Abstract

In accordance with Russian Federal program of import substitution of foreign medicines quality of Russian drugs in the N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia, played vincristine-RONC (VC-RONC), which as a drug – the generic’s passed preclinical pharmacological and toxicological testing in comparison with foreign firms vincristine Teva of Israel (VC-Teva). The aim. The aim of present study was the comparative pathomorphological evaluation of the effect of VC-RONC and VC-Teva on the internal organs of rats. Materials and methods. Used 50 weinbrenner male rats, at 10 rats per group. VC-RONC and VC-Teva rats were administered intravenously 3 times daily at aquatoxicity total dose corresponding to the MTD and 1/2 MTD. Control rats in the same regime intravenously administered of 0,9 % sodium chloride solution. Rats were deduced from the experience of 3 and 30 days after the end of administration of the drugs. Conducted macroscopic and histological examination of internal organs by conventional methods, including fixation of the material in 10 % formalin and coloring sections with hematoxylin and eosin. The micropreparations of the internal organs was analyzed under light microscope at magnifications of 100, 400, 1000. Results. VC-RONC, as VC-Teva in cumulative doses of 0,5 and 0,25 mg/kg in 3 days after the end of introductions in the internal organs of rats cause similar slightly pronounced morphological changes: hypoplasia in the bone marrow and spleen, destructive changes in the testes, focal degenerative changes in the kidney and liver of individual rats. On the 30th day after the application of both drugs, some rats regardless of the dose occurred similar symptoms residual morphological changes in the bone marrow, testes, kidneys and liver. Conclusion. Based on the results of macroscopic and histological examination the conclusion about the similarity of the influence of VC-RONC and VC-Teva on the internal organs of rats was made.

Highlights

  • VC-RONC and vincristine Teva of Israel (VC-Teva) rats were administered intravenously 3 times daily at aquatoxicity total dose corresponding to the MTD and 1/2 MTD

  • Control rats in the same regime intravenously administered of 0,9 % sodium chloride solution

  • Rats were deduced from the experience of 3 and 30 days after the end of administration of the drugs

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Summary

Introduction

ВК-РОНЦ и ВК-Teva в суммарных дозах 0,5 и 0,25 мг/кг на 3-и сутки после окончания введений вызывают во внутренних органах крыс сходные несильно выраженные морфологические изменения: гипоплазию в костном мозге и селезенке, деструктивные изменения в семенниках, очаговые дистрофические изменения в почках и печени отдельных крыс. Патоморфологическое исследование внутренних ­ор­ганов крыс на 3-и и 30-е сутки после окончания в/в введ­ ения препаратов ВК-РОНЦ и ВК-Teva в суммарных дозах 0,5 и 0,25 мг/кг.

Results
Conclusion
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