常见橡胶类药包材基材和膜材红外光谱解析  

Infrared Spectra Analysis of Rubber Substrate and Film in Common Pharmaceutical Packaging Materials

作　　者：王丹丹 徐俊 郭文旭 陈悦 俞辉 陈蕾[4] WANG Dandan;XU Jun;GUO Wenxu;CHEN Yue;YU Hui;CHEN Lei(Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310004,China;Shanghai Institute of Food and Drug Packaging Materials Testing,Shanghai 201203,China;Chinese Pharmaceutical University,Nanjing 210009,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]浙江省食品药品检验研究院,浙江省药品接触材料质量控制研究重点实验室,杭州310052 [2]上海市食品药品包装材料测试所,上海201203 [3]中国药科大学,南京210009 [4]国家药典委员会,北京100061

出　　处：《医药导报》2024年第11期1759-1764,共6页Herald of Medicine

摘　　要：目的采集并解析常见橡胶类药包材的橡胶基材和膜材红外光谱,为国家药包材标准体系中橡胶类药包材红外光谱鉴别提供技术支持和参考。方法采用傅里叶转换红外(FT-IR)-衰减全反射(ATR)法采集基材和膜材红外光谱图,对图谱中主要吸收峰进行基团归属和振动形式解析,并讨论影响红外光谱图采集结果的因素。结果对常见的橡胶基材硅橡胶、聚异戊二烯橡胶、卤化丁基橡胶,和膜材乙烯-四氟乙烯共聚物(ETFE)、四氟乙烯-六氟丙烯共聚物(FEP)、聚对二甲苯典型红外光谱进行解析。结论橡胶类药包材生产配方复杂多样,测试方法、橡胶产品生产配方、ATR晶体材料和硅油等因素均会影响红外光谱图采集结果。Objective To record and analyze the infrared spectra of rubber substrate and film in common pharmaceutical packaging materials,and to provide technical support and reference for the infrared spectra identification of rubber pharmaceutical packaging materials in the national standards system.Methods The infrared spectra of the rubber substrate and film were recorded by the Fourier transform infrared(FT-IR)-attenuated total reflection(ATR)method.The main absorption peaks in the spectra were assigned,the vibration forms were analyzed,and the influencing factors of infrared spectra were discussed.Results The infrared spectra of silicone rubber,polyisoprene rubber,halogenated butyl rubber,ethylene-tetrafluoroethylene copolymer(ETFE),tetrafluoroethylene-hexafluoropropylene copolymer(FEP)and p-xylene were analyzed.Conclusion The production formula of rubber pharmaceutical packaging materials is complex and diverse.Factors such as test methods,rubber product production formula,ATR crystal materials,and silicone oil will affect the results of infrared spectra.

关 键 词：药包材 橡胶 红外光谱 解析 

分 类 号：R95[医药卫生—药学] R921