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基于Osmohaler~(TM)装置,研究了3种具有不同格栅结构和格栅安装位置的粉雾剂吸入器的雾化性能。在60 L/min气流流量下,使用多级液体撞击器(multistage liquid impinger,MSLI)评价了模型药物甘露醇粉末的分散效果;使用计算流体力学(computational fluid dynamics,CFD)模型分析了装置中流场和颗粒的运动状态。结果表明,3种装置具有基本相同的分散机制,但雾化性能有差异。对原装置内部格栅结构及材质的修改,造成了颗粒在装置中的残留增多、微细粒子剂量(Fine Particle Dose,FPD)降低;在出口处设置的格栅并没有明显提高颗粒的分散及沉积效果。同时,通过体外沉积试验和数值模拟研究还观察到,MSLI前三级的沉积量变化趋势与相对应的微细颗粒在装置出口处运动速度的变化规律具有一定的相关性。
Based on the Osmohaler ™ device, the atomization performance of three powder inhalers with different grid structures and grille mounting positions was studied. The dispersion effect of the model drug mannitol powder was evaluated using a multistage liquid impinger (MSLI) at a flow rate of 60 L / min; the flow of the device was analyzed using a computational fluid dynamics (CFD) model Field and particle state of motion. The results show that the three devices have basically the same dispersion mechanism, but the atomization performance is different. Modification of the structure and material of the internal grid of the original device resulted in the increase of residual particles in the device and the decrease of the Fine Particle Dose (FPD). The grid disposed at the outlet did not significantly improve the dispersion and deposition of the particles effect. At the same time, it is also observed by the in vitro deposition experiment and numerical simulation that the change trend of the deposition amount of the first three stages of MSLI has a certain correlation with the variation law of the moving speed of the fine particles at the outlet of the device.