吸入粉雾剂产品的开发要点  

Development points of dry powder inhalations

作　　者：张成飞 李岩峰 杜晓英 任树龙 周振泽 王爱潮 李静[2] ZHANG Chengfei;LI Yanfeng;DU Xiaoying;REN Shulong;ZHOU Zhenze;WANG Aichao;LI Jing(Tianjin Pharmaceutical Research Institute Co.,Ltd.,Tianjin 300386,China;Tianjin KingYork Group Co.,Ltd.,Tianjin 300450,China)

机构地区：[1]天津药业研究院有限公司,天津300386 [2]天津金耀集团有限公司,天津300450

出　　处：《药物评价研究》2019年第12期2314-2318,共5页Drug Evaluation Research

基　　金：国家科技部重大专项(2017ZX09201002)

摘　　要：吸入粉雾剂是药械组合药品,制剂和装置共同决定了产品的质量和雾化性能。在装置的开发中,需要关注使用装置的类型,与制剂处方联合开发;在制剂开发中,要关注粉体的粒度分布、颗粒形态、流动性、比表面积、多晶型及结晶度,提高对物化性质的认识。在产品的检测中,不仅要关注质量标准的检测项目,还要从患者的角度出发考察产品的雾化性能,以满足不同患者的使用。从装置的开发、制剂处方的研发以及质量控制3个方面阐述了吸入粉雾剂产品开发中需要重点关注的内容,以提高粉雾剂产品研发速度和质量。Dry Powder Inhalations(DPIs) are a combination of drug substance and container closure system, which determine the quality and performance of the products. It’s the focus that the type of device, which is the connection point between the patient and the preparation. The physicochemical properties of API and excipients, involved particle size distribution, shape, flow properties,specific surface area, polymorphism and crystallinity, are the critical research content. In the detection of DPIs, we should not only pay attention to the items of quality standards, but also the atomization performance of products from the perspective of patients.The development of device, formulation and the quality control of DPIs were discussed in the review. Focusing on these aspects can improve the progress of development and the quality of DPI products.

关 键 词：吸入粉雾剂 吸入装置 雾化性能 质量控制 

分 类 号：R944.2[医药卫生—药剂学]