羟氨苄青霉素片剂的人体相对生物利用度  

Relative human bioavilability of amoxicillin tablet

作　　者：潘家祜[1] 张宏伟[1] 戴晓华 吴超[1] 李端[1] 

机构地区：[1]上海医科大学药学院药理学教研室,上海200032

出　　处：《中国临床药学杂志》1999年第4期224-226,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的:研究国产羟氨苄青霉素片剂(Am-1)与荷兰产同类产品(Am-2)间的人体相对生物利用度和生物等效性.方法:采用反相HPLC法测定健康男性志愿受试者单剂量po 500mg两种Am片后血药浓度的变化.结果:Am-1和Am-2的以AUC分别为(24.24±3.75)和(22.9±4.83)(h·μg)/ml,t_(max)分别为(1.40±0.37)和(1.26±0.13)h,C_(max)分别为(7.12±1.16)和(7.09±1.71)μg/ml.Am-1与Am-2比较的相对生物利用度为105.45%.经检验两者AUC、t_(max)、C_(max)均无显著性差异(P>0.05).结论:两种Am片剂具有生物等效性.AIM: To study the relative bioavailability of domestic amoxicillin tablet (Am-1) comparing with the product prouduced in Holland (Am-2) in 8 healthy volunteers. METHODS: The serum Am concentrations in the volunteers after a single oral dose 500 mg were assayed by reversed phase high-performance liquid chromatography method in a randomized cross-over test. The data were then treated by the 3P87 pharmacokinetic procedure. RESULTS; The AUC0-∞, for the Am-1 and Am-2 were (24. 24±3. 75) and (22.96±4.83) (h·μg)/ml; the t_(max), were (1. 40±0.37) and (1.26 ± 0. 13) h; the c_(max), were (7.12±1.16) and (7.09/1.71) fig/ml, respectively. The relative bioavilability of Am-1 comparing with Am-2 was 105. 45%. The results of statistical analysis showed that there were no significant differences for the AUC0-∞,t_(max),c_(max) between Am-1 and Am-2 (P>005). CONCLUSION:The 2 Am tablets are bioequivalent.

关 键 词：羟氨苄青霉素 相对生物刊用度 高效液相色谱法 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]