ICP-MS研究琥珀酸亚铁片剂的人体药动学及生物等效性

ICP-MS determination of human pharmacokinetics and bioequivalence of ferrous succinate tablets

目的:研究琥珀酸亚铁片剂的人体药动学和生物等效性。方法:按随机交叉实验设计,20名健康男性受试者单剂量口服给药200 mg后,应用电感耦合等离子体质谱(ICP-MS)技术测定血清铁浓度,并用BAPP 3.0软件计算主要的药动学参数。结果:参比制剂和受试制剂的Cmax分别为(3028.25±707.44)和(2986.50±621.07)μg.L-1;Tmax分别为(3.7±1.3)和(4.3±1.6)h;t1/2分别为(27.66±27.38)和(32.91±32.62)h;AUC0～τ分别为(48394.09±8419.76)和(48459.73±9242.03)μg.h.L-1;AUC0～∞分别为(81768.39±33624.43)和(91477.34±48827.18)μg.h.L-1。结论:经统计学检验表明,2种琥珀酸亚铁片剂具有生物等效性。

Objective：To study pharmacokinetics and bioequivalence of ferrous succinate tablets in healthy volunteers.Methods：A single dose of 200 mg reference or tested tablets of ferrous succinate was orally administered to 20 healthy male volunteers in a randomized crossover way.The serum concentrations of Fe were determinated by ICP-MS,and the key pharmacokinetic parameters were calculated by BAPP 3.0.Results：The pharmacokinetic parameters of the reference and tested tablets were as follows：Cmax were（3028.25±707.44） μg·L-1 and（2986.50±621.07）μg·L-1;Tmax ware（3.7±1.3）h and（4.3±1.6）h;t1/2 were（27.66±27.38）h and（32.91±32.62）h;AUC0-τ were（48394.09±8419.76）μg·h·L-1 and（48459.73±9242.03）μg·h·L-1;AUC0-∞ were（81768.39±33624.43） μg·h·L-1 and（91477.34±48827.18） μg·h·L-1.Conclusion：The statistical results showed that the reference and tested tablets were bioequivalent.