目的: 对药用玻璃注射剂瓶可提取物进行研究,并对不同元素提取情况进行差异性分析。方法: 建立电感耦合等离子体发射光谱(ICP-OES)和电感耦合等离子体质谱(ICP-MS)法测定不同侵蚀条件下注射剂瓶中17种元素提取的测定方法,并进行不同提取介质下可提取物测定。结果: 提取溶液、注射剂瓶生产厂家、生产工艺、玻璃类型等的不同会对测定结果产生显著影响。结论: 需重点关注不同类型的药品、不同生产厂家、不同生产工艺、不同玻璃类型变更对注射剂质量安全的影响。
Objective: To study the extracts of pharmaceutical glass vails and conduct differential analysis on the extracted elements. Methods: A method for the determination of 17 elements in glass vials under different erosion medium by inductively coupled plasma optical emission spectrometry (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS) was established. The determination of extracts in different medium of glass vails was carried out. Results: The difference in extraction medium, glass vials manufacturer, production process, glass type, etc. has a significant impact on the measurement results. Conclusion: It is necessary to pay attention to the impact of different types of drugs, different manufacturers, different production processes, and different glass types on the quality and safety of injections.
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