目的 對吸入用色甘酸鈉溶液的霧化質(zhì)量特性進行評價。方法 分別采用激光衍射法和撞擊法測定吸入用色甘酸鈉溶液的霧滴粒徑及其分布，并考察采用不同廠家霧化器進行霧化時微細粒子空氣動力學特性指標的區(qū)別；使用呼吸模擬器考察藥液遞送速率、遞送總量，對兩家企業(yè)的樣品進行比較分析。結果 吸入用色甘酸鈉溶液霧滴粒徑、空氣動力學粒徑分布、遞送速率和遞送總量，無顯著區(qū)別。結論 不同企業(yè)生產(chǎn)的吸入用色甘酸鈉溶液的霧化質(zhì)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