注射用米卡芬净钠中杂蛋白检测方法研究  

Study on the Detection Methods of Heteroprotein In Micafungin Sodium for Injection

作　　者：金杨巧 赵燕 高华 李泽南 Jin Yang-qiao;Zhao Yan;Gao hua;Li Ze-nan(Zhejiang Hisun Pharmaceutical Co.Ltd.,Hangzhou 311400)

机构地区：[1]浙江海正药业有限公司,杭州311400

出　　处：《国外医药（抗生素分册）》2024年第4期284-288,共5页World Notes on Antibiotics

摘　　要：目的 建立注射用米卡芬净钠中杂蛋白的检测方法。方法 采用双抗体夹心ELISA法分别检测注射用米卡芬净钠中α-乳清蛋白(α-LA)和β-乳球蛋白的含量,并对上述两种检测方法的线性、定量限和检测限、专属性和加标回收率等进行方法学研究。结果 采用α-乳清蛋白检测试剂盒检测制剂中的α-乳清蛋白含量,因制剂中活性成分米卡芬净钠对检测有干扰,加标回收率最高仅为11.8%,导致均未检出。采用AgraQuant^(®)β-乳球蛋白试剂盒检测制剂中的β-乳球蛋白,方法的线性和专属性良好,加标回收率在90.9%~114.9%,方法可行。结论 制剂中的β-乳球蛋白建议采用双抗体夹心ELISA方法进行检测,本方法准确可靠,但制剂中的α-乳清蛋白含量建议通过辅料乳糖中α-乳清蛋白的含量进行控制。Objective To establish a method for the detection of heteroprotein in micafungin sodium for injection..Methods The double antibody sandwich ELISA method was utilized to detect the contents of alphalactalbumin and beta-lactoglobulin in micafungin sodium for injection,respectively.Methodological analysis was conducted to examine the linearity,quantitation and detection limits,specificity,and standard recovery rate of these two heteroprotein detection techniques.Results The alpha-lactalbumin detection kit was used to detect the content of alpha-lactalbumin.As micafingin sodium in the preparation interferes with the detection of alpha-lactalbumin,the added recovery rate of alpha-lactalbumin is only 11.8%,resulting in the non-detection of alpha-lactalbumin in the preparation.The AgraQuant^(®) β-lactoglobulin kit was used to detect beta-lactoglobulin in the preparation,and the method was good in linearity and exclusivity,and the standard recovery rate was 90.9%to 114.9%,which was feasible.Conclusion Beta-lactoglobulin in the formulation is recommended to be detected by the double antibody sandwich ELISA method,which is accurate and reliable,but the content of alpha-lactalbumin in the formulation is recommended to be controlled by controlling the content of alpha-lactalbumin in the excipient lactose.

关 键 词：注射用米卡芬净钠 杂蛋白 α-乳清蛋白 Β-乳球蛋白 双抗体夹心ELISA法 

分 类 号：R978.5[医药卫生—药品]