RU2275928C2 - Pharmaceutical composition with immunotropic and adaptogenic activity for oral using - Google Patents

Abstract

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

Description

The invention relates to pharmacy, and in particular to funds obtained on the basis of natural origin with a wide range of therapeutic effects. Known drugs that correct the processes of immunity, thymalin, thymogen, pyrogenal, levamisole (MD Mashkovsky, Medicines, M .: "Medicine", 1993, p. 193, 197, 202). The disadvantages of these drugs include the fact that they are extractive preparations from the thymus gland or are synthetic immunostimulants that cause various side effects.

Recently, in medical practice, drugs used earlier in traditional medicine are quite widely used, among which there are many drugs that have immunotropic and adaptogenic effects. These include such medicinal plants as ginseng, aralia and others.

The closest composition to the claimed invention is RF patent No. 2063750 - a composition with adaptogenic effect and immunotropic activity. The goal is achieved in that the composition comprising ascorbic acid, a-tocopheryl acetate, additionally contains carotenoids (beta-carotene and / or canthaxanthin) and rutin in the following ratio, g: (1 tablet)

Vitamin C 0.005-0.1 A-tocopheryl acetate 0.005-0.1 Beta Carotene and / or Canthaxanthin 0.001-0.005 Routine 0.01-0.05

The disadvantages of this invention include the fact that the proposed composition contains individual selected biologically active substances from plant raw materials, without considering that the complex of biologically active substances of plant origin has a milder effect, potentiating the therapeutic effect of individual substances.

The objective of the present invention is to expand the range of restorative and tonic agents with a wide range of therapeutic effects in various diseases with preventive and therapeutic purposes by selecting the optimal composition of the starting ingredients and their quantitative ratio.

This goal is achieved by the fact that the proposed composition having immunotropic and adaptogenic activity, containing royal jelly, Eleutherococcus extract and tincture of oat milk-wax ripeness in the following proportions, ml per 100 ml:

Royal jelly 1-3 Eleutherococcus Extract 20-30 Tincture of oats milky-wax ripeness up to 100

An essential distinguishing feature of the invention is the optimally selected composition containing the tincture of oats milky-wax ripeness.

Oat of milk-wax ripeness is collected a week before the full ripening of grain, contains more biologically active substances than oat of milk ripeness, which explains the advisability of using tinctures from oats of milk-wax ripeness. Oat tincture contains important amino acids, B vitamins, minerals, trace elements and other biologically active components and has adaptogenic, immunotropic activity.

Royal jelly is a secret secreted by bee-providers at the age of 5 to 15 days. The complex chemical composition of royal jelly determines its versatile pharmacological effect. Royal jelly has a pronounced bacteriostatic, bactericidal, antiviral effect, stimulates metabolic processes, restores the functional activity of the endocrine glands, normalizes tissue respiration and metabolism in the cells of the cerebral cortex.

Eleutherococcus liquid extract - a tonic that enhances physical and mental performance. Physiologically active substances are 7 glycosides - eleutherosides. Eleutherococcus 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 appropriateness of the combined use of these components is confirmed by the fact that with the combined use of plant and animal products, an increase in pharmacological activity is observed. When choosing the optimal quantitative ratio, single doses of individual components were taken into account.

The production of the extract is carried out by the method of percolation at a ratio of raw materials-extractant 1: 1, and tinctures at a ratio of 1: 2 (Muravyov I.A.

Examples of specific performance.

Example No. 1

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

The technology for preparing the composition consists in pretreating royal jelly 1 ml of 70% alcohol. Then, 20 ml of Eleutherococcus extract and, lastly, 79 ml of tincture of oat milk-wax ripeness are introduced into the resulting mixture (1 ml filtrate). All this is thoroughly mixed.

Example No. 2

Royal jelly 3 ml, Eleutherococcus extract 30 ml, tinctures of oats milky-wax ripeness 67 ml.

The technology is identical to example No. 1

The resulting preparation is a clear brown-brown liquid with a characteristic odor.

The analysis of active substances by thin layer chromatography (TLC) and spectrophotometric method showed that with this technology for the preparation of a combined preparation, the largest amount of active substances and, accordingly, a wide spectrum of action are observed. Thus, TLC analysis showed the presence of free amino acids in the preparation, such as glutamine, serine, asparagine, valine, isoptin, etc. The acute and subacute toxicity of the claimed pharmaceutical composition was studied in outbred rats and mice. Acute toxicity was determined in the experiments - the death of animals was not observed even when the drug was administered at a dose of 6 ml per 1 kg of animal weight. With long-term administration of the drug (within 28 days) to rats of both sexes at a dose of 0.1 ml / kg of mass, no significant changes in physiological, hematological and biochemical parameters were recorded in comparison with control groups of animals. Toxic dose - 1.0 ml / kg (also administered within 28 days) - observed the death of animals (mortality 30%), an increase in cytolysis and a change in the histo-morphological picture of internal organs, which was not statistically significantly different from those of the control animals, receiving saline in the same volume throughout the experiment. The lethal dose could not be established.

When studying subacute toxicity (macroscopic and histological analysis) of the claimed composition (in accordance with the recommendations of the Pharmacological Committee of the Ministry of Health of Russia and the rules for preclinical safety assessment of pharmacological agents), it was found that the drug does not cause dystrophic changes in the internal organs of animals (lungs, kidneys, heart, liver). The study of acute toxicity was carried out on white rats males (60 pcs.) And females (60 pcs.) Weighing 200-220 g, as well as on mice of both sexes weighing 20-21 g (120 mice in total), which were administered the drug in doses of 0, 5, 1, 2, 3, 4, 6 ml / kg body weight using a probe intraperitoneally. Observation was carried out for 2 weeks after administration of the substance. The death of animals (rats and mice) during the observed period was not recorded. Thus, the claimed pharmaceutical composition in accordance with the classification of K.K.Sidorov belongs to the class of practically non-toxic compounds. The proposed composition is intended for use in practical medicine as an adaptogenic and immunotropic agent. Unlike well-known drugs with the same activity, this composition has a milder effect, which allows it to be used for a long time without the risk of side effects. Given the optimally selected qualitative and quantitative composition, the components of this composition have a potentiating effect. So, the dosage of the drug is 5-10 drops per dose.

Stability was tested in vivo for 30 months. the 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 the healing and organoleptic properties.

Table 1 The results of the study of the stability of the composition during storage,% Indicator The storage period of the composition 6 months 12 months 18 months 24 months 30 months Description Acc. Acc. Acc. Sediment Sediment Authenticity Acc. Acc. Acc. Acc. Acc. Alcohol content 35% 35% 35% 35% 35% Amount of Amino Acids 0.230 0,200 0.190 0.187 0.180

The alcohol content, dry residue during the storage period corresponding to 30 months in vivo, changed slightly. The alcohol content and dry residue were determined by the pharmacopeia method. Quantitative determination of the amount of amino acids was carried out spectrophotometrically by reaction with a 1% solution of ninhydrin in ethyl alcohol. The calculation of the amount of amino acids was carried out according to the working standard sample of glutamic acid.

In all cases, the use of the claimed funds was not detected unwanted side effects. Thus, from the presented materials it follows that the claimed agent is a practically non-toxic drug with pronounced adaptogenic and immunotropic activity, and is characterized by a minimal risk of side effects, which will expand the range of domestic immunostimulating drugs.

Claims (1)

A pharmaceutical composition for internal use, having immunotropic and adaptogenic activities, characterized in that it contains royal jelly, eleutherococcus extract and tincture of oat milk-wax ripeness as active ingredients in the following ratio of ingredients in ml per 100 ml of the drug: Royal jelly 1-3 Eleutherococcus Extract 20-30 Tincture of oats milky-wax ripeness Up to 100