六味地黄制剂多类型成分快速分析和“一测多评”方法建立

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。

Rapid Analysis Method of Different Type Components in Liuwei Dihuang Preparations and the Establishment of a Quantitative Analysis Method of Multi-component with a Single-maker

Objective: To establish a quantitative analysis method of multi-component with a single-maker (QAMS) for the four components rapid qualitative and quantitative detection in Liuweidihuang(LWDH)preparations for its quantitative evaluation. Method: A rapid HPLC method was developed to measure the content of morroniside,loganin,paeoniflorin,paeonol in LWDH preparations within 12 min with a superficially porous particle column. And a QAMS method was established by choosing paeonol as internal standard to simultaneously determine the other three components. The relative correlation factors (RCFs) were tested by four batch preparations in different HPLC systems. The identification of the method was based on eleven batch preparations from different manufacturers to evaluate the practical applicability of this QAMS method in quality evaluation of LWDH. Result: The results of the external standard method and QAMS method did not show significant differences(P>0.05). Conclusion: The QAMS method based on HPLC was established,which can be used for rapid and accurate quantitative evaluation of LWDH preparations.