葛根素标准样品的研制

摘要

目的:依据工作导则GB/T 15000,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.