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
金杨巧 1赵燕 1高华 1李泽南1
作者信息
- 1. 浙江海正药业有限公司,杭州 311400
- 折叠
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a-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.
Abstract
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 alpha-lactalbumin 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Key words
micafungin modium for injection/heteroprotein/alpha-lactalbumin/beta-lactoglobulin/double antibody andwhich elisa method引用本文复制引用
出版年
2024
NETL
NSTL
万方数据