依诺沙星胶囊在健康人体的药物动力学及相对生物利用度  

Pharmacokinetics and relative bioavailability of enoxacin in healthy volunteers

作　　者：张莉蓉[1] 乔海灵[1] 王海学[1] 

机构地区：[1]河南医科大学临床药理学教研室,郑州450052

出　　处：《中国临床药学杂志》2002年第2期89-91,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的 :研究依诺沙星胶囊的健康人体药物动力学及相对生物利用度。方法 :10名健康受试者随机交叉单剂量口服依诺沙星被试及参比制剂 ,采用微生物法测定血清中依诺沙星浓度 ,用 3P87软件经微机处理药 时数据。结果 :2种制剂的体内过程均符合一房室模型 ,与参比制剂相比 ,被试制剂的相对生物利用度为 (10 1 75± 8 17) %。结论 :对AUC、cmax进行方差分析和双单侧t检验证明 。AIM: To study the pharmacokinetics and relative bioavailability of enoxacin capsules. METHODS: Ten male healthy volunteers took a single dose of 600 mg enoxacin orally in an open randomized crossover study. The serum concentrations of enoxacin were determined by microbiology assay. Data of serum level time were disposed with 3P87 software and computer. RESULTS: The serum concentration time curves of the 2 preparations appeared to fit one compartment open model. The pharmacokinetic parameters of test and reference preparations were as follows, c max : (4.44± 0.66) mg·mL -1 and (4.72±0.67) mg·L -1 ; t max : (1.55±0.28) h and (1.50±0.24) h; AUC: (21.65± 2.63) mg·h·L -1 and (21.26±1.64) mg·h·L -1 respectively. There were no significant differences in the pharmacokinetic parameters between test preparation and reference preparation. Compared with reference preparation, the relative bioavailability of test preparation was (101.75±8.17)%. CONCLUSION: The result of statistical analysis shows that the 2 preparations are bioequivalent.

关 键 词：微生物法 氟喹诺酮类药物 依诺沙星胶囊 相对生物利用度 药物动力学 

分 类 号：R969[医药卫生—药理学]