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

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.