国产与进口头孢布烯片在健康人体的生物等效性

目的研究国产与进口头孢布烯片(β内酰胺类抗生素)在健康人体的生物等效性。方法对入选的22名男性健康受试者随机交叉给药,分别单剂量口服头孢布烯试验制剂(国产)和参比制剂(进口)各400 mg;用高效液相色谱法测定血药浓度,用3P97软件计算2者的药代动力学参数及相对生物利用度。结果试验和参比制剂主要药代动力学参数,tmax分别为(2.18±0.97)和(2.43±0.81)h;Cmax分别为(18.58±2.70)和(18.95±4.38)μg.mL-1;t1/2分别为(2.41±0.86)和(2.36±0.70)h;AUC0-t分别为(95.76±14.54)和(96.14±18.87)μg.h.mL-1。试验制剂对于参比制剂的平均相对生物利用度F为(101.77±17.72)%。结论2种头孢布烯制剂为生物等效制剂。

Bioequivalence of domestic and imported ceftibuten tablets in healthy volunteers

Objective To study the bioequivalence of domestic and im-ported cefiibuten tablets in healthy volunteers.Methods A single oral doses of 400 mg ceflibuten was given to 22 healthy volunteers in an open randomized crossover design.The concentrations of ceftibuten in plasma were determined by a HPLC method.The pharmacokinetic parameters of domestic and imported were calculated by 3 P97 software.Results The main phannacokinetic parameters of domestic and imported were as follow:t_(max) were(2.18±0.97)and(2.43±0.81)h;C_(max) were(18.58±2.70)and(18.95±4.38)μg·mL~(-1);t_(1/2) were(2.41±0.86)and (2.36±0.70)h;AUC_(0-t) were(95.76±14.54)and(96.14±18.87)μg·h·mL~(-1),respectively.The relative bioavailability of ceftibuten was(101.77±17.72)%.Conclusion The results demonstrated that the two preparations of cefiibuten were bioequivalent.