Дослідження токсикологічних властивостей нового ліпосомального засобу «Ліпохром»

Abstract

A preclinical study of a new pharmacological agent Lipochrome (a lyophilized powder for injection, produced by Nano Technologies in Medicine, Ukraine) specific activity showed that its administration in an isovolemic volume of saline 30 min after acute massive blood loss caused a moderate hemodynamic effect and prevented the development of decompensated metabolic acidosis and disseminated intravascular blood coagulation.An important stage in new potential drugs compex preclinical studies is their toxicological parameters investigation. The aim of the study was an experimental investigation of new pharmacological agent Lipochrome toxicological properties to substantiate its safety for clinical use.Lipochrome test sample acute toxicity was studied in two laboratory animals species: female white mice (18–20 g body weight) and female rats (200–210 g body weight). Intravenous injection of the pharmacological agent Lipochrome in a single dose 50 mg/kg body weight (mice) and 20 mg/kg (rats) (maximum allowable volumes for these species with intravenous injection) did not cause experimental animals death, as soon as the development of any clinical signs of toxic effects, changes in the dynamics of body weight or absolute and relative masses of internal organs. External examination, autopsy and macroscopic examination of female white mice and rats 14 days after Lipochrome test sample single injection did not detect alternate changes, signs of impaired blood circulation, inflammation or dysregenerative changes. No signs of pathological changes in the surrounding tissues were found at the Lipochrame injection site. Repeated intraperitoneal injections of the Lipochrome test sample to rats of both sexes for 14 days at a dose 10 mg/kg (supposed therapeutic) and 50 mg/kg (five times higher than supposed therapeutic) caused no death of animals, no clinical signs of toxic action, had no influence on the body weight dynamicsand general behavioral reactions. There were no negative effects on the peripheral blood hematological parameters, general metabolism violations as well as no changes in the liver and kidneys structural and functional properties in comparison with physiological norm. Under these conditions, there were no macro- and microscopic changes in the main integral indices, no hemodynamic disorders, no inflammatory reactions and degenerative lesions of internal organs and tissues.Thus, the results obtained confirm the advisability and prospectiveness of further investigation new liposomal agent Lipochrome pharmacological properties and therapeutic efficacy.