药品监管中具引湿性化学对照品应用的建议  

Suggestions for the Hygroscopic Chemical Reference Substances in Drug Regulatory Application

作　　者：刘毅[1] 吴静芳[2] 郭贤辉 丁怡[2] 陈华[1] 宁霄[1] 曹进[1] Liu Yi;Wu Jingfang;Guo Xianhui;Ding Yi;Chen Hua;Ning Xiao;Cao Jin(National Institutes for Food and Drug Control,Beijing 102629,China;Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[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

出　　处：《中国药事》2024年第12期1399-1403,共5页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划课题(编号2021YFC2401100)。

摘　　要：目的:介绍具引湿性化学对照品在药品监管应用中遇到的问题并提出建议,为国家药品标准物质更好地在药品监管中发挥作用提供参考。方法:阐述药品标准物质相关法规,分析具引湿性化学对照品在使用过程中遇到的问题,有针对性地采用动态水分吸附分析法(DVS)对部分对照品进行引湿性研究,从标准执行、说明书、包装和储存、称量和水分测定等方面提出建议。结果与结论:具引湿性化学对照品是一类比较特殊的对照品,由于其引湿特性对量值稳定性的影响,给药品监管工作带来若干问题和挑战。通过引湿性研究的成果、对照品说明书的完善和实际工作中的经验总结,各方共同努力解决问题,更好地提升国家标准物质的应用,以保证药品监管的有效性及药品的安全性。Objective:To introduce the problems of hygroscopic chemical reference substances in drug regulatory application and give suggestions,in order to provide reference for better application of national drug reference substances in drug regulation.Methods:Regulations related to pharmaceutical reference substances were expounded,and the problems encountered in the use were analyzed and the hygroscopic chemical reference substances by dynamic vapor absorption analysis(DVS)were studied.Suggestions from the aspects of standard implementation,instructions,packaging and storage,weighing and moisture determination were provided.Results and Conclusion:Chemical reference substances with hygroscopic properties are a relatively special type of reference standard.Due to their hygroscopic properties affecting the stability of measurement values,they has posed several problems and challenges to drug regulation.Through the achievements of research on hygroscopicity,the improvement of reference standard instructions,and the summary of practical work experience,all parties are working together to solve the problems and better improve the application of national reference substances,in order to ensure the effectiveness of drug regulation and the safety of drug.

关 键 词：药品监管 化学对照品 引湿性 动态水分吸附 国家药品标准物质 

分 类 号：R917[医药卫生—药物分析学]