间接ELISA法检测茵栀黄注射液中的过敏性杂质  

Analysis of Allergenic Impurities in Yinzhihuang Injection by an Indirect ELISA Method

作　　者：王兰花[1] 付白清[1] 曹莉[1] 

机构地区：[1]镇江市第一人民医院,江苏镇江212002

出　　处：《中国医药指南》2014年第15期42-44,共3页Guide of China Medicine

摘　　要：目的采用“水煮醇沉”工艺生产的茵栀黄注射液可能无法完全去除其植物蛋白等过敏源性杂质，本文拟建立间接ELISA方法对国家评价性抽样中的茵栀黄注射液样品进行大批量快速筛查。方法建立快速、灵敏的间接ELISA方法检测方法，采用该方法和中检所提供的金银花抗原抗体对茵栀黄注射液中的金银花源性过敏性杂质进行测定。结果采用间接ELISA法检测茵栀黄注射液中过敏性杂质，线性范围为1～100μg／mL（R2=0．996）检出限约为1μg／mL，定量限约为6μg／mL，平均加样回收率为85．6％，所检测的110批样品未检出对应中捡所提供的金银花抗体的过敏性物质。结论所建立的间接ELISA方法可以用来快速、高效地检测出茵栀黄注射液中过敏性杂质。Objective In Yinzhihuang injections produced with the method of water boiling and precipitation with ethanols the allergenic impurities such as plant proteins cannot be removed completely. The objective of this study is to establish an ELISA method for the determination of allergenic impurities in Yinzhihuang injections. Method An indirect ELISA method was established for the determination of the allergenic dopants in Yinzhthuang injection, employing the honeysuckle antigen and antibody provided by the National Institute for the Control of Pharmaceutical and Biological Products. Result In the indirect ELISA established, the calibration curve was linear at the concentration range of 1 μg/mL-100 μg/mL（R2=0.996）.The detection limit was 1 μg/mL while the quantitation limit was 6 μg/mL. The average efficiency of recovery is 85.6%. Conclusion The indirect ELISA method established in our research could determine the concentration of allergenic impurities in Yinzhihuang injection rapidly with high efficiency.

关 键 词：间接ELISA 茵栀黄注射液 不良反应 过敏性杂质 

分 类 号：R286[医药卫生—中药学]