摘要
目的建立沉淀滴定法测定普罗碘铵注射液含量的不确定度评定方法,分析不确定度的影响因素。方法通过建立滴定法测定含量的数学模型,分析影响不确定度的因素,并对各个不确定度进行评估、计算。结果合成标准不确定度为0.36%,扩展不确定度为0.72%(k=2)。结论建立的不确定度方法可适用于沉淀滴定法测定普罗碘铵注射液含量的不确定度分析,并对药品质量标准的研究具有重要意义。
Objective To establish a precipitation titration analysis method for uncertainty analysis of prolonium iodide injection and explore the influence factor. Methods The factors influencing the uncertainty were analyzed through establishing titration analysis assay mathematical mode,each component of the uncertainty was assessed and calculated. Results The combined standard uncertainly was 0. 36%,the extended uncertainly was 0. 72%（ k = 2）.Conclusion The mathematic model of uncertainty estimation is reasonable for determining the content of prolonium iodide injection with titration analysis,and it is important to study the drug quality standards.
出处
《实用药物与临床》
CAS
2015年第2期177-180,共4页
Practical Pharmacy and Clinical Remedies
关键词
不确定度
普罗碘铵
沉淀滴定法
Uncertainty
Prolonium iodide
Precipitation titration analysis
