EVALUATION OF THE SAFETY OF MEDICINES BASED ON A COMPLEX OF SEA URCHIN POLYPEPTIDES

Introduction. Different groups of drugs, including antibiotics and immunomodulators, are used to treat acute bronchitis. In recent years the attention of researchers has been riveted on the medicines based on raw natural materials, sea hydrobionts in particular. A peptide derived from a sea urchin, has shown antibacterial and anti-inflammatory effects in in vivo and in vitro studies. Objective: to conduct preclinical studies of the acute and chronic toxicity of the drug based on a complex of glycosylated polypeptides (working name, Strongylostin) isolated from sea urchins of the species Strongylocentrotus droebachiensis (S. droebachiensis). Material and methods. Rats were endotracheally injected with the drug at doses of 0.03, 0.1, and 0.2 mg/kg to determine its acute toxicity. For a more complete assessment of its toxic effects, the drug at doses of 0.1, 0.2, 1.2, and 5 mg/kg was intraperitoneally injected to rats and mice. In a chronic toxicity study, the drug was endotracheally administered at doses of 0.03, 0.1, and 0.2 mg/kg once daily for 90 days. The safety of the drug was evaluated from the animals’ behavioral reactions, the common blood biochemical and hematological parameters, the mass coefficients of visceral organs, followed by histological assessment of the organs over time. Results. Evaluation of the acute toxicity of the drug in outbred rats and mice could not establish the LD50 values because of the absence of their death. The multiple endotracheal administrations of the drug for 90 days had no negative impact on the animals: the hematological, biochemical, and other indicators characterizing the status of systems and organs in the animals receiving the drug had no statistically significant differences from those in the control group. Conclusion. With regard to its established safety profile, strongylostin should be considered promising for use in otolaryngology and pulmonology.