一测多评法在六味地黄软胶囊质量评价中的应用

Application of QAMS method in quantitative evaluation of Liuwei Dihuang Soft Capsule

目的建立六味地黄软胶囊中7种化合物一测多评方法学考察模式,检验该方法是否适用于六味地黄软胶囊的质量控制。方法以六味地黄软胶囊为研究对象,选择马钱苷作为内参物,采用2种校正方法(多点校正、斜率校正),建立马钱苷与没食子酸、5-羟甲基糠醛、莫诺苷、芍药苷、丹皮酚及熊果酸之间的相对校正因子(f);同时进行定量计算,实现一测多评。采用外标法测定22批六味地黄软胶囊样品7种成分的量,并将外标法测定值与2种校正因子计算所测值进行对比,检验所建立方法的准确性。结果在一定的线性范围内,以2种校正方式所得f计算值与实测值间无显著差异。结论一测多评的质量评价模式简单、精确且可行,适用于六味地黄软胶囊的质量评价和控制。

Objective To establish a quantitative analysis of multi-components by single marker（QAMS） method for the determination of seven components in Liuwei Dihuang Soft Capsule（LDSC）, and to examine the feasibilities of the method for quality control of LDSC. Methods Using LDSC as the research object, loganin was chosen as the internal reference substance by two correction methods（multipoint correction and slope correction）. The relative correlation factors（f） of 5-HMF, gallic acid, morroniside, paeoniflorin, paeonol, and ursolic acid to loganin were established. The contents of seven components in 22 batches of samples were determined by the external standard method and QAMS, so as to test the accuracy. The results were compared with these two methods finally. Results The three methods did not show significant difference in assay results according to the data. Conclusion The QAMS method is feasible and credible, and could be used to determine and control the multiple components in LDSC.