高效液相色谱指纹图谱结合一测多评法评价扶正救肺颗粒的质量

HPLC fingerprint combined with quantitation analysis of multi-components by single marker in quality evaluation of Fuzheng Jiufei granules

目的 建立扶正救肺颗粒HPLC指纹图谱,并采用一测多评法测定其中4种成分(毛蕊异黄酮葡萄糖苷、毛蕊花糖苷、橙皮苷、芒柄花素)的含量。方法 以毛蕊异黄酮葡萄糖苷为参照峰,确定共有峰,建立扶正救肺颗粒的HPLC指纹图谱;以毛蕊异黄酮葡萄糖苷为内标,确定毛蕊花糖苷、橙皮苷、芒柄花素的相对校正因子并进行含量计算;同时采用外标法测定4种成分的含量,比较计算值和实测值的差异。结果 15批样品相似度均在0.92以上。以毛蕊异黄酮葡萄糖苷为内标建立的毛蕊花糖苷、橙皮苷、芒柄花素的相对校正因子分别为0.9331、0.8916、1.7119,5批扶正救肺颗粒一测多评法计算值与实测值无显著差异,相对平均偏差小于2%。结论 建立的HPLC指纹图谱和一测多评法可用于扶正救肺颗粒的质量评价。

Objective To establish an HPLC fingerprint of Fuzheng Jiufei granules and to develop quantitation analysis of multi-components by single marker (QAMS) to determine the content of 4 components (calycosin 7-O-β-D-glucoside,verbascoside,hesperidin,and formononetin).Methods Calycosin 7-O-β-D-glucoside was used as the reference peak to establish HPLC fingerprint of Fuzheng Jiufei granules.Calycosin 7-O-β-D-glucoside was selected as the internal reference and the relative correction factors (RCF) of the other 3 components were calculated.Content of the other 3 components was calculated by QAMS.Meanwhile,the content of the 4 components was determined by external standard method.The accuracy and feasibility of QAMS were evaluated by comparing the results between the measured values by external standard method and QAMS.Results The similarity of the fingerprints of 15 sample batches was above 0.92.The relative correction factor of verbascoside,hesperidin,and formononetin to calycosin 7-O-β-D-glucoside was 0.9331,0.8916,and 1.7119 respectively.The content of the 4 components showed no significant difference between the external standard method and the QAMS,with relative average deviation<2%.Conclusion HPLC fingerprint and QAMS can be used to evaluate the quality of Fuzheng Jiufei granules.