中药注射剂作为我国传统医药的创新剂型，具有起效快、生物利用度高等优势，但在临床应用中时有不良反应的发生，严重的危害患者的生命安全。目前有关中药注射剂的非临床安全性评价研究相对较少，在一定程度上阻碍了中药注射剂的发展。因此，针对中药注射剂建立规范、完整的非临床安全性再评价体系，是保障其临床用药安全，推动中药注射剂发展的关键。概述了中药注射剂临床不良反应/事件（ADR/ADE）情况、表现及潜在原因，从一般毒性研究、过敏反应研究、刺激性和溶血性试验研究及安全药理学研究等方面就当前非临床安全性再评价的研究方法和进展进行了归纳总结，并提出了中药注射剂非临床安全性再评价的建议，为今后继续开展相关研究提供参考。

As an innovative dosage of traditional Chinese medicine (TCM), traditional Chinese medicine injection (TCMI) has been widely used in clinical practice since it has the advantage of fast absorption and high bioavailability. However, it also aroused a series of adverse reactions in clinical practice, which could be life-threatening. Consequently, it is crucial to establish a standardised and comprehensive non-clinical safety re-evaluation system for TCMI to guarantee the safety of its clinical medication and advance its progress. Herein, the research outlined the clinical adverse reaction/event (ADR/ADE) situation, manifestations and potential causes of TCMI, summarized the current research methods and progress of non-clinical safety re-evaluation in terms of general toxicity study, allergic reaction study, irritation and hemolytic test study, and safety pharmacology study. And the recommendations of non-clinical safety re-evaluation of TCMI for the continuation of future research were put forward, which will provide a reference for the continuation of relevant studies in the future.

R965.3

河南省高等学校重点科研项目计划（24A350018）；郑州大学求是科研启动基金（32212906、32213226）