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中药注射剂安全性评价及相关关键技术研究

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

作者信息

Cheng Fang, Liu Zhaoping

机构信息

Center for New Drugs Evaluation of Shandong University, Jinan 250012, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2009 Apr;34(8):1052-4.

Abstract

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.

摘要

中药注射剂起源于中国,已在临床上广泛应用。然而,已报道了一些不良药物反应(ADR)事件,其中,过敏反应(HSR)是中药注射剂的主要ADR。解决中药注射剂的ADR将是推进中药现代化的关键。本文综述了中药注射剂ADR的现状及原因。基于科技部资助项目的初步研究结果,介绍了中药注射剂安全性评价的两项关键技术,即类过敏反应评估和中药注射剂的代谢组学。期望为中药注射剂安全性评价的突破提供一些新思路。

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