激光散射法测定奥氮平原料药的粒度及分布

Determination of Particle Size and Distribution of Olanzapine Crude Drug by Laser Light Scattering Method

目的建立激光粒度散射法湿法测定水不溶性奥氮平原料药粒度及其分布。方法采用马尔文公司的Malvern Mastersizer 2000型激光粒度分析仪,Hydro 2000MU湿法进样器,分散介质为水,Tween-80作为润湿剂,超声分散50 s,背景与样品扫描时间10 s,测量次数5次,颗粒折射率1.52,样品吸收率0.01,遮光比5%~10%,浆液循环泵转速1500 r·min^(-1)。结果方法学考察结果d(0.1)、d(0.5)、d(0.9)的RSD值均小于3%;6批奥氮平原料药样品粒径分布特征值均符合d(0.9)应为8~22μm的企业质量标准规定。结论该方法准确、快速、重现性好,适合奥氮平原料药的粒度测定。

OBJECTIVE To establish a laser light scattering method(wet)for the determination of particle size and distribution of insoluble olanzapine crude drug.METHODS The Malvern Mastersizer 2000 laser size analyzer with the Hydro 2000MU wet autosampler were used.The determination conditions were surveyed as follows,dispersion medium:water,dispersant:Tween-80,samples were evenly dispersed by ultrasonic for 50 s,measurement time for background and specimen:10 s,determination times:5 times,particle refractive index:1.52,granule absorption index:0.01,laser obscuration:5%~10%,the speed of slurry circulation pump:1500 r·min^(-1).RESULTS The RSDS of methodological survey for d(0.1),d(0.5)and d(0.9)were less than 3%.All the d(0.9)values of 6 batches olanzapine crude drug were 8~22μm,which were in accordance with the enterprise internal standards.CONCLUSION The method is accurate,fast and repeatable,respectively,which is suitable for the particle size determination of olanzapine bulk drug.