吸入用硫酸特布他林溶液的空气动力学粒径分布比较

目的： 比较2个厂家生产的吸入用硫酸特布他林溶液的空气动力学粒径分布。方法： 选用3种雾化器，采用新一代撞击器（NGI）和高效液相色谱法分别对2个厂家生产的吸入用硫酸特布他林溶液进行空气动力学粒径分布（APSD）测定，通过微细粒子剂量、微细粒子分数、空气动力学质量中直径、几何标准偏差比较体外空气动力学粒径分布特征，并建立了APSD方程。结果： 相同的样品使用不同的雾化器时APSD结果有显著差异，不同的样品使用相同的雾化器时APSD结果相似；但2种吸入用硫酸特布他林溶液在3种雾化器上的空气动力学微细粒子分布方程一致性均有差异。结论： 吸入用硫酸特布他林溶液使用不同的雾化器可导致微细粒子分布差异；使用空气动力学微细粒子分布方程可以进一步评价微细粒子粒径分布的一致性。

Objective: To compare the aerodynamic particle size distribution(APSD)of terbutaline sulfate solution for nebulisation from two manufacturers. Methods: The APSD of terbutaline sulfate solution for nebulisation from two manufacturers were determined by three kinds of nebulizers by next generation impactor and HPLC method,respectively. Comparison of the characteristics of aerodynamic particle size distribution in vitro was determined by means of fine particle dose,fine particle fraction,mass median aerodynamic diameter and geometric standard deviation. The aerodynamic particle distribution function was also established. Results: The APSD results of the same sample with different nebulizers were significantly different,and APSD results were similar for different samples when the same atomizer was used. However,the consistency of APSD curves of the three nebulizers was different between the two inhalation solutions of terbutaline sulfate. Conclusion: Different nebulizers for inhalation of terbutaline sulfate solution can lead to different distribution of fine particles. The consistency of particle size distribution can be further evaluated by using aerodynamic fine particle distribution equation.

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