毛细管电泳-间接紫外法检测乙型脑炎灭活疫苗中蔗糖残留量的研究  

Determination of residual sucrose in inactivated Japanese encephalitis vaccine by capillary electrophoresis with indirect UV detection

作　　者：白建秋 吴金凤 周宽 林瑶 姜廷福[2] BAI Jianqiu;WU Jinfeng;ZHOU Kuan;LIN Yao;JIANG Tingfu(Quality Inspection Laboratory,Shandong Hengye Biotechnology Co.,Ltd.,Qingdao 266114,Shandong Province,China;不详)

机构地区：[1]山东恒业生物技术有限公司质检实验室,山东青岛266114 [2]中国海洋大学医药学院药物分析室,山东青岛266003

出　　处：《微生物学免疫学进展》2023年第6期36-41,共6页Progress In Microbiology and Immunology

摘　　要：目的建立毛细管电泳(capillary electrophoresis)间接紫外法测定乙型脑炎(乙脑)灭活疫苗中蔗糖残留量的方法。方法采用间接紫外法,建立乙脑灭活疫苗中蔗糖残留量的毛细管电泳检测方法。分别对背景电解质pH和浓度及电渗流改性剂浓度进行了优化,并对建立的方法进行专属性、线性、精密度、准确度及耐用性等方法学验证。结果蔗糖在0.500~5.000 mg/mL的质量浓度范围内与峰面积呈现良好的线性关系(R2=0.9992);检测限和定量限分别为0.200 mg/mL和0.500 mg/mL;测定样品相对标准偏差(relative standard deviation,RSD)<2.61%;加样回收率在99.420%~102.890%。结论建立的方法操作简便,准确度较高且稳定性好,可用于乙脑灭活疫苗实际样品中蔗糖残留量的测定。Objective A capillary electrophoresis(CE)method with indirect UV detection for determination of sucrose residues in inactivated Japanese encephalitis vaccine(IJEV)has been developed.Methods A stable and reliable capillary electrophoresis method was established for the determination of sucrose residues in IJEV by indirect UV detection.The pH and concentration of background electrolyte and the concentration of Electro-osmosis modifier were optimized respectively,and the established method was validated to prove its specificity,linearity,precision,accuracy and robustness.Results The established method had a good linearity of R~2=0.9992 within the sucrose concentration range of 0.500-5.000 mg/mL.The detection limit and quantification limit are 0.200 mg/mL and 0.500 mg/mL respectively.The relative standard deviation(RSD)of the measured sample was less than 2.61%.The recoveries of spiked samples were between 99.420%-102.890%.Conclusion The optimized method is easy to operate,which showed high accuracy and good stability.The established method was applied to determination of sucrose residues in inactivated Japanese encephalitis vaccine.

关 键 词：毛细管电泳 间接紫外法 乙脑灭活疫苗 蔗糖残留量 质量控制 

分 类 号：R917[医药卫生—药物分析学]