摘要
目的:比较两种国产卡马西平(Carbamazepine,CBZ)片(B,C)与北京CIBA-GEIGY产得理多(Tegretol)片(A)的人体相对生物利用度。方法:采用FPIA测定人血清CBZ浓度。12名健康志愿者口服300mgCBZ片,采用随机单盲同体交叉试验,进行B,C与A人体相对生物利用度研究。结果:B,C对A的相对生物利用度分别为(100.7±20.9)%,(110.2±23.1)%;A,B,C的Ka分别为(0.15±0.11),(5.3±6.6)和(8.0±15.3)h-1,达峰时间(Tmax)分别为(16.3±5.4),(3.4±3.8)和(2.3±1.9)h;消除半衰期(T1/2)分别为(42.0±9.9),(42.1±13.9)和(41.6±13.4)h;血药浓度曲线下面积(AUC0→∞)分别为(265.2±59.4),(265.6±82.3)和(286.1±73.6)mg.h.L-1。经统计学分析B,C与A的Tmax,Ka差异有极显著性(P<0.01),其余各参数差异均无显著性(P>0.05)。单次给药后,CBZ血药浓度-时间曲线出现双峰或多峰现象。结论:B,C生物等效。
Objective:To compare the relative bioavailability of tegretol and two domestic carbamazepine tablets in human.Methods:Carbamazepine serum concentration was determined by FPIA. A single oral dose of 300 mg Carbamazepine tablet was given respectively to 12 volunteers in a randomized, single blind, cross over study for comparison of relative bioavailability in human. Results:The relative bioavailability of two domestic Carbamazepine tablets was ( 100.72 ± 20.93 ),( 110.21 ± 23.07 )%。Absorption rate constant (Ka) was significantly smaller for Tegrelol( 0.1460 ± 0.1077 )h -1 than that for two domestic Carbamazepine tablets ( 5.2931 ± 6.5778 ),( 7.9617 ± 15.2934 )h -1 . The mean time to maximum concentration(T max ) was significantly greater after Tegretol ( 16.28 ± 5.37 )h than that after two domestic Carbamazepine tablets ( 3.35 ± 3.82 ),( 2.26 ± 1.86 )h. After single dosing,the serum level time curves appeared double or multiple peaks.Conclusion:The processes of two domcstic Carbamazepine tablets in human body are similar, but both of them are different to that of Tegretol.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1998年第10期435-438,共4页
Chinese Journal of Hospital Pharmacy
关键词
卡马西平
荧光偏振免疫法
生物利用度
Carbamazepine
Fluorescence polarization immunoassay
Biovailability
Pharmacokinetics