标示量值七叶皂苷对照提取物的研制

目的：研究制备定量用七叶皂苷对照提取物国家药品标准物质。 方法：参考中国药典2010年版一部娑罗子以及国家药品标准七叶皂苷钠项下方法，以七叶皂苷A、七叶皂苷B、七叶皂苷C、七叶皂苷D为指标，测定七叶皂苷对照提取物中4个皂苷的标示含量。 结果：通过自行纯化、标定4个单体皂苷量值，测得七叶皂苷B、C、D相对于七叶皂苷A的校正因子；通过外标法量值溯源测得七叶皂苷对照提取物中4个皂苷成分的标示含量，分别为：七叶皂苷A 19.33%、七叶皂苷B 17.21%、七叶皂苷C 25.14%、七叶皂苷D 18.10%。同时采用外标法、校正因子法对于标示量值七叶皂苷对照提取物的定值准确性予以验证。 结论：通过单体对照品溯源赋值，建立了定量用七叶皂苷对照提取物标准物质，可用于娑罗子及七叶皂苷类制剂的质量控制分析。

Objective: To study and prepare national standard of aescinate extractive reference substance for quantitative analysis. Methods: According to the analysis methods for Aesculi Semen in Chinese pharmacopoeia 2010 edition and the preparation method for sodium aescinate in national drug standards,using ecsin Ⅰa,escin Ⅰb,isoescin Ⅰa and isoescin Ⅰb as indexes,the labeled amounts of four saponins in the aescinate extractive reference substance were determined. Results: Through purification and calibration of the four saponins on our own,the correction factors of escin Ⅰb,isoescin Ⅰa and isoescin Ⅰb relative to escin Ⅰa were obtained.The labeled contents of the 4 saponins in the aescinate extractive reference substance were then detected by the external standard method,which were ecsin Ⅰa:19.33%,escin Ⅰb:17.21%,isoescin Ⅰa 25.14%,isoescin Ⅰb 18.10%.The accuracy of the assigned values for the aescinate extractive reference substance was verified using the external standard method and the correction factor method. Conclusions: Through the assigned traceability of the four saponins,the aescinate extractive reference substance for quantification is prepared,which can be used for quality control analysis of Aesculi Semen and aescine preparations.

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