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目的:研制传统中药中活性成分芸香苷的纯度标准物质,并建立有效的定值方法。方法:依据国家计量技术规范和其它相关技术规范,制备芸香苷纯度标准物质,采用高效液相色谱(HPLC)法进行均匀性检验与稳定性考察;采用面积归一化法确定芸香苷的纯度。结果:研制的芸香苷纯度标准物质符合国家有证标准物质要求,标准值与不确定度评估值为(99.79±0.3)%(k=2),并获得国家二级标准物质证书。结论:为芸香苷的分析检测提供了可靠的量值溯源保证,应用前景非常广泛。
Objective: To develop the purity standard substance of rutin in the traditional Chinese medicine and to establish an effective method of setting value. Methods: According to the National Metrology Standard and other related technical specifications, the standard compounds of rutin were prepared, and the homogeneity and stability were investigated by high performance liquid chromatography (HPLC). The area normalization method was used to determine the purity of rutin. Results: The developed rutin purity standards met the requirements of the national certified reference materials. The standard value and uncertainty evaluation value was (99.79 ± 0.3)% (k = 2), and obtained the national second-class standard material certificate. Conclusion: It provides a reliable quantitative tracing guarantee for the analysis and detection of rutin. The application prospect is very wide.