One of the basic stages of drug introduction is determination of their toxicity, including the indexes of acute toxicity in accordance with the requirements of the State pharmacological centre of the Ukrainian Ministry of Public Health. That is why the purpose of the work was to determine the indexes of acute toxicity of clotrimazol, ketokonazol and bifonazol gels. As a result of the research LD50 of the experimental gels has been found to be out of the toxicity limits of class V (LD50>2810 mg/kg), and it allows to refer them to the class of practically non-toxic substances (class V of toxicity). During the experimental work no differences between the antimycotic gels developed and reference medicines were found. It allows to consider these medicines and reference standards to be equivalent according to the toxicity index with their single application on the skin of rats. Accoding to the indexes of acute toxicity the gels of clotrimazol, ketokonazol and bifonazol developed containing carbomer and hydrophilic non-aqueous solvents: ethanol, glycerin, propylene glycol and PEO-400 in their base correspond to the toxicity level of the reference medicines such as 1% cream “Clotrimazol” (Glaxosmitkline Pharmaceuticals S.a, Poland), 2% cream “Nizoral” (Janssen Pharm., Belgium), 1% cream “Bifunal” (Actavis–Balkanfarma-Razgrad, Bulgaria), and it allows to recommend these gels for further research with the purpose of their introduction into practical medicine as antifungal agents.
Key words: antifungal agents, toxicological properties, acute toxicity.
