中国药物警戒 ›› 2025, Vol. 22 ›› Issue (9): 983-985.
DOI: 10.19803/j.1672-8629.20240450

• 基础与临床研究 • 上一篇    下一篇

具引湿性标准物质甲钴胺研制探讨

刘毅1, 王天歌2△, 郭贤辉1, 陈华1,*, 宁霄1, 曹进1   

  1. 1中国食品药品检定研究院,北京 102629;
    2沈阳市食品药品检验所,辽宁 沈阳 110000
  • 收稿日期:2024-04-04 发布日期:2025-09-22
  • 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。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2021YFC2401100）

Hygroscopic Chemical Reference Substance of Mecobalamin

LIU Yi1, WANG Tiange, GUO Xianhui1, CHEN Hua1,*, NING Xiao1, CAO Jin1   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2Shenyang Food and Drug Inspection Institute, Shenyang Liaoning 110000, China
  • Received:2024-04-04 Published:2025-09-22

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摘要： 目的 介绍甲钴胺标准物质的研制,讨论影响其含量的因素。方法 标准物质研制采用高效液相色谱法（HPLC）、水分滴定、气相色谱（GC）等定量分析和高分辨质谱等定性分析,并针对其引湿性特点应用动态水分吸附分析法（DVS）开展相关研究。结果 标准物质的结构确认和吸附水分含量分析符合预期,引湿性方面调整吸附水分含量为8%时,可以满足环境湿度（RH）40%~50%,实现本品的稳定称量。结论 需要关注原料工艺变化引起的标准物质引湿性变化;包装、存储条件及使用环境的讨论有助于更好了解甲钴胺的特点及使用时注意事项。

关键词: 甲钴胺, 标准物质, 引湿性, 动态水分吸附分析, 包装, 存储, 定量

Abstract: Objective To identify the reference substance of mecobalamin and to explore the factors that affect its contents. Methods The reference substance was determined using HPLC, water titration, GC and high-resolution mass spectrometry. The dynamic vapor sorption (DVS) method was adopted to study hygroscopicity. Results The structure of the reference substance was confirmed while the adsorbed moisture content was analyzed as expected. In terms of hygroscopicity, the adsorbed moisture content was adjusted to 8%,which could ensure stable weighing when the ambient humidity ranged from RH 40% to RH 50%. Conclusion The changes in the hygroscopicity of the reference substance caused by alterations in the processing technology deserve attention. Studies on packaging, storage conditions and environments can help users better understand the characteristics of and considerations for mecobalamin.

Key words: Mecobalamin, Chemical Reference Substance(CRS), Hygroscopicity, Dynamic Vapor Sorption(DVS), Packaging, Storage, Quantitation

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