两种撞击器测定自制吸入粉雾剂体外沉积性质的对比研究

摘要

目的 分析和比较两级玻璃撞击器(twin stage impactor,TSI)和新一代药用撞击器(next generation pharmaceutical impactor,NGI)的体外沉积率和粒度分布测定结果.方法 选用自制盐酸氨溴索吸入粉雾剂为模型药物,TurbospinR为吸入装置,运用TSI和NGI测定盐酸氨溴索吸入粉雾剂的体外沉积率和粒度分布.结果 TSI仅能得到空气动力学粒径小于6.4 μm的细颗粒量,设置较为简单,不能获得药物颗粒的空气动力学粒径及其分布；NGI设置复杂,不仅能得到空气动力学粒径在不同粒径范围内的细颗粒量,又能获得药物颗粒的空气动力学粒径及其粒度分布,而由于内部结构复杂,药物回收相对繁琐.但是其更趋于精密化和自动化,操作简便.结论 与TSI相比,NGI在评价吸入粉雾剂质量时更为完善,有利于吸入粉雾剂的开发和发展.%Objective To analyze and compare the results of fine particle fraction(FPF) and particle size distribution acquired by twin-stage impactor (TSI) and next generation pharmaceutical impactor(NGI).Methods Self-made dry powder inhaler (DPI) of ambroxol hydrochloride (AH)was selected as the model drug,and the FPF and particle size were measured by TSI and NGI through TurbospinR inhalation device.Results Fine particle drug dose with less than 6.4 micrometer aerodynamic diameter size was obtained using TSI with simple operation,but aerodynamic diameter distribution was not yielded.But both the aerodynamic diameter and aerodynamic diameter distribution were obtained using NGI.Drug recovery was complex due to its 7-stage design,but it was more exact and automated.Conclusion NGI is more comprehensive for evaluation of the quality of DH,and is conductive to the development of DPI.