头孢氨苄分散片人体药动学及相对生物利用度  

Relative bioavailability and pharmacokinetics of cefalexin dispersible tablet in normal subjects

作　　者：冯超英[1] 杨燕燕[1] 刘会臣[1] 胡玉钦[1] 高岩 孙淑平 

机构地区：[1]中国人民解放军白求恩国际和平医院临床药理室,河北石家庄050082

出　　处：《中国医院药学杂志》2000年第8期465-467,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :研究健康人体内头孢氨苄分散片药动学及相对生物利用度。方法 :12名健康志愿受试者自身交叉口服头孢氨苄分散片和头孢氨苄片 5 0 0mg后 ,采用高效液相色谱法测定血清中头孢氨苄浓度。 结果 :头孢氨苄分散片和片剂的体内过程均符合一房室模型 ,AUC分别为 :(132 8.0± 30 3 .9)和 (130 4.4± 2 6 6 .7) μg·ml-1·min ;Tmax分别为 (2 6 .6± 15 .1)和 (4 6 .6± 9.2 )min ;Cmax分别为 (13.2± 4.9)和 (10 .2± 2 .9) μg·ml-1。经方差分析 ,两药Tmax间差异有显著性 ,其他药动学参数间差异无显著性 ;对于lnAUC ,双向单侧t检验表明 ,头孢氨苄分散片与片剂具有生物等效性。结论 :头孢氨苄分散片与头孢氨苄片剂具有生物等效性 ,头孢氨苄分散片的相对生物利用度为 (10 6 .6± 33.6 ) %。OBJECTIVE:To study the pharmacokinetics and bioavailability of cefalexin dispersible tablet in healthy male volunteers.METHODS:After a single oral dose of 500mg cefalexin dispersible tablets or tablets was given to 12 healthy volunteers in a randominzed crossover study. Cefalexin concentration in serum was determined by high performance liquid chromatorgraphy.RESULTS:The concentration time curves of cefalexin dispersible tablets and tablets fitted to one-compartment model. AUC 0～∞ of dispersible tablets and tablets were ( 1 328.0 ± 303.9 ) and ( 1 304.4 ± 266.7 )μg ·ml -1 ·min; T max ( 26.6 ± 15.1 ) and ( 46.6 ± 9.2 )min; C max ( 13.2 ± 4.9 ) and ( 10.2 ± 2.9 )μg·ml -1 .Between the two preparations,there was significant difference in T max ,there was no significant difference in other pharmacokinetic parameters.CONCLUSIONS:The dispersible tablet and tablet of cefalexin were bioequivalent.The relative bioavailability of cefalexin dispersible tablet was ( 106.6 ± 33.6 )%.

关 键 词：头孢氨苄分散片 高效液相色谱法 相对生物利用度 

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