国产克拉霉素颗粒剂和胶囊剂的相对生物利用度

 目的：研究国产克拉霉素颗粒剂和胶囊与进口片剂的生物利用度和生物等效性。方法：8名健康志愿者随机分3组交叉单剂量po500mg克拉霉素颗粒剂、胶囊剂和片剂，用生物法测定血清浓度，以3P87药动学计算程序处理测定结果并计算药动学参数，采用NDST5.0程序进行统计分析。结果：三者的AUC_0～24分别为(22.13±2.65)，(21.97±2.83)，(22.56±3.26)μg·h·ml^-1；t_max分别为(1.6±0.5)，(1.7±0.6)，(1.6±0.8)h;c_max分别为(2.565±0.189)，(2.682±0.365),(2.518±0.182)μg·ml^-1。结论：统计分析结果表明三者为生物等效，以进口片为参比制剂计算国产颗粒剂和胶囊剂的相对生物利用度分别为(98.6±6.09)%和(97.37±6.29)%。

Relative bioavailability of clarithromycin granule and capsule

OBJECTIVE:To study the relative bioavailability and bioequivalence of domestic clarithromycin granule,capsule and imported tablet.METHODS:Evaluation of the relative bioavailatibities of charithromycin granule,capsule and imported tablet,respectively,8 healthy volunteers were enrolled in a randomized three way crossover study.RESULTS:AUC_0～24 of granule,capsule and tablet were(22.13±2.65),(21.97±2.83),(22.56±3.26)μg·ml^-1,respectively,t_max was (1.6±0.5),(1.7±0.6),(1.6±0.8)h,respectively,c_max was (2.565±0.189),(2.682±0.365),(2.518±0.182)μg·ml^-1 ,respectively.CONCLUSION:The mean relative bioavailability of domestic granule and capsule vs. imported tablet were (98.6±6.09)%,(97.37±6.29)% respectively.The results showed that the three forms were bioequivalce.