摘要
目的:建立甲基纤维素粒度与粒度分布测定方法。方法:使用马尔文2000激光粒度分析仪,干法测定甲基纤维素的粒度与粒度分布。光学参数为蓝光折射率1.336,遮光度范围1.5%~4.5%。结果:3个厂家的10批样品粒径分布特征值d_(0.1)在23.161~37.371μm范围,d_(0.5)在66.709~111.511μm范围,d_(0.9)在197.314~236.666μm范围,平均残差在0.161%~0.366%之间。结论:本方法适用于甲基纤维素粒度与粒度分布测定。
Objective:To establish a method for determination of the particle size distribution of methylcellulose.Methods:The Malvern 2000 laser size analyzer was used to test particle size distribution of methylcellulose by the dry measurement.The condition of determination was as follows:the refractive index of the optical parameters of the blue light was 1.336;laser obscuration was 1.5%-4.5%.Results:The d0.1 range of 10 batches of methylcellulose from 3 manufacturers was 23.161-37.371μm,the d0.5 range was 66.709-111.511μm and the d0.9 range was 197.314-236.666μm.The mean residual was between 0.161%-0.366%.Conclusion:The method is suitable for the particle size control of methylcellulose.
作者
吴燕
刘菁
安彦
李华龙
WU Yan;LIU Jing;AN Yan;LI Hua-long(Tianjin institute of Drug Control,Tianjin 300070,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2019年第4期755-762,共8页
Chinese Journal of Pharmaceutical Analysis
关键词
甲基纤维素
长链取代纤维素
药用辅料
功能性指标
粒度与粒度分布
干法测定
马尔文激光粒度仪
methylcellulose
long chain substituted cellulose
pharmaceutical excipient
functionality-related characteritics
particle size distribution
dry measurement
Malvern laser particle size analyzer