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目的:建立六味地黄制剂中4种不同类型成分的“一测多评”快速定性定量检测方法,以用于质量评价。方法:采用表面全多孔柱建立高效液相色谱快速分离方法,以快速测定六味地黄制剂中莫诺苷、马钱苷、芍药苷与丹皮酚的含量;计算莫诺苷、马钱苷、芍药苷与内参物丹皮酚间的相对校正因子,在不同高效液相系统下考察同一厂家4个批次药品相对校正因子和相对保留值的准确性,并用不同厂家共11个批次药品进行方法再验证,评价此方法在六味地黄制剂质量评价中的实用性。结果:多成分含量测定可在12 min内完成。“一测多评法”的计算结果与外标法的实测值之间无显著差异(P>0.05)。结论:本研究建立了四组分“一测多评”的高效液相色谱法,可用于六味地黄制剂快速、准确的质量评价。
Objective: To establish a rapid qualitative and quantitative method for the determination of four different types of ingredients in Liuwei Rehmanniae Preparata for quality evaluation. Methods: A rapid method for the determination of morroniside, loganin, paeoniflorin and paeonol in Liuwei Rehmanniae Preparata was established by using a superficially porous column with a high performance liquid chromatography (HPLC) method. The contents of morroniside, loganin, Glycosides and the reference substance paeonol between the relative correction factor in the different high-performance liquid system under the same manufacturer 4 batches of drugs relative correction factor and the relative retention accuracy, and with a total of 11 batches of different manufacturers of drugs Revalidation, evaluation of this method in Liuwei Rehmannia quality evaluation of the practical. Results: Multi-component determination can be completed within 12 min. There was no significant difference (P> 0.05) between the calculation results of “one test and multiple evaluation methods” and the actual measurement of external standard method. Conclusion: This study established a four-component “one test more than” high performance liquid chromatography, which can be used for rapid and accurate quality evaluation of Liuwei Rehmanniae preparations.