Accepted_test

A prototype of a hyaluronidase-based drug has been created, which involves per os use. The new drug under development should be tested in preclinical studies, as the study of toxicity and safety is one of the necessary and key stages.The concept of using an in vitro cell culture test system to assess the toxicity and pharmacological safety of drugs is currently very relevant. The toxic effect of PEG-GIAL on hepatocyte culture was studied by electron microscopy. The object of the study is pegylated testicular hyaluronidase at doses of 37ED/ml, 75ED/ml, 150ED/ml. Chanq liver human liver cell transviable culture was used. When cultured with PEG-GIAL at all doses studied, a significant increase in the content and size of microvilli on the cell membrane was observed. Autophagasomes, autolysosomes, and vesicular structures were observed. No signs of mitochondrial alteration and destruction processes were observed. Cytoplasmic membrane without disruption or fragmentation. The structure of the nucleus is unchanged. Сell damage and no disruption in the structure of the components were detected. The results of PEG-GIAL cytotoxicity evaluation presented in this work demonstrate that no cellular damage or disruption of component structures was detected. The study demonstrated the absence of toxic effect of pegylated hyaluronidase on hepatocyte ultrastructure at all doses studied.