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6种头孢克肟制剂的人体药动学特征及比较
COMPARATIVE STUDY ON PHARMACOKINETICS IN VOLUNTEERS OF DOMESTIC AND IMPORTED CEFIXIME IN 3 DO5AGEFORMS
【摘要】 在30名志愿者中观察比较3种剂型6种制剂的头孢克肟口服人体药动学特征,各批药动学参数均值:C_(max)为2.17~2.62μg/m1,AUC为25.8~29.5(μg·h)/m1,t_(1/2ke),为3.50~4.43h,MRT为7.47~8.15h,制剂间差异无显著性,T_(max)为3.4~4.6h,t_(1/2ka)为1.38~2.25h,细粒剂的T_(max)及t_(1/2ka)较胶囊及片剂短(P<0.01)。表明制剂间吸收程度、达峰浓度及消除过程基本一致,而细粒剂吸收速度较胶囊及片剂快。国产与相同剂型进口制剂的体内过程一致。血浓度检测用微生物法。
【Abstract】 The pharmacokinetic characteristics of domestic and imported cefixime in fine granules,capsule and tablet dosage forms were studied in 30 volunteers, The mean pa- rameters that have no statistic differences between domestic and imported products in dosage forms are listed below:Cmax 2.17~2.62 μg/ml, AUC 25.8~29.5(μg· h)/m1,t1/2ke 3.50~4. 43 h, MRT 7.47~8.15 h. The mean parameters do have statistic differences be- tween dosage forms are Tmax 3.4~4.6h, t1/2ka 1.38~2.25 h and fine granules are shorter than capsules and tablets(P<0.0l).The results showed that no significant difference ex- isted between domestic and imported dosage forms.The plasma level were detected by biOassay.
- 【文献出处】 中国新药杂志 ,CHINESE NEW DRUGS JOURNAL , 编辑部邮箱 ,1996年02期
- 【分类号】R969
- 【被引频次】17
- 【下载频次】246