Article(id=1291339052523971120, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.015, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1719936000000, receivedDateStr=2024-07-03, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808822040, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808822040, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808822040, creator=13041195026, updateTime=1785808822040, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=225, endPage=229, ext={EN=ArticleExt(id=1291339054386242098, articleId=1291339052523971120, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Effects of high- fat diet intake on pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects.
Methods A single-center, randomized, open, two-agent, two-sequence, four-cycle, fully repeated crossover, single-dose trial design was used in this study, healthy subjects were assigned to receive single dose of rabeprazole sodium enteric-coated tablets 0.1 g in either fasting or high-fat diet state, and blood samples were taken at different time points, respectively. The concentrations of rabeprazole sodium enteric-coated in plasma were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), the model method of the non-compartmental was used to calculate the pharmacokinetic parameters by Phoenix WinNonlin 8.2.
Results The main pharmacokinetic parameters of rabeprazole sodium enteric-coated tablets in fasting state and high-fat diet state were as follows: Cmax were (339.63±156.47) and (318.86±132.13) ng·mL-1; t1/2 were (2.34±0.68) and (3.60±2.40) h; AUC0-t were (556.62±251.65) and (528.50±201.78) ng·mL-1·h; AUC0-∞ were (563.39±255.69) and (535.15±203.24) ng·mL-1·h; tmax were 3.65 and 6.99 h. After high-fat diet, the Cmax and AUC of rapeprazole sodium after high-fat and high-calorie diet decreased, Cmax decreased by 6.12%, AUC0-t decreased by 5.05%, AUC0-∞ decreased by 5.01%, and tmax was delayed by about 3.34 h. Cmax, AUC0-t and AUC0-∞90% confidence interval were 73.13%-115.10%, 83.22%-112.28% and 83.40%-112.13%, respectively. Neither was between 85.00%-125.00%.
Conclusion High-fat diet affects the absorption rate and degree of rabeprazole sodium enteric-coated, so it is suitable to be administered on an empty stomach.
, authors=Cai-hui GUO
1, Yu-fang XU
1, Cong-yang DING
1, Guang-tao HAO
2, Hao-jing SONG
1, Xue SUN
1, Zhan-jun DONG
1, Wan-jun BAI
1, authorsList=Cai-hui GUO, Yu-fang XU, Cong-yang DING, Guang-tao HAO, Hao-jing SONG, Xue SUN, Zhan-jun DONG, Wan-jun BAI, authorCompany=null, correspAuthors=Wan-jun BAI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291339054772118067, articleId=1291339052523971120, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=高脂高热量饮食对中国健康受试者口服雷贝拉唑钠肠溶片药代动力学的影响, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察中国健康受试者空腹和高脂高热量饮食情况下口服雷贝拉唑钠肠溶片的药代动力学特征。
方法 用单中心、随机、开放、两制剂、两序列、四周期、完全重复交叉、单次给药试验设计。健康受试者分别在空腹或高脂高热量饮食条件下单剂量口服雷贝拉唑钠肠溶片0.1 g，分别按方案规定的时间点采集静脉血样，用液相色谱-串联质谱（LC-MS/MS）法测定人血浆中雷贝拉唑的血药浓度，用Phoenix WinNonlin 8.2软件按非房室模型法计算药代动力学参数。
结果 雷贝拉唑钠肠溶片空腹和高脂高热量饮食后的主要药代动力学参数：Cmax分别为（339.63±156.47）和（318.86±132.13）ng·mL-1，t1/2分别为（2.34±0.68）和（3.60±2.40）h，AUC0-t分别为（556.62±251.65）和（528.50±201.78）ng·mL-1·h，AUC0-∞分别为（563.39±255.69）和（535.15±203.24）ng·mL-1·h，tmax分别为3.65和6.99 h。高脂高热量饮食后服药与空腹条件下服药相比，雷贝拉唑钠Cmax和AUC均降低，Cmax降低6.12%，AUC0-t降低5.05%，AUC0-∞降低5.01%，tmax延迟约3.34 h。Cmax、AUC0-t、AUC0-∞ 90%置信区间分别为73.13%~115.10%、83.22%~112.28%、83.40%~112.13%，均不在85.00%~125.00%内。
结论 高脂高热量饮食影响雷贝拉唑钠肠溶片的吸收速度和吸收程度，临床适宜空腹给药。
, authors=郭彩会
1, 许玉芳
1, 丁琮洋
1, 郝光涛
2, 宋浩静
1, 孙雪
1, 董占军
1, 白万军
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郭彩会（1979-），女，副主任护师，主要从事临床药理的相关研究
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