葛根素标准样品的研制  

Preparationof Certified Reference Material of Puerarin

作　　者：林楠[1,2] 王尉[1,2] 乐胜锋[1,2] 杜宁[1,2] 高峡[1,2] 张经华[1,2] 

机构地区：[1]北京市理化分析测试中心,北京100089 [2]有机材料检测技术与质量评价北京市重点实验室,北京100089

出　　处：《现代科学仪器》2017年第2期89-93,97,共6页Modern Scientific Instruments

摘　　要：目的：依据工作导则GB／T15000，研制葛根素标准样品，并对其进行定值、均匀性和稳定性等研究。方法：采用高速逆流色谱方法制备葛根素样品，通过紫外光谱、红外光谱、质谱和核磁共振等方法对葛根素样品进行结构鉴定，并进行均匀性、稳定性检验。通过8家不同单位实验室进行联合定值，并对定值结果进行数据分析。结果：葛根素标准样品均匀性和稳定性良好，其定值结果为99．51％，置信度95％的扩展不确定度为0．0092％。结论：所制备得到的葛根素样品满足工作导则的要求，可用于有关葛根素检测方法的校正和相关产品的质量控制。Objective： According to the directives for the work of reference materials GB/T 15000, puerarin certified reference material was prepared.Methods： Puerarin was separated by high-speed countercurrent chromatography. Its chemical structure was identified by UV, IR, MS and NMR. The homogeneity and stability were systematic checked. A cooperative certification was conducted with 8 laboratories and the results of certification for puerarin were analyzed. Results： The homogeneity and stability of the reference material of puerarinwere good, and the certified value was 99.51% with the expanded uncertainty of 0.0092% in confidencecoefficient of 95%. Conclusions： The reference material of puerarinconforms to directives for the work of reference materials. And it can be used for method validation and quality control of regarding products

关 键 词：葛根素 标准样品 定值 均匀性 稳定性 

分 类 号：R286[医药卫生—中药学]