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目的 :研究国产头孢哌酮 (CPZ)和舒巴坦 (Sul)复方制剂在正常人体内的药物动力学。方法 :12名健康受试者恒速 ivgtt2 g国产或进口复方制剂 (Sul、CPZ各 1g) ,用 RP- HPL C法分别测定 CPZ和 Sul的经时血药浓度。药 -时数据用 3P87程序拟合。结果 :药 -时曲线符合二室开放模型。国产制剂单剂量 iv gtt后 ,CPZ的 AUC0→∞ 为 (2 2 9.10± 44 .2 1) μg· h/m l,T1 /2β为(2 .2 0± 0 .49) h,MRT为 (2 .96± 0 .95 ) h,Cls 为 (4 .7± 0 .9) L/h,Vc 为 (7.9± 1.3) L;Sul的 AUC0→∞ 为 (6 5 .90± 6 .71) μg·h/m l,T1 /2β为 (1.11± 0 .2 1) h,MRT为 (1.5 3± 0 .40 ) h,Cls为 (16 .0± 1.9) L/h,Vc为 (15 .7± 4.6 ) L。方差分析显示主要药物动力学参数国产与进口制剂无统计学差异 (P>0 .0 5 )。结论 :国产与进口复方制剂的药物动力学基本相似
Objective: To study the pharmacokinetics of domestic compound cefoperazone (CPZ) and sulbactam (Sul) in normal human. Methods: Twelve healthy volunteers were treated with ivgtt2 g at home or imported for 1 g each with Sul and CPZ. The plasma concentrations of CPZ and Sul were determined by RP-HPL-C method. Drug-time data fitting with 3P87 program. Results: The drug-time curve accords with the two-compartment open model. After a single dose of iv gtt, the AUC0 → ∞ of CPZ was (2 2 9.10 ± 44.21) μg · h / ml, T1 / 2β was (2.0 ± 0.49) h, and MRT was (2 .96 ± 0.95) h, Cls was (4.7 ± 0.9) L / h and Vc was (7.9 ± 1.3) L; AUC0 → ∞ of Sul was (65.9 ± 0.671) μg · H / ml, T1 / 2β was (1.11 ± 0.21) h, MRT was (1.5 3 ± 0.40) h, Cls was (16.0 ± 1.9) L / h and Vc was (15.7 ± 4.6) L. Analysis of variance showed no significant difference in the main pharmacokinetic parameters between domestic and imported preparations (P> 0.05). Conclusion: The pharmacokinetics of domestic and imported compound preparations are basically similar