用反相高效液相色谱-电化学(HPLC-ED)法对复方多巴进口片、国产甲片和国产乙片进行人体生物利用度研究,10名健康志愿者采用交叉、平行、对照法口服3种复方多巴片后,测定14h内不同时间的血药浓度。结果表明,国产片与进口片的相对生物利用度:左旋多巴国产甲片为99.40%,乙片为104.30%;卡比多巴国产甲片为99.92%,乙片为102.79%,国产片与进口片的药动学参数除左旋多巴中甲片的Tmar、乙片的Cmar、1/2有非常显著性差异(P<0.01)外,其它各项丰数均无显主性差异(P>0.05)。
Abstract
The bioavailability of levodopa-carbidopa tablets was investigated in ten healthyvoluteers after oral administration. Three kinds of levodopa-carbidopa tablets including sinemet(USA)and A Chinesetablet and B Chinese tablet were used to compare the bioavailability in bodywith cross ,parallel,contrast.The plasma of levodopa-carbidopa levels for 14 hours were deter-mined by HPLC-ED.Pharmacokinetic parameters were fitted with PKBP-N1 program on comput-er. The results show that the comparative bioavailability of A Chinese tablet was 99.40% of levodopa and 99.92% of carbidopa,and that of B Chinese tablet was 104,30%of levodopa and 102.79%of carbidopa.Excepting Tmar of levodopa in A Chinese and Cmar、T1/2 of levodopa in B Chinese were significantly different (P<0.01)between foreign and Chinese tablet,there was no significant difference(P>0.05)between foreign and Chinese tablet on other pharmacokintic parameters.
关键词
生物利用度 /
左旋多巴 /
卡比多巴 /
反相HPLC-电化学法
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Key words
bioavailability /
levodopa /
carbidoa /
reversed-phase HPLC-electrochemical detec-tion
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参考文献
1Richard LF.Carbidopa and levodopa an evalution.Drugintell Clin FAarm, 1976,10:84.
2Cedarbaum JM,Williamson R,Kutt H. Simultaneous determination of levodopa, its metabolites and carbidopa in clinical samples. J Chromatography 1987,415:393.
3Beers MF. Simultaneous determination of L-dopa and 3-omethyldopa in human serum by high-performace liquid chromatography. J Chromatography y 1984,336 : 380.
4杨友春,陈刚,李可深.计算药代动力学参数的一种非线性算法和程序.中国药理学报,1983,4(4):217.
5王士凡,孙定人,王功立,等.药物不良反应.北京:人民卫生版社,1988:479.
6王纪保,李敏,蒋永培主编.临床实用药物概要.西安:陕西科学技术出版社,1992 : 178.
7 Obach R, Menargues A, Valles JM. The pharmacokinetic profile of carbidopa in dogs,7 Pharm Pharmacol,1984,36:415.
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脚注
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