摘要
本文对国内外有关化学药品贮藏条件的法规指南、现行药典进行调研和对比分析,结合已上市药品贮藏条件表述存在的问题,提出化学药品贮藏条件制定的考虑与建议,以期为化学药品贮藏条件规范化提供参考。
In this paper,the author investigated and compared the domestic and foreign laws and regulations and current pharmacopoeias of different countries related to the storage conditions of chemical drugs,then put forward some thoughts and suggestions in combination with the existing problems of the storage conditions of chemical drugs,so as to provide reference for the establishment and standardization of the storage conditions of chemical drugs.
作者
陈淼
任连杰
CHEN Miao;REN Lian-jie(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第2期174-180,共7页
Chinese Journal of New Drugs
关键词
化学药品
贮藏条件
稳定性研究
制定
规范
chemical drugs
storage conditions
stability studies
establishment
standardization
