国家标准样品长期稳定性与加速稳定性的比较  

Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials

作　　者：马玉翠[1] 吴翠[1] 王尉[2] 王淳[1] 杜宁[2] 吴晓毅[1] 李春[1] 巢志茂[1] 

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]北京市理化分析测试中心,北京100094

出　　处：《中国实验方剂学杂志》2017年第20期51-55,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家质量监督检验检疫总局行业科研专项(201210209);国家标准化管理委员会国家标准样品研制项目(S2012087-S2012091)

摘　　要：目的:探索天然产物标准样品的长期稳定性和加速稳定性之间的关系,为标准样品的有效期确定提供必要的技术支撑。方法:在研制5个国家标准样品(肉桂醛、樱花素、长梗冬青苷、水苏糖和β-谷甾醇)的过程中,将置于0~8℃条件下的样品,分别于第0,1,2,3,6,9,12,18,24个月测定各标准样品的纯度,进行长期稳定性检验。将置于温度(40±2)℃和相对湿度(75±5)%条件下的样品,分别于第0,1,2,3,6个月时测定各标准样品的纯度,进行加速稳定性检验。结果:统计分析的结果显示,长期稳定性检验和加速稳定性检验的稳定性均良好,二者之间无显著性差异。结论:天然产物标准样品24个月的有效期可通过6个月的加速稳定性检验进行预判。Objective： To explore the relationship between long-term stability and accelerated stability of certified reference materials（ CRMs） of natural products,in order to provide technical support for the prediction of validity of CRMs. Method： In the process of development of 5 CRMs（ cinnamaldehyde, sakuranetin,pedunculoside,stachyose and β-sitosterol）, the long-term stability test was carried out by determining their purities at 0,1,2,3,6,9,12,18,24 months under the temperature of 0-8 ℃ and the accelerated stability test was carried out by determining their purities at 0,1,2,3,6 months under temperature of（ 40 ± 2） ℃ and relative humidity of（ 75 ± 5） %. Result： The results of statistical analysis showed that both long-term stability and accelerated stability were excellent and there were no significant difference between long-term stability and accelerated stability. Conclusion： The validity of 24 months of CRMs can be predicted on the bases of the result of accelerated stability test in 6 months.

关 键 词：标准样品 加速稳定性 长期稳定性 有效期 

分 类 号：R284[医药卫生—中药学] R283.6[医药卫生—中医学]