目的 考察格隆溴铵吸入喷雾剂的雾化特性。方法 采用激光成像系统和新一代撞击器等测定格隆溴铵吸入喷雾剂的喷雾模式、喷雾形态、递送剂量均一性和空气动力学粒径分布。结果 样品的椭圆度均符合美国食品药品管理局指导原则建议，不同样品喷雾模式和喷雾形态同一参数之间RSD值均小于7%，样品的罐间和罐内递送剂量均一性良好。格隆溴铵吸入喷雾剂与雾化吸入溶液的质量中值、几何标准偏差值基本一致，在肺内沉积方面上高于雾化吸入溶液。结论 格隆溴铵吸入喷雾剂具备良好的雾化特性。

Objective To investigate the nebulization characteristics of glycopyrronium bromide inhalation spray. Methods A laser imaging system and next generation impactor (NGI) were used to determine the spray pattern, plume geometry, delivery dose uniformity, and aerodynamic particle size distribution (APSD) of glycopyrronium bromide inhalation spray. Results The elliptical ratio of glycopyrronium bromide inhalation spray conformed to the FDA guidance principle. RSD values of each sample parameter of the spray pattern and plume geometry were less than 7%. The delivery dose uniformity between and within the cans of the samples was good. MMAD and GSD values of glycopyrronium bromide inhalation spray were basically same as those of atomized inhalation solution, and higher than that of atomized inhalation solution in terms of intrapulmonary deposition. Conclusion Glycopyrronium bromide inhalation spray has good atomization characteristics.

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