摘要
12名男性健康志愿者随机交叉口服单剂量40mg辛伐他汀胶囊和辛伐他汀片后，用高效液相色谱法检测血浆中辛伐他汀浓度，进行药代动力学和相对生物利用度研究。试验结果表明，口服辛伐他汀的体内过程符合一房室模型，胶囊和片剂的药代动力学参数分别为：T1／2为2.39±0.43h和2.20±0.45;Tmax为1.92±0.36h和1.79±0.45h;Cmax为7.96±2.73mg·L^-1和8.33±3.62mg·L^-1;AUC0→10为25.21±8.29mg·h·L^-1和25.99±7.85mg·h·L^-1。相对生物利用度为96.9±13.0%，主要药代动力学参数经对数转换后采用方差分析和双单侧t检验进行分析，结果显示两种辛伐他汀制剂具有生物等效。
The pharmacokinetics and relative bioavailability of simvastatin capsules were studied in 12 healthy male volunteers. A single oral dose 40mg simvastatin of reference(tablet) or test(capsules) drugs was given to each volunteer according to an open randomized crossover study. The concentrations in plasma were determined by HPLC method. The results showed that the plasma concentration-time curves of the two products were all fitted to one-compartment model. The main pharmacokinetic parameters of simvastatin were: AUC_0 - 10 25.21 ± 8.29(mg· h·L _-1) and 25.99 ± 7.85 (mg·h·L_-1), T_max l.92 ± 0.36 h and l.79 ± 0.45 h, C_max 7.96 ± 2.73 mg·L_-1 and 8.33 ± 3.62 mg·L_-1 T_1/2, 2.39 ± 0.43 h and 2.20 ± 0.45 h for capsules and tablet respectively. The relative bioavailability of capsules to tablet was 96.9% ± 13.0%. The results of statistical analysis showed that two formulations were bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第1期43-45,共3页
The Chinese Journal of Clinical Pharmacology
