注射用头孢呋辛钠不溶性微粒检查的不确定度分析  

Uncertainty analysis of particulate matter determination in cefuroxime sodium for injection

作　　者：邱海强 刘晓瑜 

机构地区：[1]无锡药品检验所,无锡214021

出　　处：《药学与临床研究》2008年第4期325-327,共3页Pharmaceutical and Clinical Research

摘　　要：目的:建立光阻法检查注射用头孢呋辛钠不溶性微粒的不确定度分析方法。方法:通过建立光阻法不溶性微粒检查的数学模型,寻找不确定度的影响因素并对各个不确定度分量进行评估。结果:计算各分量的不确定度,由此计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结论:建立的不确定度评估方法可用于光阻法检查各种静脉注射用无菌粉末不溶性微粒的不确定度分析。Objective：To evaluate the uncertainty of particulate matter determination in cefuroxime sodium for injection using light observation method. Methods： The calculation formula of uncertainty was deduced in the procedure of determining the particulate matter. Results： Each component of uncertainty was calculated by analyzing the variable parameters among the procedures. The combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables. Conclusion： The mathematic model of uncertainty measurement established in this paper is reasonable and reliable.

关 键 词：不溶性微粒 光阻法 不确定度 注射用头孢呋辛钠 

分 类 号：R927.11[医药卫生—药学]