多方法测定硫酸沙丁胺醇吸入粉雾剂空气动力学粒径分布

Determination of aerodynamic particle size distribution (APSD) profiles of salbutamol sulfate dry powder inhaler with three different technologies

目的:使用3种方法对硫酸沙丁胺醇吸入粉雾剂的空气动力学粒径分布进行研究。分析和比较了双级撞击器(TSI)、安德森级联撞击器(ACI)和新一代撞击器(NGI)的粒径分布测定结果。方法:分别采用TSI,ACI和NGI测定了硫酸沙丁胺醇吸入粉雾剂的粒径分布。结果:TSI测定法仅能测定空气动力学直径小于6.4μm的细颗粒药物剂量,但不能获得药物颗粒的空气动力学粒径分布结果,且其测得的累积药物量最小,ACI和NGI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和微粒的空气动力学粒径分布,ACI较NGI操作简便,但ACI层级间损耗高于NGI。结论:与TSI相比,ACI和NGI更全面地反映出硫酸沙丁胺醇吸入粉雾剂空气动力学粒径分布。

Objective： Using three methods to study the aerodynamic particle size distribution（ APSD） of salbutamol sulfate dry powder inhaler（ DPI）. To characterize and compare the APSD profiles determined with twostage impactor（ TSI）,Andersen cascade impactor（ ACI） and next generation impactor（ NGI）,respectively.Methods： The particle size of salbutamol sulfate DPI was measured by TSI,ACI and NGI methods,respectively.Results： Less than 6. 4 micrometers aerodynamic diameter size can be analyzed using TSI with simply operation,however,accurate aerodynamic diameter distribution was unable to be achieved. Using ACI and NGI,fine particle drug doses with different size aerodynamic diameter,as well as aerodynamic diameter distribution can be evaluated,but the inter-stage deposition in ACI were found to be higher than that in NGI. Conclusion： ACI and NGI are more precise methods for assessment of the quality of DPI compared with TSI.