采用液相色谱质谱联用(    LC-MS/MS)    法测定人血浆中辛伐他汀的浓度, 进行相关生物利用度及生物等效性试验。血浆中内源性物质不干扰辛伐他汀的测定, 线性范围:  0.1~20ng/ml, 定量下限为0.1ng/ml, 提取回收率在74.4~83.1％之间, 日内、日间RSD均小于15.0％。该方法符合生物样品分析要求上海英语口译。

The human plasma concentration of Simvastatin was determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and the experiment of relative bioavailability and bioequivalence were conducted. The endogenous substance in plasma did not interfere with the determination of the Simvastatin, the linear range was 0.1~20ng/ml, the quantitative lower limit was 0.1ng/ml, the extraction recovery rate was between 74.4％and 83.1％ and both the intra-day RSD and the inter-day RSD were less than 15.0％. The method met the analysis requirements of biological sample.

试验制剂辛伐他汀片和参比制剂辛伐他汀片之间lnAUC_0-36、lnAUC_0-∞经双向单侧t检验, AUC_0-36、AUC_0-∞的[1-2α]置信区间在参比制剂相应参数的80％-125％范围内, 表明两种制剂在吸收程度具有生物等效性;   lnC_max经方差分析和双向单侧t检验, C_max的[1-2α]置信区间在参比制剂相应参数的70％-143％范围内, 表明两种制剂在吸收的峰值浓度上具有生物等效性;   T_max经非参检验, 两制剂间无显著性差异, 表明两制剂在达峰时间上具有生物等效性俄语翻译。

The lnAUC_0-36 and lnAUC_0-∞ of experimental Simvastatin tablet and reference Simvastatin tablet were analyzed by the two one sided t test; the [1-2α] confidence interval of AUC_0-36 and AUC_0-∞ were in the 80-125％ range of the corresponding parameter of reference agent, which represented that the experimental Simvastatin tablet and reference Simvastatin tablet had the bioavailability in the absorption level. The lnC_max was analyzed by variance analysis and two one sided t test; the [1-2α] confidence interval of C_max was in the 70-143％ range of the corresponding parameter of reference agent, which represented that the experimental Simvastatin tablet and reference Simvastatin tablet had the bioavailability in the absorption peak level. T_max was analyzed by the nonparametric test; there was no significant difference between the experimental Simvastatin tablet and reference Simvastatin tablet which represented that the two reagents had the bioavailability in the peak time.