注射用美洛西林钠舒巴坦钠近红外一致性检验模型的建立

Establishment of Conformity Test Model for Mezlocilin Sodium and Sul-bactam Sodium for Injection by Near Infrared Reflectance Spectroscopy

目的利用近红外漫反射光谱(NIR)分析技术,建立注射用美洛西林钠舒巴坦钠的一致性检验模型。方法通过对四个生产企业共102批次的样品进行近红外光谱采集,筛选最优的建模谱段和预处理方法,建立一致性检验模型并验证。结果对其中三家生产企业分别建立了一致性检验模型并进行验证,三个模型均能够有效的区分参考图谱和验证图谱,CI值分别为7.0、3.1、5.1。结论所建方法准确、可靠、有效,可用于注射用美洛西林钠舒巴坦钠药品快速筛查和打假。

OBJECTIVE To establish the conformity test model for mezlocilin sodium and sulbactam sodium for injection by near infrared reflectance spectroscopy.METHODS Near infrared spectroscopy was used to collect 102 batches of samples from four manufacturers.The best modeling spectral segment and preprocessing method were selected.The conformity test model was established and verfied.RESULTS Three conformity test models were constructed and tested.The three models could effectively distinguish the reference maps and the verification maps.The CI values were 7.0,3.1 and 5.1 respectively.CONCLUSION The method is accurate, reliable and effective.It can be used for rapid screening and anti fake of mezlocillin sodium and sulbactam sodium for injection.