聂蕾, 范旭. 玻璃类注射剂用药包材内表面耐受性测试研究[J]. 分析测试技术与仪器, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016
引用本文: 聂蕾, 范旭. 玻璃类注射剂用药包材内表面耐受性测试研究[J]. 分析测试技术与仪器, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016
NIE Lei, FAN Xu. Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection[J]. Analysis and Testing Technology and Instruments, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016
Citation: NIE Lei, FAN Xu. Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection[J]. Analysis and Testing Technology and Instruments, 2022, 28(2): 210-221. DOI: 10.16495/j.1006-3757.2022.02.016

玻璃类注射剂用药包材内表面耐受性测试研究

Test and Study on Inner Surface Tolerance of Drug Packaging Materials for Glass Injection

  • 摘要: 为筛选出快速有效的玻璃脱片检出方法, 初步建立玻璃内表面耐受性的测试方法以供药品研发人员选择参考. 采用目检、亚甲基蓝染色试验、不溶性微粒、扫描电子显微镜、离子检测等测试方法, 从不同角度考察玻璃类注射剂用药包材内表面耐受性. 试验结果表明, 玻璃安瓿的内表面耐受性要强于玻璃注射剂瓶, 中硼硅玻璃的内表面耐受性要好于低硼硅玻璃, 钠钙输液瓶的最差. 氢氧化钠溶液对玻璃容器的腐蚀能力要远远强于其余4种腐蚀溶液, 并且氢氧化钠的浓度越高, 腐蚀能力越强. 使用5种不同的检测方法进行考察, 从不同角度发现玻璃形制、材质、腐蚀溶液性质、浓度及时间均对玻璃内表面耐受性有影响. 5种方法各有优缺点, 可供药品研发人员在药品研发的初期对玻璃类包材材料进行筛选时参考选择.

     

    Abstract: In order to screen out a fast and effective method for the detection of glass flake, a test method for the tolerance of the inner surface of glass has been initially established for the reference of drug research and development personnel. Visual inspection, methylene blue staining test, insoluble particles, scanning electron microscope and ion detection were used to investigate the inner surface tolerance of drug packaging materials for glass injection from different angles. The inner surface tolerance of glass ampoules was stronger than that of glass injection bottles, the inner surface tolerance of medium borosilicate glass ampoules was better than that of low borosilicate glass ampoules, and the inner surface tolerance of sodium calcium glass infusion bottles was the worst. The corrosion ability of NaOH solution to glass containers was much stronger than the other four corrosion solutions, and the higher the concentration of NaOH, the stronger the corrosion ability. Five different detection methods were used for the investigation. From the different angles, it was found that the shape and material of glass, the property, concentration and time of the corrosion solution affected the tolerance of the inner surface of glass. The five methods have their own advantages and disadvantages, which can be used for reference and selection by drug developers when screening glass packaging materials in the early stage of drug development.

     

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