研究论文干血点采样技术和干血浆采样技术在麦考酚酸药动学分析中.PDF

Drug Evaluation Research 第 35 卷 第 6 期 2012 年 12 月 - 401 - • 研究论文 • 干血点采样技术和干血浆采样技术在麦考酚酸药动学分析中的应用 * 刘 勇，魏广力 ，谷 元，王新刚，夏媛媛，司端运 天津药物研究院 释药技术与药代动力学国家重点实验室，天津 300193 摘 要：目的 探讨干血点采样技术（dried blood spots，DBS ）和干血浆采样技术 （dried plasma spots，DPS ）在麦考酚酸 药动学分析中的应用。方法 色谱柱为 Ecosil C18 （150 mm×4.6 mm，5 μm ），流动相为0.01 moL/L 甲酸水（0.1% 甲酸）- 乙 腈- 甲醇（25 ∶45 ∶30 ），体积流量为 0.4 mL/min，柱温为 30 ℃，进样量 10 μL ；质谱检测采用 ESI 离子源，正离子 MRM 方式检测；考察可能的影响因素并进行临床研究。结果 DBS 法和 DPS 法方法学和临床实验数据均良好。结论 DBS 方法 和 DPS 法较一般处理方法简便，用血量少，储存运输方便，在一些药物的药动学分析中能代替一般的处理方法。 关键词：干血点采样；干血浆采样；麦考酚酸；药动学 中图分类号：R969.1 文献标志码：A 文章编号：1674 - 6376 (2012) 06 - 0401 - 07 Application of dried blood spots and dried plasma spots technologies in pharmacokinetic analysis of mycophenolic acid LIU Yong, WEI Guang-li, GU Yuan, WANG Xin-gang, XIA Yuan-yuan, SI Duan-yun State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China Abstract: Objective To investigate the application of dried blood spots (DBS) and dried plasma spots (DPS) methods in the pharmacokinetic analysis of mycophenolic acid (MPA). Methods HPLC was performed on an Ecosil C18 column (150 mm × 4.6 mm, 5 μm) using 0.1% formic acid (0.01 moL/L)-acetonitrile-methanol (25:45:30) as the mobile phase at a flow rate of 0.4 mL/min. The column temperature was 30 ℃. Detection was carried out using an ESI interface operating in the multiple reaction monitoring (MRM) mode. Possible factors were studied and clinical trials were carried out. Results The results of DBS and DPS methods and the data of clinical trials were excellent. Conclusion DBS and DPS methods could be alternatives to conventional assays for simple method, wih the advantages of comparable exp