中药注射剂致敏成分群筛查方法研究的现状与免疫综合法

Current state of studies on screening method for sensitinogens in injections for traditional Chinese medicine and synthetic immunity method

中药注射剂在我国已有60多年的发展及应用历程,近些年来不良反应的报道层出不穷。筛查中药注射剂的致敏成分群(致敏原群)的研究为世人关注,已成为国际性难题。该文先根据其产生免疫毒性的机制,分析中药注射剂致敏原筛查技术研究的现状,然后提出采用免疫底、盖芯片及免疫指纹图谱相结合的免疫综合分析筛查中药注射剂致敏成分群,旨在为中药注射剂的研制与临床使用构筑安全性评价屏障。

Injections for traditional Chinese medicine have over 60 years of history of development and application. In recent years, however, their adverse reactions have been reported one after another. Consequently, studies on screening sensitinogens （ sensibil- igens） from injections for traditional Chinese medicine have drawn people＇s attention and become a tough problem all over the world. This essay analyzes the current state of studies on screening techniques of sensitinogens in injections for traditional Chinese medicine according their mechanism of immunotoxicity, and then proposes to adopt the synthetic immunoassay combining immunity bottle chip, immunity cover chip and immunity chromatographic fingerprint to screen sensitinogens from injections for traditional Chinese medicine, in order to build a safety evaluation barrier for development and clinical application of injections for traditional Chinese medicine.