GC-MS法测定聚丙烯药用滴眼剂瓶标签粘胶剂含量及迁移量  

Determination of adhesive content and migration in the label of polypropylene medicinal eyedrop bottle by gas chromatography-mass spectrometry

作　　者：谢桂芳 张雪梅 杨骥 蔡权超 XIE Gui-fang;ZHANG Xue-mei;YANG Ji;CAI Quan-chao(Chengdu Jingze biological pharmaceutical Co.,LTD,Chengdu,Sichuan,610000,China)

机构地区：[1]成都景泽生物制药有限公司,四川成都610000

出　　处：《化学研究与应用》2025年第3期712-717,共6页Chemical Research and Application

摘　　要：建立了聚丙烯药用滴眼剂瓶标签用胶水中粘胶剂单体乙酸乙烯酯、甲基丙烯酸甲酯、丙烯酸-2-乙基己酯的可提取量和迁移量的检测方法,保证用药安全。采用正己烷对标签中粘胶剂进行提取,采用3种不同pH值和极性的缓冲液进行模拟迁移实验,实验液用正己烷萃取并挥干用甲醇复溶,使用气相色谱-质谱联用仪进行检测。3种目标物在各自范围内线性良好(R≥0.9989),方法检测限分别为1.64μg·bottle^(-1)、0.55μg·bottle^(-1)和0.15μg·bottle^(-1),平均加样回收率为85.35%~115.37%。结果表明该方法准确可靠,可用于聚丙烯药用滴眼剂瓶标签用胶水中粘胶剂单体乙酸乙烯酯、甲基丙烯酸甲酯、丙烯酸-2-乙基己酯含量及迁移量的检测。A method was established to determine the extractable and migration amount of adhesive monomers vinyl acetate,methyl methacrylate and 2-ethylhexyl acrylate in the label glue of polypropylene medicinal eye drops bottle to ensure the safety of drug use.The adhesive was extracted from the label with hexane,and the simulated migration experiment was carried out with 3 buffer solutions with different pH values and polarity.The experimental solution was extracted with n-hexane,dried and re-dissolved with methanol,and detected by gas chromatography-mass spectrometry.The linearity of the three samples was good in all ranges(R≥0.9989).The detection limits were 1.64μg·bottle^(-1),0.55μg·bottle^(-1)and 0.15μg·bottle^(-1),respectively.The average recoveries were85.35%~115.37%.The results indicate that this method is accurate and relaiable,and can be used for the determination of the content and migration of adhesive monomers vinyl acetate,methyl methacrylate and 2-ethylhexyl acrylate in the glue for the label of polypropylene medicinal eye drops bottle.

关 键 词：滴眼剂瓶 标签 粘胶剂 气相色谱-质谱联用 

分 类 号：O632.12[理学—高分子化学]