湖北科技学院学报（医学版）2026，Vol.40Issue(2)：121-125,5.DOI:10.16751/j.cnki.2095-4646.2025082514
己酮可可碱缓释片在中国健康人体内生物等效性研究
Bioequivalence Study of Pentoxifylline Sustained-Release Tablets in Chinese Healthy Subjects
靳飞 1李欢 1甘方良 2刘启胜2
作者信息
- 1. 湖北科技学院医学部药学院,湖北咸宁 437100||咸宁市中心医院临床药理机构办公室
- 2. 咸宁市中心医院临床药理机构办公室
- 折叠
摘要
Abstract
Objective To study the pharmacokinetic characteristics of pentoxifylline sustained release tablets in healthy volunteers in China and further evaluate their bioequivalence.Methods According to a two-sequence and two-cycle completely repeated crossover design,84 healthy volunteers were divided into 42 fasting and 42 postprandial healty subjects.Each cycle used one of the test preparation(T,400 mg)or the reference preparation(R,400 mg)respectively.The concentrations of pentoxifylline and its active metabolites M1 and M5 in plasma were determined using a methodologically confirmed UPLC-MS/MS method.Finally,pharmacokinetic software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence.Results The Cmax,AUC0-t,and AUC0-∞ of pentoxifyline of the test and refer-ence formulations in the fasting trial were(251.46±99.96)and(273.96±105.79)ng/mL,(1539.80±733.54)and(1578.30±914.33)h·ng/mL,(1744.06±872.07)and(1736.29±974.11)h·ng/mL,respectively.The Cmax,AUC0-t,and AUC0-∞ of pentoxify-line of the test and reference formulations in the postprandial trial were(412.76±312.27)and(445.86±326.21)ng/mL,(1932.72±978.78)and(1956.93±882.17)h·ng/mL,(1997.97±994.27)and(2027.07±870.19)h·ng/mL,respectively.The 90％confi-dence interval for the least squares geometric mean ratio of pharmacokinetic parameters fell within the judgment range of 80％-125％.Con-clusion The test and reference formulations of pentoxifylline sustained-release tablets have bioequivalence in fasting and postprandial trials.关键词
己酮可可碱缓释片/超高效液相色谱法/生物等效性/药动学Key words
Pentoxifylline sustained-release tablets/UPLC-MS/MS/Bioequivalence/Pharmacokinetics分类
医药卫生引用本文复制引用
靳飞,李欢,甘方良,刘启胜..己酮可可碱缓释片在中国健康人体内生物等效性研究[J].湖北科技学院学报（医学版）,2026,40(2):121-125,5.
