阿替洛尔片人体生物等效性研究

目的:了解不同厂家阿替洛尔片的药动学特征和相对生物利用度的差异。方法:将22名健康受试者交叉单剂量口服受试药(T)和参比药(R)50mg后,用HPLC荧光检测法检测不同时间的血药浓度,用非房室模型计算药动学参数,并对Cmax、Tmax和AUC0→24进行生物等效性分析。结果:受试药(T)和参比药(R)的达峰时间(Tmax)分别为(2.61±0.75)h和(2.52±0.65)h;峰浓度(Cmax)分别为(322.9±107.4)ng/mL和(325±126.1)ng/mL;消除半衰期(t1/2β)分别为(5.69±1.11)h和(5.36±1.16)h;AUC0→24分别为(2587.4±808.0)ng/mL.h、(2571.3±810.4)ng/mL.h,AUC0→∞分别为(2739.8±809.7)ng/mL.h和(2704.7±823.2)ng/mL.h。结论:2家阿替洛尔片为生物等效制剂,受试药物对参比药物的相对生物利用度为(100.6±33.0)%。

Study on the bioequivalence of Atenolol tablets

Objective: To study difference in pharmacokinetices and relative bioavailability of atenolol produced by difference factories.Methods: A single oral dose of 50mg atenolol tablets was given respectively to22 healthy voluntees in an open randomized crossover test. Atenolol concentration was determined by SPE-HPLC.Pharmacokinetic parametres were calculated by non-compartment model. Bioequivalence analysis was done to C_(max)、T_(max )and AUC_(0→24). Results: The main pharmacokinetics of the two products(test and reference) were as follow.T_(max) were(2.61±0.75)h and(2.52±(0.65))h,(P>0.05);C_(max )were(322.9±107.4)ng/mL and(325±126.1)ng/mL(P>0.10);t_(1/2β) were(5.69±1.11)h and(5.36±1.16)h;AUC_(0→24) were(2587.4±808.0)ng/mL·h and(2571.3±810.4)ng/mL·h;AUC_(0→∞)were(2739.8±(809.7))ng/mL·h and(2704.7±823.2)ng/mL·h. Conclusion: The two products were bioequivalent,the relative bioavailability was(100.6±33.0)%.