医药包材中硅油量检测方法研究进展

Research Progress on Detection Methods for Silicone Oil Content in Pharmaceutical Packaging Materials

摘要: 硅油常作为医药包材的润滑剂，对药品包装的滑动性和密封性至关重要。然而，过量的硅油残留或向药液中的迁移会导致溶液澄清度下降、产生不溶性微粒，甚至引起蛋白质药物聚集。因此，建立准确、高效的硅油量检测方法对药品质量控制和安全性评价具有重要意义。本文结合现有文献，综述了红外光谱法、重量法及ICP-MS法在硅油量检测中的应用进展。

Abstract: Silicone oil is commonly used as a lubricant in pharmaceutical packaging materials and is crucial for the sliding performance and sealing of drug packaging. However, excessive silicone oil residues or migration into the drug solution may lead to reduced clarity, the formation of insoluble particles, and even aggregation of protein-based drugs. Therefore, establishing an accurate and efficient method for detecting silicone oil levels is of significant importance for pharmaceutical quality control and safety evaluation. This article reviews the progress in the application of infrared spectroscopy, gravimetric methods, and ICP-MS methods for silicone oil detection, based on existing literature.