目的 考察丙酸氟替卡松雾化吸入用混悬液的雾化特性，评价自制制剂与参比制剂的体外一致性。方法 采用呼吸模拟器研究丙酸氟替卡松雾化吸入用混悬液的递送速率和递送总量，采用激光衍射法和撞击法评价丙酸氟替卡松雾化吸入用混悬液的雾滴粒径及其分布，比较自制制剂与参比制剂的雾化特性。结果 自制制剂与参比制剂的体外雾化效果基本一致，满足群体生物等效性。结论 建立了丙酸氟替卡松雾化吸入用混悬液的雾化特性测定方法，并体外评价了自制制剂与参比制剂的群体生物等效性。

Objective To study the nebulization characteristics of fluticasone propionate nebulizer suspension and evaluate its in vitro consistency between the self-prepared formulation and the reference formulation. Methods The delivery rate and total delivery of fluticasone propionate nebulizer suspension were studied using a respiratory simulator. The droplet size and distribution of fluticasone propionate nebulizer suspension were evaluated by laser diffraction and impact methods. And the nebulization characteristics of the self-prepared formulation were compared with those of the reference formulation. Results The in vitro nebulization effects of the self-made formulation and the reference formulation were basically the same, and meet the population bioequivalence. Conclusion A method for determining the atomization characteristics of fluticasone propionate nebulizer suspension is established, and the population bioequivalence of the self-made formulation and the reference formulation is evaluated in vitro.

R974