田可及新山地明胶囊生物利用度对比  

A STUDY ON COMPARASION OF RELATIVE BIOAVAILABILITY OF DOMESTIC CICLOSPORINE CAPSULE AND SANDIMMUN CAPSULE

作　　者：赵惠萍[1,2] 刘桦[1,2] 屈桂秋[1,2] 张愚 马潞林[1,2] 

机构地区：[1]首都医科大学附属北京红十字朝阳医院 [2]北京铁路分局中心医院药剂科

出　　处：《中国新药杂志》1999年第6期391-393,共3页Chinese Journal of New Drugs

摘　　要：目的：考察国产田可与进口新山地明胶囊的生物利用度。方法：对６例健康志愿者进行自身交叉口服单剂量田可及新山地明胶囊，用ＦＰＩＡ法测其全血浓度。资料数据采用ｔ检验做统计学处理。结果：田可及新山地明胶囊的主要药代动力学参数分别为：ｔ１／２β（１０．７３±１４．５５）ｈ，ＡＵＣ（６．７６±１．８４）（ｍｇ·ｈ）／Ｌ，Ｔｍａｘ（２．８９±１．５６）ｈ，Ｃｍａｘ（６６９．５７±２１８．３６）ｍｇ／Ｌ，和ｔ１／２β（５．００±０．８２）ｈ，ＡＵＣ（７．０４±２．４８）（ｍｇ·ｈ）／Ｌ，Ｔｍａｘ（１．３５±０．２１）ｈ，Ｃｍａｘ（１３７２．０９±３５９．１２）ｍｇ／Ｌ。田可胶囊相对于新山地明胶囊的生物利用度为９６％。结论：国产田可及进口新山地明胶囊的生物利用度有显著性差异。OBJECTIVE :To compare the relative bioavailability of a domestic ciclosporine capsule with an imported one. METHODS :The study was conducted in 6 volunteers.After l single dose of domestic ciclosporine capsule or sandimmun capsule was taken,blood samples were taken and blood drug concentration was determined by FPLA method.The major pharmacokinetic parameters were calculated. RESULTS :The t1/2,AUC,Tmax,Cmax for domestic ciclosporine capsule were(10.7314.55)h,(6.671.84)mg/L,(2.891.56)h,and (669.57218.36)mg/L respectively;the t1/2,AUC,Tmax,Cmax for sandimmun capsule were(5.000.82)h,(7.042.48)(mgh)/L,(1.350.24)h,and (1372.09359.12)mg/L respectively.The relative bioavailability of of ciclosporine capsule is 96% of that of the sandimmun capsule. CONCLUSIONS :Significant difference exists between bioavailability of ciclosporine capsule and sandimmun capsule.

关 键 词：田可 新山地明 生物利用度 免疫抑制剂 

分 类 号：R979.5[医药卫生—药品]