目的 評定LC-MS 法測定人血漿中人參皂苷Re 濃度的不確定度。方法 對LC-MS 法測定人血漿中人參皂苷Re濃度的全過程進行分析,建立數(shù)學模型,確定影響不確定度的因素并對各個不確定度因素進行評估,計算合成不確定度并進行擴展。結果 置信概率P 為95%時,血漿中低、中、高(1.00、125.25、1 002.00 μg/L)質量濃度人參皂苷Re 的擴展不確定度分別為4.38、19.80、199.60 μg/L。結論 本方法適用于LC-MS 法測定人血漿中人參皂苷Re 濃度的不確定度評定,不確定度主要由線性回歸過程引入。

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.

國家“十二五”重大新藥創(chuàng)制項目;“中藥新藥臨床評價研究技術平臺”(2012ZX09303-017);國家臨床重點?？平ㄔO項目經(jīng)費資助(2013 年);國家中醫(yī)藥管理局臨床中藥學重點學科(2009 年);遼寧中醫(yī)藥大學杏林學者青藍工程(2013 年)