中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 887-891.
DOI: 10.19803/j.1672-8629.20250498

• 基础与临床研究 • 上一篇    下一篇

全自动二维液相色谱法测定美罗培南血药浓度监测方法研究

丁蕊, 陈永妍, 韩文超, 张寒娟   

  1. 郑州市第七人民医院药学部,河南 郑州 450016
  • 收稿日期:2025-07-25 出版日期:2026-08-15 发布日期:2026-08-17
  • 作者简介:丁蕊,女,硕士,副主任药师,临床合理用药。E-mail: hvqn349@163.com
  • 基金资助:
    国家自然科学基金资助项目(82000288); 河南省医学科技攻关计划项目(LHGJ20240906、LHGJ20220851)

Determination of meropenem concentrations in human plasma using 2-dimensional liquid chromatography

Ding Rui, Chen Yongyan, Han Wenchao, Zhang Hanjuan   

  1. Department of Pharmacy, the 7th People’s Hospital of Zhengzhou, Zhengzhou Henan 450016, China
  • Received:2025-07-25 Online:2026-08-15 Published:2026-08-17

摘要: 目的 探索全自动二维液相色谱(2D-LC/UV)法测定重症感染患者美罗培南血药浓度,为临床血药浓度监测提供参考。方法 基于2D-LC/UV法,通过去蛋白剂处理血浆样品,使用一维色谱柱Aston SNCB柱(4.6 mm×50 mm,5 μm),对血浆中美罗培南进行在线固相萃取,实现初步的富集分离,随后转移到二维色谱柱Aston SNBR柱(4.6 mm×200 mm,5 μm)上对目标分析物进一步分离检测。一维流动相为美罗培南-1D流动相,二维流动相为BPI-1碱性流动相,流速1.0 mL·min-1;柱温40℃;紫外检测波长310 nm;采用外标定量法进行计算。结果 美罗培南质量浓度的范围在1.837 5~147 μg·mL-1线性良好,相关系数R2=0.999 98;低、中、高(1.5、20.0、80.0 μg·mL-1)3个浓度样品的相对回收率均大于95%,日内、日间精密度(RSD%)均低于5%。结论 高效实现了美罗培南血药浓度的自动化分析,对前处理过程进行有效简化,节省成本;与以往的测定方法相比,样本溶液采用大体积进样,提高了方法的灵敏度,适用于临床美罗培南稳态谷浓度的高通量血药浓度监测。

关键词: 美罗培南, 血药浓度, 血浆, 全自动二维液相色谱, 监测

Abstract: Objective To establish a fully automated 2-dimensional liquid chromatography with ultraviolet detection (2D-LC/UV) method for determining the concentration of meropenem in plasma from critically ill patients and to apply it in clinical practice. Methods A 2D-LC/UV system was adopted. Plasma samples were processed with a protein precipitant. Online solid-phase extraction was performed on a one-dimensional column-Aston SNCB (4.6 mm×50 mm, 5 μm)-for preliminary enrichment and separation of meropenem before the target analyte was transferred to a two-dimensional column-Aston SNBR (4.6 mm×200 mm, 5 μm)- for further separation and detection. The mobile phases for the one-dimensional and two-dimensional columns were meropenem-1D and BPI-1 alkaline, respectively, at a flow rate of 1.0 mL·min-1. The column temperature was 40℃, and the detection wavelength was 310 nm. The external standard method was used for quantification. Results Meropenem showed good linearity at concentrations ranging from 1.837 5 to 147 μg·mL-1, with a correlation coefficient (R²) of 0.999 98. The relative recoveries for the low-, medium-, and high-concentration (1.5、20.0、80.0 μg·mL-1) quality controls (QCs) exceeded 95%, and both intra- and inter-day precision (RSD%) was below 5%. Conclusion This method proves to be capable of accurate and efficient automated analysis while streamlining the pretreatment process and reducing costs. Furthermore, it is sensitive enough for high-throughput monitoring of steady-state trough concentrations of meropenem.

Key words: Meropenem, Blood Drug Concentration, Plasma, 2-Dimensional Liquid Chromatography with Ultraviolet Detection(2D-LC/UV), Monitoring

中图分类号: