| 引用本文: | 陈超,史沛,程磊,訾晓伟,王国勤,俞辉.SEM-EDS解析药物对玻璃注射剂瓶内表面的侵蚀程度[J].中国现代应用药学,2018,35(12):1792-1796. |
| CHEN Chao,SHI Pei,CHENG Lei,ZI Xiaowei,WANG Guoqin,YU Hui.Analysis of the Corrosion Degree of Drugs on the Inner Surface of Glass Injection Bottle by SEM-EDS[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(12):1792-1796. |
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| SEM-EDS解析药物对玻璃注射剂瓶内表面的侵蚀程度 |
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陈超1, 史沛2, 程磊1, 訾晓伟1, 王国勤2, 俞辉1
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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 310051;2.安徽省食品药品检验研究院, 合肥 230051
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| 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。 |
| 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 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.12.008 |
| 分类号:R917.101 |
| 基金项目:国家药典委员会药品医疗器械审评审批制度改革专项课题（ZG2017-6-03） |
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| Analysis of the Corrosion Degree of Drugs on the Inner Surface of Glass Injection Bottle by SEM-EDS |
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CHEN Chao1, SHI Pei2, CHENG Lei1, ZI Xiaowei1, WANG Guoqin2, YU Hui1
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1.Zhejiang Insititute for Food and Drug Control, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial, Hangzhou 310051, China;2.Anhui Insititute for Food and Drug Control, Hefei 230051, China
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| 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. |
| Key words: SEM-EDS scanning electron microscope X-ray spectrometer low borosilicate glass injection bottle Parecoxib sodium for injection corrosion pharmaceutical packaging |
