丹皮酚化学纯度标准物质研制与定值分析方法研究  

Development of Paeonol Purity Reference Material and Method of Valuation

作　　者：徐维盛[1] 杨德智[1] 张丽[1] 杨宁[1] 马辰[1] 吕扬[1] 

机构地区：[1]北京协和医学院

出　　处：《医药导报》2011年第2期143-148,共6页Herald of Medicine

基　　金：科技部科技基础性工作专项重点项目(基金编号:2007FY130100);重大新药创制十一五规划项目(基金编号:2009ZX09501-021);卫生行业科研专项(基金编号:200902008);国家药典委员会国家药品标准提高研究(编号:1680)

摘　　要：目的研制我国具有可溯源性高准确度量值的丹皮酚化学纯度标准物质,并建立有效定值分析方法。方法依据我国一级标准物质研制技术规范与有关技术文件,制备丹皮酚化学纯度标准物质,采用高效液相色谱(HPLC)法进行均匀性检验与稳定性考察;采用高效液相色谱技术面积归一化法与溴库伦滴定法对丹皮酚化学纯度标准物质联合定值。结果研制的丹皮酚化学纯度标准物质符合我国有证标准物质要求,标准值与不确定度评估值为(99.87±0.35)%(k=2,P=0.95)。结论该实验研制的丹皮酚化学纯度标准物质与建立的联合定值方法可实现对其化学纯度的定值与不确定度评估,方法具有快速、准确的特点,提供了量值传递功能。Objective To develop the paeonol purity reference material which has measurement traceability and high accuracy,and establish an effective method of valuation. Methods The paeonol purity reference material was studied on the basis of National Standard Material technical specification requirements.The homogeneity and stability test were measured by HPLC.The purity and uncertainty evaluation of the substance was measured by the peak area normalization method of HPLC and coulometry method. Results The paeonol purity reference material developed in this study conforms to the technical requirements of national primary standard reference material.The purity value and uncertainty evaluation of paeonol was（99.87±0.35）%（k = 2,P= 0.95）. Conclusion The method established in our study was proved to be rapid,accurate and reliable,and was successfully applied to the purity value and uncertainty evaluation of paeonol purity reference material.It can provide the characteristic value transfer function.

关 键 词：丹皮酚标准物质 化学纯度 色谱法 高效液相 库伦滴定法 

分 类 号：R286[医药卫生—中药学] R927.1[医药卫生—中医学]