基于一测多评法对补肾康乐胶囊中7种成分的质量控制研究

Quality Control of Seven Components in Bushen Kangle Capsules Based on Quantitative Analysis of Multi-components by Single Marker

目的:建立一测多评法同时测定补肾康乐胶囊中莫诺苷、马钱苷、京尼平苷酸、京尼平苷、松脂醇二葡萄糖苷、淫羊藿苷和宝藿苷Ⅰ的含量。方法:采用HPLC法,选取Agilent Zorbax SB-C18(250 mm×4.6 mm,5μm)为色谱柱,流动相为乙腈-0.2%磷酸水溶液,流速为1.0 ml·min^-1,柱温为30℃。选定淫羊藿苷为内参物,建立其与莫诺苷、马钱苷、京尼平苷酸、京尼平苷、松脂醇二葡萄糖苷、宝藿苷Ⅰ的相对校正因子,计算含量,同时将外标法实测值与一测多评法的计算值进行比对,验证方法的准确性和可靠性。结果:莫诺苷、马钱苷、京尼平苷酸、京尼平苷、松脂醇二葡萄糖苷、淫羊藿苷和宝藿苷Ⅰ分别在2.07~51.75μg·ml^-1、1.76~44.00μg·ml^-1、0.68~17.00μg·ml^-1、0.86~21.50μg·ml^-1、1.29~32.25μg·ml^-1、15.67~391.75μg·ml^-1、8.98~224.50μg·ml^-1范围内线性关系良好,r分别为0.9996,0.9998,0.9997,0.9995,0.9992,0.9997,0.9993;平均加样回收率分别为98.53%,97.90%,97.35%,99.18%,96.99%,100.02%,99.54%,RSD为1.12%,1.03%,1.51%,0.99%,0.88%,0.75%,1.27%(n=9);莫诺苷、马钱苷、京尼平苷酸、京尼平苷、松脂醇二葡萄糖苷和宝藿苷Ⅰ的相对校正因子分别为0.6289,0.6608,0.8639,0.7815,0.5840,1.1872;建立的一测多评法测定补肾康乐胶囊中7种指标性成分的含量,其计算值和实测值之间无明显差异。结论:一测多评法可同时测定补肾康乐胶囊中7种成分含量,该方法简便,准确。

Objective: To establish a quantitative analysis by multi-components by single marker( QAMS) method for the determination of seven components including morroniside,loganin,geniposidic acid,geniposide,pinoresinol diglucoside,icariin and baohuoside Ⅰ in Bushen Kangle capsules. Methods: An HPLC method with an Agilent Zorbax SB-C18( 250 mm×4.6 mm,5 μm) column was applied,the mobile phase was acetonitrile-0.2% phosphoric acid solution,the flow rate was 1.0 ml·min^-1,and the column temperature was 30℃ . Using icariin as the reference,its relative correction factors with morroniside,loganin,geniposidic acid,geniposide,pinoresinol diglucoside and baohuoside Ⅰ were established and the contents were calculated. At the same time,the method was evaluated by comparison of the quantitative results between the external standard method and the QAMS method. Results: Morroniside,loganin,geniposidic acid,geniposide,pinoresinol diglucoside,icariin and baohuoside Ⅰ showed good linear relationship within the range of 2.07-51.75 μg·ml^-1( r= 0.999 6),1.76-44.00 μg·ml^-1( r= 0.999 8),0.68^-17.00 μg·ml^-1( r= 0.999 7),0.86-21.50 μg·ml^-1( r= 0.999 5),1.29-32.25 μg·ml^-1( r = 0.999 2),15.67-391.75 μg·ml^-1( r = 0.999 7) and 8.98-224.50 μg·ml^-1( r = 0.999 3),and the average recovery was 98.53%,97.90%,97.35%,99.18%,96.99%,100.02% and 99.54% with the RSDs of 1.12%,1.03%,1.51%,0.99%,0.88%,0.75% and 1.27%( n = 9),respectively. The relative correction factor of morroniside,loganin,geniposidic acid,geniposide,pinoresinol diglucoside and baohuoside I was 0.628 9,0.660 8,0.863 9,0.781 5,0.584 0 and 1.187 2,respectively. The established QAMS method was used to determine the contents of the seven index components in Bushen Kangle capsules.There were no significant differences between the calculated values and the measured values of morroniside,loganin,geniposidic acid,geniposide,pinoresinol diglucoside,icariin and baohuoside Ⅰ. Conclusion: The QAMS method is simple and accurate,which can simultaneously determine the contents of seven components in Bushen Kangle capsules.