Zatovsky I. V., Dybkova S. M., Tsyganovich O. A., Dmytrukha N. M., Gruzina T. G., Rieznichenko L. S., Panko A. V., Prokopenko V. A.

BIOSAFETY ASSESSMENT OF THE EXPERIMENTAL INNOVATIVE MEDICINAL PRODUCT “COAGULOX_N”

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Zatovsky I. V., Dybkova S. M., Tsyganovich O. A., Dmytrukha N. M., Gruzina T. G., Rieznichenko L. S., Panko A. V., Prokopenko V. A.

Heading:

BIOLOGY

Type of article:

Scientific article

Annotation:

The creation of modern, safe wound-healing medicines for both first aid and further treatment is a pressing issue today. The aim of the study was to investigate the in vitro and in vivo biosafety of medicinal product “Coagulox_N”, a product that combines the therapeutic effects of an antimicrobial, haemostatic and wound-healing agent in a single product. The biosafety of “Coagulox_N” was determined in vitro based on the parameters of genotoxicity, cytotoxicity, and the nature of its effect on the marker enzymatic Mg2+-ATPase activity of the membrane fraction of eukaryotic cells. The in vivo toxicity criteria for “Coagulox_N” were determined based on the parameters of acute oral toxicity when administered into the stomach and acute dermal toxicity when applied to the skin of white rats. The dermal irritant effect of “Coagulox_N” was determined when applied to the skin of guinea pigs. The irritant effect of the drug on the mucous membrane of the eyes was tested using rabbits. It has been shown that the experimental innovative drug “Coagulox_N” is biosafe according to in vitro indicators of genotoxicity, cytotoxicity, and biochemical marker of the effect on Mg2+-ATPase activity of the membrane fraction of the L929 test cell culture. The assessment of the accordance of “Coagulox_N” to the criteria of acute oral toxicity and acute dermal toxicity confirmed that the tested product belongs to hazard class 4 – substances of low hazard. The tested product “Coagulox_N” does not irritate the skin or the mucous membrane of the eyes of laboratory animals.

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Publication of the article:

«Bulletin of problems biology and medicine», 2025 Issue 3,178, 113-122 pages, index UDC 661.1:615.4

DOI:

10.29254/2077-4214-2025-3-178-113-122