超高效液相色谱-串联质谱联用技术在丙戊酸钠缓释片生物等效性研究中的应用
Application of ultra performance lc-mass spectrometry/mass spectrometry method in the bioequivalence study of Sodium Valproate Sustained-Release Tablets
梁彦 1陈建宁2
作者信息
- 1. 桂林医学院附属医院药学部,桂林 541001
- 2. 桂林市人民医院药学部,桂林 541002
- 折叠
摘要
目的 建立一个能够快速、简便、大批量分析检测丙戊酸血药浓度,并可应用于评价丙戊酸钠缓释片在健康志愿者中的生物等效性的检测方法学.方法 组织受试者服用规格为0.5 g的丙戊酸钠缓释片受试制剂与参比制剂,采集血样并制备血浆样本.用所建立的超高效液相色谱-串联质谱联用技术(ultra performance lc-mass spectrometry/mass spectrometry,UPLC-MS/MS)测定血浆中丙戊酸的浓度.结果 在空腹和餐后条件下,两制剂在吸收速度、吸收程度上均生物等效.结论 本实验建立了一种准确、快速地检测人血浆样本中丙戊酸含量的UPLC-MS/MS法.两种制剂具有生物等效性.
Abstract
Objective Establish a detection methodology that can quickly,easily,and in large quantities analyze and detect the blood concentration of valproic acid,and can be applied to evaluate the bioequivalence of Sodium Valproate Sustained-Release Tablets in healthy volunteers.Methods Organize subjects to take the test and reference formulations of 0.5 g sodium valproate sustained-release tablets,collect blood samples,and prepare plasma samples.Determine the concentration of valproic acid in plasma using the established ultra performance lc-mass spectrometry/mass spectrometry(UPLC-MS/MS).Results Under fasting and postprandial conditions,both formulations were bioequivalence in terms of absorption rate and degree.Conclusion This experiment established an accurate and rapid UPLC-MS/MS method for detecting the content of valproic acid in human plasma samples.Two formulations have bioequivalence.
关键词
方法学/丙戊酸钠缓释片/药物代谢动力学/生物等效性/超高效液相色谱-串联质谱Key words
methodology/Sodium Valproate Sustained-Release Tablets/pharmacokinetics/bioequivalence/ultra performance lc-mass spectrometry/mass spectrometry引用本文复制引用
出版年
2024
NETL
NSTL
万方数据