阿替洛尔片在人体内的相对生物利用度与生物等效性

Relative bioavailability and bioequivalence of Atenolol tablet in healthy male volunteers

目的考察阿替洛尔片（AT）在人体内相对生物利用度及生物等效性。方法22名男性健康受试者，采用单剂量、随机、自身交叉对照试验设计，空腹po AT试验片和参比制剂各50mg后，用RP—HPLC荧光检测法检测血浆中AT经时血药浓度，计算药动学参数和相对生物利用度。结果AT的相对生物利用度为100．6％±33．0％。主要药动学参数的方差分析和双单测t检验表明，试验制剂和参比制剂的AUC0-t Gmax无显著性差异（P〉0．05），AT试验制剂的AUC0-1、Gmax的90％的置信区间分别为90．72％-111．86％、87．48％～117．29％。结论AT试验片和参比制剂具有生物等效性。

OBJECTIVE To determine the relative bioavailability and bioequivalence of atenolol tablet in healthy male volunteers. METHODS In a randomized two - period cross - over study, a single oral dose of 50mg atenolol tablet（test and reference preparation） were given to 22 healthy male volunteers. The concentrations of atenolol in plasma were determined by HPLC - fluorescence method. The pharmacokinetic parameters of the two preparations and the relative bioavailability of atenolol were calculated with statistical analysis. RESULTS The relative bioavailability of atenolol in test were 100.6%±33.0%. There were no significant difference with the pharmacokinetic parameters between test and reference preparation （ P 〉 0.05）. The 90% confidence interval of AUC0-1 was 90.72% - 111.86%, and Cmax was 87.48% - 117. 29%. CONCLUSION The two preparations are bioequivalent.