地榆皂苷元中间体的质量标准研究

Study on the quality standard of burnet sapogenin extract

目的:建立地榆皂苷元提取物的质量标准。方法:采用薄层色谱法进行定性鉴别。参照《中华人民共和国药典》2015年版附录相关方法,对不同批次地榆皂苷元提取物的干燥失重、总灰分进行测定;采用高效液相色谱法测定地榆皂苷元的含量。结果:定性鉴别薄层色谱特征明显,专属性强,地榆皂苷元提取物干燥失重≤5.0%,总灰分≤6.0%,地榆皂苷元提取物[以地榆皂苷元(C30H48O4)计]≥49%。结论:该方法准确方便,质量控制方法重复性好,质量标准可行,能较全面地控制地榆皂苷元提取物的质量。

Objective: To establish the quality standard of burnet sapogenin extract. Methods: The marker component burnet sapogenin in the sample was identified by qualitative thin layer chromatography(TLC). According to the methods described in the appendix of Pharmacopoeia of the People's Republic of China(2015 edition), the dry weight loss and the total ash content of the extract of saponin from different burnet batches were determined. The determination of burnet sapogenin was conducted by HPLC. Results: The results showed that the qualitative identification of TLC was obvious and the specificity was strong. The dry weight loss of burnet sapogenin extract was not be over 5.0%, the total ash content of burnet sapogenin extract was not be over 6.0%, and the burnet sapogenin(C30H48O4) of burnet sapogenin extract was not be over 49%. Conclusion: The method is accurate and convenient, the quality control method is reproducible and the quality standard is feasible, which could be used for the quality control of burnet sapogenin extract.