【摘要】 本文在8例健康成人男性志愿者中进行了进口与国产氟嗪酸药代动力学比较研究。交叉试验设计,口服给药200mg,血清与尿中药物浓度用高效液相色谱法及微生物法两种方法比较测定。结果表明:两种药物从吸收、分布、排泄上都无显著性差异,其相对生物利用度为103.02%,根据所得药代动力学参数,从生物利用度角度对国产氟嗪酸质量进行了评价。更多还原

【Abstract】 The bioavailability of domestic product of ofloxacin produced by Beijing Pharmaceutcal Fac-tory was studied in eight normal male volunteers. A single oral dose of 200 mg ofloxacin tablets made inChina or Japan was given according to a cross over design. Serum and urine levels of ofloxacin were measuredby both HPLC and bioassay. Pharmacokinetic parameters obtained from our studies showed no significant dif-ference either between the two products or between two assays. The concentration-time curves of the two products of ofloxacin measured by two assays all fitted to atwo-compartment open model. Cmax of ofloxacin (China) and Cmax of ofloxacin (Japan) measured bybioassay were 1.51±0.29 and 1.67±0.29 mg/l respectively; Tmax of the two products were 1.46 and 1.41h, respectively; AUC and t1/2β were 12.21±1.41 and 13.09±1.07 mg·h/l; 6.31 and 6.38 h,respectively. The relative bioavailabilities of ofloxacin made in China measured by HPLC and bioassay were 103 % and107% respectively.更多还原