中藥注射劑是我國民族醫(yī)藥產(chǎn)業(yè)中重要的支柱產(chǎn)品，具有起效快、生物學(xué)利用度高等優(yōu)勢，在危重疾病的治療中發(fā)揮巨大作用。然而，目前上市的一些中藥注射劑品種頻頻發(fā)生過敏反應(yīng)，甚至出現(xiàn)過敏性休克或死亡。這些不良反應(yīng)嚴(yán)重地打擊了人們對中醫(yī)藥治病的信心，也制約了中醫(yī)藥民族產(chǎn)業(yè)的發(fā)展。就中藥注射劑過敏反應(yīng)發(fā)生的主要類型、中藥注射劑臨床前安全評價的現(xiàn)狀、臨床前評價的動物模型與方法等進(jìn)行闡述，為提高中藥注射劑安全性提供新的思路。

The Chinese materia medicia injection (CMMI) is a kind of important product in the medicine of national minorities. As for a rapid onset and good bioavailability, CMMI plays a great role in the treatment of critical disease. However, some hypersensitivity events with adverse drug reaction of CMMI often occurred when they came into market, even including anaphylactic shock or death. It cracks our confidence to the treatment of disease by traditional Chinese medicine (TCM), and restricts the development of TCM. In this paper, we discuss the general comments, mechanism, related guidance, and methods of preclinical safety evaluation in hypersensitivity induced by CMMI.

國家科技重大專項課題，重大新藥創(chuàng)制“新藥研究開發(fā)關(guān)鍵技術(shù)研究”（2012ZX09505001-004）