RU2706018C1 - Combination herbal medicinal product - Google Patents

Abstract

FIELD: medicine; pharmaceuticals.

SUBSTANCE: invention refers to pharmaceutical industry, namely to collection possessing antidiabetic action. An antidiabetic collection contains stevia leaves and flax seeds in a certain amount, where stevia leaves are represented by Stevia rebaudiana grown in the Crimea; northern flax is used as flax.

EFFECT: collection has pronounced antidiabetic action due to synergetic effect.

1 cl, 14 tbl

Description

The invention relates to the pharmaceutical industry, in particular to the creation of a herbal collection that can be used to prevent diabetes.

The collection contains stevia leaves and flax seeds in a certain percentage of components and can increase therapeutic efficacy; it can be used both independently and as an additional tool along with other treatment methods.

Of great theoretical and practical interest is the study of the possibilities of using new drugs that contribute to the normalization of lipid and carbohydrate metabolism, impaired in cardiovascular diseases, diabetes, metabolic syndrome, obesity.

Stevia is a source of biologically active pharmacologically valuable compounds used in complex therapy for the prevention and treatment of diseases of the endocrine system, gastrointestinal tract, cardiovascular, immune, and central nervous system. Due to the unique property of not increasing the level of glucose in the blood, it is used by people with diabetes. It is noted that stevia stimulates the secretion of insulin and reduces blood glucose. The complex effect of biologically active compounds of flax seeds and stevia leaves will allow the use of "Stelinol" for the prevention of diabetes, obesity, hypertension, as well as an antioxidant, immunomodulatory and anti-inflammatory phytogenesis.

Currently, antidiabetic macro collections of both domestic and foreign origin are known, including more than 5 components.

Known antidiabetic collection of medicinal plants containing plantain leaves, oregano grass, nettle leaves, blueberry leaves, astragalus grass, cherry leaves, yarrow grass, thistle rhizomes, Jerusalem artichoke roots, lunatic grass, wormwood grass, black currant leaves, cuff grass, rhodiola roots, sweet clover grass, coltsfoot leaves, coriander fruits, tansy flowers, willow tea grass, rowan fruits, dandelion roots, immortelle flowers, galangal roots, clover flowers in the following ratio of components, wt. h.: 4: 4: 6: 4: 6: 6: 6: 4: 4: 4: 2: 4: 6: 4: 5: 4: 2: 3: 10: 4: 6: 4: 2: 4 (RF patent 2137491, publ. 09/20/1999).

Known anti-diabetic collection of medicinal plants containing cinnamon rose hips, common bean leaves, white mulberry leaves, walnut leaves, sowing oats straw, medicinal herbal leaves, blackcurrant leaves, Chinese magnolia vine, creeping thyme grass, medicinal thyme leaves, and nettle leaves dioecious (Russian patent 2131740, publ. 06/20/1999). The collection is intended for the treatment of children aged 1-10 years with diabetes.

There is a collection for the treatment of diabetes mellitus, containing shoots of common blueberries, sash of common beans, roots of high zamanicha, horsetail grass, rose hips, St. John's wort grass, chamomile flowers (A.S. USSR No. 1456156, publ. 1989).

A disadvantage of the known fees is that they include a large number of raw materials of medicinal plants and the therapeutic effect of their use for the treatment of mild diabetes is not high enough. In addition, the risk of complications and side effects increases.

Closest to the proposed composition for the combination of essential features and the achieved result is a known collection for the treatment of diabetes mellitus, which is selected as a prototype and contains plantain leaves, St. John's wort, grass motherwort, nettle leaves, burdock roots, thallus thallus, hawthorn fruits, chicory roots , oregano grass, peppermint leaves, flax seeds, blueberries, bay leaf, kidney tea grass in a certain ratio (patent No. 2000802, publ. 05/10/1993).

The technical result of the present invention is the development of a pharmaceutical product of plant origin, which is a balanced system of polyunsaturated fatty acids, fat-soluble vitamins, steviosides as a sweetener and other biologically active compounds with increased, but at the same time gentle pharmacological activity for the prevention of diabetes, as well as its expansion spectrum of action, in particular, a decrease in blood sugar.

The technical solution is achieved by the fact that a new drug collection is being formed, which is more effective for the prevention of mild diabetes mellitus. The first collection option contains raw materials of Stevia Rebo and common flax, in the following ratio,%:

Stevia leaves 1

Flax Seeds 99

The proposed ratio of the types of medicinal raw materials included in the collection is selected empirically and represents the most appropriate quantitative combination of components. The technical result of the proposed composition is a synergistic effect with the combined use of 2 types of raw materials. The results of determining the content of the main biologically active substances in plant materials as components of the collection are shown in tables 1-7.

Table 1

Economic and biological indicators and the content of biologically active compounds in flax seeds of various origin,%

Grade Year of admission of the variety to use, * period of stay in the State Register of varieties approved for use Region of tolerance for use, * The fat content in the seeds,% The content of oleic acid in oil,% The content of linoleic acid in oil,% The content of linolenic acid in oil,% The ratio of ω _{3: ω6:} ω ₉ fatty acids seed yield, t / ha 1000 seed weight Slime forming ability, per g of air-dried seeds, Δ ml The intensity of mucus formation, per g of air-dried seeds, Δ g VNIIMK 620 1994 4,6,7,9 38.03 17,991 18,433 54,603 4: 1: 2 1.88 7,962 0.65 1.66 VNIIMK 630 2004 6 30.82 18,716 19,110 47,219 7: 1: 2 2.00 5,348 0.65 1.08 Source 2008 7 46.52 17,802 64,400 2,834 1: 16: 6 2.41 5,443 0.63 1.41 Kinelsky 2000 2004 7 41.14 29,603 16,471 43,196 2.5: 1: 2.5 nd 5,444 0.53 1.98 Squirrel 1994 2,4,7 34.50 27,987 14.102 48,026 3: 1: 2.5 1.30 4,423 0.59 1.59 Alexim 1993 2,3 31,43 26,012 14,898 48,679 3: 1: 2 1.28 4,262 0.58 1.86 Belinka * 1985-2002 nd 32.05 20,400 15,800 51,300 3: 1: 2 1.36 3,991 0.67 1.41 Heavenly 1996 4.6 42.23 30,529 16,193 41,554 2.5: 1: 2.5 1,67 6,212 0.56 1.93 Northern 1994 4,8,9,10,11 45.17 19,842 15,526 54,032 3.5: 1: 2 1.88 7,861 0.68 1.58 VNIIMK 622 * 1994-2011 nd 35.70 24,204 15,795 48,547 3: 1: 2 1.98 6,251 0.59 1.23 Brest nd nd 36.64 17,986 14,777 55,637 4: 1: 2 5,234 0.53 1,64 Brook 1998 4,6,7,8 49.00 29,315 14,906 48,861 4: 1: 2 1,61 5,131 0.56 1,56 Linola + breeding form nd 43.52 17,446 66,355 4,082 1: 16: 6 2.10 5,154 0.56 1.33 Sanlin 2008 7 43.00 17,801 67,515 2,214 1:34:15 2.25 4,354 0.74 1.25 Isilkulsky 1978 10 39.30 19,790 15,890 52,116 3: 1: 2 1.71 4,462 0.49 1.36 Centaur nd nd 40,20 28,219 37,210 16,223 1: 1: 1 2.48 4,519 0.65 1.39 Falcon 1998 4,7,10 47.70 23,234 14,479 50,440 4: 1: 2 1,52 6,213 0.53 1.56 Artik 7 * 1948-1995 nd 30.46 29,165 12,383 47,640 4: 1: 3 1.66 5,686 0.57 1.47 Karabalyksky 7 * 1979-1995 nd 36.15 18,710 14,641 54,485 4: 1,5: 1 1,64 6,894 0.56 1.33 Bahmal 1056 * 1954-1979 nd 38.00 29,238 14,989 45,242 3: 1: 2.5 1.66 6,002 0.52 1.77 Limits of Variation, Lim 30.82-49.00 17,446-30,529 12,383-67,355 2,214-55,637 1.36-2.48 3,991-7,861 0.49-0.74 1.08-1.98

Note: * 2 - North-West, 4 - Volga-Vyatka, 6 - North Caucasus, 7 - Middle Volga, 8 - Lower Volga, 9 - Ural, 10 - West Siberian.

The fatty acid composition of oils of low-linolenic flax varieties has an optimal ratio of ω-6 and ω-3 fatty acids, since according to the recommendations of the RAMS Nutrition Institute, the ratio of polyunsaturated fatty acids ω-6: ω-3 for a healthy diet is (5-10): 1, and for certain diseases for therapeutic nutrition (3-5): 1. In the fatty acid composition of flax seed oil of the traditional VNIIMK 630 linum type, the ratio linoleic ω-6 acid: linolenic ω-3 acid is 1: 6, and in the Source class 16: 1, which practically corresponds to the above recommendations and is physiologically optimal for the human body .

table 2

Economic and biological indicators of stevia of various origin,%

Variety, growing region Region of tolerance for use The yield of green mass, kg / ha Productivity of dried grass, kg / ha Liquidity,% Productivity of dried leaves, kg / ha The content of stevioside,% Ramonskaya Sweet (Voronezh) All regions of the Russian Federation 50.8-58.8 8.96-12.96 50.0-64.0 5.2-7.3 14.0 Ramona Sweet (Penza) All regions of the Russian Federation 75.0-110.0 17.50-27.50 35.0-55.0 3,5-5,5 13.5 Uslada (Voronezh) All regions of the Russian Federation 92.3-137.9 18.46-27.58 68.3-72.3 18.4-20.4 10.1 Delight (Penza) All regions of the Russian Federation 90.0-150.0 22.50-40.00 45.0-80.0 4,5-8,0 9.9 Sofia (Voronezh) All regions of the Russian Federation 73.5-77.0 14.70-15.40 50.1-60.1 7.5-9.5 15.6 Sofia (Penza) All regions of the Russian Federation 85.0-140.0 20.00-35.00 40.0-70.0 4.0-7.0 14.8 Limits of Variation, Lim All regions of the Russian Federation 50.8-150.0 8.96-40.00 35.5-80.0 3,5-20,4 9.9-14.8

Table 3

The content of biologically active compounds in the raw materials of stevia of various origin,% (average values)

Variety, growing region Glycosides Flavonoids Phenylpropanoids Carotenoids Triterpene Saponins Organic acids Sample from Paraguay 17.33 2.49 5.34 5.27 4.01 5.15 Sample from India 17.14 1.94 4.29 4.41 3.95 4.76 Ramonskaya Sweet (Crimea) 21.10 2.72 6.39 7.15 3.35 5.38 Ramonskaya Sweet (Krasnodar) 17.92 3.17 6.82 4,56 4.64 5.18 Ramona Sweet (Penza) 14.74 2.89 6.69 4.33 2,51 4.49 Ramonskaya Sweet (Tver) 14.39 2.48 6.41 5.46 3.45 3.81 Sofia (Penza) 14.64 2.62 6.40 5.40 3,50 4.07 Limits of Variation, Lim 14.39-21.10 1.94-3.17 4.29-6.82 4.33-7.15 2.51-4.64 3.81-5.38

Table 4

The content of essential amino acids in the leaves of stevia,% *

Variety, growing region Lysine Phenylalanine Leucine + Isoleucine Methionine Valine Threonine Amount of Essential Amino Acids Sample from Paraguay 0.58 0.52 0.61 0.13 0.54 0.55 2.93 Sample from India 0.57 0.58 0.75 0.16 0.66 0.67 3.39 Ramonskaya Sweet (Crimea) 0.58 0.68 0.85 0.11 0.76 0.77 3.75 Ramonskaya Sweet (Krasnodar) 0.44 0.42 0.51 0.14 0.44 0.45 2.40 Ramona Sweet (Penza) 0.43 0.41 0.48 0.19 0.82 0.85 3.18 Ramonskaya Sweet (Tver) 0.60 0.45 0.58 0.09 0.78 0.80 3.30 Sofia (Penza) 0.60 0.67 0.83 0.12 0.76 0.74 3.72 Limits of Variation, Lim 0.43-0.60 0.41-0.68 0.48-0.85 0.09-0.49 0.44-2.28 0.085-0.77 2.40-3.75

Note: * mass fraction of amino acids in the sample,%

Table 5

The chemical composition of stevia leaves,%

Variety, growing region Fatty oil Cellulose Protein Ramonskaya Sweet (Crimea) 4.90 17.00 17.32 Ramonskaya Sweet (Krasnodar) 4.88 15.36 19.05 Ramona Sweet (Penza) 3.07 26.53 18.44 Limits of Variation, Lim 3.07-4.90 15.36-26.53 17.32-19.05

Table 6

Extractive content in stevia leaves

Raw material samples Extractive substances,% Shredded raw materials Powdered raw materials Paraguay 45.62 ± 0.11 46.71 ± 0.11 India 52.62 ± 0.12 54.02 ± 0.09 Ramonskaya Sweet (Tver) 45.12 ± 0.06 47.71 ± 0.10 Ramonskaya Sweet (Crimea) 50.64 ± 0.10 52.01 ± 0.11 Ramonskaya Sweet (Krasnodar) 45.61 ± 0.11 46.22 ± 0.10 Ramona Sweet (Penza) 41.32 ± 0.04 42.92 ± 0.13

Table 7

Numerical indicators of leaf stevia,%

No. p / p Components Limits of Variation, Lim one Humidity% 5.98-7.15 2 Total ash,% 7.14-12.71 3 Ash, insoluble in 10% HCl,% 4.06-6.32 4 Particles not passing through a sieve with holes with a diameter of 5 mm 3.99-4.87 5 Particles passing through a sieve with holes with a diameter of 0.18 mm 3.07-3.30 6 Organic impurities,% 1.55-2.55 7 Mineral impurities,% 0.20-0.37

Thus, the best varieties of stevia in terms of the complex of useful signs and properties, including the content of the sum of diterpenic glycosides, are Ramonskaya sweeteners (Crimea) - 21.10%, and the best flax variety in terms of the complex of useful signs and properties, including the content of mucus-forming polysaccharides - Northern - 26 ,4 %.

Numerical indicators of the plant harvest "Stelinol": extractives extracted with water, not less than 20.0%; total ash not more than 8.0%; humidity not more than 13.0%; particles not passing through a sieve with a hole diameter of 5 mm, not more than 12.0%; particles passing through a sieve with a hole diameter of 0.5 mm, not more than 6.0%; organic impurities not more than 3%, mineral impurities not more than 2.0%.

Table 8

The chemical composition of the plant harvest "Stelinol",% (average values)

Sample (1:99) Protein Phosphorus Cellulose Fatty oil Slime forming polysaccharides Diterpenic glycosides "Stelinol" based on flax Source 22.56 0.56 8.76 46.21 15.12 0.16 "Stelinol" based on flax North 20.77 0.57 9.06 48.22 24.90 0.15 "Stelinol" based on flax Istok and Severny in a ratio of 1: 1 21.91 0.50 10.07 46.18 22.80 0.16

For the first time, a combination of stevia leaves and flax seeds is used as a medicinal plant material (LRS) to develop a new plant collection.

The selection of components, the optimization of the composition of the plant collection was carried out taking into account the rules for composing a composition of therapeutic and prophylactic action. Plant collection “Stelinol” based on flax seeds and stevia leaves is characterized by the optimal ratio of omega-3 and omega-6 fatty acids, essential amino acids, flavonoids and steviosides for the human body.

The proposed collection "Stelinol" is used in the form of a briquette and the technology for its preparation is as follows. First, an infusion of stevia leaves is prepared in a ratio of 1:50. For this, 1.0 dried powdered stevia leaves are poured into 50 ml of water and heated in a water bath at a temperature of 60 ° C with frequent stirring for 25 minutes, then 50.0 whole flax seeds are added and evaporated for 15 minutes at a temperature of 60 ° C. The prepared collection is dried at a temperature of 60 ° C, for 6 hours 30 minutes.

A comparative study of the therapeutic and prophylactic effect of the developed collection in the metabolic syndrome was carried out.

The study was conducted on 74 non-linear white rats weighing 180-350 g, contained in standard vivarium conditions with free access to water and food. All manipulations with animals were carried out in accordance with the Rules of the European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes and were approved by the local ethics committee.

For the study, rats were divided into 4 groups. Animals of the first group (N = 18) received a standard diet throughout the experiment (45 days) and were intact. Group 2 rats (N = 18, control) were modeled with alloxan metabolic syndrome, 137 mg / kg, once intraperitoneally after a preliminary 24-hour food deprivation while maintaining access to water. Animals of the 3rd (N = 18), 4th (N = 18) groups underwent phytotherapeutic correction of carbohydrate metabolism with the Stelinol plant collection: rats of the 3rd Stelinol group were administered from 1 day onwards throughout the experiment; rats of the 4th group "Stelinol" was used starting from the 21st day from the beginning of the formation of the experimental metabolic syndrome to the end of the experiment.

Under the conditions of modeling the metabolic syndrome, the influence of the Stelinol plant collection on the average life expectancy of rats, on the psychoemotional background, endurance and survival of rats was evaluated. A study of the motor activity and emotionality of rats with experimental metabolic syndrome in the test "Open field". According to the methodological recommendations, we used a round camera (1 × 1 m) made of dark plastic with a bottom wall drawn in squares (10 × 10 cm), with side walls 50 cm high. Lighting was carried out using a 75 W lamp at a height 1.5 m above the center of the field. In the lower part of the side walls there are holes with a diameter of 0.8 cm, designed to study mink reactions. During the 3-minute test, based on visual observation, the following indicators were recorded: the number of crossed sides of the squares of the chamber (in the center of the arena and on the periphery), standing on the hind legs (normal and parietal racks), mink reactions, the number and duration of fur brushing (grooming) ), the number of episodes of defecation during the test, the number and duration of episodes of fading. After each 3-minute test, the animal returned to the cage, the chamber was thoroughly washed.

The increase in horizontal and vertical activity was regarded as an indicator of the increase in stress resistance of animals in the new conditions that the Open Field test recreates. The number of episodes of grooming, defecation and fading, as well as the duration of the episodes of fading, were regarded as indicators of the emotional state of rats: an increase in these indicators was interpreted as an increase in anxiety and anxiety, a decrease as an indicator of the anxiolytic effect of the studied plant collection.

The endurance study of rats with metabolic syndrome in the forced swimming test was conducted. The first swimming was carried out with the aim of randomly selecting animals for endurance. Each animal was individually placed in a cylinder with water, with a diameter of 18 cm and a height of 40 cm, i.e. large enough for rats to swim freely. The water temperature was maintained in the range of 29-30 degrees. Animals swam to exhaustion, as evidenced by the immersion of the animal. At this point, the animal was quickly removed from the water and dried for two minutes with a dry towel. The endurance of rats was determined by the duration of swimming time.

To assess the effect of the Stelinol plant collection on the state of carbohydrate metabolism in animals with metabolic syndrome, an oral glucose tolerance test was used in dynamics, followed by determination of glucose level in the blood.

The survival rate of animals receiving Stelinol, both from the moment of formation of the metabolic syndrome and after 21 days, was higher than that in the control group. Assessment of the effect of the plant harvest "Stelinol" on the survival of rats under modeling of metabolic syndrome is presented in table 9.

Table 9

Survival of rats with experimental metabolic syndrome

Groups Group No. 1 (intact) Group No. 5 (control) Group No. 6 ("Stelinol" from the 1st day of the formation of the metabolic syndrome) Group No. 7 ("Stelinol" from the 21st day of the formation of metabolic syndrome) The number of surviving experimental animals eighteen 6 nine 12 % survival one hundred 33.3 fifty 66.7

During the experiment, the death of animals in all groups with experimental metabolic syndrome was noted, while in the control group and among rats treated with Stelinol from the 1st day of metabolic syndrome formation, mortality was 66.7% and 50%, and among animals, receiving "Stelinol" from 21 days of the experiment, killed 33.3% of rats. Thus, the survival rate of animals treated with Stelinol from the 1st day of the formation of the metabolic syndrome was 1.5 times higher than that in the control group, and 2 times higher in animals treated with Stelinol from the 21st day of formation metabolic syndrome.

The results of the study of motor activity with experimental metabolic syndrome in the test "Open field" are presented in table 10.

Table 10

Dynamics of motor activity of rats with experimental metabolic syndrome in the test "Open field", (M ± m)

Period 1 minute 2 minutes 3 minutes Groups Horizontal activity (number of cells crossed) Vertical activity Horizontal
activity (number of cells crossed) Vertical activity Horizontal activity (number of cells crossed) Vertical activity Common stands Wall racks Common stands Wall racks Common stands Wall racks Group No. 1 (intact) 23.0 ± 2.6 0 3.0 ± 1.0 16.0 ± 3.6 3.0 ± 0.0 3.0 ± 0.0 16.3 ± 6.8 1,0 ± 0,0 2.3 ± 1.5 Group No. 2 (control) 18.7 ± 4.7 0 2.0 ± 0.0 19.0 ± 3.6 3.0 ± 0.0 3.7 ± 3.1 17.7 ± 7.4 1.5 ± 0.7 3.0 ± 1.73 Group No. 3 ("Stelinol" from the 1st day of the experiment) 22.0 ± 8.0 0 4.0 ± 2.6 8.3 ± 7.5 0 * # 1.7 ± 1.2 4.7 ± 2.4 * # 0 * # 3.0 ± 0.0 Group No. 4 ("Stelinol" from the 21st day of the experiment) 20.0 ± 3.6 0 4.7 ± 1.2 * 13.3 ± 5.7 1.0 ± 0.0 * # & 4.7 ± 2.5 14.3 ± 4.7 2.0 ± 0.0 # & 3.0 ± 0.0

Note: * - statistically significant (Pk <0.05) difference from the control group; # - statistically significant (Ри˂0.05) difference from the intact group; & - statistically significant (Pc˂0.05) difference between the groups receiving "Stelinol".

The Open Field test revealed a statistically significant decrease in the number of uprights in the second and third minutes in animals receiving Stelinol from the 1st day and from the 21st day of the experiment, as well as a decrease the number of crossed cells in rats of group No. 3 at the 3rd minute. The results can be interpreted as indirect evidence of a decrease in anxiety rats when exposed to new conditions. The change in the dynamics of motor activity in the animals studied is explained by adaptation to the conditions of the "open field" in the next day, which is accompanied by a decrease in excitability. This, in turn, is accompanied by a decrease in psychogenic tension, which was expressed in an increase in the frequency of grooming. As a rule, the appearance of this reaction indicates a comfortable state of the animal, a low level of anxiety and resistance to stress conditions.

For a more detailed study of the emotional background of rats, the following indicators were determined: grooming, episodes of exit to the center and defecations, as well as peeping into holes (an indicator of curiosity). The results of the study of the emotionality of rats with experimental metabolic syndrome in the test "Open field" are presented in table 11.

Table 11

Indicators of the emotional background of rats with experimental metabolic syndrome in the test "Open field", (M ± m)

Period 1 minute 2 minutes 3 minutes Group
Movements Grooming Holes Exit to the center Defecation Grooming Holes Exit to the center Defecation Grooming Holes Exit to the center Defecation Group No. 1 (intact) 2 ± 0 1 ± 0 0 0 2 ± 0 2 ± 0 1 ± 0 0 2 ± 0 1 ± 0 0 0 Group No. 2 (control) 0 0 0 0 1.5 ± 0.70 0 1 ± 0 0 1.3 ± 0.6 1.5 ± 0.7 1 ± 0 0 Group No. 3 ("Stelinol" from the 1st day of the experiment) 3 ± 0 * 2 ± 0 * 0 0 2 ± 0 1 ± 0 * 0 * 0 3 ± 0 * 0 * 0 1 ± 0 Group No. 4 ("Stelinol" from the 21st day of the experiment) 1 ± 0 * 0 * 0 0 1 ± 0 2 ± 1.4 * 0 * 0 2.3 ± 1.6 0 * 0 1 ± 0

Note: * - statistically significant (Pk <0.05) difference from the control group; # - statistically significant (Р˂˂0.05) difference from the intact group; & - statistically significant (Pc˂0.05) difference between the groups receiving "Stelinol".

There was an increase in orientation-research activity, a tendency to a decrease in the level of anxiety in animals treated with Stelinol from the 1st day and from the 21st day of the experiment compared with animals of the control group. Changes in bowel movements in all experimental animals were not significant. Pronounced grooming in combination with a high orientation-research activity are behavioral markers of stress resistance or anxiolytic action.

During the “Forced Swimming” test, a statistically significant increase in the time of active and passive swimming was revealed in animals treated with Stelinol from 21 days of the experiment relative to similar indicators of the control group (Pk˂0.05) and animals treated with Stelinol from 1 day of the experiment ( Pc˂0.05). In this case, there were no statistically significant differences between the parameters of animals treated with Stelinol from 21 days of the experiment and intact animals (Pu> 0.05).

Animals treated with Stelinol from the beginning of the formation of the experimental metabolic syndrome did not have statistically significant differences in test parameters from the control group (Pk> 0.05).

The results of the study with experimental metabolic syndrome in the test "Forced swimming" are presented in table 12.

Table 12

The effect of the Stelinol plant collection on the forced swimming test in Wistar females with experimental metabolic syndrome

Groups Active swimming (seconds) Passive swimming (seconds) Time to dive (seconds) Group No. 1 (Intact) 286.33 ± 86.17 224.33 ± 83.43 532.00 ± 144.00 Group No. 2 (Control) 130.66 ± 12.05 # 111.0 ± 27.40 # 275.00 ± 65.00 # Group No. 3 ("Stelinol" from the beginning of the formation of metabolic syndrome) 126.66 ± 15.94 # 59.66 ± 59.01 # 214.00 ± 63.01 # Group No. 4 ("Stelinol" from the 21st day of the formation of the metabolic syndrome) 207.33 ± 11.59 * & 166.66 ± 18.33 * & 379.33 ± 49.17 * &

Note: * - statistically significant difference from the control group (Рк˂0.05); # - statistically significant difference from intact animals (Ри˂0.05); & - statistically significant difference between the rats treated with "Stelinol" (Pc˂0.05).

The study was also conducted using an oral glucose tolerance test and determining the level of glucose in the blood of animals. The results obtained are presented in table 13.

Table 13

The dynamics of glycemia in males of Wistar with experimental metabolic syndrome on the background of the introduction of Stelinol, mmol / l (M ± m)

Groups Group No. 1 (intact males) Group No. 2 (control) Group No. 3 ("Stelinol" 10 days before the formation of the metabolic syndrome) Group No. 4 ("Stelinol" from the 1st day of the formation of the metabolic syndrome) Group No. 5 ("Stelinol" from the 20th day of the formation of metabolic syndrome 1 day 6.96 ± 0.73 6.86 ± 0.31 6.58 ± 0.66 6.68 ± 0.31 7.23 ± 0.68 4 day 6.63 ± 0.84 16.58 ± 1.49 # 12.76 ± 0.77 # 13.47 ± 1.52 # 12.81 ± 0.62 & * 8 day 7.21 ± 0.97 19.13 ± 1.06 # 14.01 ± 0.67 # 14.03 ± 1.58 # 13.11 ± 0.63 & * 12 day 7.05 ± 0.64 18.94 ± 1.20 # 12.5 ± 0.73 # 12.60 ± 1.03 # 12.58 ± 0.57 * & 16 day 6.75 ± 0.68 13.64 ± 1.31 # 11.56 ± 0.64 # 11.76 ± 1.23 # 10.21 ± 0.77 * & 20 day 5.9 ± 0.50 12.65 ± 0.65 9.32 ± 1.27 8.22 ± 0.50 7.50 ± 0.90 # 24 day 6.43 ± 0.30 9.8 ± 0.78 # 7.66 ± 0.63 * 6.95 ± 0.95 * 7.42 ± 1.37 28 day 5.88 ± 0.56 9.05 ± 0.88 6.75 ± 0.45 # 5.28 ± 1.35 6.41 ± 0.90 # 32 day 6.76 ± 0.49 9.39 ± 0.33 # 8.36 ± 0.40 # * 7.82 ± 1.00 * 7.64 ± 0.64 * 36 day 4.8 ± 0.37 9.6 ± 0.69 # 5.2 ± 0.42 * 5.84 ± 0.54 * 4.83 ± 0.27 * 40 day 6.28 ± 0.54 9.32 ± 0.91 # 5.42 ± 0.99 * 6.88 ± 1.05 * 6.71 ± 0.86 * 44 day 5.93 ± 0.71 9.28 ± 1.09 # 6.02 ± 0.75 * 6.84 ± 1.12 * 6.26 ± 1.01 *

Note: * - statistically significant (Pk <0.05) difference from the control group;

# - statistically significant (Р˂˂0.05) difference from the intact group;

& - statistically significant (Pc˂0.05) difference between the groups receiving "Stelinol".

The study revealed a statistically significant (Pk <0.05) decrease in glucose compared with the control group in all groups of animals treated with "Stelinol", while in the third and fourth groups, glycemia decreased, starting from the 24th day experiment (table 12), and in the fifth group, the glucose level in comparison with the control group decreases from the 12th day of the experiment. Starting from the 32nd day, the glucose level in all groups of rats treated with "Stelinol" has no statistically significant differences with the intact group. The results obtained are presented in table 14.

Table 14

The dynamics of glycemia in Wistar females with experimental metabolic syndrome during administration of Stelinol, mmol / l (M ± m)

Groups Group No. 1 (intact females) Group No. 5 (control) Group No. 6 ("Stelinol" from the 1st day of the formation of the metabolic syndrome) Group No. 7 ("Stelinol" from the 21st day of the formation of the metabolic syndrome) 1 day 5.18 ± 0.81 7.7 ± 1.12 # 7.53 ± 1.41 7.01 ± 0.40 4 day 5.88 ± 0.84 15.85 ± 0.77 # 13.97 ± 0.72 # 13.47 ± 1.04 # 8 day 6.56 ± 0.76 17.95 ± 0.63 # 14.43 ± 1.13 # 15.4 ± 0.81 # 12 day 6.71 ± 1.08 15.9 ± 0.70 # 13.57 ± 0.95 # 13.93 ± 0.48 # 16 day 8.95 ± 0.93 15.45 ± 0.91 # 13.62 ± 0.85 # 13.26 ± 1.08 # 20 day 6.73 ± 0.91 13.55 ± 1.62 # 11.36 ± 0.40 # * 11.4 ± 0.90 # 24 day 6.6 ± 0.72 12.75 ± 0.07 # 10.96 ± 0.50 # * 10.66 ± 0.73 # * 28 day 7.11 ± 0.55 11.95 ± 0.49 # 9.33 ± 0.58 # * 10.13 ± 1.00 # * 32 day 6.7 ± 0.93 12.50 ± 1.13 # 8.66 ± 0.60 # 8.42 ± 1.03 * 36 day 7.65 ± 0.97 12.4 ± 1.69 # 9.0 ± 0.1 # 8.10 ± 0.87 * & 40 day 7.35 ± 0.89 10.0 ± 0.14 # 8.80 ± 0.14 # * 7.65 ± 0.60 * & 44 day 7.83 ± 0.89 10.75 ± 0.63 # 7.5 ± 0.70 * 6.15 ± 0.40 # * &

Note: * - statistically significant (Pk <0.05) difference from the control group;

# - statistically significant (Р˂˂0.05) difference from the intact group;

& - statistically significant (Pc˂0.05) difference between the groups receiving "Stelinol".

The study revealed a statistically significant decrease in glucose level in animals treated with Stelinol compared to the control group (Table 13). In rats treated with Stelinol since the formation of alloxan diabetes, the glucose level decreased starting from the 20th day; on the 44th day of the experiment, there were no statistically significant differences between rats of this group and intact animals (Table 12). In rats treated with Stelinol from the 20th day, the glucose level was statistically significant (Pk <0.05) decreased from the 24th day of the experiment, and from the 32nd day of the experiment the rats of the group had no statistically significant differences from this indicator from intact animals (table 12). From the 36th day of the experiment, a statistically significant difference in glucose levels was revealed between animals treated with Stelinol from the beginning of the formation of the metabolic syndrome and rats treated with Stelinol from the 20th day (Pc˂0.05, Table 12). On the 44th day of the experiment, a statistically significant (Ри˂0.05) decrease in the glucose level in the group compared with intact rats was observed (Table 12).

Therefore, under the conditions of modeling the metabolic syndrome in experimental animals, an increase in animal endurance and stress resistance, a decrease in blood sugar were revealed.

Claims (4)

The collection has an antidiabetic effect, containing stevia leaves and flax seeds in the following ratios of components, g: stevia leaves 1.0, flax seeds 99.0, characterized in that the stevia raw materials should include the leaves of the Ramonskaya sweeteners cultivated in Crimea, and the seeds of the Northern variety should be included in the collection as flax raw materials.