基于蒙特卡洛法的药品pH测量不确定度评定  

Evaluation of Uncertainty of pH Measurement in Pharmaceuticals by Monte Carlo Method

作　　者：洪小栩[1] 王玉 吴莉 罗国安[3] 唐素芳[4] 茅向军[5] 靳桂民 

机构地区：[1]国家药典委员会,北京100061 [2]江苏省食品药品监督检验研究院,南京210008 [3]清华大学化学系,北京100001 [4]天津市药品检验所,天津300070 [5]贵州省食品药品检验所,贵阳550004

出　　处：《中国药学杂志》2017年第8期671-674,共4页Chinese Pharmaceutical Journal

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。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 transmis- sion rule＇s method （GUM） and Monte Carlo method （MCM）, and the uncertainties obtained by the two methods were compared. RE- SULTS The measurement uncertainty obtained by GUM almost agreed with that by MCM. CONCLUSION MCM is easy and relia- ble, 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 

分 类 号：R917[医药卫生—药物分析学]