| 贾菲菲,赵霞,杨会英,肖新月.药用卤化丁基橡胶塞中常用硫化体系及其相容性研究进展[J].中国药事,2022,36(8):913-920 |
| 药用卤化丁基橡胶塞中常用硫化体系及其相容性研究进展 |
| Research Progress on Vulcanization System and Compatibility of Pharmaceutical Halogenated Butyl Rubber Stoppers |
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| DOI：10.16153/j.1002-7777.2022.08.009 |
| 中文关键词: 药用卤化丁基橡胶塞 硫化体系 相容性研究 添加剂检测 硫化剂 |
| 英文关键词: pharmaceutical halogenated butyl rubber stoppers vulcanization system compatibility study additive testing vulcanizing agents |
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| 中文摘要: |
| 目的：以药用卤化丁基橡胶塞中的硫化体系为研究对象，通过介绍药用卤化丁基橡胶塞中常用硫化体系及其相容性研究进展，提出开展药用卤化丁基橡胶塞与药品相容性研究工作思路，进一步保障上市药品的安全有效。方法：以相容性研究步骤为整体思路，基于文献调研与工作实践，对硫化体系中各组分的主要分类、作用机理、检测方法和结果评估进行汇总和分析，给出了相容性研究需关注的风险点，为评价药用卤化丁基橡胶塞与药品的相容性提供参考。结果与结论：硫化体系是药用卤化丁基橡胶塞中重要的配方原料，包括硫化剂、硫化促进剂和硫化活性剂等多种组分。开展相容性研究时，需要对不同硫化体系组分及其反应产物进行提取检测，并结合具体药物的迁移分析进行全面评估，以保证药用卤化丁基橡胶塞所包装药品的安全性。 |
| 英文摘要: |
| Objective: To put forward the research ideas about the compatibility between pharmaceutical halogenated butyl rubber stoppers and drugs so as to guarantee the safety and effectiveness of listed drugs by taking the vulcanization system of pharmaceutical halogenated butyl rubber stoppers as the research object to introduce the research progress on the common vulcanization systems and their compatibility with pharmaceutical halogenated butyl rubber stoppers. Methods: Taking the compatibility research steps as the overall idea combined with literature research and work practice, the main classifi cation, mechanism, detection methods and result evaluation of various components in the vulcanization system were summarized and analyzed. The risk points that should be paid attention to in the compatibility research were put forward so as to provide references for evaluating the compatibility between pharmaceutical halogenated butyl rubber stoppers and drugs. Results and Conclusion: Vulcanization system is an important formula material in pharmaceutical halogenated butyl rubber stoppers, including vulcanizing agents, vulcanizing accelerators, vulcanizing activators and other components. In the compatibility research, it is necessary to extract and detect diff erent kinds of vulcanization system components and their products, and evaluate them comprehensively in combination with the migration analysis of specifi c drugs so as to ensure the safety of drugs packaged with pharmaceutical halogenated butyl rubber stoppers. |
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