2种头孢地尼制剂在健康人体内的生物等效性研究

目的:研究国产头孢地尼分散片和进口头孢地尼胶囊在健康人体内的药动学和生物利用度,评价二者的生物等效性。方法:20名男性健康志愿者随机交叉单剂量口服受试制剂(国产)或参比制剂(进口)200mg后,采用高效液相色谱法测定人血浆中头孢地尼的浓度,以DAS3.0程序计算药物的药动学参数。结果:受试制剂与参比制剂的主要药动学参数分别为:cmax(1.818±0.544)、(1.900±0.560)ng·mL-1,tmax(3.800±0.750)、(3.925±0.766)h,AUC0～12h(9279.7±2650.3)、(9977.9±2949.3)ng·h·mL-1,AUC0～∞(9639.9±2768.0)、(10304.4±3077.4)ng·h·mL-1。受试制剂相对生物利用度为(95.5±24.3)%。结论:受试制剂与参比制剂具有生物等效性。

Bioequivalence of 2 Kinds of Cefdinir Preparations in Healthy Volunteers

OBJECTIVE:To study the pharmacokinetics and bioavailability of domestic Cefdinir dispersible tablets and imported Cefdinir capsule,and to evaluate the bioequivalence of the two preparations.METHODS:A single oral dose of 200 mg test preparation(domestic)or reference preparation(imported)were administered by randomized crossover way in 20 healthy male volunteers.The plasma concentrations of cefdinir were determined by HPLC.The pharmacokinetic parameters were calculated with DAS 3.0 program.RESULTS:The main pharmacokinetic parameters of test preparation vs.reference preparation were as follows:cmax(1.818±0.544)ng·mL-1 vs.(1.900±0.560)ng·mL-1;tmax(3.800±0.750)h vs.(3.925±0.766)h;AUC0～12 h(9 279.7±2 650.3)ng·h·mL-1 vs.(9 977.9±2 949.3)ng·h·mL-1;AUC0～∞(9 639.9±2 768.0)ng·h·mL-1 vs.(10 304.4±3 077.4)ng·h·mL-1.The relative bioavailability of test preparation was(95.5±24.3)%.CONCLUSION:The test preparation and reference preparation are bioequivalent.