抗心律失常药物作用于心肌细胞的离子通道，临床使用时常产生致心律失常等风险。药物非临床安全性评价过程中，除参考国内外指导原则外，应结合药物作用机制和适应症的特点，追加心血管系统安全性相关试验，有针对地完善试验设计，为后续试验中风险点的设置和临床使用风险的防控提供参考。

Antiarrythmic drug showed pharmacological activity on the ion channels of myocardial cell, with potential risks for proarrythmia in clinical use. In order to provide more reference for clinical trial and use, non-clinical safety evaluation should not only refer the guidelines, but also supplement researches on cardiac safety and improve the design of experiments based on the mechanism and the indication of drugs.