【摘要】 建立了液相色谱-串联质谱法测定人血浆中的非洛地平。以硝苯地平为内标,使用苯基-己基柱,采用ESI源正离子、多反应监测模式。非洛地平在0.05~40 ng/ml范围内线性关系良好,萃取回收率为71.8%~77.4%,日内、日间RSD均小于6.3%。20名健康志愿者随机交叉单次口服1缓释片(受试或参比制剂)10 mg,药动学参数如下:cmax(4.259±2.342)、(3.971±1.767)ng/ml,tmax(4.4±2.3)、(4.0±2.0)h,t1/2(13.2±3.4)、(12.4±2.5)h,AUC0→48 h(43.647±15.158)、(42.448±14.744)ng·ml-1·h,AUC0→∞(47.085±16.695)、(45.503±15.828)ng·ml-1·h。更多还原

【Abstract】 A LC-MS/MS method was established for the determination of felodipine in human plasma. Nefidipine was used as the internal standard, with the application of a Phenyl-hexyl column, in multiple reaction monitoring mode under electrospray ionization condition. It was linear in the range of 0.05- 40 ng/ml. The extraction recoveries were 71.8%- 77.4%, with the intra- and inter-day RSDs less than 6.3%. An oral dose of elodipine sustainedrelease tablet 10 mg(test or reference preparation) was administrated to 20 healthy male volunteers according to an open randomized crossover design. The main pharmacokinetic parameters were as follows: cmax(4.259±2.342) and(3.971±1.767) ng/ml, tmax(4.4±2.3) and(4.0±2.0) h, t1/2(13.2±3.4) and(12.4±2.5) h, AUC0→48 h(43.647±15.158) and(42.448±14.744) ng·ml-1·h, AUC0→∞(47.085±16.695) and(45.503±15.828) ng·ml-1·h.更多还原