激光散射法测定阿维A原料药粒度

目的：建立测定阿维A原料药的粒度及其分布的方法。方法：采用Malvern Mastersizer2000激光粒度分析仪、Hydro 2000MU湿法进样器,以《中国药典》粒度和粒度分布测定法中的光散射法进行阿维A原料药的粒度分析并进行方法学考察,泵速为1500r/min,遮光比为5%～15%,背景与样品的扫描时间为5s,样品折射率为1.569,样品吸光率为0.01。结果：方法学考察结果d（0.5）的RSD均〈3%,d（0.1）和d（0.9）的RSD均〈5%;4批阿维A原料药的d（0.1）均小于5μm,d（0.5）均小于10μm,d（0.9）均小于20μm,符合《中国药典》相关要求。结论：该方法简便、准确、重复性好,适用于阿维A原料药的粒度控制。

Determination of Particle Size of Acitretin Crude Drug by Laser Light Scattering Method

OBJECTIVE： To establish a method for the determination of particle size and distribution for acitretin crude drug. METHODS： Malvern Mastersizer 2000 laser size analyzer, Hydro 2000 MU wet autosampler were used, the light scattering method for the determination of particle size and distribution of Chinese Pharmacopeia was adopted to analyze the particle size of acitretin crude drug and then methodological study was carried out. The conditions of determination were： pump speed： 1 500 r/min, obscuration： 5%-15%, measurement time of background and sample： 5 s, sample RI： 1.569, sample Ah 0.01. RESULTS： RSD of methodological study d（0.5） was lower than 3%, and that of d（0.1） and d（0.9） were lower than 5%. All the d（0.1） of 4 batches of aeitretin drug substance were less than 5 μm, the d（0.5） were less than 10 μm and the d（0.9） were less than 20 μm, which were all in line with the requirements of Chinese Pharmacopeia, CONCLUSIONS ： The method is simple, accurate and producible, which is suitable for the particle size control of acitretin crude drug.