RU2458701C1 - Agent for preventing and treating insulin-independent diabetes - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, veterinary science, herbal medicine, food and pharmaceutical industry, and may be used in preparing herbal drugs, namely herbal extracts and microelements. The agent contains dry extracts of goat's-rue, Garsinia, linseeds, young shoots of bilberry, bean shell, Gymnema Sylvestre, hill-growing saltwort, rhizomes of a wheat grass and microelements - chromium picolinate, magnesium oxide and vanadium sulphate.

EFFECT: agent provides tissue and cell metabolic change expressed in lower blood glucose level.

7 tbl, 2 dwg

Description

The invention relates to medicine, veterinary medicine, herbal medicine, food and pharmaceutical industries, and in particular to the creation of medicines based on plant materials, intended both for the production of biologically active food additives and medicinal compositions.

It is known that the collections of dried medicinal plants are used in the food and pharmaceutical industries in the form of a decoction of teas (RF patent No. 2111430, IPC 6 A61K 35/78, publ. 1998.07.10).

However, the effectiveness of using compositions from collections of dried herbs is not always maximum due to incomplete extraction of extractive substances or loss of activity of these substances in the preparation of teas at home.

More effective is the use of compositions from extracts of medicinal plants obtained under industrial conditions, for example, a composition for the treatment of diabetes mellitus based on plant materials, which includes a concentrated extract of a mixture of Amur velvet fruits, yellowish Sophora roots and large burdock root, taken in the ratio (50-500) : (50-500) :( 50-500) (RF patent No. 2224536, IPC A61K 35/78, A61P 3/00, publ. 02.27.2004).

Typically, the compositions and their weight ratio in these inventions are selected experimentally, without theoretical and analytical justification, have multidirectional effects on the body, but at the same time give a certain cumulative effect of lowering blood glucose levels when they are taken.

Closest to the technical nature of the present invention is a composition of extracts, trace elements and vitamins included in the dietary supplement Glucosil (manufacturer - Artlife company, Certificate of state registration No. 77.99.23.3.U. 11932.10.05).

For maximum exposure in the drug Glucosil proposed thirty-seven substances that most effectively reduce blood glucose levels.

The composition of two tablets weighing 0.5 g.

No. Name Content No. Name Contain one Artichoke (root) 50 mg twenty Vitamin A 0.4 mg 2 L-carnitine 5 mg 21 Vitamin D3 3 mcg 3 Coenzyme Q10 5 mg 22 Vitamin E 3 mg four Birch (leaf) 75 mg 23 Vitamin B1 0.5 mg 5 Bromelain 10 mg 24 Vitamin B2 0.4 mg 6 Lingonberry (leaf) 70 mg 25 Calcium D-Pantothenate 2 mg 7 Ginkgo biloba (extract) 10 mg 26 Vitamin PP 5 mg 8 St. John's wort 50 mg 27 Vitamin B6 0.5 mg 9 Quercetin 15 mg 28 Folic acid 0.15 mg 10 Nettle (leaf) 50 mg 29th Vitamin B 12 0.9 mcg eleven Burdock (root) 50 mg thirty Vitamin C 25 mg 12 Raspberries (leaf) 50 mg 31 Biotin 50 mcg 13 Manganese Sulfate 5 mg 32 Routine 15 mg fourteen Peppermint 25 mg 33 Highlander bird (knotweed) 50 mg fifteen Octacosanol 2.5 mg 34 Chromium Picolinate 640 mcg 16 Ginger (root) 20 mg 35 Zinc oxide 5 mg 17 Elecampane (root) 50 mg 36 Blueberries (shoots) 300 mg eighteen Papain 10 mg 37 Garlic (extract) 10 mg 19 Sagebrush 50 mg

The range of trace elements, vitamins and plant extracts that are included in each part of the composition is extremely wide and some of them are quite rare in nature, and the methods of their administration guarantee a positive effect only with a long duration of the course of taking these drugs to obtain a positive effect.

The task to which the invention is directed is to expand the arsenal of highly effective domestic drugs used to lower blood glucose, which in turn is used to prevent and treat insulin-independent diabetes mellitus (type 2 diabetes).

The goal is achieved by our developed tool for the prevention and treatment of insulin-independent diabetes mellitus, including dry extract of blueberry and chromium picolinate shoots, the novelty of which is that it additionally contains dry extracts of the plants of the galega officinalis, Cambodian garcinia, common flax seeds, bean peel , gimnemy sylvester, hodgepodge, wheatgrass rhizomes, as well as magnesium oxide and vanadium sulfate, with the following components, weight. %:

galegi officinalis 2.94-10.78 Garcinia Cambodian 3,9-11,76 flax seed 1.0-4.9 young blueberry shoots 9.8-49.0 bean peel 19.0-30.0 jimnema sylvester 4.12-15.5 hodgepodge 4.12-15.5 wheatgrass rhizomes 2.94-10.8 chromium picolinate 0.005-0.008 magnesium oxide 1,685-2,78 vanadium sulfate 0.006-0.009

The proposed composition alters the tissue and cellular metabolism, which is reflected in a decrease in blood glucose, and can be used in pharmaceutical compositions in conjunction with components suitable for inclusion in food selected from the group of fiber (including microcrystalline cellulose), flavoring agents, preservatives , dyes, emulsifiers, starch, calcium carbonate (chalk), sweeteners (including lactose, sucrose, fructose) while maintaining an effective dose of the complex.

The above complexes can be in liquid form, in solid form and used in the form of pills, powder, tablets, capsules, granules or syrups.

All types of plants from which dry plant extracts are obtained, which are part of this composition, are widely used in scientific and folk medicine and the claimed composition is optimal for complex effects on the body in order to achieve maximum therapeutic effect. The recommended daily dose is an average of 2900 mg, taken during one course according to the following scheme: 3 times a day 10-30 minutes before meals.

The main differences between the claimed composition and analogues is the widespread use of extracts of domestic herbs: Gimnema and Garcinia extracts are supplemented with five domestic plant extracts, and their combined use with the claimed microelements ensures the achievement of a technical result expressed in a decrease in glucose level with a reduced daily dose of the complex of components.

Table 1 shows the antioxidant activity of the Compounds based on the claimed means for the prevention and treatment of insulin-independent diabetes mellitus by a change in color development (%) depending on their composition.

Table 2 shows the concentration of glucose in the blood (mm) of experimental animals.

Table 3 shows the comparative characteristics of patients with type 2 diabetes of the two groups.

Table 4 shows the dynamics of body weight, body mass index (BMI) and blood pressure in patients with type 2 diabetes during treatment (M ± m),

where 1 - before treatment; 2 - after a course of treatment;

* - p <0.001; ** - p <0.01 - compared with the initial level.

Table 5 shows the dynamics of basal and after-food glycemia and glycated hemoglobin HbA _1c in patients with type 2 diabetes during treatment (M ± m),

where 1 - before treatment; 2 - after a course of treatment;

* - p <0.01; ** - p <0.05 - compared with the initial level.

Table 6 shows the dynamics of post-food glycemia in patients with type 2 diabetes after a carbohydrate load (50 g of carbohydrates in the form of wheat bread) with the addition of Composition-1 and standard carbohydrate load (M ± m),

where 1 - before treatment; 2 - after a course of treatment;

* - p <0.01; ** - p <0.05 - compared with the initial level.

Table 7 shows the change in biochemical parameters of blood serum in patients with type 2 diabetes during treatment (M ± m),

where 1 - before treatment, 2 - after a course of treatment;

* - p <0.01; ** - p <0.05 - compared with the initial level.

Figure 1 shows the change in post-food glycemia (in% of the initial level) in patients with type 2 diabetes after a carbohydrate load (50 g of carbohydrates in the form of wheat bread) with the addition of Composition-1 and a standard carbohydrate load, where

1 - wheat bread with the addition of Composition-1;

2 - wheat bread (control).

Figure 2 shows the area (S) under the glycemic curves in patients with type 2 diabetes after a carbohydrate load (50 g of carbohydrates in the form of wheat bread) with the addition of Composition-1 and standard carbohydrate load (50 g of carbohydrates in the form of wheat bread).

Example 1. Obtaining dry extracts

Plant extracts are obtained by known methods of water extraction of plant materials followed by removal of the solvent and drying of the concentrates to dry extracts, after which the components are mixed according to the proportions indicated in the claims.

Specific formulations of some of the claimed agents are given below.

Composition 1: 300 g of dry extract obtained from 21 g (6.87%) of the galega officinalis, 24 g (7.84%) of Cambodian garcinia, 9 g (2.94%) of common flax seeds, 90 g (29.40 %) blueberry shoots, 63 g (20.588%) bean peel, 36 g (11.76%) gimnema sylvester, 36 g (11.76%) hill hodgepodge, 21 g (6.87%) wheatgrass rhizomes, as well as 0 0163 g (0.005%) of chromium picolinate, 6.0 g (1.961%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Total weight 306,0363 g.

Composition 2: 210 g of dry extract obtained from 14.7 g (6.80%) of the galega officinalis, 16.8 g (7.78%) of Cambodian garcinia, 6.3 g (2.92%) of common flax seeds, 63 g (29.173%) of blueberry shoots, 44.1 g (20.41%) of bean peel, 25.2 g (11.66%) of Gimnema sylvester, 25.2 g (11.66%) of hodgepodge, 14, 7 g (6.8%) of wheatgrass rhizomes, as well as 0.0163 g (0.008%) of chromium picolinate, 6 g (2.78%) of magnesium oxide and 0.02 g (0.009%) of vanadium sulfate.

Total weight 216.03 63 g.

Composition 3: 350 g of dry extract obtained from 24.5 g (6.88%) of the galega officinalis, 28 g (7.86%) of Cambodian garcinia, 10.5 g (2.95%) of common flax seeds, 105 g (29.494 %) blueberry shoots, 73.5 g (20.64%) bean peel, 42 g (11, 80%) gimnema sylvester, 42 g (11.80%) hodgepodge, 24.5 g (6.88%) wheatgrass rhizomes, as well as 0.0163 g (0.005%) of chromium picolinate, 6.0 g (1.685%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Composition 4: (exorbitant composition) 300 g of dry extract obtained from 21 g (6.91%) of the galega officinalis, 24 g (7.89%) of Cambodian garcinia, 9 g (2.96%) of common flax seeds, 90 g (29.609%) blueberry shoots, 63 g (20.72%) bean peel, 36 g (11.84%) gimnema sylvester, 36 g (11.84%) hill hodgepodge, 21 g (6.91%) wheatgrass rhizomes as well as 0.009 g (0.003%) of chromium picolinate, 4.0 g (1.316%) of magnesium oxide and 0.005 g (0.002%) of vanadium sulfate.

Total weight 304,014 g.

Composition 5: (transcendental composition) 300 g of dry extract obtained from 21 g (6.84%) of the galega officinalis, 24 g (7.81%) of Cambodian garcinia, 9 g (2.93%) of common flax seeds, 90 g (29.304%) blueberry shoots, 63 g (20.52%) bean peel, 36 g (11.72%) gimnema sylvester, 36 g (11.72%) hill hodgepodge, 21 g (6.84%) wheatgrass rhizomes as well as 0.0170 g (0.006%) of chromium picolinate, 7.0 g (2.3%) of magnesium oxide and 0.03 g (0.01%) of vanadium sulfate.

Total weight 307,047 g.

Composition 6: 300 g of dry extract obtained from 33 g (10.78%) of the medicinal galega, 36 g (11.76%) of Cambodian garcinia, 15 g (4.9%) of common flax seeds, 30 g (9.8 %) blueberry shoots, 58.2 g (19.008%) bean peel, 47.4 g (15.5%) gimnema sylvester, 47.4 g (15.5%) hodgepodge, 33 g (10.78%) wheatgrass rhizomes, as well as 0.0163 g (0.005%) of chromium picolinate, 6.0 g (1.961%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Total weight 306,0363 g.

Composition 7: (exorbitant composition) 300 g of dry extract obtained from 36 g (11.8%) of the medicinal galega, 39 g (12.7%) of Cambodian garcinia, 18 g (5.9%) of common flax seeds, 27 g (8.828%) blueberry shoots, 39 g (12.7%) bean peel, 49.5 g (16.2%) gimnema sylvester, 49.5 g (16.2%) hill hodgepodge, 42 g (13.7 %) wheatgrass rhizomes, as well as 0.0163 g (0.005%) of chromium picolinate, 6.0 g (1.961%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Total weight 306,0363 g.

Composition 8: 300 g of dry extract obtained from 9 g (2.94%) of the galega officinalis, 12 g (3.908%) of Cambodian garcinia, 3 g (1.0%) of common flax seeds, 150 g (49.0%) blueberry shoots, 91.8 g (30.0%) bean peel, 12.6 g (4.12%) gimnema sylvester, 12.6 g (4.12%) hodgepodge, 9 g (2.94%) wheatgrass rhizomes, as well as 0.0163 g (0.005%) of chromium picolinate, 6.0 g (1.961%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Total weight 306.0363 g.

Composition 9: (exorbitant composition) 300 g of dry extract obtained from 6 g (1.96%) of the galega officinalis, 9 g (2.94%) of Cambodian garcinia, 1.5 g (0.49%) of common flax seeds, 151.5 g (49.517%) of blueberry shoots, 60 g (19.6%) of bean peel, 54 g (17.64%) of Gimnema sylvester, 12.05 g (3.921%) of hodgepodge, 6 g (1.96 %) wheatgrass rhizomes, as well as 0.0163 g (0.005%) of chromium picolinate, 6.0 g (1.961%) of magnesium oxide and 0.02 g (0.006%) of vanadium sulfate.

Total weight 306,0363 g.

Example 2. The study of antioxidant activity

The study of antioxidant activity was carried out using the so-called FRAP assay, based on the reduction of Fe ³⁺ iron ions in Fe ²⁺ and the concomitant color change. Thymol was used as a standard. The measurements were carried out at 505 nm. For calibration, an aqueous solution of 1000 μm / L Fe ₂ SO ₄ × 7H ₂ O was used.

As can be seen from the above table 1, the studied compositions corresponding to the claimed tool have a pronounced antioxidant activity that exceeds the activity of the standard - thymol. Moreover, it should be noted that the highest activity of Composition-1, which makes it the most preferred of the claimed Compounds. Violation of the quantitative content of both the extracts themselves and trace elements leads to a decrease in the antioxidant activity of the claimed drug (see Compounds 4, 5, 7, 9).

Example 3. The study of hypoglycemic activity of Composition-1 on a diabetes model

The study of hypoglycemic activity Composition-1 was carried out on white Wistar male rats. Diabetes was caused by a single intraperitoneal injection of an alloxan solution at a rate of 200 mg per kg of body weight. As a rule, diabetes in animals developed 3-5 days after injection of alloxan. Rats with advanced diabetes were selected for the experiment (blood glucose level exceeded 20 mM). Blood samples were taken from the tip of the tail and glucose levels were determined using a standard One Touch Ultra glucose analyzer. Animals were divided into three groups. Group I - animals with diabetes, untreated. Group II - animals with diabetes treated with Composition-1. The third group included healthy animals that received Composition-1. The drug was given with drinking water in the form of a 0.04% solution. Animals were observed for 4 weeks of treatment, conducting weekly weighing, determination of water, food and blood glucose (table 2).

In patients with untreated rats, body weight gradually decreased. Under the action of Composition-1, body weight was maintained and even increased during this period in both healthy animals and rats with diabetes.

Indicative is the level of glucose in the blood of animals with diabetes.

As can be seen from table 2, during treatment with Composition-1 in rats with diabetes, there was a decrease in the concentration of glucose in the blood by almost half. At the same time, the level of glucose in the blood of healthy animals with the appointment of Composition-1 remained the same, which indicates undoubted hypoglycemic activity of the drug.

Example 4. Evaluation of the clinical effectiveness of the action of Composition-1

Studies were conducted on 25 patients with a verified diagnosis of type 2 diabetes with concomitant obesity.

Inclusion Criteria:

1. Women and men suffering from type 2 diabetes aged 40 to 69 years.

2. The state of metabolic subcompensation.

3. Lack of insulin requirements.

Exclusion Criteria:

1. Type 1 diabetes.

2. Age up to 40 years and over 69 years.

3. Decompensation of carbohydrate metabolism.

4. Insulin demand.

5. Acute or exacerbation of chronic concomitant diseases requiring intensive pharmacotherapy.

The clinical characteristics of the patients selected for the study are presented in Table 3. The age of the patients on average throughout the observation group was 55.3 ± 1.7 years, the duration of the disease was 7.5 ± 1.2 years, all patients had obesity I-III degree. The weight of patients on average throughout the observation group was 96.9 ± 3.0 kg, body mass index - 35.6 ± 1.1 kg / m ² . The level of basal glycemia in venous blood was 8.8 ± 0.4 mmol / L, in capillary - 8.3 ± 0.4 mmol / L. Of the other concomitant diseases, the observed patients had arterial hypertension, discirculatory encephalopathy, coronary heart disease, cholelithiasis, postcholecystectomy syndrome, polyosteoarthrosis, chronic spondylosis and spinal osteochondrosis.

Patients with type 2 diabetes were randomly divided into two groups of the same type: the main group (15 people) and the comparison group (10 people) (see table 3).

Study design

All patients were previously informed about the research procedure, methodology and duration of use, the expected therapeutic effect of Composition-1, the consent of all patients to participate in this study was obtained.

All patients received therapy reduced in calorie diet and the usual scheme of pharmaceuticals, which did not change during the study. The calorie content of the diet was reduced to 1,500 kcal per day, mainly due to animal fat, refined carbohydrates.

Patients of the main group for 3 weeks were prescribed Composition-1 1 capsule 3 times a day. The comparison group received conventional treatment.

During the observation process, all patients underwent a daily medical examination to assess the tolerance of Composition-1, the severity of the clinical symptoms of type 2 diabetes, blood pressure, body weight, and the appearance of side effects. The study of glycemia in capillary blood was performed on an empty stomach and 40 minutes after eating (breakfast, 2nd breakfast, lunch) twice with an interval of 21 days before the appointment and after the end of taking Composition-1. In the comparison group, the glycemic profile was carried out at the same time. A biochemical blood test, including glycemia, glycated hemoglobin HbA _1c , lipid spectrum, liver and kidney functional status, was performed twice before and after the course of treatment. The studies were performed on a Konelab 30i automatic analyzer (Finland).

The effectiveness of Composition-1 was evaluated on the basis of a comparative analysis of the dynamics of biochemical parameters of carbohydrate, lipid metabolism in blood serum, blood pressure, body weight in the compared groups of patients.

In patients of the main group, the levels of post-food glycemia and the area under the glycemic curve after a dosed carbohydrate load (50 g of carbohydrates in the form of wheat bread) and the same load with the addition of 2 capsules of Composition-1 to food were determined. Capillary blood glucose was examined on an empty stomach and 30, 60, 120 and 180 minutes after exercise. Glycemia was determined using a One Touch® Ultra ™ glucose meter. The calculation of the areas under the glycemic curves was carried out according to the generally accepted methodology of Wolever, T.M.S., Jenkins, D.J.A, Jenkins, A.L., Josse, R.G. (1991) The glycemic index: Methodology and clinical implications. Am J Clin Nutr 54, pp. 846-854.

according to the formula:

[(A + B / 2) × t] + [(B + C) × T / 2] + [(C + D) × T / 2] - if the last glycemic point (180 min) was above the basal level; or

[(A + B / 2) × t] + [(B + C) × T / 2] + (C ² × T) / [2 × (C + D)] - if the last glycemic point (180 min) was located below the basal level.

A, B, C, D - an increase in blood glucose, i.e. the difference between its basal level and content at the studied time intervals (t. T).

Hypoglycemic and other drugs were not used during exercise.

The effectiveness of Composition-1 was evaluated on the basis of a comparative analysis of post-food glycemia and the areas under glycemic curves in the same group of patients after loading with carbohydrates and the same load with the addition of 2 capsules of Composition-1.

The obtained research results were processed statistically on a PC using the SPSS 11.5 application package for Windows. The results are presented as average values, standard error of the average value (M ± m). The significance of differences in the average values was assessed using Student's t-test.

Safety Assessment of the Applicant

In the process of observation, all undesirable phenomena were recorded and evaluated, both in the main group and in the comparison group. The tolerability of Composition-1 was evaluated by the presence and severity of side effects associated with its intake.

During treatment, the well-being of all patients improved, weakness decreased, and exercise tolerance increased. In the main group, a significant portion of patients (13 out of 15 patients) noted a decrease in appetite and feelings of hunger, despite a reduction in the calorie content of the diet. In the comparison group, only 3 out of 10 patients noted a decrease in appetite and hunger. All patients of the main group showed an increase in urination in the first 7-10 days of taking Composition-1.

All patients showed a decrease in body weight and BMI (table 4). There were no differences between the main group and the comparison group, which is associated with the same degree of reduction in the caloric content of the diet. However, in patients of the main group, tolerance of the reduced diet was easier due to a decrease in the feeling of hunger.

As can be seen from table 4, during the observation, the blood pressure level significantly decreased in all patients, both systolic and diastolic blood pressure significantly decreased in patients of the main group and the comparison group. It is known that the correction of blood pressure in diabetes mellitus allows a greater degree of reduction in the incidence of vascular complications compared with the correction of hyperglycemia.

Dynamics of basal and after-food glycemia and glycated hemoglobin HbA _1c in patients with type 2 diabetes during treatment

A comparative assessment of the dynamics of basal and post-food glycemia in capillary blood during treatment (table 5) showed a significant decrease in all patients. However, in the main group, the degree of reduction in glycemia was more pronounced. Basal glycemia in capillary blood in patients of the main group decreased by 28.2%, in patients of the comparison group - by 18.8%. After-eating glycemia at three measurement points in the main group decreased by 28%, 28% and 24%, in the comparison group - by 23.5%, 11, and 11.8%, respectively. Differences in the dynamics of glycemia in venous blood between groups are less pronounced. The level of glycemia significantly decreased in all patients by about one third in both groups.

The content of glycated hemoglobin HbA _1c during treatment significantly decreased in all patients, however, in the main group, the degree of decrease was 2 times higher than in the comparison group. The content of glycated hemoglobin HbA _1c in the main group of patients reached the recommended level, decreased by more than 1%. It is known that a 1% decrease in glycated hemoglobin HbA _1c helps to reduce the risk of microvascular complications by 37%, and the risk of myocardial infarction by 14%.

A more pronounced decrease in basal and post-food glycemia in capillary blood and the level of glycated hemoglobin HbA _1c in the main group is apparently associated with the action of the components contained in Composition-1 (chromium, vanadium, Gimnema sylvester extract), which have a positive effect on the control glycemia, increasing the formation and biological activity of insulin, increasing the sensitivity of receptors to insulin, reducing the rate of absorption of glucose in the small intestine.

When comparing the dynamics of post-food glycemia in 11 patients with type 2 diabetes after a load of 50 g of carbohydrates and the same load with the addition of 2 capsules of Composition-1 (table 6, figure 1), there were no significant differences in the increase in glycemia over the next 180 minutes. Accordingly, the area under the glycemic curves after the carbohydrate load and the same load with the addition of 2 capsules of Composition-1 did not differ significantly (Fig. 2).

The results obtained indicate that Composition-1 does not have a noticeable effect on the absorption of glucose in the small intestine and its utilization. Its effect on glycemic control in patients with type 2 diabetes is largely associated with a decrease in insulin resistance and / or increased insulin secretion by beta cells of the pancreas.

Changes in serum biochemical parameters in patients with type 2 diabetes during treatment

A comparative analysis of the dynamics of lipid parameters in blood serum in the observation groups (table 7) showed a statistically significant decrease in all patients. However, the degree of decrease in total cholesterol, and especially serum triglycerides in patients with type 2 diabetes of the main group was significantly more pronounced than in the comparison group. The content of total cholesterol during treatment in the main group of patients decreased by 12%, triglycerides - by 36%, while in the comparison group these indicators decreased by 9% and 8%, respectively.

The increase in the lipid-lowering effectiveness of the treatment of patients with type 2 diabetes in the main group is apparently associated with the influence of a number of components of Composition-1, in particular with the proven lipid-lowering effect of chromium, vanadium, gimnema sylvester, and Cambodian garcinia.

The biochemical parameters characterizing the functional state of the kidneys in the observed patients with type 2 diabetes were not changed and during the treatment did not significantly change in all patients, both in the main group and in the comparison group.

The biochemical parameters characterizing the functional state of the liver (total bilirubin, alkaline phosphatase) in the observed patients with type 2 diabetes were not changed and during treatment varied within normal values.

There were no clinically significant adverse events when taking Composition-1.

Thus, the use of the claimed agent for the prevention and treatment of insulin-independent diabetes mellitus was well tolerated by patients with type 2 diabetes, including with concomitant diseases of the gastrointestinal tract, no clinically pronounced side effects were noted during their administration. The inclusion of the claimed drug in the traditional treatment regimen contributes to a more pronounced treatment effectiveness and is manifested in a decrease in basal and after-food glycemia in capillary blood and a decrease in glycated hemoglobin HbA _1c in patients with type 2 diabetes, and also leads to a decrease in hyperlipidemia, especially triglycerides. Their inclusion in the complex of therapeutic measures did not affect the decrease in blood pressure and overweight in patients with type 2 diabetes. Most patients with type 2 diabetes who received the claimed in the present invention, noted a decrease in appetite and feelings of hunger while observing a hypocaloric diet.

Table 1 No. Title % color development one Composition-1 42.6 2 Composition-2 48,2 3 Composition-3 46.7 four Composition-4 56.4 5 Composition-5 61.8 6 Composition-6 46.9 7 Composition-7 65,2 8 Composition-8 48.3 9 Composition-9 78.3 10 thymol 56.8

table 2 Group of animals Glucose concentration (mm) Before treatment Days after starting treatment with Composition-1 7 fourteen 21 28 Control (healthy) 5.2 ± 0.2 5.0 ± 0.5 6.0 ± 0.3 5.7 ± 0.5 5.8 ± 0.4 Alloxan diabetes treated with Compound-1 19.6 ± 0.3 16.4 ± 0.2 11.1 ± 0.5 10.8 ± 0.3 10.9 ± 0.1 Alloxan diabetes, untreated 21.1 ± 0.5 20.5 ± 0.4 20.2 ± 0.6 20.3 ± 0.5

Table 3 Indicator Group Main Comparisons Age years 54.3 ± 2.3 56.9 ± 2.5 Duration of the disease, years 7.9 ± 1.1 7.0 ± 2.6 Weight, kg 98.4 ± 4.4 94.6 ± 4.0 Height, m 1.66 ± 0.03 1.65 ± 0.02 Body mass index (BMI), kg / m ² 36.0 ± 1.6 34.9 ± 1.6 The level of basal glycemia (at the time primary examination), mmol / l: deoxygenated blood 8.71 ± 0.6 9.03 ± 0.6 capillary blood 8.38 ± 0.6 8.14 ± 0.6

Table 6 Time intervals The level of glycemia, mmol / l 50 g of carbohydrates and dietary supplements-1 50 g of carbohydrates (control) On an empty stomach 6.48 ± 0.32 6.67 ± 0.33 30 minutes after exercise 9.82 ± 0.56 10.4 ± 0.59 % of initial level +51.5 +55.9 60 min after exercise 12.4 ± 0.91 13.2 ± 0.76 % of initial level +91.4 +97.9 120 min after exercise 10.5 ± 1.03 10.5 ± 0.82 % of initial level +62.0 +57.4 180 min after exercise 8.14 ± 0.6 7.86 ± 0.65 % of initial level +25.6 +17.8

Table 7 Indicator Main group Comparison group Normal values one 2 % one 2 % Total cholesterol, mmol / l 6.23 ± 0.3 5.46 ± 0.3 * 12,2 678 ± 0.7 6.15 ± 0.7 ** 9.3 3.4-6.0 Triglycerides, mmol / L 3.3 ± 0.6 2.11 ± 0.2 ** 36.1 2.49 ± 0.4 2.29 ± 0.4 8.0 0-1.7 Creatinine, μmol / L 68.3 ± 2.9 73.5 ± 3.1 8.9 72.7 ± 2.3 74.9 ± 3.6 3.0 50-105 Uric Acid, μmol / L 341.0 ± 14.8 347.7 ± 18.3 2.0 348.7 ± 13.4 379.4 ± 25.7 8.8 140-340 Total bilirubin, µmol / l 16.6 ± 1.4 13.7 ± 1.4 ** 17.5 15.1 ± 1.3 11.9 ± 0.8 * 21,2 0-20 Alkaline phosphatase, IU / L 82.9 ± 3.7 73.5 ± 3.2 * 11.3 91.4 ± 6.8 85.7 ± 6.7 6.2 42-98 ALT, ME / L 33.6 ± 4.3 41.5 ± 5.6 ** 23.5 30.2 ± 2.9 34.4 ± 5.7 13.9 0-35 ACT, ME / L 22.8 ± 2.3 26.7 ± 3.7 ** 17.1 25.6 ± 2.9 25.6 ± 2.7 0 0-35

Claims (1)

An agent for the prophylaxis and treatment of insulin-independent diabetes mellitus, including extract of blueberry shoots and chromium picolinate, characterized in that it additionally contains dry extracts of the plants of the galega officinalis, Garcinia cambogia, common flax seeds, bean peel, gimnema sylvester, hill hodgepodge, wheat rhizome , as well as trace elements of magnesium oxide and vanadium sulfate in the following components, wt.%:
galega officinalis 2.94-10.78 Garcinia Cambodian 3,9-11,76 flax seed 1.0-4.9 young blueberry shoots 9.8-49.0 bean peel 19.0-30.0 jimnem sylvester 4.12-15.5 hodgepodge 4.12-15.5 wheatgrass rhizomes 2.94-10.8 chromium picolinate 0.005-0.008 magnesium oxide 1,685-2,78 vanadium sulfate 0.006-0.009

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