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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 multi-assessment methodological study on seven compounds in Liuwei Dihuang soft capsule and test whether the method is suitable for the quality control of Liuwei Dihuang soft capsule. Methods Liuweidihuang soft capsule was chosen as the research object. Using two kinds of calibration methods (multi-point calibration and slope calibration), two samples of loganin were selected as internal reference materials, and the effects of loganin, gallic acid, 5-hydroxymethylfurfural, , Paeoniflorin, paeonol and ursolic acid relative correction factor (f); at the same time quantitative calculation, to achieve a test more evaluation. The external standard method was used to determine the amount of seven components in 22 batches of Liuwei Dihuang soft capsule samples. The accuracy of the established method was tested by comparing the measured value of the external standard method with that of the two kinds of correction factors. The results in a certain linear range, with two kinds of correction methods f calculated values and measured values between no significant difference. Conclusion The quality evaluation mode of multiple assessment is simple, accurate and feasible, which is suitable for the quality evaluation and control of Liuwei Dihuang soft capsule.