化学对照品引湿性研究路线的探讨

doi:10.19803/j.1672-8629.20230331

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (3): 280-282.
DOI: 10.19803/j.1672-8629.20230331

• 药品质量控制及评价专栏 • 上一篇下一篇

化学对照品引湿性研究路线的探讨

刘毅, 耿颖, 覃玲, 郭贤辉, 陈华^*, 裴宇盛

中国食品药品检定研究院化学药品鉴定所,化学药品质量研究与评价重点实验室,北京 102629

收稿日期:2023-06-28 出版日期:2024-03-15 发布日期:2024-03-18
通讯作者: ^*陈华,男,硕士,主任药师,化学药品质量分析。E-mail: chenhua@nifdc.org.cn
作者简介:刘毅,男,博士,主任药师,化学药品质量分析。
基金资助:
中国食品药品检定研究院化学药品检定所重点实验室学科建设项目（2023HYZX25）; 国家重点研发计划（2019YFC1200704）; 北京市自然科学基金资助项目（L222010）

Research routes of hygroscopicity of chemical reference substances

LIU Yi, GENG Ying, QIN Ling, GUO Xianhui, CHEN Hua^*, PEI Yusheng

Institute for Chemical Drug Control, National Institutes for Food and Drug Control‚ NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 10262, China

Received:2023-06-28 Online:2024-03-15 Published:2024-03-18

摘要/Abstract

摘要： 目的探讨化学对照品引湿性研究的应用路线,为药品质量和用药安全奠定基础。方法主要采用动态水分吸附分析法（DVS）开展引湿性研究,DVS设定温度为25℃,载气N₂流速200 mL·min^-1,程序调控相对湿度变化和时间。结果结合溴吡斯的明研究实例,较系统地解析了3步骤的化学对照品引湿性研究路线。结论相关研究路线的探讨有助于加强基于水分吸附的化学对照品引湿性研究。

关键词: 引湿性, 化学对照品, 动态水分吸附, 溴吡斯的明, 研究路线, 环境湿度

Abstract: Objective To investigate the research routes of hygroscopicity of chemical reference substances. Methods Dynamic vapor absorption analysis (DVS) was mainly used to study related hygroscopicity. During the analysis with DVS, the temperature was 25℃, the gas flow rate of N₂ was 200 mL·min^-1, and the relative humidity changes and time were program-controlled. Results Based on a case study of pyridostigmine bromide, the three-step research routes of hygroscopicity of chemical reference substances were analyzed in depth. Conclusion Studies on related research routes can contribute to research on hygroscopicity of chemical reference substances based on water adsorption.

Key words: hygroscopicity, chemical reference substance (CRS), dynamic vapor absorption analysis (DVS), pyridostigmine bromide, research route, ambient humidity

中图分类号:

R916

刘毅, 耿颖, 覃玲, 郭贤辉, 陈华, 裴宇盛. 化学对照品引湿性研究路线的探讨[J]. 中国药物警戒, 2024, 21(3): 280-282.

LIU Yi, GENG Ying, QIN Ling, GUO Xianhui, CHEN Hua, PEI Yusheng. Research routes of hygroscopicity of chemical reference substances[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 280-282.

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化学对照品引湿性研究路线的探讨

Research routes of hygroscopicity of chemical reference substances

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