对丹参注射液不溶性微粒检查的不确定度的评定  

Evaluation Studies on Uncertainty for Test of the Insolubale Particles in Dansen Injection

作　　者：范治云 程春雷 刘琦 管玉民 

机构地区：[1]山东省药品检验所,济南250012

出　　处：《中国药事》2008年第3期235-236,共2页Chinese Pharmaceutical Affairs

摘　　要：建立光阻法检查丹参注射液不溶性微粒的不确定度评定方法;找出影响不确定度的因素,对不确定度进行分析、评估;计算出丹参注射液不溶性微粒检查的标准不确定度及扩展不确定度;建立的不确定度评估方法可适用于光阻法检查小容量注射剂不溶性微粒的不确定度分析。A method for uncertainty analysis of the insolubale particles in Dansen injection by light observation was established. The source of uncertainty was analyzed and its composition was evaluated. The standard and extend uncertainty of the test of the insolubale particles in Dansen injection were assessed. The mathematic model of uncertainty measurement established in this paper is reasonable and reliable.

关 键 词：丹参注射液 不溶性微粒 不确定度 

分 类 号：R927.12[医药卫生—药学]