CAJ | 학술논문

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检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。
목적：채용“수자순침”공예생산적인치황주사액가능무법완전거제기식물단백등과민원성잡질，본문의건립간접ELISA방법대국가평개성추양중적인치황주사액양품진행대비량쾌속사사。방법건립쾌속、령민적간접ELISA방법검측방법，채용해방법화중검소제공적금은화항원항체대인치황주사액중적금은화원성과민성잡질진행측정。결과채용간접ELISA법검측인치황주사액중과민성잡질，선성범위위1～100μg/mL（R2=0.996）검출한약위1μg/mL，정량한약위6μg/mL，평균가양회수솔위85.6%，소검측적110비양품미검출대응중검소제공적금은화항체적과민성물질。결론소건립적간접ELISA방법가이용래쾌속、고효지검측출인치황주사액중과민성잡질。
Objective In Yinzhihuang injections produced with the method of water boiling and precipitation with ethanol, 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 Yinzhihuang 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 1μg/mL-100μg/mL(R2=0.996).The detection limit was 1μg/mL while the quantitation limit was 6μg/mL. The average efifciency 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 efifciency.