国产利福平胶囊的人体相对生物利用度

本文采用高效液相色谱法测定人血清中利福平浓度，在9例健康男性志愿者体内研究了国产利福平胶囊的人体相对生物利用度。单剂量空腹口服（600mg）利福平胶囊测试药品与参比药品后，体内过程符合一级吸收的二房空模型，达峰时间、峰浓度、曲线下面积分别为1.49±0.69h和1.84±0.68h，16.72±3.08μg／ml和17.84±4.86μg／ml,123.83±21.52μg／（ml·h）和126.64±34.02μg／（ml·h）。方差分析结果表明，两药的药代动力学参数无显著性差异（P＞0.05）;双向单侧T-检验结果表明，两药具有生物等效性;测试药品的相对生物利用度为97.78％。

The Relative Bioavalibility of Domestic Rifampin Capsules in Healthy Volunteers

A study on the relative bioavailability of domestic rifampin capsules was performed in 9 healthy volunteers. According to the corss-over randomized design, each volunteer was given domestic and imported rifampin capsules in single dose of 600mg alternatively. The serum drug concentrations were determined by HPLC method. The pharmacokinetics of rifampin could be described by a two compartment model with first order absorption. The Tpeak, Cmax, AUC of two preparations were 1.49±0.69h and 1. 84±0. 68h. 16. 72±3. 08μg/ml and 17. 84±4. 86μg/ml. 123. 83±21. 52μg/(ml·h) and 126.64±34. 02μg/(ml·h), respectively. There were no significant differences in the pharmacokinetic parameters between two preparations. The relative bioavalibility of domestic capsules was 97.78%. The results suggested that the bioavalibility of the two preparations was simillar.