论文部分内容阅读
8名健康男性受试者随机自身交叉给药,分别口服单剂量40mg国产辛伐他汀片剂和进口片剂进行相对生物利用度研究。采用气相色谱/质谱联用测定血浆中辛伐他汀的体内水解物 β-羟基酸代谢物浓度,经3p97生物利用度计算程序处理拟合,符合一室模型,并得国产和进口辛伐他汀片剂的试验结果如下:AUC0 -∞ 分别为19.016±2.255μg·h·L-1 和20.444±2.830μg·h·L -1,Tpeak 分别为2.71±0.19h和2.69±0.20h,Cmax 分别为1.82±0.23μg·L -1和1.93±0.31μg·L-1 ,经配对t-检验,两者的主要药代动力学参数均无显著性差异(P>0.05)。经方差分析和双单侧检验结果表明两者具有生物等效性。国产辛伐他汀片剂的相对生物利用度为94.9 %±6.0 %。
Eight healthy male subjects were randomly assigned to receive either a single oral dose of 40 mg domestic simvastatin tablets or imported tablets for relative bioavailability. The concentrations of β-hydroxy acid metabolites of simvastatin in plasma were determined by gas chromatography / mass spectrometry and fitted by 3p97 bioavailability calculation program, which accorded with one-compartment model and obtained domestic and imported simvastatin tablets The results of the test were as follows: AUC0-∞ of 19.016 ± 2.255μg · h · L-1 and 20.444 ± 2.830μg · h · L -1, Tpeak of 2.71 ± 0.19h and 2.69 ± 0.20h, Cmax of 1.82 ± 0.23μg · L -1 and 1.93 ± 0.31μg · L -1, respectively. There was no significant difference in the main pharmacokinetic parameters between the two groups (P> 0.05). Analysis of variance and double unilateral test showed that the two were bioequivalent. The relative bioavailability of domestic simvastatin tablets was 94.9% ± 6.0%.