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| 关注荧光素钠注射液质量标准以及临床应用安全性 |
| Quality Standards and Clinical Safety of Fluorescein Sodium Injection |
| 投稿时间：2020-04-29 修订日期：2020-12-22 |
| DOI： |
| 中文关键词: 荧光素钠注射液 质量标准 药典 临床安全性 |
| 英文关键词: fluorescein sodium injection quality standard pharmacopoeia clinical safety |
| 基金项目:首都卫生发展科研专项项目（首发2018-3-4017）；中国医学科学院医学与健康科技创新工程项目（编号2017-I2M1-011） |
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| 中文摘要: |
| 目的：对荧光素钠注射液的相关质量标准进行汇总分析，为质量标准的提升及临床安全性的提高提供更充分的依据和更合理的建议。方法：全面检索国内外药典及近15年相关文献，比较荧光素钠注射剂及荧光素钠的相关质量标准的变迁和异同。结果：各国药典对荧光素钠注射液和荧光素钠的收录有所不同，质量标准也越来越严格；中国药典自2010年版开始对荧光素钠注射液增设有关物质的检测，并改进含量测定方法。结论：荧光素钠注射液质量标准的提升很有必要，药师应持续关注质量标准提升后临床应用的不良反应发生情况，以确保临床用药的安全性。 |
| 英文摘要: |
| Objective: Analyze and summarize the relevant quality standards of fluorescein sodium injection to provide a fuller basis and more reasonable suggestions for the improvement of quality standards and clinical safety. Methods: Pharmacopoeias at home and abroad and the relevant literatures of the past fifteen years were comprehensively searched to compare the changes and differences of quality standards of fluorescein sodium injection and fluorescein sodium. Results: The inclusion of fluorescein sodium injection and fluorescein sodium are different in the pharmacopoeias of varius countries, and the quality standards are more and more strict. The Chinese pharmacopoeia started to test the related substances for fluorescein sodium injection and improve the method of assay in 2010.Conclusion: The improvement of the quality standard of fluorescein sodium injection is very necessary, and pharmacists should continue to pay attention to the occurrence of adverse reactions in clinical application after the improvement of the quality standard, so as to ensure the safety of clinical medication. |
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