激光粒度仪测定醋酸肤轻松乳膏粒度的方法学研究

Methodological study of particle size of fluocinonide cream by laser particle analyzer

目的:建立醋酸肤轻松乳膏粒度分布的测定方法。方法:使用马尔文激光粒度分析仪,通过外部磁力搅拌60 min和超声30 min的方法分散均匀样品,分散介质水900 mL,泵的转速2 000 r·min^(-1);光学参数为红光折射率1.49,吸收率0.01;遮光度界限约在10%~15%之间。结果:6个厂家的10批样品中醋酸氟轻松乳膏粒径分布特征值d_(0.1),在0.608 5~2.037 0μm范围,d_(0.5)在2.139 0~6.743 5μm范围,d_(0.9)在4.117 5~19.702μm范围,平均残差在0.264 5%-0.783 5%之间。结论:本方法适合醋酸氟轻松乳膏粒度检查的测定。

Objective： To establish a method for determination of the particle size distribution of fluocinonide cream. Methods： The Malvern Mastersizer 2 000 laser size analyzer and the HYDRO 2 000 MU wet autosampler were used. The conditions of determination were as follows ： external magnetic stirring for 60 min and ultrasonic stirring for 30 min to evenly disperse the sample in 900 mL water, the pump of Malvern laser particle size analyzer set at 2 000 r· min^-1 ; the refractive index of the optical parameters of the red light was 1.49, the sample absorption of 0.01 ; laser obscuration was set between about 10%-15%. Results： All the do.l range of 10 batches of fluocinonide cream was 0.608 5-2.037 0 μm, the d0.5 range was 2.139 0-6.743 5 μm and the d0.9 range was 4.117 5-19.702μm. The mean residual was less than 0.8%, all less than the requirements of Chinese pharmacopeia. Conclusion： The method is simple, accurate and producible, which is suitable for the particle size control of fluoeinonide cream.