Study on the Detection Methods of Heteroprotein In Micafungin Sodium for Injection
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.
micafungin modium for injectionheteroproteinalpha-lactalbuminbeta-lactoglobulindouble antibody andwhich elisa method
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