国产与进口头孢布烯片在健康人体的生物等效性

Bioequivalence of domestic and imported ceftibuten tablets in healthy volunteers

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。

Objective To study the bioequivalenee of domestic and imported eeftibuten tablets in healthy volunteers. Methods A single oral doses of 400 mg cefiibuten was given to 22 healthy volunteers in an open randomized crossover design. The concentrations of eeftibuten in plasma were determined by a HPLC method. The pharmaeokinetic parameters of domestic and imported were calculated by 3P97 software. Results The main pharmacokinetic parameters of domestic and imported were as follow：tmax were （2. 18 ±0. 97） and （2.43 ±0. 81 ） h; Cmax were （ 18.58 ± 2.70） and （18.95 ±4.38） μg · mL^-1; t1/2 were （2.41 ±0.86） and （2.36±0. 70） h; AUC0-1 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 ceftibuten were bioequivalent.