[关键词]
[摘要]
近年来注射剂的安全性问题引起了社会各界的广泛关注,注射用辅料引发的类过敏反应是导致注射剂临床使用安全隐患的主要原因之一,而目前尚未建立完善的可用于评价注射用辅料类过敏反应的非临床研究方法。对近年来国内外在该方面的研究进展做一综述,旨在为注射用辅料类过敏反应非临床评价方法的发展提供一些帮助和启示。
[Key word]
[Abstract]
The safety issues of injection have evoked more public concern recently. Pseudoallergy induced by injective excipient is one of the main causes. However, non-clinical evaluation methods for this have not yet developed well. This paper reviewed the progress in this field in order to get more recognition for non-clinical evaluation of pseudoallergy induced by injective excipient.
[中图分类号]
[基金项目]
科技部“十一五”国家科技支撑计划重点项目——药用新辅料临床前安全性评价及药品与包装材料的相容性安全研究(2008BAI55B03)