摘要
与大多数制剂不同,吸入粉雾剂的装置设计直接影响制剂性能和临床疗效。本文就吸入粉雾剂给药装置的分类、发展历程、患者使用及监管要求方面进行了综述。最后,结合处方工艺、质量研究和给药装置各方面,对吸入粉雾剂进行了综合评价。
Unlike most drug products,the design of the device can influence the performance and clinical efficacy of a dry powder inhaler drug product directly. In this review,we focus on the classification,development,patient use and regulatory requirements of the device. Furthermore,we made a briefly comprehensive evaluation on the formulation,quality attributes,device of dry powder inhaler drug products.
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335-337,共3页
Chinese Journal of New Drugs
关键词
吸入粉雾剂
装置
监管要求
综合评价
dry powder inhaler
devices
regulatory requirements
review