中国医院用药评价与分析2025，Vol.25Issue(7)：801-804,4.DOI:10.14009/j.issn.1672-2124.2025.07.006
血清拉莫三嗪治疗药物监测自建色谱法的开发及临床应用
Development and Clinical Application of Self-Developed Chromatographic Method for Serum Lamotrigine Therapeutic Drug Monitoring
摘要
Abstract
OBJECTIVE:To establish the method for serum lamotrigine therapeutic drug monitoring(TDM)and laboratory quality control system.METHODS:Serum samples were pretreated with ice-cold acetonitrile for protein precipitation,and a quantitative method for determining serum lamotrigine concentration was established by using high performance liquid chromatography(HPLC).Westgard multi-rule internal quality control procedure was implemented based on methodological validation data.The self-developed HPLC method was used to determine the steady-state trough concentration of lamotrigine in patients and retrospective analysis was conducted.The reliability of the method was further assessed through the external quality assessment organized by the National Center for Clinical Laboratory.RESULTS:An HPLC method suitable for TDM of lamotrigine was established,showing no interference from endogenous substances or co-administered drugs.This method showed a good linear relationship within the range of 1.00 to 64.00 μg/mL(r2＞0.99).The average recovery rate(91.2％-95.8％),precision(intra-day RSD ≤4.31％,inter-day RSD≤6.84％),accuracy(-6.70％≤ RE ≤ 4.34％),and stability all meet the technical requirements specified in the Guidelines for Validation of Quantitative Analysis Methods for Biological Samples of the 2020 edition of Chinese Pharmacopoeia:Part Ⅳ.Sigma metrics for three-level quality control were respectively 4.07,4.12 and 4.07,supporting the adoption of the 1-3s/2/3-2s/R-4s/3-1s multi-rule protocol(n=3,r=1).The method received full scores in the 2024 external quality assessment.From Mar.to Oct.2024,37 clinical TDM of lamotrigine were completed,and the compliance rate was 70.27％(26 cases).CONCLUSIONS:This study provides methodological reference for the internal quality control of lamotrigine TDM methods and chromatographic analysis methods.关键词
治疗药物监测/高效液相色谱法/室内质量控制/室间质量评价/拉莫三嗪Key words
Therapeutic drug monitoring/High performance liquid chromatography/Internal quality control/External quality assessment/Lamotrigine分类
医药卫生引用本文复制引用
宋帅,任刘丽,陈慧娟,孙小珊,韩传广,解婷婷,夏泉..血清拉莫三嗪治疗药物监测自建色谱法的开发及临床应用[J].中国医院用药评价与分析,2025,25(7):801-804,4.基金项目
安徽省高校自然科学研究项目(No.2022AH051154) （No.2022AH051154）
澳门特别行政区科学技术发展基金(No.0005/2024/AKP) （No.0005/2024/AKP）
安徽省"十三五"临床重点专科建设项目(No.卫科教秘[2017]529号) （No.卫科教秘[2017]529号）
