沙美特罗替卡松粉雾剂微细粒子剂量测试方法研究

Study on the method of measuring the fine particle dose of salmeterol xinafoate and fluticasone propionate powder for inhalation

目的:建立沙美特罗替卡松粉雾剂微细粒子剂量测试方法。方法:采用新一代药用撞击器(next generation pharmaceutical impactor,NGI),对测试吸数、提取溶剂种类、提取时间、涂层与否、涂层静置时间等因素下的空气动力学粒径分布进行了测试,以微细粒子剂量为评价指标进行了对比研究。结果:提取溶剂种类以及涂层与否因素均会对微细粒子剂量产生影响,而测试吸数、适宜的提取时间以及涂层静置时间因素均不会对微细粒子剂量产生影响。结论:本方法操作简便、准确可信,为粉雾剂微细粒子剂量测试方法的选择提供了参考。

Objective:To establish an accurate and effective in vitro method for determining fine particle dose of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation.Methods:The next-generation pharmaceutical impactor(NGI)was used to test the aerodynamic particle size distribution under the test number,extraction solvent type,extraction time,coating type,coating resting time,and other factors.A comparative study was carried out with the FPD as the evaluation index.Results:The type of extraction solvent and the type of coating can affect the dose of fine particles,while the number of test aspirates,the appropriate extraction time,and the standing time of coating have little effect on the dose of fine particles.Conclusion:The method is simple,accurate,and reliable,which provides a reference for the selection of fine particle dose measurement methods for dry powder inhalation.