关注荧光素钠注射液质量标准以及临床应用安全性  

On Quality Standards and Clinical Safety of Fluorescein Sodium Injection

作　　者：唐筱婉 都丽萍[1] 杨晨 梅丹[1] Tang Xiaowan;Du Liping;Yang Chen;Mei Dan(Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Beijing Longfu Hospital,Beijing 100010,China)

机构地区：[1]中国医学科学院北京协和医院,北京100730 [2]北京市隆福医院,北京100010

出　　处：《中国药事》2021年第1期37-43,共7页Chinese Pharmaceutical Affairs

基　　金：首都卫生发展科研专项项目(编号首发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)。

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用药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;《中华人民共和国药典》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:药师应持续关注荧光素钠注射液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。Objective:To analyze and summarize the relevant quality standards of fluorescein sodium injection and to provide a firmer basis and more reasonable suggestions for the improvement of quality standards and the safety of clinical medication.Methods:Pharmacopoeias at home and abroad and the relevant literature 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 is different in the pharmacopoeias of different countries,and the quality standards are increasingly stricter.The Chinese pharmacopoeia introduced the test of related substances for fluorescein sodium injection and improve the method of assay in 2010.Conclusion:Pharmacists are supposed to pay continuous attention to the occurrence of adverse reactions in clinical application after the quality standards of fluorescein sodium injection are improved so as to ensure the safety of clinical medication.

关 键 词：荧光素钠注射液 质量标准 药典 临床用药安全性 

分 类 号：R95[医药卫生—药学] R969.3[医药卫生—药理学]