【摘 要】
：
采用中国药典(CP 2010)法和美国药典(USP 34) DUSA管法分别检测装配不同规格驱动器的硫酸沙丁胺醇气雾剂的每揿主药含量(DD);采用二级玻璃撞击采样器和八级撞击采样器检测雾
【机 构】
：
上海信谊药厂有限公司,上海市食品药品检验所
论文部分内容阅读
采用中国药典(CP 2010)法和美国药典(USP 34) DUSA管法分别检测装配不同规格驱动器的硫酸沙丁胺醇气雾剂的每揿主药含量(DD);采用二级玻璃撞击采样器和八级撞击采样器检测雾滴(粒)分布(FPF).结果表明,DUSA管法测得的DD比CP法测得结果平均低16.9％,原因是CP法结果中包含驱动器上的残留药量.八级撞击采样器可测定粒径小于4.7μm的颗粒,而二级撞击采样器测得的是小于6.5 μm的颗粒,因此前法能更准确地评价肺部实际沉积的药量.并且,驱动器孔径增大或孔长延长均会使喉管部位的残留量增大,主要吸收层级(即S2～S6中颗粒的总和)分布量减少.
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