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Siberian Scientific Medical Journal

2018 year, number 1

PRECLINICAL STUDY OF THE TOXICITY OF THE ORAL FORM OF PEGYLATED INTERFERON О±-2b UNDER ITS LONG-TERM USE

Alexey Alexandrovich CHURIN1, Eugeniy Yur’evich SHERSTOBOEV1, Dmitriy Nikolaevich KINSHT2,3, Tatyana Sergeevna TARTYNOVA2, Pavel Gennad’evich MADONOV2,3
1Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk National Research Medical Center of RAS
2Novosibirsk State Medical University of Minzdrav of Russia
3Siberian Center of Pharmacology and Biotechnology
Keywords: interferon О±-2b, pegylation, electron-beam immobilization, chronic toxicity, preclinical trials, интерферон О±-2b, пегилирование, электронно-лучевая иммобилизация, хроническая токсичность, доклинические исследования

Abstract

The aim of the study is to investigate the chronic toxicity of the oral finished dosage form of pegylated interferon α-2b, obtained with the help of electron-beam synthesis technology. Materials and methods. The preparation was orally administered to rats and rabbits at the calculated therapeutic doses and doses exceeding them. The drug effect on the general condition and body weight, hematological parameters, myelogram, blood biochemical parameters, excretory and cardiovascular system, CNS were studied. As well as pathomorphological examination was carried out. Results and discussion. The drug has no toxic and locally irritating effect under its long-term use per os.