目的 评定LC-MS 法测定人血浆中人参皂苷Re 浓度的不确定度。方法 对LC-MS 法测定人血浆中人参皂苷Re浓度的全过程进行分析,建立数学模型,确定影响不确定度的因素并对各个不确定度因素进行评估,计算合成不确定度并进行扩展。结果 置信概率P 为95%时,血浆中低、中、高(1.00、125.25、1 002.00 μg/L)质量浓度人参皂苷Re 的扩展不确定度分别为4.38、19.80、199.60 μg/L。结论 本方法适用于LC-MS 法测定人血浆中人参皂苷Re 浓度的不确定度评定,不确定度主要由线性回归过程引入。

Objective To evaluate the uncertainty in determination of ginsenoside Re in human plasma by LC-MS. Methods The uncertainty caused by various factors in the whole process of determination was analyzed. Mathematical model was established. Influential factors of uncertainty were identified and evaluated. The combined uncertainty was calculated and the expanded uncertainty was obtained. Results The expanded uncertainty for the low-, mid-, and high-dose (1.00, 125.25, and 1 002.00 μg/L) ginsenoside Re was 4.38, 19.80, and 199.60 μg/L, respectively (P= 95%). Conclusion This method is applicable to uncertainty evaluation of ginsenoside Re determination in human plasma, and the uncertainty of this method was mainly caused by linear regression.

国家“十二五”重大新药创制项目;“中药新药临床评价研究技术平台”(2012ZX09303-017);国家临床重点专科建设项目经费资助(2013 年);国家中医药管理局临床中药学重点学科(2009 年);辽宁中医药大学杏林学者青蓝工程(2013 年)