中国已上市理血类中药注射剂安全性问题思考  

Consideration on the Safety of Regulating Blood Traditional Chinese Medicine Injections on the Market in China

作　　者：冯叶 梁伟敏 梁佩琳 吕冠欣 FENG Ye;LIANG Weimin;LIANG Peilin;LV Guanxin(Key Laboratory of Drug Metabolism Research and Evaluation,National Medical Products Administration,Shunde Institute for Drug Control,Foshan,Guangdong 528300,China;School of Pharmacy,Southern Medical University,Guangzhou,Guangdong 510515,China)

机构地区：[1]佛山市顺德区药品检验所,国家药监局药物代谢研究与评价重点实验室,广东佛山528300 [2]南方医科大学药学院,广东广州510515

出　　处：《今日药学》2023年第5期392-396,共5页Pharmacy Today

摘　　要：目的分析我国已上市的理血类中药注射剂现状,为临床用药安全提供参考。方法通过查阅国家药品监督管理局数据库、药品说明书及相关文献资料,就我国已上市理血类注射剂品种概况,包括品种分布、临床应用、药品不良反应或事件及说明书现况进行整理分析,探讨其安全性问题。结果我国已上市理血类中药注射剂共37种,获批文号共350个,涉及理血剂药品类型4种,以活血化瘀剂为主。理血类中药注射剂存在较多的不良反应/事件文献报道,且部分药品说明书内容标注不完善。结论建议生产企业不断提高中药注射剂标准及产品质量,药品监督管理部门及生产企业及时加强说明书修订工作,临床应用中药注射剂时,应关注其重视其合理使用。OBJECTIVE To analyze the current situation of traditional Chinese medicine injectionsin China,so as to provide reference for clinical medication safety.METHODS The data of regulating blood traditional Chinese medicine injections in China including distribution,clinical application,adverse reactions and drug instructions were collected from State Food and Drug Administration(SFDA)website,drug instructions and the related documents for statistical analysis and study of safety.RESULTS There were 37 kinds of regulating blood traditional Chinese medicine injections in China and 350 approval numbers all together,including 4 types of blood regulating formula,which were mainly for promoting blood circulation and removing blood stasis.There were many reports of adverse reactions and events in the literature of regulating blood traditional Chinese medicine injections,and the package inserts of some drugs were not perfect.CONCLUSION It's suggested that manufacturers should continuously improve the standard and quality of traditional Chinese medicine injections.Drug regulatory departments and manufacturers should strengthen the revision of the instruction manual.In regard to clinical application of traditional Chinese medicine injections,attention should be paid to its rational clinical use.

关 键 词：中药注射剂 理血剂 品种 安全性 

分 类 号：R28[医药卫生—中药学]