基于HPLC法同时测定人血清中4种抗癫痫药物浓度且与CLIA法检测值的一致性评价  

Simultaneous determination of four antiepileptic drugs in human serum based on HPLC and evaluation of consistency with CLIA method

作　　者：赵娜[1] 史永志 曹贤[3] 肖音 韩晓燕 牛艺璇 肖斌[1] ZHAO Na;SHI Yong-zhi;CAO Xian;XIAO Yin;HAN Xiao-yan;NIU Yi-xuan;XIAO Bin(Clinical Pharmacy Laboratory of Ordos Central Hospital,Ordos 017000,China;Department of Critical Care Medicine,Ordos Central Hospital,Ordos 017000,China;Department of Laboratory,Ordos Central Hospital,Ordos 017000,China;Haikou City People's Hospital/Haikou Hospital Affiliated to Xiangya College of Medicine,Central South University,Haikou 570208,China)

机构地区：[1]鄂尔多斯市中心医院临床药学实验室,内蒙古鄂尔多斯017000 [2]鄂尔多斯市中心医院重症医学科,内蒙古鄂尔多斯017000 [3]鄂尔多斯市中心医院医学检验科,内蒙古鄂尔多斯017000 [4]海口市人民医院/中南大学湘雅医学院附属海口医院,海南海口570208

出　　处：《中国药物应用与监测》2022年第4期229-234,共6页Chinese Journal of Drug Application and Monitoring

基　　金：内蒙古自治区卫生计生科研计划项目(201701115);内蒙古医科大学科技百万工程联合项目[YKD2018KJBW(LH)089]。

摘　　要：目的:基于高效液相色谱(HPLC)法建立同时测定4种抗癫痫药物浓度的方法,并与化学发光免疫(CLIA)法检测值对比,为临床个体化诊疗提供实验室数据。方法:血清样本经甲醇沉淀蛋白后过滤,进样分析。色谱柱为Agilent Eclipse Plus C_(18)柱(4.6 mm×250 mm,5μm);流动相:甲醇-水(44∶56);流速:0.9 mL·min^(-1);柱温:37℃;检测波长:218 nm。采集患者服药后稳态谷浓度样本,分别用以上2种方法检测。结果:在该色谱条件下4种抗癫痫药物分离度良好,各自系列浓度与峰面积呈良好的线性关系,日内、日间精密度RSD均<11%;稳定性及各自相对回收率均符合方法学要求。两种方法测定值有很好相关性,线性回归方程为Y=1.371+0.856 X,r=0.912,CLIA法检测值较HPLC法检测值高0.64%(95%CI:–1.27%~2.56%)。结论:本方法灵敏度、精密度、准确性均较高,操作简便,临床应用成本较低,更适合在基层医院开展。Objective:To establish a high performance liquid chromatography(HPLC)method to simultaneously determine the concentration of four antiepileptic drugs,and compare the results with those of the chemiluminescence immunoassay(CLIA)method in order to provide a laboratory evidence for individualized diagnosis and treatment in clinic.Methods:The serum samples were precipitated by methanol before chromatographic determination.The chromatcolumn Agilent Eclipse Plus C_(18)(4.6 mm×250 mm,5μm)with the mobile phase consisting of methanol-water(44∶56).The flow rate was 0.9 mL·min^(-1) and the column temperature was set at 37℃.The detection wavelength was 218 nm.The blood samples were collected after reaching steady state and were determined by HPLC and CLIA method.Results:The four antiepileptic drugs were well separated under the chromatographic conditions.The concentrations had a stable linear relationship with the peak areas.Both the relative standard deviations(RSDs)of intra-day and inter-day precision were less than 11%.The stability and relative recovery rate reached the chromatographic requirements.The two methods showed good relevance,with the linear regression equation as:Y=1.371+0.856 X,r=0.912.The detection value of CLIA was 0.64%higher than that of HPLC(95%CI:–1.27%–2.56%).Conclusion:This method was easy to operate with high sensitivity,precision and accuracy,and low clinical cost,which was more suitable for primary hospitals.

关 键 词：卡马西平 苯巴比妥 苯妥英钠 拉莫三嗪 高效液相色谱法 

分 类 号：R971.6[医药卫生—药品]