雷贝拉唑钠肠溶片在健康受试者中的生物等效性研究  

Bioequivalence of Rabeprazole sodium enteric-coated tablets in healthy subjects

作　　者：田杰 姜雅琦 张婷[1,2] 李梦瑶 饶夏莉 甘方良 TIAN Jie;JIANG Yaqi;ZHANG Ting;LI Mengyao;RAO Xiali;GAN Fangliang(Office of Clinical Pharmacology,The First Affiliated Hospital of Hubei University of Science and Technology/Xianning Central Hospital,Hubei Xianning 437100,China;School of Pharmacy,Faculty of Medicine,Hubei University of Science and Technology,Hubei Xianning 437100,China)

机构地区：[1]湖北科技学院附属第一医院/咸宁市中心医院临床药理机构办公室,湖北咸宁437100 [2]湖北科技学院医学部药学院,湖北咸宁437100

出　　处：《中国医院药学杂志》2024年第6期624-628,647,共6页Chinese Journal of Hospital Pharmacy

基　　金：咸宁市科技计划社发类研发重点专项(编号:2021SFYF005)。

摘　　要：目的:研究健康受试者在空腹和餐后条件下单剂量口服雷贝拉唑钠肠溶片受试制剂和参比制剂的生物等效性。方法:空腹与餐后试验各入组26例健康受试者,分别空腹和餐后口服10 mg受试制剂或参比制剂。采用超高效液相色谱-串联质谱(UPLC-MS/MS)法检测人血浆中雷贝拉唑的浓度,使用Phoenix Win Nonlin 8.2统计软件的非房室模型法(NCA模块)计算雷贝拉唑的药动学参数,并进行生物等效性评价。结果:空腹试验受试制剂和参比制剂雷贝拉唑的C_(max)、AUC_(0-t)和AUC_(0-∞)的几何均值比的90%CI分别为85.32%~124.01%、93.76%~111.61%和93.89%~110.21%;餐后试验受试制剂和参比制剂的C_(max)、AUC_(0-t)和AUC_(0-∞)的几何均值比的90%CI分别为86.73%~114.09%、92.33%~110.62%和98.74%~110.57%。空腹和餐后条件下受试制剂与参比制剂主要药动学参数的几何均值比的90%CI均在80%~125%范围内。结论:在空腹和餐后条件下单剂量口服雷贝拉唑钠肠溶片受试制剂和参比制剂具有生物等效性。OBJECTIVE To investigate the bioequivalence of rabeprazole sodium enteric-coated tablets and reference tablets in healthy subjects under fasting and postprandial conditions.METHODS A total of 26 healthy volunteers were enrolled in fasting and postprandial tests,and 10 mg of test preparation or reference preparation was taken orally on fasting and postprandial respectively.The concentration of rabeprazole in human plasma was determined by UPLC-MS/MS.The pharmacokinetic parameters of rabeprazole were calculated by the non-atrioventricular model(NCA module)of Phoenix WinNonlin 8.2 statistical software,and the bioequivalence was evaluated.RESULTS The 90%CI of C_(max),AUC_(0-t) and AUC_(0-∞)geometric mean ratio of fasting test preparation and reference preparation rabeprazole were 85.32%~124.01%,93.76%~111.61%and 93.89%~110.21%.The 90%CI of C_(max),AUC_(0-t) and AUC_(0-∞)geometric mean ratio of test preparations and reference preparations in postmeal test were 86.73%~114.09%,92.33%~110.62%and 98.74%~110.57%.Under fasting and postprandial conditions,90%CI of geometric mean ratio of pharmacokinetic parameters between test preparations and reference preparations were in the range of 80%~125%.CONCLUSION The test preparation and reference preparation of rabeprazole sodium enteric-coated tablets were bioequivalent under fasting and postprandial conditions.

关 键 词：雷贝拉唑钠 生物等效性 药动学 肠溶片 

分 类 号：R969.1[医药卫生—药理学]