血浆中辛伐他汀分析方法及药代动力学研究

Analysis Method and Pharmacokinetic Studies of Simvastatin in Plasma

采用GC/MS的SIM(选择离子监测)定量模式,以洛伐他汀做内标,经乙酸乙酯萃取后,测定人体血中辛伐他汀的浓度.标准曲线在0.27～54μg/L之间呈良好的线性关系,r>0.999,高中低3个浓度点的日间日内RSD(相对标准偏差)小于5.2%,回收率可达96%～103%,并应用在10例健康志愿者口服40mg辛伐他汀的药代动力学的研究.

A method for the determination of simvastatin in plasma was established by using the ion monitoring mode (SIM) in gas chromatography/mass spectrometry. Lovastatin was used as the internal standard. Sample was extracted by ethyl acetate, and then determined. The standard curve was linearbetween 0.27 to 54μg/L, with correlation coefficients of 0.999 and the relative standard deviations ofintra-day, inter-day were less than 5.2% in the three different concentrations. The recovery was 96%-103 % . This method was applied successfully to the studies of pharmcokinetics of simvastatin after given a single 40mg oral dose of capsules and regular tablets in healthy people.