吸入粉雾剂粒径测定方法的评价:3种撞击器的比较

Critica levaluation of determination methods of the particle size of dry powder inhaler:a comparison of three impactors

目的:分析和比较两级玻璃撞击器、Andersen多级撞击器(Andersen cascade impactor,ACI)和多级液体采样器(Multi-stage liquid impinger,MSLI)的粒度分布测定结果。方法:分别采用两级玻璃撞击器、ACI和MSLI测定了环索奈德吸入粉雾剂的粉雾粒度分布。结果:两级玻璃撞击器操作简单,能快速获得空气动力学直径小于6.4μm的细颗粒药物剂量,却不能获得药物颗粒的空气动力学粒度大小分布;ACI和MSLI均既能获得空气动力学直径在不同大小范围内的细颗粒药物剂量,又能获得药物颗粒的空气动力学粒度大小分布,但ACI不适合在高于28.3 L.min-1的流速下操作,且药物颗粒在ACI各级间的损耗高于MSLI。结论:与两级玻璃撞击器和ACI相比,MSLI在评价吸入粉雾剂质量时更为完善。

Objective：To analyze and compare two-glass impactor,Andersen cascade impactor（ACI）and Multi-stage liquid impinger（MSLI）.Method：The particle size of ciclesonide dry powder inhaler（DPI） was measured by two-glass impactor,ACI and MSLI.Results：Fine particle drug dose with less than 6.4 micrometer aerodynamic diameter size can be obtained using two-glass impactor with simply operation,but aerodynamic diameter distribution cannot be yielded.Using ACI and MSLI,fine particle drug doses with different size aerodynamic diameter,as well as aerodynamic diameter distribution can be given,but ACI was found to less suitable for DPI testing at flow rates considerably higher than 28.3 L·min-1,and the interstage deposition or＂wall losses＂in ACI were found to be higher than those in MSLI.Conclusion：Comparing with two-glass impactor and ACI,MSLI is more prefect for evaluation of the quality of DPI.