Abstract: Objective To evaluate the genotoxicity of Yanhuning for injection and to provide data for clinical safety medication. Methods Genotoxicity of Yanhuning for injection was studied using standard combination [bacterial reverse mutation test (Ames), In vitro chromosomal aberration test, mouse bone marrow erythrocyte micronucleus test]. In Ames test, there were five dose groups respectively as follows: 50, 158, 500, 1 581 5 000 μg per dish. In vitro chromosome aberration test, there were three dose groups respectively as follows: 0.125, 0.250,0.5 mg·mL^-1; In mouse bone marrow erythrocyte micronucleus test, there were three dose groups respectively as follows: 100, 200, and 400 mg·kg^-1, for 2 days, once per day. Results In Ames test, both under metabolic and non-metabolic activation conditions, Yanhuning for injection had no significant increase in the number of colonies of histidine auxotrophic Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 strains. In vitro CHL cell chromosome aberration test, both under metabolic and non-metabolic activation conditions, Yanhuning for injection had no significantly increase in the number of chromosomal aberrations. In mouse bone marrow erythrocyte micronucleus test, Yanhuning for injection had no significantly increase in the number of micronucleus in bone marrow erythrocyte. Conclusion No significant genetic toxicity was observed for Yanhuning for injection.

Key words: Yanhuning, genotoxicity, Ames, chromosome aberration, micronucleus