RU2183127C1 - "lamivit" preparation to increase body adaptational responses - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: suggested preparation includes a copper complex of chlorophyll or the extract of thick laminaria on conversion to the content of copper derivatives of chlorophyll, vitamin A, aromatic additive and 95% ethanol. As an aromatic additive it could contain a citric essence. EFFECT: higher efficiency of "Lamivit" due to its sedative action upon the central nervous system, decreased emotional loading, increased working capacity. 2 cl, 4 tbl

Description

 The invention relates to medicine, namely to the creation of agents based on algae with adaptogenic activity.

 Among the adaptogens of plant origin, tinctures and extracts of medicinal plants of ginseng, lemongrass, radiola, leuzea and eleutherococcus are known (Mashkovsky MD "Medicines", M., Medicine, 1993, v. 1, p. 161-165).

 The closest technical solution is the "Adaptogenic agent" (RU 2139082 from 12/15/98), containing kelp extract, α-tocopherol acetate and ethyl alcohol.

 The objective of the present invention is to expand the range of tools that increase the adaptive response of the body.

The problem is solved by the proposed tool containing a copper complex of chlorophyll or thick kelp extract in terms of the active substance (0.0008-0.0013 wt.%), Vitamin A (retinol acetate or retinol palmitate) (0.0008-0.0013 wt. .%), an aromatic additive (food flavoring) (0.2-0.5 wt.%) and 95 ^o ethyl alcohol - the rest. As an aromatic additive, the product may contain lemon essence.

 Laminaria - seaweed - refers to the genus of kelp kelp. Some types of kelp are consumed, in traditional medicine kelp powder is used for anemia, stomach diseases, in the official - for atherosclerosis, for the prevention of cancer, etc. In this case, the product contains a chlorophyll copper complex (TU 9284-024-00462769-00) or thick kelp extract (VFS 42-3294-98) in terms of the content of chlorophyll copper derivatives.

 Vitamin A belongs to the group of fat-soluble compounds. The daily requirement for an adult is 0.8-1.0 mg, for children - 0.4-1.0 mg. The composition of the proposed product includes retinol acetate according to FS 42-3029-94 or retinol palmitate FS 42-2229-94 or imported, registered in the Russian Federation.

The product may contain lemon essence as an aromatic additive (OST 18-103-84). In addition, the tool contains 95 ^o ethyl alcohol (FS 42-3072-00).

A method of preparing the proposed funds in the amount of 1 liter of the finished solution is as follows. In a calculated amount of 95 ^o ethyl alcohol, the copper complex of chlorophyll or the thick kelp extract is dissolved in terms of the content of copper derivatives of chlorophyll 0.01 g, then 0.01 g of vitamin A is dissolved in the next portion, and the resulting solutions are filtered and combined. Then 0.3 g of lemon essence is added to the alcohol solution and mixed for 30 minutes. Filter and pack.

 The resulting product is a clear greenish liquid with a specific odor.

Authenticity is determined by chlorophyll derivatives and vitamin A (retinol acetate or retinol palmitate). The UV spectrum of the drug solution should have a maximum in the wavelength range from 635 to 665 nm and shoulders in the region from 400 to 430 nm (chlorophyll derivatives) and with respect to retinol — the retinol peak retention time in the chromatogram of the drug corresponds to the retinol peak retention time in the PCR retinol chromatogram . Density - 0.795-0.815 g / cm ³ . Derivatives of chlorophyll (spectrophotometrically) and vitamin A (HPLC) are quantified. Store the drug in a cool, dark place. The product is given the name "Lamivit".

 A preclinical test of the drug was conducted on white male rats and mice grown in the nursery of the Pyatigorsk State Pharmaceutical Academy.

 In the study of acute toxicity, Lamivit was administered at a dose of 20 ml / kg of animal body weight, taking into account the maximum allowable amount of fluid that can be introduced into the stomach of white rats.

 Lamivitis did not cause animal death when administered orally. In animals, inhibition of motor activity was observed within 4-5 hours after administration, which was restored after 5-6 hours. Observation of the animals was carried out for two weeks. During the entire observation period, rats of all experimental groups remained awake, quickly responded to light, sound, and pain stimuli. The condition of the hair and skin, the consumption of food and water, the frequency of urination remained normal.

 The results of the studies indicate that according to the tabulation of toxicity classes ("Methods for determining the toxicity and hazard of substances", edited by prof. I.V. Sanotsky, M., Medicine, 1970, 343 pp.), This drug is Lamivit - when administered orally, it belongs to the 4th class of toxicity and is low toxic (almost non-toxic).

 The study of pharmacological activity was carried out according to tests of influence on working capacity and endurance, resistance to hypoxia, as well as on tests reflecting the effect on the central nervous system: a rotating rod, an open field.

 Lamivit and the comparison drug Adaptovit (RU 2139082) were studied with intragastric administration to animals at a dose of 1 ml / kg (2 times diluted with water). Dilution with water is necessary to eliminate the damaging effects of 95% alcohol on the mucous membranes of the gastrointestinal tract. The studied dose of Lamivit 1 ml / kg of body weight of the animal was chosen not by chance, but depending on the average daily dose proposed for use in humans. The calculation showed that the maximum average daily dose of Lamivit for a person can be 7 ml (given that 1 ml can contain from 16 to 20 drops of the proposed solution of the drug Lamivit). Based on the proposed (recommended for calculation) average human body weight of 70 kg, we obtain the following: 0.1 ml of the drug per 1 kg of body weight. When transferring data on doses of drugs from the human body to the body of laboratory animals, it is customary to increase the dose of the drug by 10 times (due to a decrease in the sensitivity of animal organs and tissues to the action of drugs). Thus, the studied dose of Lamivit was 1 ml / kg. At the same dose (1 ml / kg), the comparison drug Adaptovit was studied.

 Control animals received saline in adequate volumes.

 The data obtained as a result of experiments were processed statistically. The results in the tables are presented as average values with a confidence interval (M ± m) or standard deviation.

 The antihypoxic effect of Lamivit was determined in a standard test on a model of hypoxic hypoxia with hypercapnia when animals were kept in a pressurized volume until they died. Animals (mice) were placed in hermetically sealed containers with a volume of 750 ml (one individual in each container). In each group, 6 white mice weighing 19-20 g.

 Lamivit was administered at a dose of 1 ml / kg into the stomach 60 minutes before placing the mice in a pressurized volume. The results are shown in table 1.

 Conclusion: Lamivit at a dose of 1 ml / kg (once) did not significantly increase the resistance of mice to hypoxia both in relation to the control and to the comparison drug Adaptovit, although there is a tendency to increase the resistance of animals to hypoxia compared to control experiments.

 When studying neurotropic activity, the Open Field method was used in the experiments, designed to study the main parameters of behavior and neurological status under conditions of short-term psycho-emotional stress caused by placing the animal in an open area.

 In the experiment, 18 rats (3 series) weighing 190-200 were used. Lamivit and Adaptovit at a dose of 1 ml / kg were administered intragastrically 60 minutes before testing in an open field, physiological saline was administered to control animals. The experimental results are shown in table 2.

 Conclusion: Lamivit at a dose of 1 ml / kg significantly reduces the number of crossed squares, the time spent in the center of the arena and significantly reduces the number of boluses, which indicates the presence of a sedative effect on the function of the central nervous system. Given that when studying the general toxic effect of Lamivit at a dose of 10 ml / kg for 28 days, the drug did not affect the tests in the open field, it should be concluded that a single administration has a sedative effect, and there is no effect with the course administration (addiction may develop).

 The effect of Lamivit on the coordination of movements was studied on male mice weighing 19-20 g in the standard setting "Rotating Rod". There were 6 mice in each group. Animals were placed on a “rotating rod” 60 and 120 minutes after administration of Lamivit, saline and Adaptovit. Lamivit and Adaptovit were administered at a dose of 1 ml / kg, physiological saline in an adequate volume. The results of the experiment are presented in table 3.

 Conclusion: Lamivit significantly increases the coordination of animal movements compared with control and Adaptovit. This result is due not only to a positive effect on the coordination of movements, but also to the adaptogenic effect of Lamivit.

 The effect of Lamivit on physical performance was studied in the forced swimming test of mice. The experiments used white outbred male mice weighing 19-20 g, 6 animals in each group.

Lamivit was administered at a dose of 1 ml / kg of animal body weight intragastrically, Adaptovit at a dose of 1 ml / kg. Control animals were injected with physiological saline in the same volume. Water temperature - 28 ^o C.

 Swimming began 60 minutes after the administration of Lamivit, Adaptovit and saline. Animals swam before the first immersion in water. The results are shown in table 4.

 Conclusion: Lamivit increases the physical performance of animals in comparison with control experiments.

 Based on studies on laboratory animals (white rats and mice), Lamivit at a dose of 1 ml / kg body weight has a sedative effect on the central nervous system, reduces emotional activity, increases coordination activity and increases physical performance. All of the above allows us to recommend Lamivit for use in medical practice as a means of increasing the body's adaptive reactions.

 The introduction of vitamin A into the drug made it possible (as proved by tests on laboratory animals) to increase the indicator of coordination activity, increase physical performance, increase the sedative effect (with a single dose).

Claims (1)

1. A tool that enhances the adaptive reactions of the body, characterized in that it contains a copper complex of chlorophyll or thick kelp extract in terms of the content of copper derivatives of chlorophyll, vitamin A (retinol acetate or retinol palmitate), an aromatic additive and 95 ^o ethyl alcohol in the following ratio ingredients, wt. %:
Chlorophyll copper complex or thick kelp extract in terms of the content of chlorophyll copper derivatives - 0.0008-0.0013
Vitamin A (retinol acetate or retinol palmitate) - 0.0008-0.0013
Aromatic additive - 0.2-0.5
95 ^o ethyl alcohol - Other
2. The tool according to claim 1, characterized in that it contains lemon essence as an aromatic additive.

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