【摘要】 目的测定卡托普利片在人体内的相对生物利用度。方法 18名健康志愿者单剂量口服卡托普利片,以反相高效液相色谱法测定其血药浓度。结果受试制剂和参比制剂中卡托普利主要药物动力学参数为:达峰时间为(0.83±0.23)h和(0.81±0.28)h,达峰时药物质量浓度为(22.88±13.64)mg·L-1和(20.96±8.06)mg·L-1,消除相半衰期为(1.95±0.11)h和(1.89±0.11)h,药时曲线下面积为(66.92±11.15)mg·h·L-1和(67.85±12.33)mg·h·L-1。结论试验制剂与参比制剂两种制剂生物等效。更多还原

【Abstract】 Objective To study the relative bioavailability of captopril tablets in human being.Methods The randomized,crossed-over study was conducted in 18 healthy volunteers.After a single dose(containing 100 mg captopril),the plasma drug levels were determined by RP-HPLC.Results The main pharmacokinetic parameters of captopril in the test and reference formulation were as follows: tmax were( 0.83±0.23) and(0.81±0.28) h;cmax were(22.88±13.64) and(20.96±8.06) mg·L-1,t1/2were(1.95±0.11)and(1.89±0.11) h;AUC0→∝were(66.92±11.15) and(67.85±12.33) mg·h·L-1,respectively.Conclusion It can be showed that the two formulations are bioequivalent.更多还原