摘要
目的评价健康人体内硫普罗宁肠溶胶囊(试验制剂,T)与硫普罗宁片(参比制剂,R)生物等效性。方法18名健康志愿者按体质量随机交叉口服试验制剂硫普罗宁肠溶胶囊和参比制剂硫普罗宁片(凯西莱),剂间间隔为2周,剂量均为200mg,HPLC-MS/MS法测定血清中硫普罗宁浓度并进行相关药动学参数分析,计算相对生物利用度并进行两种制剂生物利用度的评价。结果受试制剂和参比制剂药时曲线均符合二室开放性模型,两制剂Cmax(μg·ml-1)分别为3.612±1.2393(R)和3.644±1.540(T),tmax为4.333±1.0853(R)和3.611±1.420(T),t1/2(h)为18.245±11.270(R)和23.403±10.500(T),AUC0-t(μg·h·ml-1)为18.732±6.92318(R)和18.713±6.585(T),AUC0-∞(μg·h·ml-1)为21.900±7.31220(R)和20.780±7.965(T)。硫普罗宁肠溶胶囊与片剂比较相对生物利用度为(103.712±23.956)%。肠溶胶囊ln(AUC0-72)、ln(AUC0-∞)90%置信区间为91.1%~111....
Objective To evaluate the bioequivalence of tiopronin enteric capsules (testing preparation, T) versus tablets (reference preparation, R). Methods A single oral dose of tiopronin enteric capsules or tablets at 200 mg was administered in 2 groups of Chinese healthy volunteers (n=9) in a randomized crossover design at the interval of 2 weeks. The plasma concentrations of tiopronin were measured by HPLC-MS/MS, and the pharmacokinetic parameters were calculated by DAS 2.0 program. The bioequivalence between the...
出处
《南方医科大学学报》
CAS
CSCD
北大核心
2009年第8期1632-1634,共3页
Journal of Southern Medical University
