摘要
中药注射剂是我国特有的中药新剂型,颇具开拓国际市场潜在优势。由于中药注射剂尚存在一系列问题,亟待上市后再评价。笔者重点阐述中药注射剂上市后再评价的主要内容——安全性、有效性、处方组成、制备工艺、质量标准、功能主治和药物经济学,并就再评价的重点品种、主要措施和方法提供参考意见。
Traditional Chinese medicine injection which is the unique new way of using traditional Chinese medicine of our country has great potentials in the international markets. It is urgent for post-marketing reevaluation because of a series of problems of traditional Chinese medicine injection.ln the paper,just after the importance and urgency of the Chinese traditional medicine injection comes the focus of this paper of the following aspects： safety,efficiency,composition of prescription,the process technique,the quality criteria,curative effect and medicine-economics. It also offers suggestions in terms of main breeds, measures and methods.
出处
《中国药物警戒》
2006年第3期129-130,134,共3页
Chinese Journal of Pharmacovigilance
关键词
中药注射剂
上市后再评价
traditional Chinese medicine injection
post-marketing reevaluation
