湖北科技学院学报（医学版）2025，Vol.39Issue(2)：103-106,4.DOI:10.16751/j.cnki.2095-4646.2024070110
盐酸替扎尼定口服液在中国健康人体内的生物等效性研究
Bioequivalence Study of Tizanidine Hydrochloride Oral Liquid in Healthy Chinese Volunteers
姜敏生 1朱琦涛 1华玉 1尹咸淼 1宋欢 1丁峰 1郭东生 2甘方良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 tizanidine hydrochloride oral solution in healthy Chi-nese volunteers and further evaluate its bioequivalence.Methods According to a two sequence four cycle completely repeated cross-over design,66 healthy volunteers(fasting 36 and postprandial 30)were treated with either the test formulation(T,100mL∶40mg)or the reference formulation(R,4mg)per cycle.The drug concentration in plasma was detected using UPLC-MS/MS method.Final-ly,pharmacokinetic software was used to calculate its pharmacokinetic parameters and evaluate its bioequivalence.Results The Cmax,AUC0-t,and AUC0-∞ of the test and reference formulations of tizanidine in the fasting test were(4.129±2.538)and(3.980±2.227)ng/mL,(11.4±8.3)and(11.1±8.0)h·ng/mL,(11.6±8.4)and(11.3±8.2)h·ng/mL,respectively.The Cmax,AUC0-t,and AUC0-∞ of tizanidine in the postprandial trial and reference formulation were(3.655±2.065)and(3.073±2.144)ng/mL,(11.2±6.4)and(10.5±5.9)ng/mL,(11.4±6.5)and(10.7±6.0)ng/mL,respectively.The 90％confidence interval of the least squares geometric mean ratio of pharmacokinetic parameters falled within the judgment range of 80％-125％.Conclusion The test and reference formulations of tizanidine hydrochloride have bioequivalence in fasting and post-prandial trials.关键词
盐酸替扎尼定口服液/UPLC-MS/MS/生物等效性/药动学Key words
Tizanidine hydrochloride oral solution/UPLC-MS/MS/Bioequivalence/Pharmacokinetics分类
药学引用本文复制引用
姜敏生,朱琦涛,华玉,尹咸淼,宋欢,丁峰,郭东生,甘方良..盐酸替扎尼定口服液在中国健康人体内的生物等效性研究[J].湖北科技学院学报（医学版）,2025,39(2):103-106,4.
