激光散射法测定磺胺嘧啶银原料粒度分布

摘要

目的：建立激光散射法测定磺胺嘧啶银原料粒度分布。方法：采用Malvern Mastersizer 2000激光粒度分析仪；Hydro 2000 MU湿法进样器；泵速：2000 rpm ，样品折射率：1.679，颗粒吸收率：0.01，分散介质折射率：1.33，测量次数：5次；样品与背景测量时间：10 s，遮光度：10%～20%。结果：7批原料d（0.5）均小于10μm，RSD均小于6%，d（0.1）和d（0.9）均小于3.5μm和25μm， RSD均小于10%，符合《中国药典》相关要求。结论：所建立方法经考察，可用于磺胺嘧啶银原料的粒度测定。%Objective: To establish a laser light scattering method for the determination of particle size distribution for sulfadiazine silver. Methods:The Malvern Mastersizer 2000 laser size analyzer and the Hydro 2000 MU wet autosampler were used. The conditions of determination were as follows: the pump speed of 2000 rpm,the sample RI of 1.679, the sample absorption of 0.01,the measurement times of 5 times, the measurement time of background and sample of 10 s,and the obscuration of 10%-20%. Results:RSD of d(0.5) was lower than 6%,and that of d(0.1) and d(0.9) was lower than 10%. All the d(0.1) of 7 batches of sulfadiazine silver was less than 3.5μm, the d(0.5) was less than 10μm and the d(0.9) was less than 25μm which were all in line with the requirements of China Pharmacopeia. Conclusion:The method was simple, accurate and producible,which was suitable for the particle size control of sulfadiazine silver.