Study of acute toxicity of the drug «Prazitsid®-Complex»

Abstract

Preclinical testing of the new drug «Prazid®-complex», developed by LLC «Apisenna» (Russia, Moscow, Smolenskaya-Sennaya sq., 27, building 1A, apartment 74), containing 102 mg of praziquantel in 1 ml, 5 mg ivermectin, 100 mg of fipronil and excipients were carried out on non-linear laboratory mice purchased from the branch of the National Research Center «Kurchatov Institute» PNPI - PLZh «Rappolovo». The acute toxicity of the drug was determined according to GOST 32644-2014 and «Guidelines for experimental (preclinical) study of new pharmacological substances» (2005)» on 6 mice (3 females and 3 males in each group. To determine the LD50 of the drug, five experimental groups of six animals each (3 males and 3 females) were formed from 30 mice. To calculate the parameters of acute toxicity, we used the method of determining LD50 using probit analysis according to Litchfield and Wilcoxon, which is based on taking into account the mortality of animals from administered doses of the drug under study. The hazard class of the drug was determined according to GOST 12.1.007-76. It was found that the drug «Prazicide®-complex» in doses of 2.0; 3.5; 5.0; 6.5 g/kg causes death in 100% of experimental animals within 24 hours. When the drug is administered at a dose of 0.5 g/kg body weight for 14 days, death is observed in 50% of experimental mice. LD50 of the Prazitsid®-complex drug is 0.5 g/kg body weight. According to the classification (GOST 12.1.007-76), the drug «Prazid®-complex» should be classified as a low-toxic compound (hazard class 3) and used for clinical trials on animals.