Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (6): 321-324.

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Preclinical Safety Research of Epirubicin Hydrochloride Injection

LIU Fen1,XU Xin-chang2,ZHAO Tao1,LV Jin-gang1,YAO Jing-chun1,XUE Fang-xi1*   

  1. 1Center for New Drug Safety Evaluation of Lunan Pharmaceutical Group Corporation, Shandong Linyi 273400, China;
    2Department of Pharmacy, Central Hospital of Zaozhuang Mining Group, Shandong Zaozhuang 277000, China
  • Received:2015-04-25 Online:2015-06-08 Published:2015-07-27

Abstract: Objective To study the safety of epirubicin hydrochloride injection and provide theoretical evidence for clinical application. Methods The safety of epirubicin hydrochloride injection was observed through vascular and bladder mucosa irritation test, hemolytic test in vitro and active systemic anaphylaxis(ASA). Results Epirubicin hydrochloride injection had no obvious vascular and bladder mucosa irritation, no allergic reaction, however it had hemolytic reaction. Conclusion The hemolysis phenomenon may occur when epirubicin hydrochloride injection is used in clinic, and dilution is recommended.

Key words: epirubicin, vascular irritation, bladder mucosa irritation, hemolytsis, active systemic anaphylaxis(ASA)

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