扫描电子显微镜-能谱联用在鉴别药包材上的应用

Application of Scanning Electron Microscopy-Energy Dispersive Spectroscopy in Identification of Pharmaceutical Packaging Materials

  • 摘要: 开发了一种以扫描电子显微镜-能谱联用为主的药用包装材料鉴别手段. 通过扫描电子显微镜-能谱联用,联合红外分光光度计和差示扫描量热仪,对未知成分的胶塞和复合膜进行了分析鉴别,并对厚度进行了测定. 通过分析鉴别,胶塞为覆有乙烯-四氟乙烯共聚物膜的溴化丁基胶塞,覆膜厚度约为24 μm,复合膜为聚对苯二甲酸乙二醇酯/低密度聚乙烯/铝/低密度聚乙烯复合膜,厚度分别约为38、19、13、14 μm. 扫描电子显微镜-能谱联用技术可以确定未知化合物的元素组成和比例,可以解决传统鉴别手段在鉴别未知物时所遇到的瓶颈,极大地提高了鉴别效率和准确度,为鉴别药用包装材料提供了一种全新的思路.

     

    Abstract: A new identification method for pharmaceutical packaging materials has been developed based on the scanning electron microscope-energy dispersive spectroscope (SEM-EDS). SEM-EDS combined with infrared spectrophotometer and differential scanning calorimeter to analyze and identify the rubber stopper and laminated film of unknown composition, and the thickness was measured. The rubber stopper was a brominated butyl rubber stopper covered by ethylene-tetra-fluoro-ethylene with a thickness of about 24 μm, and the laminated film was a polyethylene terephthalate/low density polyethylene/aluminum/low density polyethylene laminated film with a thickness of about 38, 19, 13 and 14 μm, respectively. The SEM-EDS identification method for pharmaceutical packaging materials can determine the elemental composition and proportion of unknown compounds, thus solves the bottleneck encountered by the traditional identification, improves the efficiency and accuracy of identification greatly, and provides new ways for identifying pharmaceutical packaging materials.

     

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