3种撞击器测定沙美特罗替卡松吸入粉雾剂的空气动力学粒径分布

目的： 采用不同的级联撞击器测定沙美特罗替卡松粉雾剂的空气动力学粒度分布，比较并评价不同方法的测定结果。方法： 分别采用双级撞击器（twin stage impactor，TSI）、安德森撞击器（Andersen cascade impactor，ACI）和新一代药用撞击器（next generation pharmaceutical impactor，NGI）测定了沙美特罗替卡松粉吸入剂的粉雾剂空气动力学粒径分布，并用软件计算微细粒子剂量（fine particle dose，FPD）、质量中值空气动力学直径（mass median aerodynamic diameter，MMAD）及几何标准偏差（geometric standard deviation，GSD）等参数结果。结果： TSI操作简单，能快速获得空气动力学直径小于6.4 μm的细颗粒药物剂量，但获得的药物颗粒的空气动力学粒度大小分布并不精准；ACI和NGI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，又能获得药物颗粒相对全面的空气动力学粒度大小分布，ACI各级间的药物颗粒损耗高于NGI。结论： 与TSI相比，ACI和NGI在评价沙美特罗替卡松粉吸入剂的体外雾化特性时更为完善。

Objective: To analyze and compare aerodynamic particle size distribution(APSD)of salmeterol and fluticasone propionate powder for inhalation with the three impactors.Methods: APSD of salmeterol and fluticasonedry powder for inhalation was determined by twin stage impactor(TSI),Andersen cascade impactor(ACI)and next generation pharmaceutical impactor(NGI),respectively. And the results of the fine particle dose(FPD),mass median aerodynamic diameter(MMAD)and geometric standard deviation (GSD)were calculated by statistic software. Results: Fine particle dose with less than 6.4 μm of aerodynamic diameter could be obtained by TSI with simply operation,but the APSD of the obtained drug particles was not accurate. FPD with different range aerodynamic diameter particle and comprehensive APSD could be determined by ACI and NGI,The loss of granules with ACI was higher than that with NGI. Conclusion: ACI and NGI are more comprehensive for evaluation of the quality of DPI than TSI.

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