中藥注射劑作為我國傳統(tǒng)醫(yī)藥的創(chuàng)新劑型，具有起效快、生物利用度高等優(yōu)勢，但在臨床應(yīng)用中時有不良反應(yīng)的發(fā)生，嚴(yán)重的危害患者的生命安全。目前有關(guān)中藥注射劑的非臨床安全性評價研究相對較少，在一定程度上阻礙了中藥注射劑的發(fā)展。因此，針對中藥注射劑建立規(guī)范、完整的非臨床安全性再評價體系，是保障其臨床用藥安全，推動中藥注射劑發(fā)展的關(guān)鍵。概述了中藥注射劑臨床不良反應(yīng)/事件（ADR/ADE）情況、表現(xiàn)及潛在原因，從一般毒性研究、過敏反應(yīng)研究、刺激性和溶血性試驗研究及安全藥理學(xué)研究等方面就當(dāng)前非臨床安全性再評價的研究方法和進(jìn)展進(jìn)行了歸納總結(jié)，并提出了中藥注射劑非臨床安全性再評價的建議，為今后繼續(xù)開展相關(guān)研究提供參考。

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

河南省高等學(xué)校重點科研項目計劃（24A350018）；鄭州大學(xué)求是科研啟動基金（32212906、32213226）