硫酸沙丁胺醇吸入气雾剂递送剂量测定方法比较

Comparison of measurement methods of delivered-dose uniformity of salbutamol sulfate inhalation aerosol

目的:采用不同递送剂量(delivered-dose uniformity,DDU)测定装置,测定吸入气雾剂递送剂量均一性,比较测定结果差异,为选择吸入气雾剂递送剂量的测定方法提供参考。方法:采用DUSA管和改良单剂量玻璃取样装置测定硫酸沙丁胺醇吸入气雾剂的递送剂量均一性,分别测定3批样品各10支的标示首揿和末揿的递送剂量,比较不同装置的测定差异。结果:DUSA管测定结果均值为82.7~83.6μg,改良单剂量玻璃取样装置测定结果均值为92.4~94.6μg。结论:DUSA管测定递送剂量重现性良好,建议选择适当的装置测定递送剂量。取样揿数考察了气雾剂的瓶内和瓶间差异具有代表性。

Objective： To determine the difference in delivered-dose uniformity（ DDU） of salbutamol sulfate inhalation aerosol measured by different devices,thus to provide basis for selection of method for DDU determination of aerosol inhalation. Methods： The dose at the beginning of use and the end of use were determined for 10 individual inhalers by DUSA and modified glass sampling device,and the results were compared. Results：The delivered-dose was 82. 7 ~ 83. 6 μg as determined by DUSA method,and 92. 4 ~ 94. 6 μg by the method using modified glass sampling device. Conclusion： The results of DUSA were more reproducible and less variable than the method using modified glass sampling device. The DDU of inhalers represent the difference of delivered-dose during the use of the same bottle and between different bottles.