Study of acute toxicity of a new drug “AOS” for the treatment of osteoporosis.

Abstract

Background. Osteoporosis is one of the most common diseases, which, along with myocardial infarction, stroke, cancer, and sudden death, occupies a leading place in the structure of morbidity and mortality of the population. Postmenopausal women are most vulnerable and are approximately 4 times more likely to be affected than men (80 % of all patients), and osteoporosis-related fractures are responsible for a significant increase in morbidity, disability, and mortality, especially in the elderly.Objective. To study the acute toxicity of the new drug “Antiosteoporosis drug” (patent No. 02-04-16643/15-0 dated February 26, 2015) with a single intragastric administration to mature outbred rats of both sexes.Design and methods. The study was conducted on outbred rats of both sexes according to protocol OECD 420, GOST 32296-2013. The development of a toxic effect was concluded based on behavioral tests, clinical examinations, changes in body weight, the results of pathomorphological examination of organ tissue and biochemical parameters of blood and urine.Results. According to the results of the study, the tested drug was classified according to the active substance into category 5 according to the GHS classification (2000<LD50 (i/g)<5000 mg/kg). An assessment of the dynamics of body weight in experimental animals showed that a single intragastric administration of the test drug had no effect on this indicator. The study of individual behavior as part of the main study on the 14th day after a single intragastric administration of the test drug showed that a single intragastric administration of the test drug at a dose of 2000 mg/kg did not have a delayed effect on the general condition and indicative research activity of experimental animals. Autopsy and pathological examination of animals on the 15th day after a single intragastric administration of the test drug did not reveal the presence of any residual effects associated with the administration of the test drug. The tested drug did not have a local irritant effect on the injection site — the gastrointestinal tract. In all tests, the degree of change in indicators caused by the test drug was the same: there were no statistically significant differences in the recorded parameters between the test drug and the control group.