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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%。
In this paper, the determination of rifampicin concentration in human serum by high performance liquid chromatography, the relative bioavailability of domestic rifampicin capsules in nine healthy male volunteers in vivo. A single dose of fasting oral (600mg) rifampicin test drugs and reference drugs, the body process in line with a two-compartment empty model of absorption, peak time, peak concentration, area under the curve were 1.49 ± 0.69h and 1.84 ± 0.68 h, 16.72 ± 3.08 μg / ml and 17.84 ± 4.86 μg / ml, 123.83 ± 21.52 μg / (ml · h) and 126.64 ± 34.02 μg / (ml · h), respectively. Analysis of variance showed that there was no significant difference in pharmacokinetic parameters between the two drugs (P> 0.05). Bilateral unilateral T-test showed that the two drugs were bioequivalent. The relative bioavailability of the tested drugs was 97.78% .