曲马多滴剂的相对生物利用度  

RELATIVE BIOAVAILABILITY OF TRAMADOL DROPS

作　　者：余琛[1] 张慧[1] 洪有采[1] 陈秋潮[2] 

机构地区：[1]上海市徐汇区中心医院,上海200031 [2]上海医科大学中山医院,200032

出　　处：《中国临床药学杂志》1997年第1期5-7,共3页Chinese Journal of Clinical Pharmacy

摘　　要：采用反相高效液相色谱-荧光检测法检测血清中曲马多的浓度,比较研究了进口和国产曲马多滴剂在9名男性健康志愿者的药物动力学参数和生物利用度,结果:国产滴剂C_(max)=327.7±92.8ng·ml^(-1),T_(max)=1.567±0.781h,T_(1/2)=11.85±5.46h,AUC=2940±750ng·h^(-1)·nl^(-1);进口滴剂C_(max)= 340.9±74.2ng·ml^(-1) ,T_(max)=1.204±0.698h,T_(1/2)=8.857±7.326h,AUC=2938±607ng·h^(-1)·ml^(-1).国产滴剂的生物利用度为进口滴剂的99.85%.两种滴剂AUC、T_(1/2)数据经对数转换后的配对t检验结果均无显著性差异(P>0.05).生物等效性检验合格.The bioavailability of domestic tramadol drops was studied in 9 healthy male volunteers after a single oral dose of 1 mg·kg-1 compared with imported tramadol.The serum levels of tramadol were assayed by high performance liquid chromatography with fluorescence detection. The oral administration pharmacokinetic model was described as a two-compartment model. The pharmacokinetic parameters of the China-made and Germany-made tramdol were: AUC 2940±750 and 2938±607ng·ml-1; T1/2 11.85±5.46 and 8. 857±7. 326h;Cmax327.7±92.8 and 340.9±74.2ng·ml-1;Tmax 1.567±0.781 and 1.204±0.698h respectively. The relative bioavailability of the China-made tramadol was 99.85% and the bioequivalence of the two tramadol drops was qualified.

关 键 词：曲马多滴剂 高效液相色谱 生物利用度 镇痛药 

分 类 号：R971.1[医药卫生—药品]