摘要
吸入粉雾剂(DPI)的质量直接影响疗效和安全,也是注册研究的核心内容之一。本文就吸入粉雾剂原料药、辅料和制剂的质量研究进行了综述,并对比分析了各监管机构对质量控制方面的相关技术要求。
The quality of dry powder inhaler has( DPI) a direct influence on its safety and efficacy. This review focuses on the quality requirements of active ingredients,excipients,and drug product of DPI. Furthermore,we compared the differences in technical requirements of quality standards by various regulatory agencies.
作者
高蕾
马玉楠
王亚敏
宁黎丽
姚方耀
GAO Lei;MA Yu-nan;WANG Ya-min;NING Li-li;YAO Fang-yao(Center for Drug Evaluation,National Medical Products Administration,NMPA,Beijing 100038,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第3期332-334,共3页
Chinese Journal of New Drugs
关键词
吸入粉雾剂
质量研究
技术要求
dry powder inhaler
quality control
technical requirements
