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头孢克罗泡腾片的相对生物利用度
Relative bioavailablity of cefaclor effervescent tabletsin human volunteers
【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。
【Abstract】 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.
【Key words】 cefaclor; effervescent tablets; relative bioavailability; reversed phase-high performance liquid chromatographay;
- 【文献出处】 中国临床药理学与治疗学 ,Chinese Journal of Clinical Pharmacology and Therapeutics , 编辑部邮箱 ,2000年02期
- 【分类号】R969
- 【下载频次】41