Introduction. Chondroprotectors are the group of drugs containing structural elements of the natural cartilaginous tissue, chondroitin sulphate in particular. It is one of the major components of the extracellular matrix of the cartilaginous connective tissue and is classified as biologically active substance. At that, of a special importance becomes to be a safe use of biologically originated chondroprotectors, since they may contain impurities and hence have side effects. One of the steps in the development of drugs at the stage of preclinical trials is their toxicological studies. That is why the purpose of our research was to study a sub-acute toxicity of the new chondroprotector “Chondrosut”.
Study methods. The study of “Chondrosut” sub-acute toxicity was carried out on the white non-pedigree rats under the condition of its daily use during 28 days. In all groups of animals we registered the survival, water and food consumption and manifestations of intoxication, proceeding from the general physical condition of the animals. At the beginning and after the end of experiment we determined the body weight, spontaneous daily diuresis and performed clinical and biochemical blood tests, as well as clinical urinalysis.
Results and discussion. It was found that a 28-day intraperitoneal administration of “Chondrosut” in doses of 35, 175 and 350 mg/kg does not cause the animals’ death, does not change the condition of the skin integuments and mucous membranes, behavior, activity, body temperature and body weight dynamics of the experimental rats. The results of studying the basic indicators of the clinical urine and blood tests as well as biochemical blood tests give evidence that the medical product being studied does not change the peripheral blood indicators, does not exert any effect on the protein, carbohydrate and lipid metabolism, does not disorder the function of hepatobiliary and urinary systems.
Conclusions. Analysis of the data obtained bears record to the absence of toxic effect in preparation “Chondrosut” when it is multiply and durably used in ultra-high doses, this making it possible to rank the medica product among nontoxic substances, safe for humans.