目的 評定LC-MS法測定人血漿中五味子醇甲的不確定度.方法 對LC-MS法測定人血漿中五味子醇甲的全過程進行分析,建立數(shù)學模型,確定影響不確定度的因素并對各個因素進行評估,計算合成不確定度及擴展不確定度.結果 置信概率P為95%時,血漿中低、中、高(0.61、12.26、245.20 μg/L)濃度五味子醇甲的擴展不確定度分別為1.08、1.76、27.00 μg/L.結論 本方法適用于LC-MS法測定人血漿中五味子醇甲的不確定度評定,不確定度主要由線性回歸過程引入.

Objective To evaluate the uncertainty in determination of schisandrin 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, medium and high levels (0.61, 12.26, and 245.20 μg/L)of schisandrin was 1.08, 1.76, and 27.00 μg/L, respectively (P = 95%). Conclusion This method is applicable to the uncertainty evaluation of schisandrin 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);國家臨床重點專科建設項目經(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)