头孢拉定胶囊的人体生物等效性研究

Study on Bioequivalence of Cephradine Capsules in Volunteers

目的:研究国产头孢拉定胶囊的相对生物利用度,评价其生物等效性。方法:18名健康受试者单剂量口服受试制剂(A)和参比制剂(B)500mg后,采用HPLC法测定血浆中的药物浓度。结果:A和B的Cmax分别为16.32±2.30和14.70±3.98mg·L-1;tmax分别为0.86±0.21和l.04±0.33h;AUC0-f分别为22.75±3.11和22.84±3.92mg·h·L-1;AUC0-∞分别为23.88±3.44和24.02±4.16mg·h·L-1。经统计学分析,A和B两药的制剂间和周期间均无显著性差异(P＞0.05),A的相对生物利用度为100.43%±10.02%。结论:两种头孢拉定胶囊具有生物等效性。

OBJECTIVE: To study relative bioavailability of cephradine capsule andto evaluate its bioequivalence. METHOD: Plasma concentrations were determinedby HPLC method following a single oral dose 500mg two different brand cephradinepreparation. RESULTS: The pharmacokinetic parameters of the test capsule andthe reference capsule in plasma were as following;Cmax were l6.32±2.30mg.L-1and l4.70±3.98mg.L-1;tmax were0.86±0.2l hand l.04±0.33h;AUC0-t,were22.75±3.llmg.h.L-1 and 22.84±3.92mg.h.L-1;AUC0-∞were 23.88±3.44 mg.h.L-1 and24.02±4.l6 mg.h.L-1,respectively. The statistic results show that A and B arebioequivalent formulations. The relative bioavailability of A was l00.43%±l0.02%.CONCLUTION:The two cephradine capsules were of bioequivalence.