PRECLINICAL TESTS OF BIOMAGN DRUG ON THE LABORATORY ANIMALS AND WITH THE USE OF CULTURE INFUSOR TETRAHYMENA PYRIFORMIS

Abstract

Introduction. The toxicological control of the veterinary drugs prevents possible metabolic disorders, negative effect for organs and tissues, the occurrence of side effects and long-term consequences, creates the preconditions for determining the optimal therapeutic doses, methods and timing of application, ways and time of excretion from the body, which in turn contributes to development of new highly effective competitive drugs.

The aim of the study – to carry out preclinical tests of Biomagn test drug: determine immediate toxicity and possible toxicity of the drug at a single introduction into the body of animals and determine toxic and lethal doses.

Research Methods. Product toxicity and harmfulness were evaluated in tests on the simplest test organisms Tetrahymena pyriformis and laboratory animals (white mice). The study of Biomagn immediate toxicity was carried out on white non-bred non-linear mice weighing (22.5±0.2) g, which were fed with standard granule food according to feeding norms. The toxicological examinations were performed according to the monograph "Preventive Studies of Veterinary Medicinal Products" (Kotsyumbas I.Y. and others, 2006) and СОU 85.2-37-736:2011 "Veterinary Medicinal Products. Determination of acute toxicity". To determine the degree of cumulation of the test agent we used method by Y. S. Kagan and V. V. Stankevich.

Results and Discussion. Studies have established that Biomagn immunomodulatory drug based on magnesium chloride, chitosan, a mixture of probiotic bacteria and enzymes does not exhibit toxic properties when interacting with ciliates for 30 minutes, since 100 % of the vital activity of the tetrachimene culture remains, as in control tubes. According to the research results, it was found that the acute toxicity in laboratory animals of Biomagn, is LD50 – 5000 mg/kg of animals live weight. During the clinical observation of the research groups of animals, no deviations were found in each group, the skin was smooth, shiny, there was no refusal of feed, no disturbances in the functioning of the gastrointestinal tract and the central nervous system were found in one of the groups, deaths and diseases were not observed. The immunomodulatory drug has no harmful effect, and stimulates the improvement of metabolism, which in turn contributes to an increase in the weight of animals. The hematological parameters of the peripheral blood of mice did not change significantly during the use of the drug. All indicators were within the physiological norm and remained so until the end of the experiment, indicating the safety and non-toxicity of the investigated agent. According to the established signs, the drug belongs to the 4-th class of hazard. Composition of a mixture of probiotic baceria Bacillus subtilis, Bacillus licheniformis, Enterococcus faecium and dried fermentation products of microorganisms Lactococcus Lactis, Bacillus subtilis, Bacillus licheniformis, magnesium chloride, chitosan, which ensures the normalization of the metabolism of animals, affects the increase in the general resistance of the body, stimulates the work of the digestive system.

Conclusions. According to the results of research carried out with the purpose of determining Biomagn toxicity we can conclude that this medicine is non-toxic (SOU 85.2-37-736:2011). Synthesis of Biomagn in different concentrations is non-toxic for the simplest Tetrahymena pyriformis.