中药注射剂诱发过敏性反应的临床前安全性评价  

Research progress in preclinical safety evaluation on hypersensitivity induced by traditional Chinese medicine injections

作　　者：张頔[1] 屈哲[1] 霍桂桃[1] 吕建军[1] 杨艳伟[1] 张硕[1] 高苏涛[1] 李佩佩[1] 林志[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物评价研究》2013年第4期241-244,共4页Drug Evaluation Research

基　　金：国家科技重大专项课题;重大新药创制"新药研究开发关键技术研究"(2012ZX09505001-004)

摘　　要：中药注射剂是我国民族医药产业中重要的支柱产品,具有起效快、生物学利用度高等优势,在危重疾病的治疗中发挥巨大作用。然而,目前上市的一些中药注射剂品种频频发生过敏反应,甚至出现过敏性休克或死亡。这些不良反应严重地打击了人们对中医药治病的信心,也制约了中医药民族产业的发展。就中药注射剂过敏反应发生的主要类型、中药注射剂临床前安全评价的现状、临床前评价的动物模型与方法等进行阐述,为提高中药注射剂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.

关 键 词：中药注射剂 药物不良反应 过敏反应 类过敏反应 安全性评价 

分 类 号：R965.3[医药卫生—药理学]