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

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.