目的研究六味地黄丸的质量控制方法。方法采用高效液相色谱法, 色谱柱为Agilent Zorbax SB C₁₈(250 mm×4.6 mm, 5μm), 乙腈-水梯度洗脱, 柱温:30e, 体积流量:10 mL/min, 检测波长为236 nm, 并利用聚类分析法和主成分分析法分析结果。结果通过聚类分析将不同厂家和批次的25个样品分为3类, 不同剂型的六味地黄制剂HPLC指纹图谱存在明显的差异。主成分分析分类结果与聚类分析分类结果一致, 经主成分分析, 8个共有峰可综合为3个主成分, 其累积贡献率达8.844%, 马钱苷的相对峰面积为六味地黄丸指纹图谱中影响比较大的指标。结论此方法可较系统地用于六味地黄丸的质量控制。

Objective To establish a method for the quality control of Liuwei Dihuang Pills.MethodsHPLC Method was developed to establish the fingerprint of Liuwei Dihuang Pills.The separation was performed on Agilent Zorbax SB C18(250 mm×4.6 mm,5 μm) column gradient eluted with the mobile phase consisting acetonitrile and water at the flow rate of 1.0 mL/min.The detection wavelength was 236 nm.Hierarchical cluster analysis(HCA) and principal component analysis(PCA) were applied to investigating the test data.Results The HCA result showed that 25 samples from various manufacturers and various batches can be divided into three groups.The differences between various dosage forms could be obvious.The classification result according to PCA was consistent with the HCA.The PCA showed that eight common peaks were integrated into three principal components(PC) and their accumulation contributing rate amounted to 82.844%.The PCA result showed that the relative peak area of loganin was the discriminating factor of the fingerprint of Liuwei Dihuang Pills.Conclusion This method can be used for quality control for Liuwei Dihuang Pills.

天津市科技发展计划项目(05SYSYGX25000)