Tonic and actoprotector remedy

FIELD: medicine.

SUBSTANCE: remedy comprises mixture of phytoecdysteroids of 20-hydroxyecdysone and 25S-inocosteron extracted from aerial plant top of Serratula genus of Asteraceae family, preferably from leaves gathered in vegetation phase, mass budding phase or at the beginning of flowering.

EFFECT: enhanced effectiveness of treatment; wide range of medical applications.

 

The invention relates to dietary supplements, and therapeutic drugs tonic action and act-protective action and can be used as a new tool for asthenic and asthenodepressive States, accompanied by the weakening of the processes of protein synthesis during prolonged infections and intoxications, neurasthenia, neurosis, and hypotension, as well as in athletes during intense exercise in dysfunction of the cardiovascular system, especially with clear signs of strain on the myocardium and increased protein catabolism during preparation for a competition.

Known tonic "Ecdysten" (A.S. 1312774 the USSR, Tonic // Abubakirov NICHOLAS, MB sultans, Cheeses NR. and others; Mamatkhanov AU, Shamsutdinov M - R.I., Shakirov TT the Secretion of ecdysone from the root of Rhaponticum carthamoides // Chemistry of natural compounds. - 1980. - N4. - C-530), the active principle of which is ecdysteroid 20-hydroxyecdysone, obtained from the roots with rhizomes of wild or cultivated plants of Rhaponticum safavides (Rhaponticum carthamoides (Willd.) Iljin, SEM. Asteraceae).

The method of obtaining tonic "Ecdysten from plants of the genus Rhaponticum is the extraction of raw materials 70%ethanol, removed from the concentrated extract of related substances by the EC is dragonbane organic solvents, purification of the product column adsorption chromatography on alumina and subsequent crystallization. The yield by weight of raw material is 0.1%.

The disadvantage of this analogue is the low yield of ecdysteroids. In addition, using as raw material the roots with rhizomes reduces the reproducibility of medicinal plants, indicating the high economic cost of creating the raw material base.

The present invention is the expansion of the means of toning effect on a living organism, providing annually reproducible resource base with a high content of ecdysteroids, obtaining drug low cost.

This is a technical result.

The technical result is achieved by the fact that as a tonic and act-protective means using a mixture of ecdysteroids, isolated from the aerial parts of plants of the genus Serratula of the Asteraceae family, preferably the leaves, collected in the vegetation phase, the mass of budding or flowering.

A known mixture of ecdysteroids, selected according to the method described in the patent of Russian Federation №2153346 containing 20-hydroxyecdysone - not less than 75% and 25S-inokosterone not less than 10% with the structural formula:

which active substances exhibiting physiological shall aktivnosti, similar largest drug equivalent.

The proposed tool, called by us Serpisten, is a white crystalline powder, odorless, little soluble in water, soluble in methanol and 70%ethanol.

A mixture of phytoecdysteroids get in a known manner (patent 2153346) as follows.

Raw material, preferably the leaves, carried out in the vegetation phase, the mass of budding or flowering. It was established experimentally that in these phases of the development of the content of active ecdysteroids as possible. The study of the distribution of ecdysteroids in plants sebuhi crowned conducted in middle-aged flowering individuals. By ecdysteroids sabuha crowned more than rhapontic carthamoides. The use of above-ground parts of the plant unlike rhizomes of rhapontici greatly facilitates the procurement and processing ecdysteroidogenesis plant materials.

Powdered plant material (aerial part of plants of the genus Serratula family Asteraceae) repeatedly extracted with water at a temperature not exceeding 100°With no more than 1 hour with constant stirring and the ratio of raw material:extractant is 1:10, respectively. Thick aqueous extract evaporated under reduced pressure, treated with a mixture of ethyl acetate-methanol, taken at the a rate of 4:1, or chloroform-methanol at a ratio of 6:1. The procedure is repeated until the complete removal of ecdysteroids from the thick extract. The organic extract evaporated to dryness, then ecdysteroids purified by chromatography on aluminium oxide in the system chloroform-methanol or ethyl acetate-methanol of increasing polarity and recrystallization in the system ethyl acetate-methanol or ethyl acetate-ethanol at a ratio of 9:1.

An example of the method.

6 kg of the crushed leaves of plants of the genus Serratula family Asteraceae fill in 60 l of water and extracted for 1 hour at a temperature of 50°with constant stirring, and then the extract is drained and the plant material is subjected to re-extraction. The combined extract was evaporated in a vacuum rotary film evaporator at reduced pressure up to 2 litres 2 litres of thick extract treated three times 8 l of a mixture of ethyl acetate : methanol at a ratio of 4:1 with constant stirring and filtered. The filtrate is evaporated to dryness, the residues are combined and transferred to a column of aluminum oxide and elute with a mixture of chloroform-methanol of increasing polarity. The eluate is collected in a flask of 1 liter and define them ecdysteroids by thin layer chromatography (TLC). The target fractions containing ecdysteroids, evaporated to dryness and recrystallized in a mixture of ethyl acetate-methanol (9:1).

Thus, the method allows to obtain the substance Serpisten, representing a mixture of phytoecdysteroids, containing not less than 75% 20-hydroxyecdysone and not less than 10% of inokosterone (white crystalline powder, odorless, slightly soluble in water (1,9 g/l), soluble in 70%ethanol (61 g/l) and methanol (75 (g/l)), used as a tonic and act-protective means. Exit - 42 g, or 0.7%, to the weight of raw material, which is 70% of theoretically calculated output.

There is a method of allocating 20-hydroxyecdysone and 25S-inokosterone (RF patent 2155599, allowing to obtain individual compounds from a mixture of phytoecdysteroids and mix them in an effective amount.

Check tonic and act-protective action of the substance Serpisten was carried out in laboratory conditions on laboratory mice of two groups: white mongrel and linear CBA. Surveyed 113 animals three ages: adult (6 months), young (2.5 months) and immature (1 month). Body weight of animals was: white Mature males 25,3±3.8 g, immature mice of both sexes 10,2±1.3 g, linear males IAS 18,7±2,6, Mice were kept in individual cages on a standard diet in the same vivarium conditions (20° (C), All animals were screened for body mass, endurance (holding the body weight on the pole)and the ability to swim. The investigated substance Serpisten in aqueous solution (0.2 ml per 20 g body weight) was administered to mice per os in doses of 1 mg/kg and 10 mg/kg for 5 and 10 days. Control animals were kept under the same conditions in the same period and received per os distilled water (placebo). The mass of each animal was measured daily, respectively, it was corrected input volume of the solution. Just studied five groups of animals: control (placebo) and four experimental groups treated per os substance Serpisten in the final doses: 5 mg/kg, 10 mg/kg, 50 mg/kg, and 100 mg/kg all animals were held control and experimental measurements of the parameters of strength and endurance during dynamic and static load was measured reactivity of higher nervous activity and evaluated the tone of the Central nervous system. Physical performance and the influence of substance Serpisten meant as act-protective action of the substance Serpisten and rated by standard methods (Elizarova, 1962). The resistance to dynamic loading in animals was evaluated by time swimming in the standard test (swimming "to failure") at a water temperature of 30°C. Static load was measured by the value of the maximum weight that the animal can raise, and by the time hanging on the pole. The tone of the Central nervous system and the influence of substance Serpisten hereafter is made as CNS-toning effect of the substance Serpisten and rated speed of finding the animals exit the double T-shaped maze (Tolman, 1980). All measurements were done twice: in the first and fifth day of the test, which excluded the possibility of training animals. Statistical processing was subjected to the results of the individual pairwise comparisons of physiological parameters before and after exposure to the substance Serpisten. Evaluation of significance of differences was performed using t-student test.

Example 1. In mice study act-protective action of the substance Serpisten to increase the dynamic and static health of animals. Immature female mice at the dose of 5 mg/kg endurance while swimming (dynamic efficiency) increased by 80%. Adult white mice at the dose of 10 mg/kg endurance increased on average by 63%, and in mice of CBA by 107%. Static efficiency (load retention) under the influence of substances Serpisten increased on average by 42%. Increase endurance to extreme physical activity persists in animals and 7 days after cessation of drug administration.

Example 2. In mice study CNS-toning effect of the substance Serpisten. Despite dose, species and individual differences in sensitivity to the action of Serpisten", we observed high CNS-toning effect of the drug as Mature and immature mice. The detected acceleration is approximately-ASCS is edutella reactions and stimulation of memory in animals receiving substance Serpisten, which was reflected in the activation of the search, memorizing the route and the acceleration of finding the way out of the maze ("mental health"). Improving the tone of the Central nervous system has evolved simultaneously with the increase of parameters of physical health in animals after administration of the drug (coeff. Corr. equals 0.58). Under the influence of Serpisten at a dose of 50 mg/kg running time of the maze in adult animals was reduced by 40%, and immature white mice with the introduction of a total dose of 5 mg/kg mileage labyrinth increased twice in comparison with controls (p<0,05).

Currently Serpisten undergoing clinical trials. Decorated monograph on raw materials, substance and pharmaceutical form.

The use of a mixture of phytoecdysteroids 20-hydroxyecdysone and 25S-inokosterone isolated from the aerial parts of plants of the genus Serratula of the Asteraceae family, preferably the leaves, collected in the vegetation phase, the mass of budding or flowering beginning, as a tonic and act-protective means.



 

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