目的 对吸入用色甘酸钠溶液的雾化质量特性进行评价。方法 分别采用激光衍射法和撞击法测定吸入用色甘酸钠溶液的雾滴粒径及其分布，并考察采用不同厂家雾化器进行雾化时微细粒子空气动力学特性指标的区别；使用呼吸模拟器考察药液递送速率、递送总量，对两家企业的样品进行比较分析。结果 吸入用色甘酸钠溶液雾滴粒径、空气动力学粒径分布、递送速率和递送总量，无显著区别。结论 不同企业生产的吸入用色甘酸钠溶液的雾化质量特征具有一致性。

Objective To evaluate the atomization characteristics of Sodium Cromoglicate Solution for inhalation. Methods The atomizing particle distribution of different Sodium Cromoglicate Solution for inhalation were determined by particle size analysis-laser diffraction methods and next generation impactor (NGI). The difference in the aerodynamic characteristics of fine particles was investigated when atomizers from different manufacturers were used for atomization. The delivery rate and delivered amount of Sodium Cromoglicate Solution for inhalation solution were measured by breathing simulator. Samples from two manufactures were compared. Results The in vitro nebulization of Sodium Cromoglicate Solution for inhalation could be characterized by the determination of the delivery rate and delivered amount and the aerodynamic particle size distribution. Conclusion The atomization characteristics of Sodium Cromoglicate Solution for inhalation from different manufactures were consistent.

R974