基于蒙特卡洛法的药品pH测量不确定度评定

洪小栩, 王玉, 吴莉, 罗国安, 唐素芳, 茅向军, 靳桂民

中国药学杂志 ›› 2017, Vol. 52 ›› Issue (8) : 671-674.

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中国药学杂志 ›› 2017, Vol. 52 ›› Issue (8) : 671-674. DOI: 10.11669/cpj.2017.08.013
论著

基于蒙特卡洛法的药品pH测量不确定度评定

  • 洪小栩1, 王玉2*, 吴莉2, 罗国安3, 唐素芳4, 茅向军5, 靳桂民1
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Evaluation of Uncertainty of pH Measurement in Pharmaceuticals by Monte Carlo Method

  • HONG Xiao-xu1, WANG Yu2*, WU Li2, LUO Guo-an3, TANG Su-fang4, MAO Xiang-jun5, JIN Gui-min1
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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

Key words

uncertainty evaluation / pH measurement / Monte Carlo method / pharmaceuticals

引用本文

导出引用
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   

参考文献

[1] ISO/IEC GUIDE 98-3-2008 uncertainty of measurement part 3:Guide to the expression of uncertainty in measurement (gum:1995)[J/OL]. 2008:[2016-09-28].http://www.zbgb.org/74/StandardDetail653998.htm
[2] JJF 1059.1(2012)(测量不确定度评定与表示)[S]. 2012.
[3] LU L J,JIANG Y,ZHAO J,et al. Uncertainty evaluation of total error from instrument indicated value for determining pH of water extract of Chinese materia medica [J]. Chin J Exp Tradit Med Form (中国实验方剂学杂志),2013,19(13):1-3.
[4] LI N. Evaluation of uncertainty about indication error of pH meters in measurement[J]. Metrol Measur Technol (计量与测试技术),2013,40(12):31-32.
[5] XIU H Y, HE X Y. The uncertainty component caused by the different grade pH meter in measurement[J]. Acta Metrol Sin (计量学报),2007,28(4):391-393.
[6] HAO Y H. Evaluation of measurement uncertainty of indication error of pH meter[J]. Metrol Measur Technol(计量与测试技术),2004,31(8):39-41.
[7] Ch. P (2015) Vol Ⅱ(中国药典2015年版.二部) [S]. 2015:1271.
[8] Ch. P (2015) Vol Ⅳ(中国药典2015年版.四部) [S]. 2015:77.
[9] LI Y L. Chinese Standard Operating Procedures for Drug Quality Control (中国药品检验标准操作规范)[M]. Beijing:China Medical Science Press,2010:172.
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