摘要
目的 对药品中pH测定的不确定度进行评定。方法 以葡萄糖氯化钠注射液pH测定为例,分别采用基于不确定度传播律(GUM)法和基于蒙特卡洛(MCM)法评定pH测定的不确定度,用MCM法验证GUM法评定不确定度的可靠性。结果 GUM法和MCM法得到的测量结果以及不确定度基本一致。结论 MCM法用于不确定度评定,是一个简便、可靠,且适用性更广的可选择方法。
Abstract
OBJECTIVE To evaluate the uncertainty of pH measurement in pharmaceuticals. METHODS Taking glucose and sodium chloride injection as an example, the uncertainty of pH measurement in pharmaceuticals was evaluate by uncertainty transmission rule's method (GUM) and Monte Carlo method (MCM), and the uncertainties obtained by the two methods were compared. RESULTS The measurement uncertainty obtained by GUM almost agreed with that by MCM. CONCLUSION MCM is easy and reliable, and can be used as an alternative method for evaluation of the measurement uncertainty in pharmaceutical analysis.
关键词
不确定度评价 /
pH测量 /
蒙特卡洛法 /
药品
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Key words
uncertainty evaluation /
pH measurement /
Monte Carlo method /
pharmaceuticals
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洪小栩, 王玉, 吴莉, 罗国安, 唐素芳, 茅向军, 靳桂民.
基于蒙特卡洛法的药品pH测量不确定度评定[J]. 中国药学杂志, 2017, 52(8): 671-674 https://doi.org/10.11669/cpj.2017.08.013
HONG Xiao-xu,WANG Yu*,WU Li,LUO Guo-an,TANG Su-fang,MAO Xiang-jun,JIN Gui-min.
Evaluation of Uncertainty of pH Measurement in Pharmaceuticals by Monte Carlo Method[J]. Chinese Pharmaceutical Journal, 2017, 52(8): 671-674 https://doi.org/10.11669/cpj.2017.08.013
中图分类号：
R917
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参考文献
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