摘要
中药注射剂作为一种新型中药剂型,为我国医疗水平的进步贡献了重要的力量。但由于中药注射剂发展历史比较短,且早期国家监管措施不够完善,种种原因导致中药注射剂的质量参差不齐,在临床上出现了一系列的不良反应,中药注射剂的安全性问题受到了质疑,引发了社会的关注。为提高中药注射剂的质量,国家食品药品监督管理局提出了中药注射剂再评价工作方案。目前,中药注射剂再评价工作正在开展之中,文章拟从中药注射剂存在的问题对再评价工作的必要性进行分析,并从安全性、有效性、物质基础、作用机理、相关法规政策等5个方面对目前再评价工作的研究进展进行阐述。
As a new dosage form of Traditional Chinese Medicine(TCM),TCM injection has played an important role in the advancement of China s medical level.However,the development history of TCM injection is relatively short,and the early national regulatory measures are not professional enough.Various reasons have led to uneven quality levels of TCM injections,and a series of adverse reactions have reported in the clinic.The safety of TCM injections has been challenged and triggered attention to society.In order to improve the quality of TCM injections,the State Food and Drug Administration(SFDA)proposed a revaluation work plan.At present,the revaluation of TCM injections is in full swing.This article will explain the importance of revaluation work from some existing problems of TCM injections.and from the five aspects of safety,effectiveness,material basis,mechanism of action,and relevant laws,the research progress of the revaluation work was described.
作者
吴红根
陈玉茹
朱永波
李元祥
仇萍
李正
李文龙
WU Honggen;CHENYuru;ZHU Yongbo;LI Yuanxiang;QIUPing;LI Zheng;LI Wenlong(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Hunan Zhengqin Pharmaceutical Group Co.,Ltd,Huaihua 418000,China;College of Chemistry and Materials Engineering,Huaihua University,Huaihua 418000,China)
出处
《中国民族民间医药》
2022年第11期41-45,共5页
Chinese Journal of Ethnomedicine and Ethnopharmacy
基金
天津市科技计划项目(20ZYJDJC00090)资助。
关键词
中药注射剂
再评价
安全性
有效性
监管法规
TCM Injection
Revaluation
Safety
Effectiveness
Regulatory Regulations
