中国药事2024，Vol.38Issue(8) ：922-926.DOI:10.16153/j.1002-7777.20240330

基于维生素B12的引湿性研究谈国家药品标准物质的管理方法

Discussion on Management Methods for National Drug Reference Standards based on the Hygroscopicity Study of Vitamin B12

刘毅 吴静芳 丁怡 陈华
中国药事2024，Vol.38Issue(8) ：922-926.DOI:10.16153/j.1002-7777.20240330
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基于维生素B12的引湿性研究谈国家药品标准物质的管理方法

Discussion on Management Methods for National Drug Reference Standards based on the Hygroscopicity Study of Vitamin B12

刘毅 1吴静芳 2丁怡 2陈华1
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作者信息

  • 1. 中国食品药品检定研究院,北京 102629
  • 2. 广州市药品检验所,广州 510160
  • 折叠

摘要

目的:基于维生素B12的引湿性研究,探讨有引湿性化学对照品的管理方法,进一步完善和提高国家药品标准物质的管理工作.方法:采用动态水分吸附法(DVS)分析维生素B12对照品的引湿性;基于分析结果,从各个环节探讨有引湿性的国家药品标准物质的管理.结果:湿度在RH 20％～80％变化时,维生素B12的水分吸附不断上升,引湿性明显.样品在RH 20％环境失重1.4％,在RH 50％环境时,样本质量变化显著增加至1.3％.进一步对该批对照品进行应用区域RH 25％～45％的DVS分析,结果RH 25％时,样品失重0.7％;RH 45％时,样品增重0.56％.故建议维生素B12对照品应在RH 30％～40％的环境中快速称量.结论:对于有引湿性的化学对照品,应在原料筛选、分装、包装、标签和说明书、稳定性考察等环节针对其特性制定相应的管理方法,以全面提升国家药品标准物质的管理和质量,为药品质量标准的实施和用药安全提供保障.

Abstract

Objective:To discuss the management methods for hygroscopic chemical reference standards based on the hygroscopicity study of vitamin B12,so as to improve and enhance the management of national drug standards substance.Methods:The hygroscopicity of vitamin B12 reference standard was analysed by dynamic water absorption method.Based on the analysis results,the management methods of hygroscopic national drug reference standards substance were discussed from each aspect.Results:When humidity changed at 20％-80％RH,the water adsorption of vitamin B12 continued to increase,which indedicated significant hygroscopicity.The sample lost 1.4％weight at RH 20％environment,and the change in sample quality significantly increased to 1.3％at RH 50％environment.Further DVS for this batch of reference standard in application area RH 25％to 45％,the sample lost 0.7％weight at RH 25％and increased 0.56％at RH 45％.Therefore,it was recommended that vitamin B12 reference standard should be rapidly weighed at RH 30％-40％.Conclusion:In order to comprehensively enhance the management and quality of national drugreference standards and provide guarantees for the implementation of drug quality standards and medication safety,corresponding management methods,which according to the hygroscopic chemical standards substance,should be developed for its characteristics in the stages of raw material screening,packaging,packages,labels and instructions,stability inspection and so on.

关键词

国家药品标准物质/维生素B12/引湿性/动态水分吸附法/管理方法

Key words

national drug reference standards/vitamin B12/hygroscopicity/dynamic vapor absorption analysis/management methods

引用本文复制引用

出版年

2024
中国药事
中国食品药品检定研究院（中国药品生物制品检定所）

中国药事

CSTPCD
影响因子：0.844
ISSN：1002-7777
参考文献量7
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