RU2747985C1 - Solid-phase composition for correction of metabolic disorders in type 2 diabetes mellitus - Google Patents

Abstract

FIELD: pharmaceuticals.

SUBSTANCE: invention relates to pharmaceuticals, namely to a solid-phase composition for the correction of metabolic disorders in Type 2 diabetes mellitus. Solid-phase composition for the correction of metabolic disorders in Type II diabetes mellitus, which is an ultrafine powder containing sodium bicarbonate and crushed thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke (Helidnthus tuberosus), while the mass ratio of thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke (Helidnthus) 7:3, and the sodium bicarbonate content is 0.9-1.2 wt % based on the weight of plant products.

EFFECT: above-described solid-phase composition helps to accelerate and increase the degree of correction of metabolic disorders in Type II diabetes mellitus, namely, it effectively reduces the level of glucose and glycated hemoglobin (HbA1c) in the blood, normalizes lipid metabolism, including the atherogenic coefficient, until these indicators stabilize in the middle of the normal range.

1 cl, 2 tbl

Description

The invention relates to the field of medicine and pharmacology, in particular to endocrinology, namely, to the creation of composite medicines and biologically active food additives from plant raw materials, and can be used to correct metabolic disorders in type 2 diabetes mellitus (DM2).

Diabetes mellitus (DM) is a metabolic disease associated with impaired glucose metabolism due to absolute or relative insufficiency of insulin, as well as impaired transmission of the insulin signaling cascade in the target tissues of insulin. At the same time, the key in the pathogenesis of T2DM, especially in its early stages, is not a violation of insulin synthesis in β-cells of the pancreatic islets of Langerhans, but inhibition of its secretion as a result of disturbances in bioenergetic processes in these cells and changes in the structure and properties of cell membranes, leading to to the formation of a number of defects associated with "distortions" of the process of "recognition" of glucose or glucose sensitivity of receptors on the membrane of pancreatic β-cells, or disruption of the transport function of ion channels. As a result of a decrease in the level of insulin in the blood or a violation of the transmission of the insulin signaling cascade in target cells, the transport of glucose to the target cells of insulin is disrupted, a state of hyperglycemia and glucosuria is formed, while the target cells themselves are deficient in glucose; as a result, the entire complex of bioenergetic processes in the corresponding tissues is disrupted [1-3]. The most common cardiovascular complications of diabetes are: arterial hypertension, diabetic angio- and retinopathy, ischemic heart disease and a number of other complications. The same complications are considered to be the cause of premature disability and high mortality from diabetes.

Traditional antihyperglycemic therapy includes hypoglycemic and antihyperglycemic agents. At the same time, hypoglycemic agents (derivatives of sulfonylureas, meglitinides, etc.) stimulate the secretion of endogenous insulin (this is accompanied by an increase in body weight) and are capable of causing hypoglycemic conditions, and antihyper-glycemic agents (blockers of alpha-glucosidase, biguanides (metformin), thiazolidinone ) improve peripheral glucose utilization, but do not have a stimulating effect on pancreatic β-cells. Therefore, they do not increase blood insulin levels and do not cause hypoglycemic conditions. The use of the above methods of glucose-normalizing drug therapy does not allow achieving the accuracy of glycemic regulation, has a number of side effects and contraindications for concomitant diseases, therefore, new developments in this area are aimed at studying a fundamentally new mechanism for regulating glucose homeostasis through incretins, peptide hormones of the gastrointestinal tract, produced in response to food intake and causing glucose-dependent stimulation of insulin secretion, as well as to the creation of drugs that restore the intactness of pancreas β-cell membranes, bioenergetic homeostasis and functional activity of ion channels involved in glucose-stimulated insulin secretion.

A wide range of pharmacological drugs with different mechanisms of action aimed at normalizing glucose homeostasis are used to treat patients with T2DM. For many years, these drugs, which target β-cells and peripheral tissues, have dominated the pharmaceutical market [4]. At the same time, it was found that, despite the large assortment of different groups of oral glucose-lowering drugs, it is rarely possible to achieve and maintain the target values of glycated hemoglobin for a long time. In addition, long-term oral administration of hypoglycemic pharmaceuticals often leads to side effects and has strict contraindications for exacerbations of complications [4].

Phytopreparations with the ability to reduce the concentration of glucose in blood and urine do not have these disadvantages. They include various medicinal plants with hypoglycemic (antidiabetic) effects, primarily by increasing the level of insulin secretion by β-cells of the pancreas, as a main or additional treatment, and also by arresting the deficiency of bioenergetic monosaccharides in cells. Plants with hypoglycemic properties have been used in folk medicine for a long time. And they are the source of active substances for a number of antidiabetic pharmaceuticals. For example, medicinal goat's rue (Latin Galega officinalis ), containing the alkaloid galegin with antihyperglycemic properties. Galegin is a structural analogue of metformin, a drug widely used in the treatment of T2DM. Currently, it is becoming urgent to search for new, previously unused natural compounds or their mixtures in the prevention of T2DM, which is reduced to the creation of compositions of bioactive substances for hypoglycemic purposes and used in conjunction or in combination with standard antihyperglycemic therapy.

Known liquid-phase biological product "Yagel", obtained by aqueous-alcoholic extraction of thalli of lichens of the genus Cladonia , pretreated with carbon dioxide in the state of supercritical fluid (one of the main active substances - lichen β-oligosaccharides) [5], which has the effect of stimulating insulin secretion by insulinoma cells in 1.8-2.0 times when added to the incubation medium for 3-4 weeks due to the restoration of insulin-secretory capacity, due to the modification of the cellular and mitochondrial membranes of β-cells with lichen β-oligosaccharides [6]. Further, the level of transmembrane glucose transfer into the cell increases, the intensity of cellular respiration and mitochondrial activity in muscle cells increase [6]. Clinical studies of the effectiveness of the dietary supplement "Yagel" conducted for the prevention of T2DM showed that after a 3-week intake of the drug, the proportion of people with increased glucose content decreased 3.0 times (up to 14.3%), cholesterol - 1.6 times ( up to 33.3%), the coefficient of atherogenicity - 2.6 times, and with the combined elevated levels of glucose and cholesterol - more than 5 times [7]. As a result, the Yagel dietary supplement was recommended for the prevention of the development of cardiovascular diseases and metabolic disorders caused by hyperglycemia.

A known method for correcting metabolic disorders in type II diabetes mellitus, in which for the correction of metabolic disorders in T2DM using a composition consisting of bioactive substances of lichen thalli of the genus Cladonia , lingonberry leaves Vaccinium vítis-idaéa , bearberry leaves Arctostáphylos úva-úrsi . The biological product is obtained by mechanochemical activation of these components in a ratio of 18: 1: 1, respectively. The resulting mixture is encapsulated at 400 mg in one capsule and 2-3 capsules are administered per day. The method provides a decrease in the level of glycated hemoglobin and correction of lipid metabolism in the absence of side effects. RF patent for invention No. 2613271, IPC A61K 36/09, A61K 36/45, A61P 3/10, published 03/15/2017.

Known solid-phase composition of natural bioactive ingredients for the correction of metabolic disorders in type II diabetes mellitus according to the RF patent for invention No. 2661622 (IPC A61K 36/09, A61K 36/28, A61P 3/10, published on 17.07.2018), selected as the closest analogue. The solid-phase composition, which has the property of correcting metabolic disorders in type II diabetes mellitus, is an ultrafine powder mechanochemically activated in the presence of 0.7-0.9 wt. % of the mass of plant raw materials sodium bicarbonate of a mixture of lichen thalli of the genus Cladonia and Jerusalem artichoke tubers ( Helidnthus tuberosus ) in a mass ratio of 9: 1, which contains lichen β-oligosaccharides, fructose oligosaccharides, fructose in a certain concentration.

In contrast to the known solid-phase composition, the claimed composition is a mixture of powders of crushed lichen thalli of the genus Cladonia and Jerusalem artichoke tubers ( lat.Helidnthus tube rosus), in a mass ratio of 7: 3, subjected to joint mechanochemical activation in the presence of 0.9 ÷ 1.2 wt. % (by weight of plant raw materials) sodium bicarbonate, which leads to an increase in the depth of mechanochemical degradation of strong lichen β-polysaccharides, an increase in the content of fructose oligosaccharides and fructose, and allows to accelerate and increase the degree of correction of metabolic disorders in DM2 when taking the claimed composition.

The objective of the claimed technical solution is to create a composition for the correction of metabolic disorders in type 2 diabetes mellitus, which, with regular consumption, faster, in comparison with known agents, leads to a decrease in blood glucose levels for the prevention and relief of metabolic disorders in type 2 diabetes. The technical result consists in accelerating and increasing the degree of correction of metabolic disorders in T2DM when taking the claimed composition, namely, in reducing the level of glucose and glycated hemoglobin (HbA1c) in the blood, as well as in the normalization of lipid metabolism indicators, including the coefficient of atherogenicity, up to the stabilization of these indicators in the middle of the normal range.

The task is solved and the claimed technical result is achieved by the fact that in the solid-phase composition for the correction of metabolic disorders in type II diabetes mellitus, which is a powder containing sodium bicarbonate and crushed thalli of lichens of the genus Cladonia and Jerusalem artichoke tubers ( Helidnthus tuberosus ), the mass ratio of lichen thalli genus Cladonia and Jerusalem artichoke tubers ( Helidnthus tuberosus ) is 7: 3, and the sodium bicarbonate content is 0.9 ÷ 1.2 wt. % of the mass of plant materials.

An increase in the concentration of sodium bicarbonate by 10-40% in comparison with the prototype and, most importantly, in 3 times the proportion of Jerusalem artichoke tubers, leads to the fact that the content of fructose oligosaccharides and 3 times of fructose in the resulting composition increases more than 2 times, compared with the prototype (Table 1). In the course of practical tests, it was found that a further increase in the content of sodium bicarbonate again leads to a decrease in the content of fructose oligosaccharides, fructose, and β-oligosaccharides, apparently due to an increase in the alkalinity of the solid phase, which goes beyond the pH optimum of the mechanochemical reactions of inulin degradation and β-polysaccharides.

An unexpected result, at the same time, is that the claimed ratio of ingredients leads to an increase of 1.4 times (from 0.58 to 0.83%) the depth of cleavage of strong lichen β-polysaccharides in the process of mechanochemical activation, which leads to the fact that, despite to reduce the proportion of lichen thalli in the original mixture by 1.3 times, the content of lichen β-oligosaccharides in the claimed composition increases by 11.5%.

All this, due to the mechanisms described below for the participation of fructose-oligosaccharides, fructose and β-oligosaccharides in the correction of metabolic disorders in type 2 diabetes mellitus, leads to an improvement in laboratory blood parameters of patients with diabetes mellitus, in comparison with the prototype, when the claimed composition is taken for 3 months (Table 2).

Dried and preliminary roughly crushed lichen thalli of the genus Cladonia and Jerusalem artichoke tubers in a mass ratio of 7: 3 undergo joint mechanochemical activation in the presence of 0.9 ÷ 1.2 wt. % (based on the mass of plant raw materials) sodium bicarbonate, which, in the absence of solvents, leads to: (1) an increase in the proportion of cleaved β-glycosidic bonds in lichen β-polysaccharides from 0.58 to 0.83% with an increase in the content of β-oligosaccharides (active filler ) by 11.5%; (2) cleavage of some of the strong 1-2 glycosidic bonds in inulin that are not hydrolyzed in the gastrointestinal tract to form fructose oligosaccharides (FOS) and fructose; (3) the formation of supramolecular complexes of the "active filler" with FOS, due to which their bioavailability increases by 2.0-2.5 times.

The main thing, in relation to the purpose of the present invention, is that long-term consumption of the claimed composition containing increased concentrations, in comparison with the prototype, of supramolecular complexes of lichen β-oligosaccharides with FOS and other bioactive substances from Jerusalem artichoke tubers, inulin molecules that are not cleaved in the gastrointestinal tract and fiber of tubers Jerusalem artichoke, lowers blood glucose levels, and is an effective means of preventing and arresting metabolic disorders in type 2 diabetes.

The mechanisms of this are as follows: (1) molecules of lichen β-polysaccharides, inulin and fiber, which are not cleaved during mechanochemical activation and are not cleaved in the gastrointestinal tract, are capable of removing a significant amount of dietary glucose and preventing its absorption into the blood, which helps to reduce the level of glucose in the blood after eating; (2) lichen β-oligosaccharides and FOS absorbed into the blood bind and remove from the body toxic products of impaired metabolism: acetone and other ketone bodies; (3) in the blood, FOS and organic polyoxyacids (malic, fumaric, maleic, citric, amber, etc.) also perform antioxidant and antitoxic functions, reducing the severity of the course of the disease; (4) FOS and lichen β-oligosaccharides are able to integrate into the cell wall, facilitating insulin-independent passage of glucose into the cell, although in relatively small amounts compared to the norm; (5) fructose, penetrating into the cells of all organs without the participation of insulin, is able to fully replace glucose in metabolic processes, significantly reducing the intracellular glucose deficiency in bioenergetic processes.

All this leads to a significant and persistent decrease in the concentration of glucose in the blood, which is not accompanied by sharp fluctuations in this indicator during the day. A steady decrease in blood glucose levels leads to an increase in the production of its own insulin by the β-cells of the pancreas. This is also facilitated by the high content of zinc, silicon, potassium in Jerusalem artichoke tubers, which are necessary for the synthesis of insulin, and an increase in their bioavailability due to the formation of supramolecular complexes with lichen β-oligosaccharides. At the same time, in those patients who are on insulin therapy, the patient's daily need for injected insulin decreases. With the regular use of the claimed composition of mechanochemically activated lichen thalli and Jerusalem artichoke tubers, there is a significant slowdown or absence of the development of diabetic nephropathy, threatening renal failure; diabetic retinopathy leading to blindness; vascular lesions of the extremities ("diabetic foot") fraught with the development of gangrene and other negative consequences of metabolic disorders in diabetes mellitus.

The invention can be implemented as follows.

The claimed composition is made in the following way. The thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke (Latin Helidnthus tuberosus ) are pre-dried and crushed to a particle size of 1-3 mm. A mixture of powders in a mass ratio of thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke ( Helidnthus tuberosus ) 7: 3 is subjected to joint mechanochemical activation in the presence of 0.9 ÷ 1.2 wt. % (based on the mass of plant raw materials) sodium bicarbonate, for example, in centrifugal planetary activator mills of continuous industrial type or discrete, laboratory type under the following conditions: rotation frequency> 1000 rpm and acceleration of grinding bodies g> 30.

Mechanochemical activation is understood as a chemical process that occurs in the solid phase, without the participation of solvents, due to the collision of grinding bodies, which activates the chemical interaction of the components and serves when obtaining the claimed composition for the chemical transformation (splitting) of a part of very strong and non-hydrolysable in the human gastrointestinal tract of lichen β- polysaccharides to β-oligosaccharides, as well as part of the inulin of Jerusalem artichoke tubers, which is also practically not hydrolyzed in the gastrointestinal tract, to fructose oligosaccharides and fructose. β-oligosaccharides are easily absorbed in the intestine, act as a "vehicle" that increases the degree of bio-assimilation of other bioactive substances from Jerusalem artichoke tubers due to the formation of easily assimilable supramolecular complexes with them, and are also detoxicants of the internal environment of the body from exo- and endotoxins. Fructose oligosaccharides and fructose also perform very important functions in relation to the correction of metabolic disorders in diabetes mellitus.

Sodium bicarbonate in the composition is used to create a weakly alkaline reaction necessary for a mechanochemical reaction in the solid phase due to the activation of particles of reactants due to contact with grinding bodies.

As a result of mechanochemical activation, an ultrafine powder is obtained, which is encapsulated in hard gelatin capsules with a predetermined dosage, preferably 400 ± 20 mg per capsule for oral administration.

The resulting composition is characterized by the following composition of the main active substances (table. 1).

Table 1.

The name of indicators The claimed composition Composition of the closest analogue (RF patent 2661622) Known composition according to RF patent 2613271) The content of β-oligosaccharides, mg / g 5.8 ± 0.5 5.2 ± 0.4 2.1 ± 0.2 Content of fructose-oligosaccharides, mg / g 62.2 ± 5.6 30.0 ± 3.0 - Fructose content, mg / g 36.8 ± 2.2 12.0 ± 1.1 0.2 ± 0.08

A decrease in the level of glucose and glycated hemoglobin (HbA1c) in the blood, the normalization of lipid metabolism, leading to the correction of metabolic disorders in T2DM were confirmed in the course of the studies.

The indication for prescribing the drug was a verified diagnosis of type 2 diabetes mellitus with metabolic disorders against the background of tableted antihyperglycemic therapy. No previous antihyperglycemic therapy was corrected. When examining patients, standard instrumental and laboratory criteria were used, indicating metabolic disorders: (1) hyperglycemia (fasting venous plasma glucose> 6.1 mmol / l, HbA1c> 6.5%); (2) dyslipidemia (TC> 4.5 mmol / L, LDL> 2.6 mmol / L, HDL <1.0 mmol / L (men) HDL <1.2 mmol / L (women), TG> 1, 7 mmol / L); (3) arterial hypertension (BP> 130/80 mm Hg); (4) overweight and obesity (BMI> 25 kg / m²).

The research program included complex treatment and examination of a sample of 75 patients: group No. 1 (control) - 25 patients who received placebo ; group No. 2 (comparison) - 25 patients who received the composition of the prototype ; group No. 3 - 25 patients who received the claimed composition . The corresponding drug was prescribed in addition to the standard tableted antihyperglycemic therapy and was taken per os , 1 capsule 3 times a day, the course of administration was 3 and 6 months.

Clinical and laboratory control to assess the effectiveness of the claimed composition, compared with the prototype, was carried out after 3 and 6 months. It included: general clinical and instrumental examination, biochemical and clinical blood tests, determination of the content of HbA1c (glycated hemoglobin). Informed consent was obtained from all patients participating in the study. To process the results, statistical packages were used - Stat Soft Statistica v.6.0, SPSS 9.0.

Dynamic observation showed that the biologics of the claimed composition and the prototype, as well as the placebo, were well tolerated by the patients, no side effects were observed. The results are shown in Table 2.

table 2

Indicators Group 1 (control) Group 2 (prototype) Group 3 (claimed comp) 1. (Glucose, fasting, venous plasma) _outcome , mM (N <6.1 mM) 11.6 ± 2.2 11.9 ± 1.6 12.0 ± 1.6 (Glucose, fasting, venous plasma) _{after 3 months.} , mm 9.5 ± 1.7 7.0 ± 1.1 6.0 ± 1.1 ^*) (Glucose, fasting, venous plasma) _{after 6 months.} , mm 9.8 ± 1.8 6.3 ± 1.0 ^*) 5.6 ± 1.0 ^*) 2. (НвА1с) _outcome ,% (N <6.5%) 9.2 ± 2.1 9.8 ± 2.1 10.1 ± 2.1 (НвА1с) _{after 3 months} ,% 8.2 ± 1.9 7.3 ± 1.6 6.6 ± 1.6 ^*) (НвА1с) _{after 6 months} ,% 8.4 ± 1.9 6.5 ± 1.4 ^*) 6.3 ± 1.4 ^*) 3. (Total cholesterol) _outcome , mM
(N = 3.2-5.6 mM) 6.8 ± 0.8 6.8 ± 1.8 6.9 ± 1.8 (Total cholesterol) _{after 3 months} , mM 6.6 ± 0.7 5.7 ± 1.0 5.5 ± 1.0 (Total cholesterol) _{after 6 months} , mM 6.9 ± 0.9 5.6 ± 1.0 5.2 ± 1.0 4. (HDL) _outcome , mM
(Nopt <2.6 mM) (Nwife = 0.86-2.28; Nman = 0.7-1.73) 0.82 ± 0.22 0.78 ± 0.16 0.76 ± 0.16 (HDL) _{after 3 months} , mM 0.80 ± 0.20 1.40 ± 0.31 1.50 ± 0.31 ^*) (HDL) _{after 6 months} , mM 0.90 ± 0.22 1.50 ± 0.35 ^*) 1.55 ± 0.35 ^*) 5. (Coefficient of atherogenicity) _outcome
(Nopt <3.0; N = 2.2-3.5) 7.3 7,7 8.1 (Coefficient of atherogenicity) _{after 3 months} 7.2 3.1 2.7 ^*) (Coefficient of atherogenicity) _{after 6 months} 6,7 2.7 ^*) 2.4 ^*) 6. (LDL) _outcome , mM (Nman = 2.25-4.82; Nwife = 1.92-4.51) 4.60 ± 1.05 5.06 ± 1.02 5.01 ± 1.02 (LDL) _{after 3 months} , mM 4.55 ± 1.02 3.30 ± 0.72 3.20 ± 0.72 ^*) (LDL) _{after 6 months} , mM 4.70 ± 1.02 3.10 ± 1.02 ^*) 3.00 ± 1.02 ^*) 7. (VLDL) outcome, mM
(N = 0.26-1.04) 1.10 ± 0.09 1.13 ± 0.11 1.13 ± 0.11 (VLDL) after 3 months, mm 1.13 ± 0.10 0.90 ± 0.09 0.80 ± 0.09 (VLDL) after 6 months, mm 1.08 ± 0.09 0.72 ± 0.07 ^*) 0.68 ± 0.07 ^*) 8. (Triacylglycerides) _outcome , mM
(N = 0.41-1.82 mM) 2.22 ± 0.42 2.27 ± 0.12 2.28 ± 0.12 (Triacylglycerides) _{after 3 months} , mM 2.28 ± 0.31 2.11 ± 0.11 2.01 ± 0.11 (Triacylglycerides) _{after 6 months} , mM 2.18 ± 0.28 1.92 ± 0.10 1.92 ± 0.10

* ⁾ confidence interval p <0.01

Controlling the level of glycated hemoglobin showed a decrease in the level in all study groups. At the same time, a statistically significant decrease was noted in group No. 2, who took the drug for 6 months, and in group No. 3, after 3 months of administration. Fasting venous blood glucose values also showed a statistically significant decrease in group No. 3 already at the 3rd month of the study, and by the 6th month in groups No. 2 and 3. Some improvement in the parameters in the comparison group receiving placebo can be explained by more frequent self-control of patients. lifestyle modification. There was a significant significant improvement in lipid metabolism in group No. 2 and especially in group No. 3, which was expressed in a decrease in the atherogenic coefficient primarily due to an increase in the level of high-density lipoproteins (HDL).

Monitoring the dynamics of blood pressure and body mass index did not reveal any significant changes in all three groups during the study period.

Thus, the claimed composition has a significantly 10-15% more significant and 2 times accelerated effect in relation to the correction of carbohydrate-lipid metabolic disorders in DM2, compared with the prototype, manifested in a decrease in the level of glycated hemoglobin (HbA1c) and glucose in the blood of patients T2DM, an increase in the atherogenic coefficient due primarily to an increase in the HDL content, in the mode of a stable therapeutic effect.

Literature

1. Muoio D.M., Newgard C.V. (2006) Obesity-related derangements in metabolic regulation. Annu Rev Biochem. 75, 367-401.

2. Ahren, B. (2005) Type 2 diabetes, insulin secretion and beta-cell mass. Curr Mol Med. 5, 275-286.

3. Sharoyko V.V. Metabolic and signaling pathways that control insulin secretion by beta cells of the pancreatic islets of Langerhans, and their role in health and diabetes. Dissertation for the degree of Doctor of Biological Sciences / Saint Petersburg State University. St. Petersburg, 2011 .-- 340 p.

4. Ametov A.S. Modern methods of therapy for type 2 diabetes mellitus // Regular issues of "RMZh". - No. 4. - 2008 .-- S. 170-177.

5. Certificate of state registration, sanitary and epidemiological conclusion and TU for dietary supplement "Yagel" / Certificate of EVRAZES on state. Registration of Rospotrebnadzor of the Russian Federation No. RU.77.99.11.003.E.051236.11.11 dated 17.11.2011.

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Claims (1)

A solid-phase composition for the correction of metabolic disorders in type II diabetes mellitus, which is an ultrafine powder containing sodium bicarbonate and crushed thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke ( Helidnthus tuberosus ), characterized in that the mass ratio of thalli of lichens of the genus Cladonia and tubers of Jerusalem artichoke ( Helidhus tuber ) is equal to 7: 3, and the sodium bicarbonate content is 0.9-1.2 wt.% of the mass of plant materials.