中药注射剂安全性评价与关键技术的研究  

Safety evaluation of traditional Chinese medicine injections and study of related key technology

作　　者：程芳[1] 刘兆平[1] 

机构地区：[1]山东大学新药评价中心,山东济南250012

出　　处：《中国中药杂志》2009年第8期1052-1054,共3页China Journal of Chinese Materia Medica

基　　金：国家科技支撑计划项目(2006BAI14B00)

摘　　要：中药注射剂是我国独创的一类药物,目前在临床上应用广泛,但诸多不良反应限制了其应用和发展。过敏反应是中药注射剂的主要不良反应,解决此问题是实现中药现代化的迫切需要。本研究综述了中药注射剂不良反应发生的现状和原因,并结合科技部支撑课题计划研究取得的初步结果,提出了中药注射剂安全性评价的2个关键技术,即中药注射剂的类过敏反应研究和代谢组学研究,希望能为解决中药注射剂的安全性问题提供一些思路。Traditional Chinese medicine （TCM） injections originated in China and have been extensively used in clinic. However, some events the adverse drug reactions （ADRs） have been reported, among which, hypersensitivity reactions （HSRs） are the main ADRs of TCM injections. To solve the ADRs of TCM injections will be the key to proceed of the modernization of TCM. This paper reviewed the current situation and causes of the ADRs of TCM injections. On the basis of primary findings obtained from the project granted by the Ministry of Science and Technology, two pivotal technologies of the safety evaluation of TCM injections were introduced, which are anaphylactoid reaction ussessment and metabonomics for TCM injections. It is expected to provide some new ideas for the breakthrough of the safety evaluation of TCM injections.

关 键 词：中药注射剂 药物不良反应 安全性评价 类过敏反应 代谢组学 

分 类 号：R286[医药卫生—中药学]