药用橡胶塞中多环芳烃研究进展

Progress of Research on Polycyclic Aromatic Hydrocarbons in Pharmaceutical Rubber Stoppers

多环芳烃(polycyclicaromatic hydrocarbons,PAHs)具有广泛的致癌、致畸、致突变作用。药用橡胶塞中的PAHs可能来源于其在成型时必不可少的主要原材料炭黑,若残留的PAHs迁移进药液中,则会对药品安全产生不良影响。笔者全面调研国内外药用橡胶制品中多环芳烃类化合物相关文献资料,综述了药用橡胶塞中多环芳烃相关法规要求、方法标准、检测技术进展,提出安全性评估策略,以期为药品与橡胶密封组件相容性研究时多环芳烃的检测提供参考。

Polycyclic aromatic hydrocarbons(PAHs)have a wide range of carcinogenic,teratogenic,and mutagenic effects.PAHs in pharmaceutical rubber stoppers may originate from carbon black,the main raw material essential for molding,and if the residual PAHs migrate into the pharmaceutical solution,they will have an adverse effect on the safety of drugs.In this paper,it is comprehensively investigated the literature related to PAHs in pharmaceutical rubber products at home and abroad,summarized the regulatory requirements,methodological standards,and technological advances in the testing of PAHs in pharmaceutical rubber stoppers,and proposed a safety assessment strategy,with a view to provide a reference for the testing of PAHs in the compatibility study of pharmaceuticals and rubber sealing components.