摘要
目的建立激光粒度仪测定盐酸吗啡原料药粒度分布的方法。方法使用马尔文2000激光粒度仪,以干法测定,分散气压为3.0 bar,振动进样速度为70%,进样时间为10 s,折射率为1.52。结果3批样品粒度分布特征值D(0.1)在1.330~1.918μm范围,D(0.5)在4.418~5.154μm范围,D(0.9)在10.641~12.847μm范围。结论本方法简便、快速、重现性好,适用于盐酸吗啡原料药的粒度测定。
OBJECTIVE To establish a method for the determination of the particle size distribution of morphine hydrochloride.METHODS The particle size distribution of the samples was determined by laser diffraction using a Mastersizer 2000 equipped with a Scirocco 2000 dry dispersion unit.The test conditions were as follows:the air pressure was 3.0 bar;the feed rate was 70%;the sample measurement time was 10s;the refractive index of the optical parameters was 1.52.RESULTS The D(0.1)range of 3 batches of morphine hydrochloride was 1.330-1.918μm,the D(0.5)range was 4.418-5.154μm and the D(0.9)range was 10.641-12.847μm.CONCLUSION The method is simple,rapid and reproducible,which is suitable for the particle size control of active pharmaceutical ingredients of morphine hydrochloride.
作者
徐登
XU Deng(Chongqing Institute for Food and Drug Control,Chongqing 401121,China;NMPA Key Laboratory of Quality Monitoring of Anaesthetic and Psychotropic Substances,Chongqing 401121,China)
出处
《海峡药学》
2021年第2期53-55,共3页
Strait Pharmaceutical Journal
基金
国家“重大新药创制”科技重大专项资助项目(2017ZX09101001006-002)。
关键词
盐酸吗啡
激光粒度仪
粒度及粒度分布
Morphine Hydrochloride
Laser Particle analyzer
Particle size distribution
