| 谢兰桂,孙会敏,杨会英,赵霞,肖新月.塑料类药包材抗氧剂的检测分析策略[J].中国药事,2022,36(9):1002-1009 |
| 塑料类药包材抗氧剂的检测分析策略 |
| Analysis Strategy of Antioxidants Detection for Plastic Packaging Materials |
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| DOI：10.16153/j.1002-7777.2022.09.005 |
| 中文关键词: 药包材 抗氧剂 相容性 药品安全 质量分析 |
| 英文关键词: pharmaceutical packaging materials antioxidant compatibility drug safety quality analysis |
| 基金项目: |
| 作者 | 单位 | | 谢兰桂 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 孙会敏 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 杨会英 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 赵霞 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 肖新月 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 |
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| 中文摘要: |
| 目的：综述塑料类药包材中常用抗氧剂的种类和特性、检测方法和分析策略，为药品及药包材行业检测人员开展药品与包材的相容性研究提供参考。方法：基于《化学药品注射剂与塑料包装材料相容性研究技术指导原则》和国内外药典及相关文献资料，对塑料类药包材抗氧剂的类型、检测方法和分析策略进行汇总分析。结果与结论：常用的塑料类药包材抗氧剂类型有受阻酚类抗氧剂、亚磷酸酯类抗氧剂、硫代酯类抗氧剂及复合类抗氧剂。根据抗氧剂的结构特点和光学性质，常用的分析方法有红外光谱法、核磁共振法、气相色谱法、高效液相色谱法、超高效超临界色谱分析法。为全面和高效检测塑料类药包材中的抗氧剂，需要从提取方法、提取溶剂、定性鉴别和定量分析等多方面统筹考虑，综合施策。 塑料类药包材中抗氧剂的分析正朝着高通量、信息化、集成化的方向发展。 |
| 英文摘要: |
| Objective: To summarize the types, characteristics, detection methods and analysis strategies of antioxidants commonly used in plastic pharmaceutical packaging materials, so as to provide references for practitioners in the pharmaceutical and pharmaceutical packaging industry to study the compatibility between drugs and packaging materials. Methods: Based on "Technical Guiding Principles of Compatibility Research between Chemical Injections and Plastic Packaging Materials", Chinese Pharmacopoeia, foreign Pharmacopoeias and related literatures, the types, detection methods and analysis strategies of antioxidants in plastic packaging materials were summarized and analyzed. Results and Conclusion: The commonly used antioxidants of plastic packaging materials include hindered phenolic antioxidants, phosphite antioxidants, thioester antioxidants and composite antioxidants. According to the structural characteristics and optical properties of antioxidants, the commonly used analytical methods include infrared spectroscopy, nuclear magnetic resonance, gas chromatography, high performance liquid chromatography and ultra-high performance supercritical chromatography. In order to realize comprehensive and efficient detection of antioxidants in plastic pharmaceutical packaging materials, it is necessary to consider extraction methods, extraction solvents, qualitative identification and quantitative analysis, and take comprehensive measures. The analysis of antioxidants in plastic packaging materials is developing towards high throughput, informationization and integration. |
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