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液相色谱-串联质谱法测定健康人体血浆中米格列醇浓度及其药代动力学研究

Determination the concentration of miglitol in healthy human plasma and study on its pharmacokinetics by LC/MS/MS

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【作者】 肇丽梅孙亚欣邱枫何晓静

【Author】 ZHAO Li - mei, SUN Ya - xin, QIU Feng, HE Xiao-jing (Laboratory of Clinical Pharmacology, China Medical University No. 2 Hospital, Shenyang 110004, China)

【机构】 中国医科大学附属第二医院临床药理研究室中国医科大学附属第二医院临床药理研究室 辽宁沈阳110004辽宁沈阳110004

【摘要】 目的建立测定血浆中米格列醇片(降血糖药)的液相色谱-串联质谱法,考察米格列醇在中国健康志愿者体内的药代动力学。方法血浆样品经液-液提取后,进行色谱分离,在三重四极杆串联质谱仪上,以多反应离子监测(MRM)方式进行定量分析,用于监测的离子为m/z 208.3→m/z 146.1 (米格列醇)和m/z 268.5→m/z 250.4(内标,伏格列波糖)。结果米格列醇的最低定量浓度为5.0 μg·L-1,线性范围为5~2 000 μg·L-1,精密度与准确度符合生物样品分析要求。结论该法操作简便、快速、灵敏度高,适于临床药代动力学研究。

【Abstract】 Objective To establish a rapid and sensitive LC/MS/MS method for the analysis of miglitol in plasma and study the pharmacoki-netics of miglitol in China healthy volunteers. Methods Plasma samples containing miglitol and voglibose (internal standard, IS ) were extracted with liquid - liquid extraction, followed by liquid chromatographic separation and on - line MS/MS using turboionspray ionization as an interface detection. Multy reaction monitoring with mass transitions m/z 208. 3→ 146. 1 and m/z 268. 5→250.4 were used for miglitol and IS, respectively. Results The limits of quantitation of method for miglitol was 5.0 μg · L-1, the calibration curves in plasma was linear in the range of 5 to 2000 μg · L-1 and intra - and inter - day precision over this range were less than 3.0%. Conclusion The method is shown to be accurate and convenient, and suitable for clinical pharmacokinetics.

  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2006年03期
  • 【分类号】R96
  • 【被引频次】3
  • 【下载频次】234
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