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作 者:裘福荣[1] 季金梅 陈波[1] 曾照宏[1] 孙华[1] 冒国光[1]
机构地区:[1]皖南医学院弋矶山医院临床药理研究所,芜湖241001 [2]芜湖市第二人民医院
出 处:《中国临床药理学与治疗学》2000年第2期142-144,共3页Chinese Journal of Clinical Pharmacology and Therapeutics
摘 要:目的研究头孢克罗泡腾片在健康志愿者体内的相对生物利用度。方法采用双交叉试验 ,12名健康志愿者口服单剂量头孢克罗泡腾片和胶囊两种制剂0.75g,RP_HPLC法测定人血浆中头孢克罗浓度 ,药_时数据用ATPK拟合 ,按一室模型计算药物动力学参数。结果泡腾片和胶囊Tmax 分别为 (0.58±0.12)和 (0.73±0.17)h,Cmax 分别为 (31.27±5.81)和 (30.56±5.25) μg·ml-1 ,AUC0~4 分别为 (35.5±4.65)和 (35.9±2.90) μg·h·ml-1 。试验品的相对生物利用度为 (98.6±7.5) %。结论头孢克罗泡腾片与胶囊生物等效。Aim To study relative bioavailablity of cefaclor effervescent tablets in healthy volunteers. Methods According to the crossover design, A volunteers were each orally given a single does of the 0.75 g cefaclor effervescent tablets and cefaclor capsules with an interval of 5 days between the two formulations.The plasma concentrations of the drug were determined by RP-HPLC.Pharmacokinetic parameters were obtained by ATPK programe,and calculated on the basis of open single compartment model.Results After a single oral dose, the peak levels in plasma averaged Cmax(31.27±5.81)μg·ml-1 and(30.56±5.25) μg·ml-1 at (0.58±0.12)h and(0.73±0.17)h and AUC0~4(35.48±4.65) μg·h·ml-1 and (35.89±2.90) μg·h·ml-1 for tablet and capsule,respectively. Conclusion The result shows that two formulations are bioequivalence.
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