目的 采用计算流体动力学（CFD）进行药物微粒在生地黄低聚糖干粉吸入剂（RRODPI）所用2种装置内部的运动轨迹模拟，并与体外沉积结果进行对比，验证该结果的准确性。方法 采用新一代药用撞击器（NGI）进行体外沉积实验得到相关数据后，根据2种吸入装置的实际尺寸，采用UGNX 10.0软件建立2种干粉吸入装置三维模型，将此模型导入ICEM CFD软件中进行网格的划分，划分网格之后在检查网格质量合格后，将其导入Fluent软件中进行相关参数的设置。设置好参数之后进行数据的迭代和收敛，当数据计算处于稳态之后进行数值分析，最终得到药物微粒在2种干粉吸入装置的运动轨迹图，并与体外沉积结果进行对比，验证模拟结果。结果 体外沉积实验结果表明圆筒型装置的有效沉积率高于刺破型装置，CFD结果表明不同粒径的微粒在圆筒型装置中均能到达出气口，而对于刺破型装置，药物微粒在某一个粒径范围内无法到达出气口，2种结果均表明圆筒型装置更适合作为RRODPI所用装置。结论 采用CFD进行药物微粒在干粉吸入装置中运动轨迹的模拟，得到的结果较为直观，与体外沉积实验结果相一致，可以很好地预测药物微粒在干粉吸入装置中的运动状况。

Objective To simulate the kinematics of drug particles in two kinds of dry powder inhalation devices for Rehmanniae Radix oligosaccharide dry powder inhalation (RRODPI) by computational fluid dynamics (CFD), and to compare simulation results with the in vitro deposition results in order to verify the accuracy of the results. Methods NGI was used to carry out in vitro deposition experiments, and the relative experiment data were obtained. UGNX 10.0 software was adopted to establish three-dimensional models of two kinds of dry powder inhalation devices according to their actual sizes, and then the models were imported into ICEM CFD software to divide mesh. After checking mesh quality, mesh was imported to Fluent software and the related parameters were set. When the data was in steady state after iteration and convergence, the data analysis was carried out; Finally the kinematics results of drug particles at three kinds of particle sizes in two kinds of dry powder inhalation devices were gained. The kinematics results were compared with the in vitro deposition results to verify the simulation results. Results In vitro deposition experiment results showed that the effective deposition rate in twister was higher than that in osmohaler. CFD results showed that drug particles at different sizes in twister could all reach the outlet but for drug particles in osmohaler, it could not reach the outlet at a certain range of sizes. The two results showed that twister was more suitable for the dry powder inhaler device of RRODPI. Conclusion It is comparatively intuitive to use CFD to carry out the kinematics simulation of drug particles in two kinds of dry powder inhalation devices and the result is consistent with the in vitro deposition experiment results, which can well predict the motion state of drug particles in the two dry powder inhalation devices.

上海市科技计划基金项目（05dz19102）