注射用美洛西林钠舒巴坦钠药物混合过程在线混合均匀度的近红外光谱监测

On-line Blend Uniformity Monitoring of Mezlocillin Sodium and Sulbactam Sodium for Injection by Near-infrared Spectroscopy

利用近红外光谱技术,建立了舒巴坦钠的定量测定模型和基于移动块标准偏差法的定性分析模型,共同用于在线监测注射用美洛西林钠舒巴坦钠的药物混合过程,以实现混合终点的有效判断。结果显示,本法能有效监测美洛西林钠舒巴坦钠混合过程,建立的近红外光谱分析模型能够准确判断混合终点。

A quantitative determination model for sulbactam sodium and a qualitative analysis model based on moving block standarddeviation （MBSD） were built with the application of near-infrared （NIR） spectroscopy. These two models were combined for the on-line blend uniformity monitoring of mezlocillin sodium and sulbactam sodium for injection to achieve an effective judgement for a blending endpoint of the blending process. The results indicated that the blending process of mezlocillin sodium and sulbactam sodium for injection could be effectively monitored by this method, and the blending endpoint could be exactly determined by the NIR spectroscopy models.