论文部分内容阅读
10名健康志愿者,随机交叉口服单剂量噻氯匹定胶囊或片剂,采用HPLC测得血浆中药物浓度分别在2.94±1.02和2.41±0.65h达到峰值2253.3±664.1和2054.5±337.6μg/L。两种制剂的消除相半衰期分别为12.6±1.55和12.9±2.19h;AUC分别为16918.2±2673.7和17217.3±2851.7μg·h·L-1。药时曲线符合一级吸收的二室模型。以进口噻氯匹定片为标准,算得国产噻氯匹定胶囊的相对生物利用度为98.5±7.82%,经双单侧t检验,两种制剂具有生物等效性。
Ten healthy volunteers were randomized to receive a single dose of ticlopidine capsules or tablets. The plasma concentrations measured by HPLC reached the peak of 2253.3 at 2.94 ± 1.02 and 2.41 ± 0.65 hours, respectively ± 664.1 and 2054.5 ± 337.6 μg / L. The elimination half-lives of the two formulations were 12.6 ± 1.55 and 12.9 ± 2.19 h, respectively; AUC was 16918.2 ± 2673.7 and 17217.3 ± 2851.7 μg · h · L -1, respectively. Drug curve in line with the absorption of a two-compartment model. The relative bioavailability of domestic ticlopidine capsules was 98.5 ± 7.82% based on the import of ticlopidine tablets. The bioavailability of the two formulations was bioequivalent by double-sided t-test.