摘要
目的建立激光散射法测定瑞舒伐他汀钙原料药的粒度分布。方法采用Malvern Mastersizer3000型激光粒度分析仪,HYDRO MV型湿法进样器,样品采用葵花油分散,样品折射率1.60,样品吸光度0.1,遮光度10%~20%,超声1 min,泵速2000 r·min^-1,样品测量时间15 s,样品测量2次。结果3批样品的测定结果,d(0.1)、d(0.5)和d(0.9)分别为3.16、3.12、3.09μm;17.2、17.8、17.1μm;80.1、79.4、79.2μm;3批样品d(0.5)值的RSD均小于3%,d(0.1)和d(0.9)值的RSD均小于5%。结论本法简便、准确、可靠,可用于瑞舒伐他汀钙原料药粒度分布的测定。
Objective To determine the particle size distribution of rosuvastatin calcium substances by laser light scattering method. Methods Malvern Mastersizer 3000 laser particle size analyzer and HYDRO MV wet sampler were used. The sunflower oil was used for the dispersion, sample refractive index was 1.60, sample absorbance was 0.1, shading at 10%-20%, ultrasound for 1 min, pump speed at 2000 r·min^-1, sample measurement for 15 s twice. Results The d(0.1), d(0.5) and d(0.9) of three batches of sample was 3.16, 3.12, 3.09 μm;17.2, 17.8, 17.1 μm;80.1, 79.4, 79.2 μm;The RSD of the d(0.5) of 3 batches of sample was less than 3%, and the RSD of the d(0.1), d(0.9) value were lessthan 5%. Conclusion This method is simple, accurate and reliable, and can be used for the determination of particle size distribution of rosuvastatin calcium substances.
作者
宋玉鹏
寻明金
冯中
王静
SONG Yu-peng;XUN Ming-jin;FENG Zhong;WANG Jing(National Engineering and Technology,Research Center of Chirality Pharmaceutical,Lunan Pharmaceutical Group Co.,Ltd.,Linyi Shandong 276000;International Pharmaceutical Engineering Lab in Shandong,Shandong New Times Pharmaceutical Co.,Ltd.,Linyi Shandong 273400)
出处
《中南药学》
CAS
2020年第3期474-476,共3页
Central South Pharmacy
基金
国家手性制药工程技术研究中心(No.2016GGH4528)。
关键词
激光散射法
瑞舒伐他汀钙原料药
粒度
laser light scattering method
rosuvastatin calcium substance
particle size
