3种撞击器法测定吸入气雾剂体外沉积性质的差异性研究

目的：对两级玻璃撞击器（twin stage impactor，TSI）、Andersen多级撞击器（Andersen cascade impactor，ACI）和新一代药用撞击器（next generation pharmaceutical impactor，NGI）的体外沉积率及粒度分布测定结果进行分析比较，筛选出效果较优的撞击器。方法以自制丙酸氟替卡松吸入气雾剂为模型药物，使用TSI，ACI和NGI测定其体外沉积率和粒度分布。结果 TSI设备较为简单，能相对快速地得到＜6.4μm细颗粒药物剂量，在保证气密性前提下，回收率相对较高，但不能获得药物空气动力学粒径分布结果。ACI与NGI设备精巧，药物回收相对复杂，两者均能获得不同粒径范围的药物剂量，同时又能测定药物颗粒空气动力学直径以及粒度大小分布，相较ACI装置，NGI装置虽形体笨重，但不需要洗涤筛板，收集过程更加便捷。结论在进行微细粒子剂量空气动力学相关参数测定时，3种撞击器中，NGI装置可作为优先参考对象。

Determination methods for in vitro deposition of metered dose inhalers:differences of three impactors

Objective To analyze and compare fine particle fraction(FPF)and particle size distribution(PSD)measured by twin-stage impactor(TSI),Andersen cascade impactor(ACI)and next generation pharmaceutical impactor(NGI). Methods Self-made metered dose inhaler(MDI) of fluticasone propionate was selected as the model drug,and the FPF and PSD were determined by TSI,ACI and NGI. Results The device of TSI was simple,and fine particle drug dose with less than 6.4 micrometer aerodynamic di?ameter size was acquired quickly,and the recovery rate was relatively high under the good seal,but aerodynamic diameter distribution was not obtained. In contrast,both the aerodynamic diameter and particle size distribution were obtained with ACI and NGI. Different from ACI,for NGI it was not necessary to wash the sieves,although NGI is heavy. So,the operation of NGI is simpler. Conclusion NGI can be chosen as the priority for the determination of the aerodynamics related parameters.