撞击器法测定吸入粉雾剂空气动力学粒径分布颗粒反弹的研究

摘要

目的 对撞击器(cascade impactor,CI)法检测吸入粉雾剂空气动力学粒径分布(aerodynamic particle size distributions,APSDs)时颗粒反弹和二次夹带进行研究,为涂层材料的选择提供方法.方法 用甘油、硅油分别对收集杯/盘进行涂层或不涂层处理后,分别在30~90 L·min-1流速下,按照《美国药典》601项下规定进行样品收集并分析检测结果.结果 对收集杯/盘进行涂层处理能明显减少滤膜沉积率;用硅油涂层后,相同流速下质量平均空气动力学粒径(mass median aerodynamic diameter,MMAD)不随收集剂量的变化而变化,APSDs也较稳定.结论 使用撞击器法检测吸入粉雾剂APSDs时,对收集表面进行涂层很大程度上能够消除颗粒反弹和二次夹带;新一代碰撞取样器(next generation impactor,NGI)检测格隆溴铵吸入粉雾剂APSDs时,用硅油对收集杯进行涂层,可使检测结果更准确.%Objective To study particle bounce and re-entrainment of cascade impactor used for determination of aerodynamic particle size distributions(APSDs) of dry powder for inhalation.And give an investigation about different coating material.Methods Following the guidance of USP,the samples were made by using cascade impactor,where collection cups/plates were either left uncoated or coated with Glycerin or Silicone oil,at flow rates ranging from 30~90 L·min-1.Different does were delivered.Results Coating collection surfaces had reduced the deposition on filter paper.And silicone oil coating had an unapparent impact on mass median aerodynamic diameter(MMAD),and the APSDs were nearly regardless of does.Conclusion This study showed that collection surface coating can eliminate particle bounce and re-entrainment.For glycopyrronium bromide dry powder for inhalation determined by next generation impactor(NGI),the use of Silicone oil as cup coating,preferably with Glycerin,reduced particle bounce.