| 陈曦,肖艳芳,丁仰,洪伟涛,麦丽君,曾璇.同时测定人血清中12种抗精神病药物及其主要代谢物的方法[J].四川精神卫生杂志,2026,(2):140-148.Chen Xi,Xiao Yanfang,Ding Yang,Hong Weitao,Mai Lijun,Zeng Xuan,A method for the simultaneous determination of 12 antipsychotic drugs and their main metabolites in human serum[J].SICHUAN MENTAL HEALTH,2026,(2):140-148 |
| 同时测定人血清中12种抗精神病药物及其主要代谢物的方法 |
| A method for the simultaneous determination of 12 antipsychotic drugs and their main metabolites in human serum |
| 投稿时间：2025-11-14 |
| DOI：10.11886/scjsws20251114002 |
| 中文关键词: 抗精神病药物 血清药物浓度 超高效液相色谱-串联质谱 |
| 英文关键词:Antipsychotic drugs Serum drug concentration UPLC-MS/MS |
| 基金项目:2023年潮州市第三批科技专项（项目名称：基于药物基因组学和血药浓度监测指导的棕榈酸帕利哌酮长效针剂个体化用药研究，项目编号：202303GY02） |
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| 中文摘要: |
| 背景 抗精神病药物及其代谢物的血药浓度监测能够指导临床用药方案的调整，有助于提高疗效，降低不良反应，但目前还缺乏一种能够准确、高效地定量检测多种抗精神病药物及其代谢物的方法。目的 建立一种基于超高效液相色谱-串联质谱（UPLC-MS/MS）同时测定人血清中12种抗精神病药物及其主要代谢物的定量分析方法。方法 采用UPLC-MS/MS技术，使用蛋白沉淀法进行前处理，选用Agela Technologies Durashell C8色谱柱（50 mm×3.0 mm，5 μm），梯度洗脱进行色谱分离，流速为0.4 mL/min，总分析时长为5 min，柱温40℃。质谱检测采用多反应监测（MRM）模式，并使用同位素内标法进行定量。结果 12种抗精神病药物及其主要代谢物在低、高质量浓度下，内标归一化基质效应因子的RSD均小于15%，提取回收率为85%~115%。它们在各自的标准曲线范围内线性关系良好（r>0.995）。在低、中、高质量浓度下，准确度为85.24%~114.71%，批内、批间精密度的RSD均≤14.15%，且稳定性较好。结论 本方法各项分析性能指标均满足验证要求，为人血清中抗精神病药物及其主要代谢物的定量检测提供了分析手段。 |
| 英文摘要: |
| Background Monitoring the blood concentrations of antipsychotic drugs and their metabolites can guide the adjustment of clinical treatment plans， improving therapeutic efficacy while reducing adverse effects. However， there is currently a lack of a method that can accurately and efficiently quantitatively detect multiple antipsychotic drugs and their metabolites.Objective To establish a ultra-high performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） method for the simultaneous identification and quantitation of 12 antipsychotic drugs and their main metabolites in human serum.Methods Using UPLC-MS/MS technology， protein precipitation method was employed for sample pretreatment. An Agela Technologies Durashell C8 chromatographic column （50 mm×3.0 mm， 5 μm） was selected for chromatographic separation with gradient elution. The flow rate was 0.4 mL/min， and the total analysis time was 5 minutes. The column temperature was 40℃. The mass spectrometry detection was carried out in the multiple reaction monitoring （MRM） mode， and the isotope internal standard method was used for quantification.Results The relative standard deviation （RSD） of the internal standard normalization matrix effect factor for 12 antipsychotic drugs and their main metabolites at low and high quality concentrations was all less than 15%. The extraction recovery rate was 85% to 115%. They showed good linear relationships within their respective standard curve ranges （r>0.995）. At low， medium， and high quality concentrations， the accuracy was 85.24% to 114.71%， and the RSD of intra-batch and inter-batch precision was all ≤14.15%， with good stability.Conclusion All the analytical performance indicators of this method meet the verification requirements， providing an analytical means for the quantitative detection of antipsychotic drugs and their main metabolites in human serum. ［Funded by The Third Batch of Science and Technology Projects in Chaozhou City in 2023 （number， 202303GY02）］ |
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