SEM-EDS解析药物对玻璃注射剂瓶内表面的侵蚀程度

Analysis of the Corrosion Degree of Drugs on the Inner Surface of Glass Injection Bottle by SEM-EDS

关键词:  SEM-EDS  扫描电镜  X射线能谱仪  低硼硅玻璃注射剂瓶  注射用帕瑞昔布钠  侵蚀  药包材

Key words:  SEM-EDS  scanning electron microscope  X-ray spectrometer  low borosilicate glass injection bottle  Parecoxib sodium for injection  corrosion  pharmaceutical packaging

摘要:

目的 研究碱性药物对直接接触的低硼硅玻璃注射剂瓶内表面的侵蚀情况，考察药品包装材料与药物的相容性。方法 采用扫描电镜观察灌装注射用帕瑞昔布钠的低硼硅玻璃注射剂瓶内表面，并结合X射线能谱仪确证侵蚀部位。结果 通过对低硼硅玻璃注射剂瓶内表面的扫描电镜图的研究，显示阳性对照样品能较好区分不同的侵蚀程度，加速试验的各时期样品均未发生明显侵蚀现象。结论 扫描电镜结合X射线能谱仪能直观显示低硼硅玻璃注射剂瓶内表面结构被接触药物侵蚀的程度，可作为药包材和药物相容性的评价依据。

Abstract:

OBJECTIVE To study the effect of alkaline drugs on the inner surface of direct contact borosilicate glass bottles, and investigate the compatibility of pharmaceutical packaging and drugs. METHODS The inner surface of low borosilicate glass injection bottle filling Parecoxib Sodium for Injection was observed by scanning electron microscopy, and combined with X-ray spectrometer confirmed erosion position. RESULTS Based on the scanning electron microscope (SEM) study of the inner surface of low borosilicate glass injection bottle, showed that the positive control sample was able to distinguish different erosion degrees, and no obvious erosion occurred in the samples in each period of the accelerated test. CONCLUSION Scanning electron microscope combined with X-ray spectrometer can visually show the extent of the erosion of the inner surface structure of low borosilicate glass injection by contact drug, and can be used as the basis for evaluating the compatibility of pharmaceutical packaging and drugs.