天然产物研究与开发2011，Vol.23Issue(6)：1031-1037,7.
HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究
Determination of Bulleyaconitine A in Human Plasma by HPLC-MS/MS and Its Bioequivalence Study
摘要
Abstract
A high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC-ESIMS/MS) method was developed and validated for the determination of Bulleyaconitine A (BLA) in human plasma using carbamazepinum as internal standard (IS).Plasma samples were extracted with Waters Oasis HLB solid-phase cartridges,separated on a reversed C18 column (150 mm × 4.6 mm,5 μm) with a mobile phase of methonal - 10 mmol/L ammonium acetate solution containing 0.1％ formic acid (85:15,v/v).Bulleyaconitine A and IS were detected in the multiple reaction monitoring mode (MRM) with precursor to product ion transitions of m/z644.4/584.4 and 237.2/ 194.2,respectively.The method exhibited a linear range of 0.010-1.0 ng/mL for BLA in human plasma.The lowest limit of quantification (LLOQ) was 0.010 ng/mL,which was sensitive enough for the pharmacokinetic study of BLA.Acceptable precision and accuracy were obtained for concentrations of the calibration standard and the quality control (QC).The validated method was successfully applied for evaluation of a bioequivalence study in Chinese healthy volunteers.The main pharmacokinetics parameters after oral administration of 0.4 mg BLA test or reference formulation were as follows:Cmax (0.325 ± 0.110),(0.323 ± 0.115 ) ng/mL;AUC0-16 ( 1.627 ± 0.489),( 1.732 ± 0.556) ng · h/mL;AUC0-∞ (1.730 ±0.498),(1.831 ±0.562) ng · h/mL;t1/2 (4.26 ±0.95),(3.80 ±0.90) h;Tmax (1.34 ±0.54),(1.83±0.99) h.关键词
HPLC -MS/MS/草乌甲素/血药浓度/生物等效性Key words
HPLC-MS/MS/bulleyaconitine A/plasma drug concentration/bioequivalence分类
医药卫生引用本文复制引用
李相鸿,孙华,贾元威,周理想,王伟佳,戴敏,赵亚男,谢海棠..HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究[J].天然产物研究与开发,2011,23(6):1031-1037,7.基金项目
This research project was supported by the Youth Science Foundation of Wannan Medical College(No.WK200918F). （No.WK200918F）
