摘要
目的:基于维生素B_(12)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B_(12)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B_(12)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RH25%时,样品失重0.7%;RH 45%时,样品增重0.56%。故建议维生素B_(12)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。
Objective:To discuss the management methods for hygroscopic chemical reference standards based on the hygroscopicity study of vitamin B_(12),so as to improve and enhance the management of national drug standards substance.Methods:The hygroscopicity of vitamin B_(12) 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 B_(12) 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 B_(12) 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.
作者
刘毅
吴静芳
丁怡
陈华
Liu Yi;Wu Jingfang;Ding Yi;Chen Hua(National Institutes for Food and Drug Control,Beijing 102629,China;Guangzhou Institute for Drug Control,Guangzhou 510160,China)
出处
《中国药事》
CAS
2024年第8期922-926,共5页
Chinese Pharmaceutical Affairs
关键词
国家药品标准物质
维生素B_(12)
引湿性
动态水分吸附法
管理方法
national drug reference standards
vitamin B_(12)
hygroscopicity
dynamic vapor absorption analysis
management methods
