes can be well controlled by various treatment means. Mainly comprises 5 aspects: education of diabetics, self-monitoring of blood glucose, dietary therapy, exercise therapy and medication. The drugs for diabetes comprise sulfonylurea drugs, biguanide hypoglycemic drugs, insulin and the like, and have large side effects after long-term use.

Disclosure of Invention

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition with the efficacy of reducing blood sugar, and a preparation method and application thereof.

The invention relates to a pharmaceutical composition with the efficacy of reducing blood sugar, which is a preparation prepared from the following raw materials in parts by weight: 10-30 parts of ginseng, 80-120 parts of astragalus membranaceus, 80-120 parts of Chinese yam, 50-70 parts of rehmannia, 30-50 parts of rhizoma anemarrhenae and 50-70 parts of radix scrophulariae.

Preferably, the composition is a preparation prepared from the following raw materials in parts by weight: 10-20 parts of ginseng, 50-100 parts of astragalus membranaceus, 50-100 parts of Chinese yam, 30-60 parts of rehmannia, 20-40 parts of rhizoma anemarrhenae and 30-60 parts of radix scrophulariae.

Preferably, the composition is a preparation prepared from the following raw materials in parts by weight: 20 parts of ginseng, 100 parts of astragalus, 100 parts of Chinese yam, 60 parts of rehmannia, 40 parts of rhizoma anemarrhenae and 60 parts of radix scrophulariae.

Wherein the rehmannia is rehmannia root.

The preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

Wherein the formulation is an oral formulation; preferably, the oral preparation is decoction, powder, capsule, tablet and granule.

The invention also provides a method for preparing the pharmaceutical composition, which comprises the following steps:

1) weighing the raw materials according to the weight ratio;

2) the preparation is prepared by taking the medicinal powder of the raw material medicaments, water or organic solvent extract and adding pharmaceutically acceptable auxiliary materials or auxiliary components.

The invention also provides application of the composition in preparing a hypoglycemic medicament.

Wherein the medicament is a medicament for treating diabetes.

Wherein the diabetes is type II diabetes.

Type II diabetes is comparable to diabetes in traditional Chinese medicine. The traditional Chinese medicine considers that the diabetes is based on yin deficiency and marked by dryness-heat, and is accompanied by qi deficiency. Su Wen & Yin Yang correspondence theory states that: "forty years and half of yin qi in the first year". The formula takes rehmannia root and figwort root which nourish yin and promote the secretion of saliva or body fluid as the monarch drug, ginseng and astragalus root which tonify qi as the minister drug, rhizoma anemarrhenae which clear heat and purge fire and Chinese yam which tonifies spleen and nourishes stomach as the adjuvant drug. The medicine has the effects of nourishing yin, clearing heat, tonifying qi and promoting the production of body fluid, and is particularly suitable for diabetes with deficiency of both qi and yin.

Experimental results prove that the composition has the efficacy of reducing blood sugar, can be prepared into a medicament for treating diabetes, and has wide market application prospect.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Drawings

FIG. 1 shows the acute hypoglycemic effect of hyperglycemic mice

FIG. 2 is a graph showing the percent acute blood glucose drop in hyperglycemic mice

FIG. 3 shows the long-term hypoglycemic effect of hyperglycemic mice

FIG. 4 is a graph showing the percentage of long-term blood glucose reduction in hyperglycemic mice

FIG. 5 Effect on glucose tolerance in hyperglycemic mice

FIG. 6 weight changes in hyperglycemic mice

FIG. 7 percent weight growth compared to molded precursor

Detailed Description

Example 1 preparation of a pharmaceutical composition of the invention

20g of ginseng, 100g of astragalus, 100g of Chinese yam, 60g of rehmannia root (namely rehmannia root), 40g of rhizoma anemarrhenae and 60g of figwort are taken, crushed, decocted, concentrated and spray-dried to prepare water extract powder, and the water extract powder is added with microcrystalline cellulose, evenly mixed, granulated and tabletted.

Example 2 preparation of a pharmaceutical composition of the invention

Taking 10 g of ginseng, 120 g of astragalus root, 80 g of Chinese yam, 70 g of radix rehmanniae, 30 g of rhizoma anemarrhenae and 70 g of radix scrophulariae, crushing, decocting, concentrating, spray drying to prepare water extract powder, adding microcrystalline cellulose, mixing uniformly, granulating and tabletting.

Example 3 preparation of a pharmaceutical composition of the invention

30 g of ginseng, 80 g of astragalus, 120 g of yam, 50 g of radix rehmanniae, 50 g of rhizoma anemarrhenae and 50 g of radix scrophulariae are taken, crushed, decocted, concentrated and spray-dried to prepare water extract powder, and the water extract powder is added with microcrystalline cellulose, evenly mixed, granulated and tabletted.

Test example 1 animal test for reducing blood sugar by the drug of the present invention

1.1 materials

1.1.3 Experimental animals

The number of Kunming mice, half male and female, and body weight (20. + -.2 g) were provided by Sichuan Dynasty Daoshuo.

The mice are raised in 6 cages each time, and are randomly grouped, the raising room temperature is 23 +/-1 ℃, the humidity is proper, the ventilation and air cleanness degrees are good, and the illumination is moderate. In the feeding process, the feed is fed every 24h, water is freely drunk, and the padding is kept dry, wherein the feed for feeding is common feed and is provided by Sichuan achio company.

1.2 Experimental methods

1.2.1 preparation of herbs

1.2.1.1 preparation of Qi benefiting composition

And the qi tonifying group is prepared by taking 20g of smashed ginseng, 100g of astragalus and 100g of Chinese yam according to a proportion, adding 10 times of water, soaking for 2h, heating and decocting, continuously decocting for 1.5h after the water is boiled, continuously adding water during the period to keep the water content unchanged, repeatedly decocting once after filtering, merging and filtering, decocting and concentrating the filtrate to 1:1, continuously concentrating by using a rotary evaporator until the filtrate is in an extract state, pouring out, and weighing.

1.2.1.2 preparation of Yin-nourishing group medicine

60g of smashed rehmanniae radix, 40g of rhizoma anemarrhenae and 60g of radix scrophulariae are taken according to the proportion and soaked in 10 times of water for 2h, and the rest steps are the same.

1.2.2 analysis of cause of disease

The factorial analysis refers to the arrangement and combination and cross analysis of each level of two or more factors, the analysis of the effect of each influencing factor and the existence of interaction, and the experimental design of the optimal pairing combination is found out through analysis.

The reasonable compatibility of the traditional Chinese medicines is that the combination is the core of the prescription, the whole formula is divided into a qi tonifying group and a yin nourishing group according to the theory of traditional Chinese medicine, and each group is respectively provided with a high dose and a low dose for orthogonal combination, namely high-low, low-high, low-low and high-high. Finally, analysis of the causes is carried out to find out which group of medicines in the prescription plays a main role in diabetes.

1.3 animal drug test

1.3.1 preparation of reagents

Alloxan (ALX) solution: the alloxan is prepared into a 2% alloxan solution by using 0.9% physiological saline.

The cautions in preparation are as follows: because the alloxan solution is unstable and is easy to generate oxidation reaction at normal temperature to form alloxan acid and make it lose activity, in order to prevent its oxidation, it is temporarily prepared before making mould every time, and its whole process is implemented in ice bath.

Pentobarbital sodium solution: the preparation is carried out one day before anesthesia, and a 1% sodium pentobarbital solution is prepared by 0.9% normal saline.

1.3.3 drug effect experiment of analysis of cause of hyperglycemia mice

1.3.3.1 preparation of hyperglycemic mouse model

100 Kunming mice are prepared, the weight is 20 +/-2 g, the male and female mice are separately bred, and 5 mice are randomly grouped in each group. After adaptive feeding for one week, 10 mice are left as blank controls, the rest mice are fasted for 24h and freely drink water, each mouse is injected with alloxan solution in an intraperitoneal mode according to the dose of 180mg/kg, the mice are fed normally after injection, blood is taken after tail breaking after 7 days, glucose kit determination and enzyme labeling instrument detection are carried out, and the mice with the blood sugar value of more than 11.1mol/L are classified as diabetes models.

1.3.3.2 analysis of cause of disease mice grouping and administration

Mice are divided into: blank control group (NC group; Normal mice), positive control group (Xiaokejiangtang Capsule, 900mg/kg), model control group (Diabetes mellitus group, DM group; diabetic mice were not treated), and qi-tonifying group and yin-nourishing group were combined into A, B, C, D four dose groups according to different doses:

group A: qi-benefiting group (low dose) + Yin-nourishing group (low dose)

Group B: qi-benefiting group (high dose) + Yin-nourishing group (low dose)

Group C: qi-benefiting group (low dose) + Yin-nourishing group (high dose)

Group D: qi-benefiting group (high dose) + Yin-nourishing group (high dose)

In total, 7 groups of mice, 10 mice in each group, and male and female halves, were administered twice a day, 0.4ml once, according to the dose conversion table of human and animal, and the administration of experimental mice is shown in table 1.1.

TABLE 1.1 administration of groups

XXXXXXmg/kg in this table refers to the amount of crude drug.

Design A1 represents a low dose (3000mg/kg) for the qi-tonifying group, A2 represents a high dose (6000mg/kg) for the qi-tonifying group, B1 represents a high dose (3000mg/kg) for the yin-nourishing group, and B2 represents a low dose (6000mg/kg) for the yin-nourishing group, and the levels are combined one by one to form a 2X 2 design, which is modeled as follows:

A2B2 is set into 1 group, A2BI is set into 2 groups, A1B2 is set into 3 groups, A1B1 is set into 4 groups, and the differences are detected by a spread software whether the differences exist among the groups or not and are not obvious.

1.3.3.4 influence on acute hypoglycemic effect of hyperglycemic mice

Before the first day of administration, fasting is carried out for 24h, blood is taken after tail breaking, the blood sugar value of 0h is measured, blood is taken after 2h of administration, the blood sugar value of 2h is measured after tail breaking, and the influence of the two groups of blood sugar values on the acute blood sugar reduction effect of the hyperglycemic mice is measured.

1.3.3.5 Effect on Long-term hypoglycemic Effect of hyperglycemic mice

Before the first day of administration, the fasting blood glucose value is measured by cutting off the tail and taking blood, the same dosage is continuously administered for 21 days, fasting is carried out for 24h, and the blood is taken by cutting off the tail on the 22 th day, the fasting blood glucose value is measured, and the influence of the two groups of blood glucose values on the long-term blood glucose reduction effect of the hyperglycemic mice is obtained by comparing.

The percentage of blood glucose reduction was calculated as follows:

in the formula: a-blood glucose value before administration; b-blood glucose value after administration.

1.3.3.6 Effect on glucose tolerance in diabetic mice

After administration for 21 days, fasting is carried out for 24 hours, blood is taken after tail cutting on the 22 th day, the fasting blood glucose value is measured, the blood glucose value is taken as the blood glucose value with the sugar tolerance of 0 hour, the medicine is filled into each group of mice, after 40 minutes, the blood glucose value is measured at 30min, 60min and 120min after administration by orally administering 2.0g/kg of glucose solution to the mice at 30min, 60min and 120min respectively. And calculating and comparing the change of the area under the blood glucose curve (AUC), and observing the influence on the glucose tolerance of the hyperglycemic mice.

The area under the blood glucose curve is calculated as follows:

AUC＝0.5(Bg₀+Bg₃₀)/2+0.5(Bg₃₀+Bg₆₀)/2+(Bg₁₂₀+Bg₆₀)/2

in the formula Bg₀、Bg₃₀、Bg₆₀、Bg₁₂₀Is blood glucose value of 0 hr on empty stomach 30min, 60min, and 120min after administration.

1.3.3.7 Effect on the morphological indices of hyperglycemic mice

From before mouse modeling to 21 st administration, the food intake, water intake, defecation amount, urination amount, liveness degree, body and hair color changes of the mice are recorded every day, and the influence on the morphological index of the hyperglycemic mice is observed.

1.3.3.8 Effect on hyperglycemic mouse body weight

The body weights of the mice before molding, after molding, on the 7 th day of administration, on the 14 th day of administration, and on the 21 st day of administration were weighed and recorded, and the effect on the body weight of the hyperglycemic mice was observed.

1.4 results and analysis

1.4.3 analytical cause analysis Experimental results and analysis

1.4.3.1 Effect on acute hypoglycemic Effect in hyperglycemic mice

According to the graph of fig. 1, it can be seen that after the gastric lavage drug, the blood sugar of each group is reduced more or less, the change of the positive control group, the group C and the group D is larger according to the change of the bar chart, the front and the back of the group a and the group B are also changed to a certain extent, the most column reduction is the group D, and the next is the group C, the positive control group and the group B, and the lowest reduction is the group a according to the change of the bar chart of fig. 2. According to the table 1.2, compared with the model control group, the effect of the group D is very significant (p is less than 0.01), the effect is reduced by 26.56%, the effect of the group C and the positive control group is significant (p is less than 0.05), the effect of the group C and the positive control group is respectively reduced by 20.05% and 19.25%, and the group A and the group B have no significant difference. All the graphs are combined for analysis, so that the group D has extremely obvious acute blood sugar reducing effect, and in addition, the positive control group and the group C have obvious acute blood sugar reducing effect.

TABLE 1.2 Effect on acute hypoglycemic Effect in hyperglycemic mice

Note: compared with the model control group, P is less than 0.05, and the difference is significant; p <0.01, with very significant differences,

0h refers to the fasting blood glucose value before administration after successful modeling, and 2h refers to the fasting blood glucose value 2h after administration.

1.4.3.2 Effect on Long-term hypoglycemic Effect of hyperglycemic mice

After the model is made by the mouse, the mouse is stable for 7 days, blood is taken out after the tail is broken, the fasting blood glucose value is detected, the mouse which is extremely small and unstable and can automatically recover normal blood glucose is removed, the fasting blood glucose of other mice is obviously increased, and the success of the model making of the mouse hyperglycaemia model is proved. As is apparent from the change in the bar graph of fig. 3, after 21 days of gavage administration, the blood glucose levels of the positive control group, group a, group B, group C and group D were significantly decreased, compared to the fasting blood glucose before administration, wherein the change in the bar graph of group D and group C was the largest, and then the positive control group, group B and group a were in order, and the group a was the smallest, and the decrease rates of group D, group C, positive control group, group B and group a were 46.47%, 42.55%, 38.25%, 30.44% and 23.25%, respectively, in combination with table 1.3 and fig. 4. Table 1.3 shows that the significance between the groups is <0.01, and the difference is very significant. According to analysis of all graphs, the blood sugar of the mice is extremely obviously reduced after long-term positive drug diabetic lavage treatment, which shows that diabetic has extremely obvious blood sugar reducing effect on the hyperglycemic mice; compared with a model control group, the p of other self-prepared prescription groups is less than 0.01, the self-prepared prescription groups have extremely obvious difference and very obvious blood sugar reducing effect, wherein the blood sugar reducing effect of the group D and the group C is the best, and the blood sugar reducing rate is even higher than that of diabetic patients.

It can be seen from table 1.3 that the differences among groups 1, 2, 3 and 4 are very significant, and the blood glucose reduction rate in table 1.3 is combined to be analyzed, so that the yin-nourishing group plays a decisive role in the treatment of the hyperglycemic mice, the higher the dosage of the yin-nourishing group is, the better the effect is, and the better the high-dosage yin-nourishing group is matched with the qi-tonifying group.

TABLE 1.3 Effect on Long-term hypoglycemic Effect in hyperglycemic mice

Note: compared with the model control group, P is less than 0.05, and the difference is significant; p <0.01, with very significant differences, before administration means fasting blood glucose values before administration after successful modeling, and after administration means fasting blood glucose values after the last administration on day 22 after administration.

1.4.3.3 Effect on glucose tolerance in hyperglycemic mice

As can be seen from FIG. 5, the fasting blood glucose values of all groups increased significantly when glucose load was given for 30min, with the blood glucose value of the model control group being the highest; when glucose load was given for 60min, fasting blood glucose values of each group began to decline slowly; when glucose load was given for 120min, fasting blood glucose returned to a value comparable to 0h in the blank, positive control, group a and group C, slightly greater in groups B and D compared to 0h fasting blood glucose, and higher in the model control group compared to the model control group. In conjunction with Table 1.4, the AUC for the model control group was the greatest and 48.47, while the AUC for the blank control group was the smallest and 15.55. The larger the AUC is, the smaller the influence on the glucose tolerance of the hyperglycemic mouse is, and the poorer the glucose-reducing effect is; conversely, the smaller the AUC, the greater the influence on the glucose tolerance of the hyperglycemic mouse, and the better the glucose-reducing effect. From the group of the prescription, the group D and the group C have the best effect, and the AUC are respectively 24.66 and 27.63, which are better than the positive control group; AUC of the positive control group, the A group and the B group are 30.59, 30.79 and 34.55 respectively, and the blood sugar reducing effect D group > C group > A group and the positive control group.

TABLE 1.4 Effect on glucose tolerance in hyperglycemic mice

Note: compared with the model control group, P is less than 0.05, and the difference is significant; p <0.01 with very significant differences

1.4.3.4 Effect on the morphological indices of hyperglycemic mice

When people have severe hyperglycemia, the symptoms of eating more, drinking more and urinating more and losing weight are caused, and the symptoms also occur in a hyperglycemia model mouse, and meanwhile, activities, hairs, body shapes and the like also change correspondingly, so that the daily food intake, water intake, defecation amount, urination amount, activity wave degree, body shape and hair color change of the hyperglycemia mouse are recorded, and the influence of different medicines on the morphological indexes of the diabetic mouse is verified.

As can be seen from Table 1.5, the indexes of the mice in the blank group are all normal, and the indexes of the other hyperglycemic mice are changed to different degrees, which is obviously different from the normal mice in the blank group. In terms of food intake and water intake, the food intake and water intake of the blank mice per day are slowly increased along with the time increase; the number of model groups is obviously increased after modeling, and the food intake and the water intake of each day are obviously increased along with the increase of time; food intake and water intake of other groups are also obviously increased after modeling, but the food intake and water intake increase is reduced compared with that of a model control group along with gastric lavage, but is still more than that of a blank control group. In the aspect of defecation amount and urination amount, changing the padding once 3 days after the blank group is opened, and changing the padding once 2 days after the food intake is increased by about 2 weeks; after modeling of the model group, changing the padding for one day at the beginning in two days, and changing the padding for one day after about 10 days; the remaining groups were left for two days with two pads, and the last week was changed to three days with two pads. In the aspect of the activity wave range, blank mice are always normal; the model group wilted for two days after the model group is modeled, and then the mental state is improved but the model group wilted; the rest groups wilted for two days after the model building, and after the stomach filling administration, the mental state is transferred to a certain extent, and the activity is slightly more obvious than that of the model control group. In the aspect of body and hair color changes, mice in the remaining groups were generally leaner and slightly darker in hair color than the blank group.

TABLE 1.5 Effect on the morphological indices of hyperglycemic mice

1.4.3.5 Effect on hyperglycemic mouse body weight

It can be seen from table 1.6 and fig. 6 that the body weight gain of mice in each group was significant from the time before modeling to the 21 days of administration, with the blank group having the most body weight gain of 16.43g, and the model, positive, a, B, C, and D groups having 11.57g, 10.76g, 10.89g, 11.06g, 10.53g, 11.02g, and 11.65g, respectively. Changes in the bar graphs of table 1.7 and fig. 7 show that the rate of weight gain was highest in the blank compared to before modeling, reaching 36.41% at 21 days of dosing; in the other groups, the group D has the highest growth rate, and the growth rate reaches 30.55 days after administration; the second is model group, positive group, A group and C group, the lowest is B group, the growth rate is 29.52%, 28.72%, 27.09% and 26.27% respectively. Comprehensive analysis shows that compared with a model control group, the weight growth of the group C is basically not changed greatly after administration, the growth rate of the group D is slightly higher, and the blood sugar reducing effect of the group C is presumed to be optimal.

TABLE 1.6 Effect on the body weight of hyperglycemic mice

TABLE 1.7 percent weight growth compared to molded precursor

1.4.3.6 summary analysis

Acute blood sugar reducing effect: group D > group C > positive control > group B > group a; long-term hypoglycemic effect: group D > group C > group a > positive control > group B > group a; glucose tolerance AUC: supposing that the higher the AUC, the less obvious the blood sugar reducing effect is, so the blood sugar reducing effect is: group D > group C > group B; the rate of weight gain: the group D has the highest growth rate, and the growth rate reaches 42.77 after 21 days of administration; the second is model group, B group, positive group, C group, and the lowest is A group. Morphological index effects: the symptoms of each group of mice were relieved after administration, and the effect was more remarkable as the administration time was increased. Analysis of cause of disease: the difference between the small groups is very obvious, and by combining the experimental analysis, the yin nourishing group plays a decisive role in the treatment of the hyperglycemic mice, the higher the dosage of the yin nourishing group is, the better the effect is, and the high-dosage yin nourishing group is matched with the high-dosage qi tonifying group, the better the effect is. The best group for reducing blood sugar is group D, and then group C, positive control group, group A and group B.

Experimental results show that the pharmaceutical compositions with different proportions can effectively reduce the blood sugar concentration and treat diabetes, wherein the effects of 20g of ginseng, 100g of astragalus, 100g of Chinese yam, 60g of radix rehmanniae, 40g of rhizoma anemarrhenae and 60g of radix scrophulariae are optimal.

Test example 2 clinical statistics of the hypoglycemic agents of the invention

1. Test article

1.1 test treatment groups

The preparation method comprises the steps of roughly crushing 20g of ginseng, 100g of astragalus, 100g of Chinese yam, 60g of radix rehmanniae, 40g of rhizoma anemarrhenae and 60g of radix scrophulariae, decocting, concentrating, spray-drying to prepare water-soaked powder, adding microcrystalline cellulose, uniformly mixing, granulating and tabletting, wherein each tablet is 0.8g (equivalent to 3g of medicinal materials).

1.2 control group 1

The preparation method comprises the steps of roughly crushing 20g of ginseng, 100g of astragalus and 100g of Chinese yam, decocting, concentrating, spray-drying to prepare water soaking powder, adding microcrystalline cellulose, uniformly mixing, granulating and tabletting, wherein each tablet is 0.8g (equivalent to 3g of the medicinal materials). 1.3 control group 2

The preparation process is the same as 1.2 according to the proportion of 60g of radix rehmanniae, 40g of rhizoma anemarrhenae and 60g of radix scrophulariae. Each tablet weighs 1.0g (equivalent to 3g of medicinal materials).

1.4 control group 3

The preparation method is the same as 1.2 with the ratio of rehmanniae radix 60g and Ginseng radix 20g, and each tablet contains 0.8g (equivalent to 3g medicinal materials). 2. Clinical observations

2.1 objects

There were 160 patients with type II diabetes diagnosed as the criteria of WHO1999 diagnosis, 86 men and 74 women. Age 30-70 years, weighted 53 years, mean course 4.9 years. 160 patients were randomized into 4 groups of 40 patients each.

2.2 test subjects

The type II diabetes patients who are not satisfied with blood sugar control and are willing to better control blood sugar are taken as the subjects by selecting the type II diabetes patients who are treated by oral hypoglycemic drugs or oral hypoglycemic drugs and injected insulin. Inclusion criteria were: 7.8-12.2 mmol/L of fasting blood sugar and 11.0-20.5 mmol/L of postprandial blood sugar. The test adopts the front and back controls of the patient, and the test article is added to the tested object on the basis of maintaining the original treatment method.

The usage and dosage are as follows: the composition is orally administered in 4 tablets each time, 3 times daily. The observation is carried out for 2 months, and fasting blood sugar and postprandial blood sugar of 2 hours are measured every week.

2.3 therapeutic efficacy assessment criteria

The blood sugar reduction of more than or equal to 30 percent is effective when the blood sugar is reduced in fasting state and 2 hours after meal, 10 to 30 percent is effective, and less than or equal to 10 percent is ineffective.

2.4 statistical methods

X before and after test data²Test, when P < 0.05, the difference is considered as statisticalMeaning. When P <0.01, it is a very significant difference.

TABLE 2 hypoglycemic test results for type II diabetics

The chi-square test of the data in table 2 shows that the P values of the differences in the significant efficiency between the test treatment group and the 3 control groups are all less than 0.01, which indicates that the test treatment group and each control group have very significant differences in the significant efficiency; p is more than 0.01 and less than 0.05 in the aspect of inefficiency, which indicates that the test treatment group and the control group have difference and have statistical significance. X on test data²The test result shows that: compared with three control groups, the pharmaceutical composition has better blood sugar reducing effect.

The experimental results show that the composition has excellent effect on treating diabetes, and the effect is superior to the combination of three control groups such as ginseng, rehmannia root and the like, and the curative effect is more excellent only under the matching of the medicine.

Claims

1. A pharmaceutical composition with blood sugar reducing effect is characterized in that: the preparation is prepared from the following raw materials in parts by weight: 10-30 parts of ginseng, 80-120 parts of astragalus membranaceus, 80-120 parts of Chinese yam, 50-70 parts of rehmannia, 30-50 parts of rhizoma anemarrhenae and 50-70 parts of radix scrophulariae.

2. The pharmaceutical composition of claim 1, wherein: the preparation is prepared from the following raw materials in parts by weight: 10-20 parts of ginseng, 50-100 parts of astragalus membranaceus, 50-100 parts of Chinese yam, 30-60 parts of rehmannia, 20-40 parts of rhizoma anemarrhenae and 30-60 parts of radix scrophulariae.

3. The pharmaceutical composition of claim 1, wherein: the preparation is prepared from the following raw materials in parts by weight: 20 parts of ginseng, 100 parts of astragalus, 100 parts of Chinese yam, 60 parts of rehmannia, 40 parts of rhizoma anemarrhenae and 60 parts of radix scrophulariae.

4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the rehmannia is raw rehmannia.

5. The pharmaceutical composition according to any one of claims 1 to 4, wherein: the preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

6. The pharmaceutical composition according to any one of claims 1 to 5, wherein: the preparation is an oral preparation; preferably, the oral preparation is decoction, powder, capsule, tablet and granule.

7. A process for preparing a pharmaceutical composition according to any one of claims 1 to 6, wherein: it comprises the following steps:

1) weighing the raw materials according to the weight ratio;

8. Use of the composition of any one of claims 1 to 6 for the preparation of a hypoglycemic medicament.

9. Use according to claim 8, characterized in that: the medicine is used for treating diabetes.

10. Use according to claim 9, characterized in that: the diabetes is type II diabetes.