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国产与进口头孢布烯片在健康人体的生物等效性 被引量:1

Bioequivalence of domestic and imported ceftibuten tablets in healthy volunteers
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摘要 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.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2010年第1期19-22,共4页 The Chinese Journal of Clinical Pharmacology
关键词 头孢布烯 高效液相色谱 药代动力学 生物等效性 ceftibuten HPLC pharmacokinetic bioequivalence
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