葡萄糖酸锌片溶出度两种不同测定方法的测量不确定度比较  

Comparison of Uncertainty of Dissolution of Zinc Gluconate Tablet Determinded by Two Method

作　　者：黎晓欣 李琼霞 LI Xiao-xin;LI Qiong-xia(Guangzhou Yuexiu Municipal Food and Drug Inspecting and Testing Center,Guangzhou 510055,China)

机构地区：[1]广州市越秀区食品药品检验检测中心,广东广州510055

出　　处：《海峡药学》2022年第2期81-85,共5页Strait Pharmaceutical Journal

摘　　要：目的建立并比较两种不同方法测定葡萄糖酸锌片溶出度的测量不确定度。方法识别葡萄糖酸锌片溶出度测定的不确定度来源,建立数学模型,分析不确定度分量,计算95%置信区间时的扩展不确定度。结果电感耦合等离子体质谱法(ICP-MS)测定葡萄糖酸锌片溶出度的扩展不确定度为U=4.9%,原子吸收分光光度法(AAS)为U=4.4%。结论两种方法的扩展不确定度大小相当,主要来源均为标准溶液配制和标准曲线拟合,ICP-MS法可用于葡萄糖酸锌片溶出度的检测。OBJECTIVE To evaluate and compare the uncertainty of dissolution of zinc gluconate tablet determinded by two method.METHODS Discern the sources of uncertainty of dissolution of zinc gluconate tablet,mathematical mode was established for analyzing the uncertainty components and determining the expanded uncertainty under 95%confidence level.RESULTS The expanded uncertainty of dissolution of zinc gluconate tablet by inductively coupled plasma-mass spectrometry(ICP-MS)was U=4.9%,which by atomic absorption spectrophotometry(AAS)was U=4.4%.CONCLUSION The uncertainty of two method were numerically equivalent,and their sources were both mainly from preparation of standard solution and the curve fitting.ICP-MS method can be used for detection of dissolution of zinc gluconate tablet.

关 键 词：不确定度 电感耦合等离子体质谱法 原子吸收分光光度法 葡萄糖酸锌 

分 类 号：R927[医药卫生—药学]