氧氟沙星胶囊生物利用度和药物动力学的研究

目的 :考察氧氟沙星胶囊的人体相对生物利用度及药代动力学 ,生物等效性 ,从而评价其临床疗效。方法 :泰利必妥片为对照品 ,选 10名志愿受试者 ,随机分成 2组 ,自身交叉服用 ,以高效液相色谱法检测血药、尿药浓度及生物利用度 ,进而对主要动力学参数进行分析。结果 :交叉口服氧氟沙星胶囊和泰利必妥片后 2组药物动力学特性接近 ,药动学参数基本一致 ,试验药品的相对生物利用度平均为 (10 6 2 3± 5 3 6) %。结论 :氧氟沙星胶囊和泰利必妥片生物等效。

STUDY ON THE PHARMACOKINETICS AN RELATIVE BIOAVAILABILITIES OF OFLOXACINS IN HEALTH VOLUNTEERS

Objective:Compared with ofloxacin tablets,to study the pharmacokineties and relative bioavailabilities of ofloxacin capsules.Methods:10 male health volunteers orally took a single does of 300mg ofloxacins in randomized selfcrossover way.ofloxacin concetration was determined by high performance liquid chromatography.Data of serum level-time were disposed with PKBP-N1 of software and computer.Results:The concentration time data of ofloxacin was fitted to two compartment model and the main pharmacokinetic parameters are as following sapsule:C max =(5.22±0.87)ug/ml;T max =(0.96±0.04)h;AUC 0-24 =(33.46±3.92)μg/(ml·h);t 1/2 (β)=6.02±0.40)h.Tablet:C max (5.09±0.77)μg/ml;T max =(0.89±0.21)h;AUC 0-24 =(31.46±2.8)μg/ml·h;t 1/2 (β)=(6.12±0.39)h.Relative:Bioavaiability of capsule was (106.23±5.63).Compared with tablet.Conclusion:The two formulations are of bioequivaicnce.