粒度检测方法研究及其在口服吸入制剂研发中的应用  

Research on particle size measurement and its importance in development of oral inhaled preparations

作　　者：宋晓娇 夏俊 陈峰 李志万 张杰[2] SONG Xiaojiao;XIA Jun;CHEN Feng;LI Zhiwan;ZHANG Jie(Tianjin Pharmaceutial Research Institute Co.,Ltd.,Tianjin 300462,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300462 [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2319-2324,共6页Drug Evaluation Research

摘　　要：随着我国药品研发与生产行业的不断发展,以及相关法律法规与检查机制的逐步完善,原料、辅料及成品的粉体性质逐渐被重视,尤其是在吸入制剂领域,粒度分布作为粉体重要性质之一,对于产品的质量和性能起着至关重要的作用。检测粒度分布的方法种类繁多,对常见几种检测方法进行比较研究,介绍粒度检测在口服吸入制剂研发中的重要性。Along with the continuous development of pharmaceutical research and manufacturing industry in China, as well as the gradual improvement of relevant laws and regulations and inspection mechanism, the powder properties of raw materials, excipients and finished products are gradually valued by researchers, especially in the field of inhalation preparations, particle size distribution,as one of the important qualities of powder, plays an important role in the quality and performance of products. There are many methods to detect the particle size distribution. In this paper, several common detection methods are compared, and the importance of particle size detection in the development of oral inhalation preparations is introduced.

关 键 词：粉体 粒度分布 激光粒度检测 口服吸入制剂 质量控制 

分 类 号：R944[医药卫生—药剂学]