目的建立稳定可控的银黄制剂的HPLC-ELSD的指纹图谱,探讨主成分分析法和聚类分析法在中药制剂指纹图谱中的应用。方法用梯度洗脱法对样品进行HPLC-ELSD测定,且采用聚类分析和主成分分析法对不同厂家和批次的样品图谱进行化学模式识别研究。结果建立的银黄制剂指纹图谱表征了不同厂家和批次的制剂之间的客观差异。结论聚类分析和主成分分析法能有效地应用于是银黄制剂的指纹图谱分析,为有效的控制该制剂的质量提供评价依据。

Objective To evaluate the quality of Yinhuang preparations effectively and develop a credible method for the quality control of Chinese materia medica.Methods Fingerprints of different Yinhuang preparations were obtained by HPLC-ELSD method.The technique of projection discriminate study based on hierarchical cluster analysis and principal component analysis was applied to investigate the experimental data.Results The developed fingerprints showed that there were differences among the Yin-huang preparation by different manufacturers.Conclusion This method using the hierarchical cluster analysis and principal component analysis could be effectively applied to the quality control of Chinese materia medica.