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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (3): 298-301.

• 研究原著 • 上一篇    下一篇

高效液相-质谱联用法(HPLC-MS) 测定灯盏乙素血药浓度及其临床药代动力学研究

居文政1,2,3, 张军1,2, 谈恒山4, 蒋萌1,2, 陈玟1,2, 熊宁宁1,2   

  1. 1南京中医药大学附属医院临床药理科,2江苏-安徽中西药临床药代动力学联合实验室, 南京210029, 江苏;
    3南京大学生命科学院, 南京210093, 江苏;
    4南京军区南京总医院, 南京210002, 江苏
  • 收稿日期:2005-01-27 修回日期:2005-03-12 出版日期:2005-03-26 发布日期:2020-11-18
  • 通讯作者: 居文政, 男, 博士生, 副主任药师, 研究方向:中药新药人体药代动力学。Tel:025-86617141-80518 E-mail:njwz1008@jlonline.com
  • 作者简介:熊宁宁, 男, 教授, 主任医师, 博士生导师, 研究方向:临床药理。Tel:025-86506055 E-mail:xiongnin@public1.ptt.js.cn
  • 基金资助:
    科技部“临床试验关键技术及平台研究”课题资助(No2004AA2Z3766)

Determination of scutellarin in human plasma by LC-MS method and its clinical pharmacokinetics in Chinese healthy volunteers

JU Wen-zheng1,2,3, ZHANG Jun1,2, Tan Hen-shan4, JIANG Meng1, CHEN Ming1,2, XIONG Ning-ning1   

  1. 1Department of Clinical Pharmacology, Affiliated Hospital, Nanjing University of Traditional Chinese Medicine, 2Jiangsu-Anhui Provincial United Laboratory for the Clinical Pharmacokinetics of Traditional Chinese Medicine and Western Medicine, Nanjing 210029, Jiangsu, China;
    3School of Life Science, Nanjing University, Nanjing 210093, Jiangsu, China;
    4General Hospital of Armed Forces of Nanjing, Nanjing 210002, Jiangsu, China
  • Received:2005-01-27 Revised:2005-03-12 Online:2005-03-26 Published:2020-11-18

摘要: 目的:研究灯盏花素片在中国人体内的药代动力学。方法:20 名健康志愿者单剂量口服120 mg灯盏花素片, 用高效液相-质谱联用法测定血浆中灯盏乙素总苷元。结果:本实验建立的血药浓度测定方法, 血浆中杂质不干扰样品的测定, 线性范围为0.0126~3.24 mg°L-1;日内和日间精密度均小于12.0%。20 名健康受试者单剂量口服灯盏花素片(120 mg) 后, 主要药代动力学参数:Tmax=7.0±2.3 h、Cmax=0.9±0.5 mg°L-1、AUC0-tn=5.6±1.6mg°h°L-1、AUC0-∞=5.8±1.6 mg°h°L-1、MRT0-tn=8.0±1.1 h、MRT0-∞=8.6±1.4 h。结论:建立的LC-MS 法适用于灯盏乙素人体药代动力学研究。灯盏花素片口服药代动力学特点是达峰时间较长, 约占受试者总人数45% 的药时曲线有双峰现象。

关键词: 灯盏花素片, 灯盏乙素, 高效液相-质谱联用法, 血药浓度, 药代动力学

Abstract: AIM: To determination of scutellarin in human plasma by LC-MS method and investigate the pharmacokinetics of breviscapine tablets in Chinese healthy volunteers.METHODS: 20 male healthy volunteers were received a single oral dose of 120 mg breviscapine tablets.The plasma concentration of scutellarin aglycone was determined by HPLC-MS method.RESULTS: The linear range was 3.24-0.0126 mg°L-1.Within-day RSD and between-day RSD were less than 12%.The main pharmacokinetic parameters were as follows:Tmax was 7.0±2.3 h, Cmax was 0.9±0.5mg°L-1, AUC0-24h was 5.6±1.6 mg°h°L-1, AUC0-∞ was 5.8±1.6 mg°h°L-1, MRT0-24h was 8.0±1.1 h, and MRT0-∞ was 8.6±1.4 h.CONCLUSION: This method is sensitive, fast, and accurate, and it can be used for pharmacokinetic studies of scutellarin in humans.

Key words: breviscapine tablets, scutellarin, plasmadrug concentration, LC-MS, pharmacokinetics

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