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

作　　者：梁彦 陈建宁 LIANG Yan;CHEN Jian-Ning(Department of Pharmacy,Affiliated Hospital of Guilin Medical University,Guilin 541001,China;Department of Pharmacy,Guilin People's Hospital,Guilin 541002,China)

机构地区：[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

出　　处：《实验室检测》2024年第12期32-34,共3页Laboratory Testing

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。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 

分 类 号：O657.63[理学—分析化学] TQ460.72[理学—化学]