两种测定布地奈德气雾剂雾粒分布方法的比较  

Comparison of Two Methods for Determination of Budesonide Aerosol Droplet Distribution

作　　者：徐玉文[1] 梁翠荣[1] 谢元超[1] 王志军[2] 

机构地区：[1]山东省食品药品检验所,山东济南250101 [2]国家药典委员会,北京100061

出　　处：《中国医药工业杂志》2013年第9期921-924,共4页Chinese Journal of Pharmaceuticals

基　　金：国家药典委员会"气雾剂品种质量标准提高"专项课题(2011-668)

摘　　要：分别采用中国药典2010年版二级碰撞器法和美国药典35版药用多级碰撞器法(NGI)测定了4批布地奈德气雾剂的雾粒分布,并比较了两种方法的测定结果。结果表明,两种方法测得的雾粒分布基本一致。NGI法更能模拟布地奈德气雾剂在呼吸道中每个部位的沉积情况,获得的空气动力学粒径参数与人类的呼吸道系统一致。为了更好地控制布地奈德气雾剂的质量,有必要在布地奈德气雾剂质量标准中增订NGI法进行雾粒分布检查。The droplet distribution of four batches of budesonide aerosol were measured by two stage impactor method in Chinese pharmacopoeia （ChP 2010） and next generation impactor （NGI） method in United States pharmacopoeia （USP 35）, respectively. The comparison of the two methods was carried out. The results showed that the consistency of the two methods was basically confirmed. The NGI method could simulate the budesonide aerosol deposition in each part of the respiratory tract and the aerodynamic diameter parameters from the NGI method were identical with the data from the real respiratory tract system. In order to control the drug quality, it was necessary to add the test item of droplet distribution measured by NGI method in the quality standard of budesonide aerosol.

关 键 词：布地奈德气雾剂 雾粒分布 碰撞器法 

分 类 号：R944.9[医药卫生—药剂学]