泮托拉唑钠肠溶片的生物等效性研究  

Bioequivalence Study of Pantoprazole Sodium Enteric-Coated Tablets

作　　者：姜雅琦 田杰 李梦瑶 张婷[1,2] 甘方良 刘启胜 JIANG Ya-qi;TIAN Jie;LIU Qi-sheng(School of Pharmacy,Xianning Medical College,Hubei University of Science and Technology,Xianning Hubei 437100,China)

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

出　　处：《湖北科技学院学报（医学版）》2024年第2期118-121,126,共5页Journal of Hubei University of Science and Technology(Medical Sciences)

基　　金：咸宁市科技计划社发类研发重点专项项目(2021SFYF0005)。

摘　　要：目的研究泮托拉唑钠肠溶片在中国健康受试者人体药物代谢动力学和生物等效性。方法空腹和餐后组分别纳入36、42例受试者,每周期随机交叉单次空腹或餐后口服受试或参比制剂40mg,用UPLC-MS/MS法测定人血浆中泮托拉唑浓度,Phoenix WinNonlin8.2统计软件计算药代动力学参数,分析两种制剂的生物等效性。结果空腹状态下口服泮托拉唑受试制剂和参比制剂的C_(max)分别为(3295.143±1187.421)、(3600.662±1598.281)ng/mL;T_(max)分别为3.00(1.50,4.50)、3.50(1.50,5.53)h;AUC_(0-t)分别为(13148.4±11834.9)、(13400.2±12421.9)ng·h/mL;AUC_(0-∞)分别为(13877.3±13820.2)、(14990.7±15111.0)ng·h/mL。餐后状态下口服泮托拉唑受试制剂和参比制剂的C_(max)分别为(3146.162±1045.245)、(3497.986±1176.926)ng/mL;T_(max)分别为7.00(5.00,15.00)、7.00(5.00,15.50)h;AUC_(0-t)分别为(11201.7±10554.4)、(11894.2±11191.2)ng·h/mL;AUC_(0-∞)分别为(9012.1±10204.5)、(7487.5±6753.6)ng·h/mL。空腹和餐后口服泮托拉唑受试制剂与参比制剂的主要药动学参数(C_(max)、AUC_(0-t)和AUC_(0-∞))几何均值比90%置信区间在80.00%~125.00%生物等效范围内。结论两种泮托拉唑钠肠溶片在中国健康受试者单次空腹和餐后给药条件下具有生物等效性。Objective To study the pharmacokinetics and bioequivalence of pantoprazole sodium enteric-coated tablets in healthy Chinese subjects.Methods A total of 36 and 42 subjects were included in the fasting and postprandial groups,respectively,and 40 mg of the test or reference preparation were orally administered on a fasting or postprandial with crossed random methodbasis once per cycle.The concentrations of pantoprazole in human plasma were determined by UPLC-MS/MS method,and the pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.2 statistical software.The bioequivalence of the two preparations was analyzed.Results Key pharmacokinetic parameters for oral administration of pantoprazole test and reference formulations on an empty stomach:C_(max)(3295.143±1187.421),(3600.662±1598.281)ng/mL;T_(max)3.00(1.50,4.50),3.50(1.50,5.53)h;AUC_(0-t)(13148.4±11834.9),(13400.2±12421.9)ng·h/mL;AUC_(0-∞)(13877.3±13820.2),(14990.7±15111.0)ng·h/mL.Key pharmacokinetic parameters of the postprandial oral pantoprazole test and reference formulations:C_(max)(3146.162±1045.245),(3497.986±1176.926)ng/mL;T_(max)7.00(5.00,15.00),7.00(5.00,15.50)h;AUC_(0-t)(11201.7±10554.4),(11894.2±11191.2)ng·h/mL;AUC_(0-∞)(9012.1±10204.5),(7487.5±6753.6)ng·h/mL.Afetr the fasting and postprandial oral pantoprazole subject formulations or the reference formulation,the 90%confidence intervals of the least-squares geometric mean ratios for each pharmacokinetic parameter(C_(max),AUC_(0-t)and AUC_(0-∞))fell within the range of 80.00%to 125.00%.Conclusion The two types ofpantoprazole sodium enteric-coated tablets are bioequivalent under single fasting and postprandial administration in Chinese healthy subjects.

关 键 词：泮托拉唑钠 生物等效性 超高效液相色谱法 药物代谢动力学 

分 类 号：R969.1[医药卫生—药理学]