Pharmaceutical composition with immunotropic and adaptogenic activity for oral using

FIELD: medicine, pharmacy.

SUBSTANCE: invention relates to the development of medicinal agents based on natural components showing the broad curative effect. Invention proposes a pharmaceutical composition for oral using that possesses immunotropic and adaptogenic activities and comprises bee mother milk, Eleutherococcus senticosus plant extract and milkwax stage of oat ripeness tincture. Proposed agent doesn't cause adverse effects and shows the broad spectrum of effect.

EFFECT: valuable medicinal properties of composition.

1 tbl, 2 ex

 

The invention relates to a pharmacy, namely the funds received on the basis of natural origin with a wide range of therapeutic actions. Known medications, corrective processes immune adjuvant, timogen, pyrogenes, levamisole (PPM Mashkovsky, Medicines, M.: "Medicine", 1993, s, 197, 202). The disadvantages of these drugs can be attributed to the fact that they are extractive preparations of thymus or are synthetic Immunostimulants, causing various side effects.

Recently in medical practice widely used drugs, used in folk medicine, among them a lot of money with immunotropic and adaptogenic action. These include herbs like ginseng, sarsaparilla, and others.

The closest in composition to the claimed invention is a patent of the RF No. 2063750 - formulated with adaptogenic action and ionotropes activity. The aim is achieved by a composition comprising ascorbic acid, a-Tocopheryl-acetate, optionally contains carotenoids (beta-carotene and/or canthaxanthin) and rutin in the following ratio, g: (1 pill)

Ascorbic acid0,005-0,1
While averil-acetate 0,005-0,1
Beta-carotene and/or canthaxanthin0,001-0,005
Rutin0,01-0,05

The disadvantages of this invention include that the proposed composition contains individual selected biologically active substances from plant raw material sources, without taking into account that the complex of biologically active substances of plant origin has a milder action, potentsiruya therapeutic effect of the individual substances.

The present invention is to expand the range of restorative and tonics with a wide range of therapeutic effects in various diseases with preventive and therapeutic purposes by the selection of the optimum composition of the original ingredients and their numerical relationships.

This objective is achieved in that a composition with immunotropic and adaptogenic activity that contains Royal jelly extract, Siberian ginseng, and tincture of oats milky-wax ripeness in the following proportions ml per 100 ml:

The main feature of the invention is optimally balanced composition containing tincture of oats milky-wax ripeness.

Oats milky-wax ripeness going a week before full ripening of the grain, contains more biologically active substances than oats milky stage, which explains the appropriateness of that tincture of oats milky-wax ripeness. Tincture of oats contains important amino acids, vitamins, minerals, microelements and other biologically active components and has adaptogenic, immunotropic activity.

Royal jelly is a secretion, secreted by bees-breadwinners in age from 5 to 15 days. The complex chemical composition of Royal jelly is the cause of its diverse pharmacological action. Royal jelly has a pronounced bacteriostatic, bactericidal, potyviruses effect, stimulates metabolism, restores the functional activity of the endocrine glands, normalizes tissue respiration and metabolism in the cells of the cerebral cortex.

Extract of Siberian ginseng liquid tonic that improves physical and mental performance. Physiologically active substances are 7 - glycosides eleutherosides. Siberian ginseng has a pronounced adaptogenic effect, increases the body's resistance to adverse external influences. Thus, all selected components have a pronounced adaptogenic and immunotropic effect. In addition, the feasibility of the combined use of these components confirms the fact that the combined application of funds of plant and animal origin, has increased pharmacological activity. When choosing the optimal quantitative ratios were considered single doses of individual components.

The production of the extract by percolation with a ratio of raw materials-extractant 1:1, and tinctures at a ratio of 1:2 (Ant IA Technology of drugs. Vol. 1 str)

Examples of specific performance.

Example 1

Royal jelly 1 ml extract, Eleutherococcus 20 ml tincture of oats milky-wax ripeness 79 ml.

Technology of preparation of the composition is in the pre-treatment Royal jelly 1 ml of 70% alcohol. Then in the resulting mixture, the filtrate volume 1 ml) injected 20 ml of the extract of Eleutherococcus and at least 79 ml of tincture of oats milky-wax ripeness. All this is thoroughly mixed.

Example # 2

Royal jelly 3 ml of extract, Eleutherococcus 30 ml of tincture of oats Moloch the-wax ripeness 67 ml.

The technology is identical to example No. 1

The resulting product is a clear liquid brown color with a characteristic smell.

The analysis of active substances by thin-layer chromatography (TLC) and spectrophotometric method showed that the technology of preparation of combined drug has the highest number of content of the active substance and, accordingly, a broad spectrum of action. So, TLC analysis showed the presence of the drug free amino acids such as glutamine, serine, asparagine, valine, isoptin and other studies of acute and subacute toxicity of the inventive pharmaceutical composition in outbred rats and mice. In our experiments we determined the acute toxicity - death of animals was not observed even with the drug at a dose of 6 ml per 1 kg of weight of animal. With long-term administration of the drug (within 28 days) rats of both sexes at a dose of 0.1 ml/kg of body weight did not register significant changes in physiological, hematological and biochemical parameters compared with the control groups of animals. Toxic dose of 1.0 ml/kg (injected within 28 days) was observed in the animals death (case fatality rate of 30%), the growth of cytolysis and change histo-morphological picture of internal organs, which is statistically not the best of the elk from those parameters control animals, treated with saline in the same volume throughout the experiment. Sredneseriynoe dose could not be determined.

In the study of subacute toxicity (macroscopic and histological analysis) of the proposed structure (in accordance with the recommendations of the Pharmacological Committee of Ministry of health and by the rules of the preclinical safety assessment of pharmacological agents) found that the drug does not cause distroficheskiy changes in animals ' internal organs (lungs, kidneys, heart, liver). Study of acute toxicity was carried out on white rats-males (60 pieces) and females (60 PCs) weighing 200-220 g, as well as in mice of both sexes weighing 20-21 g (a total of 120 mice), which was administered in doses 0,5, 1, 2, 3, 4, 6 ml/kg body weight using a probe intraperitoneally. The monitoring was conducted within 2 weeks after administration of the substance. The death of animals (rats and mice) during the observed period were not recorded. Thus, the claimed pharmaceutical composition in accordance with the classification Kev belongs to the class of practically non-toxic compounds. The proposed composition is intended for use in practical medicine as an adaptogenic and immunotropic funds. In contrast to known drugs with the same activity of the composition has a softer action that allows to use it for a long time without the risk of side effects. Given the optimally balanced qualitative and quantitative composition, the components of this composition have a potentiating effect. Thus, the dosage is 5-10 drops to accept.

Stability was tested in vivo for 30 months. method of accelerated storage at 60°C. the Precipitate appears after 18 months. storage (table 1). The amount of amino acids varies slightly. Thus, the proposed composition has a shelf life of 1.5 years without changing medical and organoleptic properties.

Royal jelly1-3
Extract of Siberian ginseng20-30
Tincture of oats milky-wax ripeness100
Table 1
The results of studying the stability of the composition during storage, %
IndexThe storage period of the composition
6 months.12 months.18 months.24 months.30 months.
DescriptionACC.ACC.ACC.The precipitateThe precipitate
AuthenticityACC.ACC.ACC.ACC.ACC.
The alcohol content35%35%35%35%35%
The amount of amino acids0,2300,2000,1900,1870,180

The alcohol content of dry residue in the retention period corresponding to 30 months under natural conditions, were changed slightly. The alcohol content and the dry residue was determined pharmacopoeial method. Quantitative determination of the amount of amino acids was performed by the spectrophotometric method by the reaction with 1% ninhydrin solution in ethanol. The calculation of the content, the amount of amino acids was performed according to the working standard sample glutamic acid.

In all cases the use of funds has not been identified unwanted side effects. Thus, it follows that the claimed tool is practically non-toxic drug with pronounced adaptogenic and immunotropic activity, and has a minimal risk of side effects, which will expand the range of domestic immunostimulatory drugs.

Pharmaceutical composition for internal use with immunotropic and adaptogenic activity, characterized in that as the active substances it contains Royal jelly extract, Siberian ginseng, and tincture of oats milky-wax SP is lost in the following ratio of ingredients in ml per 100 ml preparation:

Royal jelly1-3
Extract of Siberian ginseng20-30
Tincture of oats milky-wax ripeness100



 

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