丙酸氟替卡松鼻喷雾剂的研制及喷雾特性

Preparation of fluticasone propionate nasal spray and its spray characteristics

摘要: 采用高压均质工艺对丙酸氟替卡松原料进行微粒化，应用Box-Behnken效应面设计对微粒化工艺中均质压力、循环次数、混悬液药物浓度等3项参数进行了优化，得到的优化微粒化工艺为均质压力50 MPa、循环6次、混悬液药物浓度10%。在此基础上制备的丙酸氟替卡松鼻喷雾剂雾滴粒径分布及喷射模式均符合美国药典的要求，具有良好的喷雾特性。

Abstract: Fluticasone propionate was micronized by the high pressure homogenization method. Box-Behnken design was employed to aid the optimization of the homogenization pressure，cycle frequency and the concentration of drug suspension in the preparation processes.The optimized parameters regarding the micronization process were 50 MPa of the homogenization pressure,6 of the cycle frequency,and 10% of fluticasone propionate in the suspension.The fluticasone propionate nasal spray has a good spraying characteristics with the droplet size distribution and spray pattern in compliance to the specifications of United States Pharmacopeia.