摘要
目的:研究兰索拉唑肠溶片与肠溶胶囊在健康人体的生物等效性。方法:20名健康志愿者采用双周期交叉试验,单剂量空腹口服兰索拉唑肠溶片和肠溶胶囊各30mg,HPLC法测定其血清中兰索拉唑浓度,血药浓度-时间数据经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果:兰索拉唑肠溶片与肠溶胶囊的主要药代动力学参数:t1/2为1.808±1.031和1.341±0.498h、Cmax为0.764±0.385和0.902±0.369μg·ml-1、Tmax为3.639±0.744和2.500±1.000h、AUC0-10h为3.024±1.941和3.098±1.742μg·h·ml-1。兰索拉唑肠溶片的相对生物利用度为109.57%±59.48%。结论:两种制剂具有生物等效性。
AIM： To investigate the bioequivalence of lansoprazole enterosoluble tablets and capsules in Chinese healthy volunteers. METHODS： Twenty volunteers were randomly divided into two groups （test and reference）, with double cross over design. The concentration in serum was determined by HPLC and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics pharmacokinetic parameters of lansoprazole enterosoluble tablets and capsules were as follows： t1/2 were 1. 808 ±1.031 and 1.341 ± 0.498 h, Cmax were 0.764 ± 0.385and 0.902 ± 0. 369 μg· ml^- 1, Tmax were 3. 639 ± 0. 744and 2.500 ± 1.000 h, AUC0-10h were 3.024 ± 1.941 and 3.098 ± 1.742μg· h· ml^- 1 . The relative bioavalibility of lansoprazole enterosoluble tablets was 109.57% ±59.48%. CONCLUSION： The statistical analysis showed that the test and reference preparation were bioequivalent.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第5期558-561,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
