Yang Lin, Li Yan, Hou Yuanfang, Wu Yongfu, Tan Lihong, Mu Zhenqiang, Zhu Zhaojing, He Dan
Chongqing Pharmaceutical Preparation Engineering Technology Research Center, Chongqing Medical and Pharmaceutical College, Chongqing 401331, China.
Traditional Chinese Medicine Factory Co. Ltd., Taiji Group Chongqing, Chongqing 402284, China.
J Anal Methods Chem. 2023 Sep 15;2023:6648668. doi: 10.1155/2023/6648668. eCollection 2023.
An effective and comprehensive quality evaluation method for Liuwei Dihuang pills (LDP) was established by the simultaneous determination of 8 active components in LDP by the quantitative analysis of multicomponents by single marker (QAMS) method and high-performance liquid chromatography (HPLC) fingerprint combined with chemometrics. These 8 active components were determined by QAMS and the external standard method (ESM), and the quantitative results of the two methods were compared to validate the accuracy and feasibility of the QAMS method. 8 active components showed good linear relationships within their ranges, whose average recoveries were 99.7∼102.3%. No significant difference was found ( > 0.05) in the quantitative results determined by QAMS and ESM. Furthermore, the fingerprint of LDP was also established, with 11 common peaks identified, and the similarity of the fingerprints of 21 batches of LDP was greater than 0.95. The 21 batches of LDP were basically divided into 3 groups by hierarchical cluster analysis (HCA) and principal component analysis (PCA), and 3 differential markers were screened out by orthogonal partial least squares discriminant analysis (OPLS-DA). The established QAMS method is accurate, economical, fast, and convenient and can simultaneously determine the content of 8 active components in LDP. HPLC fingerprint combined with chemometric analysis more comprehensively evaluated the quality consistency of different batches of LDP and analyzed the markers that cause quality differences between batches. It can provide a scientific basis and reference of quality consistency evaluation for the manufacturers and drug regulatory departments of the preparation.
采用一测多评法（QAMS）结合高效液相色谱（HPLC）指纹图谱并运用化学计量学方法同时测定六味地黄丸（LDP）中8种活性成分，建立了一种有效且全面的LDP质量评价方法。采用QAMS法和外标法（ESM）对这8种活性成分进行测定，并比较两种方法的定量结果以验证QAMS法的准确性和可行性。8种活性成分在其范围内呈现良好的线性关系，平均回收率为99.7%～102.3%。QAMS法和ESM法测定的定量结果无显著差异（>0.05）。此外，还建立了LDP的指纹图谱，鉴定出11个共有峰，21批LDP指纹图谱的相似度大于0.95。通过层次聚类分析（HCA）和主成分分析（PCA）将21批LDP基本分为3组，并通过正交偏最小二乘判别分析（OPLS-DA）筛选出3个差异标志物。所建立的QAMS法准确、经济、快速且简便，可同时测定LDP中8种活性成分的含量。HPLC指纹图谱结合化学计量学分析更全面地评价了不同批次LDP的质量一致性，并分析了导致批次间质量差异的标志物。可为该制剂的生产厂家和药品监管部门提供质量一致性评价的科学依据和参考。
