时间分辨荧光免疫法定量检测给药食蟹猴血清中纳武利尤单抗  

A Time-resolved Fluorescence Immunoassay for Determination of Nivolumab in Serum of Cynomolus Monkey

作　　者：刘欢 沙春洁 邵馨 刘万卉[1,2] LIU Huan;SHA Chun-jie;SHAO Xin;LIU Wan-hui(School of Pharmacy,Key Laboratory of Molecular Pharmacology and Drug Evaluation(Yantai University),Ministry of Education,Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong,Yantai University,Yantai 264005,China;State Key Laboratory of Long-acting and Targeting Drug Delivery System,Shandong Luye Pharmaceutical Co Ltd,Yantai 264003,China)

机构地区：[1]烟台大学药学院,分子药理和药物评价教育部重点实验室(烟台大学),新型制剂与生物技术药物研究山东省高校协同创新中心,山东烟台264005 [2]山东绿叶制药有限公司长效和靶向制剂国家重点实验室,山东烟台264003

出　　处：《烟台大学学报（自然科学与工程版）》2022年第1期42-47,100,共7页Journal of Yantai University(Natural Science and Engineering Edition)

基　　金：国家自然科学基金资助项目(81773679)。

摘　　要：建立并验证了基于时间分辨荧光免疫分析技术评价药物纳武利尤单抗在食蟹猴体内的药代动力学的方法,并与酶联免疫吸附法(ELISA)进行比较。96孔板包被PD-1用以捕获药物,Eu螯合物标记山羊抗人IgG抗体用于检测。该方法的灵敏度为2 ng·mL^(-1),线性范围2~2500 ng·mL^(-1),定量上限、定量下限的批内精密度在3.6%~14.2%范围内,批间精密度在10.0%~10.6%范围内。低、中、高质量浓度质控的批内精密度在1.2%~16.5%内,批间精密度在9.6%~12.2%范围内。定量上下限的准确度在-14.3%~11.9%。低中高质量浓度质控准确度在-14.3%~11.4%范围内。该方法与ELISA相比有更宽的检测范围,且两种方法的检测结果差异不具备统计学意义(P<0.05),说明此方法稳定可靠。A time-resolved fluorescence immunoassay(TRFIA)is to established and validated for the determination of nivolumab in cynomolgus monkey serum,and is compared with enzyme-linked immunosorbent assay(ELISA).Here,96-well plates coated with PD-1 are used for capture,and Eu chelate-labeled goat anti-human IgG is used for detection.The sensitivity of our method is 2 ng·mL^(-1)and the linear range is 2-2500 ng·mL^(-1).The within-run precision of the upper limit of quantification(ULOQ)and lower limit of quantification(LLOQ)are in the range of 3.6%-14.2%,whereas the between-run precision is 10.0%-10.6%.For low,medium,and high QCs,the values are in the range of 1.2%-16.5%and the between-run precision is 9.6%-12.2%.The accuracy is in the range of-14.3%-11.9%for ULOQ and LLOQ,and-14.3%-11.4%for low,medium,and high QCs.Compared with ELISA,TRFIA has a wider detection range,and there is no significant difference between the two methods(P<0.05).

关 键 词：时间分辨荧光免疫法 酶联免疫法 纳武利尤单抗 单抗 

分 类 号：R917[医药卫生—药物分析学]