中国临床药学杂志

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

AIM: To study the pharmacokinetics of cefoperazone/sulbactam following intravenous administration. METHODS: Twelve healthy volunteers were administered cefoperazone sulbactam (1 g∶1 g) combination as a 15 min infusion. The serum concentration of cefoperazone and sulbactam were determined by different reversed phase high performance liquid chromatography (RP HPLC) method. Pharmacokinetic parameters were obtained using 3P87 program. RESULTS: For cefoperazone, the AUC 0→∞ was (229 10±44 21) μg·h/ml, T 1/2β was (2 20±0 49) h, MRT was (2 96±0 95) h, Cl s was (4 7±0 9) L/h, V c was (7 9±1 3) L. For sulbactam, the AUC 0→∞ was (65 90±6 71) μg·h/ml, T 1/2β was (1 11±0 21) h, MRT was (1 53±0 40) h, Cl s was (16 0±1 9) L/h, V c was (15 7±4 6) L for domestic preparation. These parameters were similar to those of the imported preparation. CONCLUSION: The results show that there is no significant difference between the domestic (Lin Lan Xin) and imported preparations in pharmacokinetics.