Agent and method of treating diabetes mellitus

FIELD: medicine.

SUBSTANCE: agent for treating diabetes mellitus involving dry aqueous extract of Geranium Dieisianium Knuth and dry aqueous extract of Uncaria tomentosa (Willd) D.C. bark enclosed into gelatine capsules. A method of treating diabetes mellitus provides prescribing the above agent in a daily dose of 180-360 mg after a meal. The above agent enables treating diabetes mellitus effectively by reducing dosages of blood glucose lowering drugs.

EFFECT: agent causes the positive effect on carbohydrate metabolism and possesses non-specific immunomodulatory action.

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The invention relates to medicine, namely to therapy and pharmacology, and relates to means for the treatment of diabetes.

Diabetes mellitus is a chronic disease with syndrome chemical hyperglycemia that develops as a result of the impact of genetic and echogenic factors. The prevalence of this disease among the population in some countries is six per cent or more. To date, the globe diabetes affects more than 60 million people.

Treatment of diabetes integrated, depends on the type, stage of the process and develops, as a rule, from insulin therapy, dietary interventions, oral sulfonamides (euglucon, glutaryl, gliclazide) and Begunov (glucophage, adebit).

However, oral antihyperglycemic drugs absolutely contraindicated in ketoacidosis, lactation, diabetic nephropathy. They cause lactic acidosis, exacerbate the underlying disease, and also contribute to the aggravation of diabetic neuropathy.

These shortcomings deprived of phytotherapeutic drugs used in diabetes as a primary or adjunctive treatment.

Hypoglycemic effects have blueberries, chamomile, bergenia crassifolia, juniper berries, burdock root, etc.

Known drug for treatment�finally diabetes Arfazetin containing blueberry leaves (0.2 g); bean leaf (0.2 g); zamanihu high (0.15 g); horsetail grass (0.1 g); chamomile flowers (0.1 g) [1]. However, the hypoglycemic activity of this drug is small. In addition, the drug is poorly combined with insulin therapy, with sulfa and biguanide drugs.

The closest analogue is a device incorporating a Peruvian plant of pasuchaca Geranium Dieisianium Knuth in the form of dry extract in gelatin capsules by 0.1-0.5 or in the form of broth at a ratio of components, wt.%, 1,0-5,0 extract pasuchaca to 100,0 water. Effectively means as monotherapy, as well as in the complex treatment of diabetes mellitus [2]. However, this tool does not have a positive influence on the immune status of patients with diabetes mellitus. Targeted effects on the immune system that suppress the autoimmune reaction against the beta cells, can slow down or even stop the course of insulin-dependent diabetes mellitus. Theoretically, this treatment should help patients with genetically determined insulin dependent diabetes mellitus (spontaneous autoimmune reaction against beta cells), and patients with insulin dependent diabetes mellitus viral or toxic etiology (with induced autoimmune reaction).

The disadvantages of the closest analogue� can be eliminated by assigning phyto, affecting the immunological status on carbohydrate and energy metabolism in patients with diabetes mellitus. This drug, developed by the authors of the invention contains an extract of the Geranium plants dielsianum Knuth (90 mg), famous people of Peru as a “Pasuchaca”, and the bark extract of the plant Uncaria tomentosa (Willd) D.C. (90 mg), famous people of Peru as “Cat's claw”. Plant extracts in a weight ratio of 1:1, enclosed in a capsule made of gelatin and are intended for oral use: 1-2 capsules per day depending on destination specialist (dosage 180-360 mg/day).

As a medicinal raw material is used the bark of the Liana Uncaria tomentosa (Willd) D.C., Geranium dielsianum Knuth used the whole plant. Procurement of plant raw material is produced in distinct areoles Peru, which in this case is the foothills perowsky of the Andes, and in a certain seasonal period is the first month of summer, when concetrate biologically active substances in plants is in the maximum amounts.

The composition of Geranium dielsianum Knuth are: flavonoids, saponins, glycosides, anthraquinones, tannins, fats, wax, resin. The composition of Uncaria tomentosa (Willd) D.C. includes alkaloids: isopteropodine, ringfile, pteropodine, mitraphylline, semitrailer, isorhynchophylline. Polyphenols: triterpenes, plant sterols. Glycosides: glycyrrhizin, glycyrrhizinate acid. Flavone�ID: protoanemonin. Dry extract of Geranium dielsianum Knuth is an amorphous brown powder with a characteristic odor and a bitter astringent taste. Hygroscopic, slightly clump.

Obtaining a dry extract comprises the following steps: washing and grinding of raw material, water extraction of raw materials, filtration, drying by spraying with the use of enveloping substances that preserve the quality of the extract. Dry extract of Uncaria tomentosa (Willd) D.C. is an amorphous powder from gray to pale pink color with the same parameters and extraction technology.

To reveal the essence and relevance of our proposal below presents the results of experimental and clinical research in diabetes mellitus.

1. The experimental study.

1.1. The study of the toxicity of the claimed funds in the acute and chronic experiment.

In the first series of experiments determined the toxic dose of the drug after oral and intraperitoneal administration. The drug was administered in a wide dose range of 0.5-50 g/kg In doses of 0.5-20 g/kg no deaths were observed. With the introduction of a dose of 30 g/kg was observed for the death of 10% of the animals. Only with the introduction of a dose of 50 g/kg was observed 100% mortality of animals.

Thus, the LD50was 35 g/kg.

Assessment of behavioral responses during the entire period of observation showed the presence of the mill�artney motor activity, excitability and reactivity in the normal range. Estimated reflexes unchanged. Only with the introduction of the drug to toxic doses exceeding the LD50was observed excitation, increased motor activity, restlessness, shortness of breath. In a subsequent phase of the excitation is replaced by depression.

In the study of chronic toxicity of the drug was administered to the animals for 21 days with subsequent pathological study of the internal organs (the color of the hematoxylin-Sosin and Sudan-III). When inspecting the bodies normal blood supply. Hemorrhages in organs is not revealed. Liver weights in the normal range. Signs of intoxification liver, i.e., atrophy, vacuolization of cells, polymorphism, piknoz not found.

Blood counts - without pathological changes.

Thus, the data presented indicate non-toxicity of the claimed means in the conditions of acute and chronic experiment.

1.2. The study claimed the funds on the model of alloxan diabetes.

Antidiabetic activity of the claimed funds were studied on the model of alloxan diabetes on 100 male rats weighing 200±10 g.

The alloxan model of diabetes was established by well-known methods by injection of alloxan in a dose of 50 mg per 1 kg weight of the animal, four times every 7 days. To prevent the compensation�ornago reaction from surviving beta cells of the pancreas was injected with allocean dose of 50 mg/kg in 2 months after the start of the experiment, three times with an interval in 2 weeks. The day was injected, allowed to drink animals only, a 5% glucose solution. Resistant diabetes mellitus was noted 4 months after the start of the experiment, as evidenced by high levels of sugar in the blood 9,81±0.8 mmol/l, with a background level of sugar in the blood of 5.7±0.5 mmol/l. By this time the animals have seen the lack of appetite, weight loss, profuse hair loss, aggressiveness.

After receipt of the counter model of diabetes, the animals were divided into 2 groups: 1 group was administered the claimed vehicle, group 2 was the control.

About antidiabetic activity was judged by the level of glucose in the blood and urine of the health of animals and their survival.

The results are presented in table.1, 2, 3.

Thus, as can be seen from the presented data (tables 1-3), declared it exhibits a pronounced gipolipidemicescoy activity on the model of alloxan diabetes.

Impact on immunological status and carbohydrate-energy metabolism of patients with diabetes mellitus is exemplified in clinical trials.

Simple open outpatient, randomized, placebo-controlled trial was attended by 5 people in the test group (4 people with 2 diabetes type 1 diabetes and people with diabetes type 1); 4 pax�century in the placebo group (1 person with type 1 diabetes and 3 people with type 2 diabetes mellitus).

Were evaluated the following performance indicators: fasting glycemia, immunoglobulins G, A, M, E, the indices of body mass index (BMI) and fat tissue in the body special weights company Tanita Corp., additionally, in some patients we evaluated the levels of glycated hemoglobin (HbA1c), C-peptide, proinsulin, immunoreactive insulin.

The benchmarks were: daily glucosuria, levels of total cholesterol, blood pressure, pulse, vibration sensitivity in the lower extremities, the dose gipoglikemisiruushih funds, the dose of medication prescribed complications and/or comorbidities.

All indicators were assessed on the day of appointment of the drug or placebo and after 90-100 days after continuous administration of the drug or placebo 1 capsule after meals with liquid 2 times a day.

Characteristics comparison of tested and control groups on the first day of the beginning of the test and after the test, taking into account factors that could influence the test results presented in table 4.

Dynamic modification of performance criteria during the test is shown in table 5 in the mean of the values.

Results:

1. In the test group decreased fasting glycemia and glycated hemoglobin levels, with the exception of the groups� patient P-th, terminated contrary to the order receiving sulfanilamide during the test. This is the only patient in the group that showed an increase in fasting glycemia and glycated hemoglobin. The significance of this increase is reflected in the average figures due to a small sample size, when excluding from the sample the given patient in the rest of the group showed reduction in fasting glycemia and glycated hemoglobin. In the control group was noted implausible increases in the levels of fasting glycemia and glycated hemoglobin levels. If in the test group decreased dosages saharosnijayuschih drugs, in the control group, the dose thereof has been increased. In both groups increased the average daily consumption of carbohydrates (HEH) that the annual rhythm power due to the large consumption of refined carbohydrates in late the autumn months and winter months compared to summer and early autumn.

2. At the same time there were positive changes in lipid metabolism of the tested group compared with the control, manifested in a slight decrease in the level of total cholesterol in the test group, while in the control group cholesterol was increased. In the test group decreased body mass index, while in the control group ind�COP body weight slightly, but there was more. When using zhiroanalizatory marked relative reduction in the mass of adipose tissue in patients of the test group while the marked increase in the mass of adipose tissue in the control group. More significant increase of average daily caloric intake among those in the test group relative to the control.

3. It should be noted the existing trend in the test group to higher levels of IgG and a clear tendency to lower levels of IgE, which is especially apparent in the patient To me, who initially had dramatically increased (more than 5 times from the norm) IgE. In this patient occurred the most significant reduction in IgE after taking the drug. Significant effect on the levels and IgM is not marked.

Described in p. 1 and p. 2 the results can be explained by the relative increase in the hormone b-cell levels of C-peptide, and hence endogenous insulin, while the relative decrease of the increase of proinsulin to load the sample HE that was noted in 3 patients of the test group. It was not a part of this test, so other subjects patients hormone levels were not determined.

Significant changes in the levels of blood pressure, pulse, vibration sensitivity in the lower extremities was noted.

When asking patients about the presence of napurano�completely drug or side effects data has been received.

Thus, a combination drug has a positive effect on carbohydrate metabolism in patients with diabetes, allowing significantly reduce the dosage of hypoglycemic agents, to reduce the average levels of glycemia in the absence of reducing the average daily consumption of carbohydrates in the diet. Product improves fat metabolism, reducing cholesterol levels in the blood, indices of body weight and fat tissue in the body in the absence of reducing daily caloric intake. The drug has a nonspecific imunomoduliruyuschee action, consisting in the possibility to reduce the initially elevated levels of IgE and increase in the normal range IgG levels.

Sources of information

1. Efimov A. S. Clinical endocrinology. M.: Medicine, 1991.

2. Patent RU 2139718, 20.10.1999.

1. The agent for treating diabetes, comprising a dry aqueous extract of Geranium Dieisianium Knuth, characterized in that it further comprises a dry aqueous extract of the bark of Uncaria tomentosa (Willd) D.C., enclosed in a gelatin capsule at a weight ratio of 1:1.

2. A method of treating diabetes d�of abeta, providing for the appointment of a means according to claim 1 at a daily dose of 180-360 mg after meals.



 

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