中药注射剂不良反应及类过敏反应研究进展  

Research progress on adverse reactions and pseudo-allergic reactions of traditional Chinese medicine injections

作　　者：易艳[1] 李春英[1] 赵雍[1] 梁爱华[1] YI Yan;LI Chun-ying;ZHAO Yong;LIANG Ai-hua(Key Laboratory of Beijing for Identification and Safety of Chinese Medicine,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中药研究所中药鉴定与安全性检测评估北京市重点实验室,北京100700

出　　处：《中国中药杂志》2021年第7期1711-1716,共6页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2015ZX09501004,2018ZX09101002-003);国家自然科学基金项目(81974534);中国中医科学院自主选题研究项目(ZZ-13-035-10,ZZ10025);中央级公益性科研院所基本科研业务费专项(ZZ13-YQ-055)。

摘　　要：从2009年中药注射剂安全性再评价工作启动至今,部分中药注射剂企业和科研院所做了大量工作,并且随着我国药品研制和生产技术水平的提高,一些中药注射剂品种的安全性也得到了大幅提高。中药注射剂存在着安全风险,主要体现在药用物质基础不明确、生产工艺比较简单、质量标准可控性较差,以及药品说明书不规范、使用环节存在不合理用药等。该文就中药注射剂上述这几个方面的研究进展进行了相关阐述。另外笔者团队发现中药注射剂的不良反应是以类过敏反应为主,因此在类过敏反应检测,机制研究和风险控制方面做了大量工作,故结合这部分工作内容本文也进行了概括总结。Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.

关 键 词：中药注射剂 不良反应 安全性再评价 类过敏反应 

分 类 号：R285[医药卫生—中药学]