此文基于文献数据,较为系统地总结了喜炎平注射液非临床安全性研究、药理研究和上市后安全性研究,包括幼年和成年动物的急性毒性试验、长期毒性试验、生殖毒性试验、主动被动过敏试验、疗效机制研究、上市后的有效性临床实验研究、安全性主动监测、被动监测的SRS数据分析、真实世界的HIS数据分析、文献分析等研究,讨论了其研究证据的互补性,以点带面,总结其研究思路,为中药注射剂系统研究方案的制定提供参考。 Based on the literature data, this article systematically summarizes the non-clinical safety studies of Xiyanping injection, pharmacological studies and post-market safety studies, including acute toxicity test, long-term toxicity test, reproductive toxicity test, active Passive allergy test, mechanism of efficacy study, effective clinical trial after listing, active safety monitoring, SRS data analysis of passive monitoring, real-world HIS data analysis and literature analysis. The complementarity of the research evidence is discussed. To point and surface, summed up their research ideas for the formulation of traditional Chinese medicine injection system to provide a reference.