试论国家药品标准物质的稳定性及期间核查

Discussion on Stability of National Pharmaceutical Reference Standards and Interval Monitoring Projects

目的为做好国家药品标准物质期间核查工作提供参考。方法介绍了国家对标准物质期间核查的基本要求及国家药品标准物质的稳定性核查工作,详细论述了稳定性的定义、影响药品标准物质稳定性的因素、保证药品标准物质稳定性的措施以及药品标准物质稳定性核查工作的原则、核查品种、核查间隔、核查项目、核查方法及核查结果评价等内容。结果与结论国家药品标准物质是药品质量分析中使用的实物对照,也是药品检验不可缺少的物质。中国食品药品检定研究院将进一步加强药品标准物质的稳定性核查工作,以确保药品标准物质的有效性。

Objective It was provided a reference for the interval monitoring projects of national pharmaceutical reference standards.Methods This article introduced the basic requirements of reference standards and the interval monitoring projects of national pharmaceutical reference standards.Discussing in detail the definition of stability,influence factors of stability,to ensure drug standard substance stability measures as well as principle,variety,interval,index,method,results evaluation of interval monitoring projects of national pharmaceutical reference standards.Results and Conclusion Pharmaceutical reference standards are required by pharmacopoeia testing and pharmaceutical control in general.In the future,NIFDC will further strengthen the stability of national pharmaceutical reference standards to ensure the their effectiveness.