“一测多评”法同时测定清清颗粒中10种指标成分

Simultaneous Determination of Ten Constituents in Qingqing Granule by Quantitative Analysis of Multi-components by Single-marker

关键词:  清清颗粒  一测多评  相对校正因子  高效液相色谱法  质量控制

Key words:  Qingqing granule  quantitative analysis of multi-components by single-marker  relative correction factor  HPLC  quality control

摘要:

目的 建立“一测多评”法测定清清颗粒中10种主要活性成分的高效液相色谱分析方法。方法 以黄芩苷为内参物，建立其与其他9种成分(没食子酸、白芍苷、芍药苷、甘草苷、甘草酸、汉黄芩苷、黄芩素、汉黄芩素、小檗碱)的相对校正因子，并用该校正因子进行计算，实现一测多评；同时采用外标法对这10种成分进行含量测定，通过比较2种方法的结果来验证该方法的准确性。结果 “一测多评”法的计算值与外标法实测值之间没有明显差异。结论 “一测多评”法可用于清清颗粒中10种成分的含量测定，方法可靠，结果准确，能有效、快速控制该制剂质量。

Abstract:

OBJECTIVE To establish a method for simultaneous determination of ten bioactive components in Qingqing granule by quantitative analysis of multi-components by single-marker(QAMS). METHODS Qingqing granule was chosen as the research object, baicalin as index, relative correction factors of gallic acid, albiflorin, paeoniflorin, liquiritin, glycyrrhizic acid, wogonoside, baicalein, wogonin and berberine were established by HPLC and calculated to achieve QAMS. The contents of 10 components in the samples were determined with the external standard method. The accuracy of the method was validated by compare the results of the above two methods. RESULTS No significant differences were found between the calculated results by QAMS and the measured results by external standard method. CONCLUSION The described method is reliable, accurate, and can be used to control the quality of ten bioactive components of Qingqing granule.