中国临床药理学杂志2024，Vol.40Issue(1)：92-96,5.DOI:10.13699/j.cnki.1001-6821.2024.01.019
艾普拉唑肠溶片不同给药方案对其抑制胃酸分泌影响的研究
Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
庞廷媛 1李俊龙 2韩智慧 3钟国平 4程国华 2胡海棠 3王芷 5胡姊姝 2申子涵 2王悦琦 2陈雅倩 2钱学兵 2梁锦莹 2易良英2
作者信息
- 1. 广州医科大学附属肿瘤医院药学部,广东广州 510095
- 2. 暨南大学药学院,广东广州 511400
- 3. 丽珠医药集团股份有限公司,广东珠海 519090
- 4. 东莞康华医院临床试验研究中心,广东东莞 523080||中山大学临床药理研究所,广东广州 510080
- 5. 东莞康华医院临床试验研究中心,广东东莞 523080
- 折叠
摘要
Abstract
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH＞3 after 20 mg qd and 10 mg bid were 82.64％and 61.92％,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.关键词
艾普拉唑/中国健康受试者/胃酸pH监测/药代动力学Key words
iprrazole/Chinese healthy subjects/pH monitoring of gastric acid/pharmacokinetics分类
医药卫生引用本文复制引用
庞廷媛,李俊龙,韩智慧,钟国平,程国华,胡海棠,王芷,胡姊姝,申子涵,王悦琦,陈雅倩,钱学兵,梁锦莹,易良英..艾普拉唑肠溶片不同给药方案对其抑制胃酸分泌影响的研究[J].中国临床药理学杂志,2024,40(1):92-96,5.
