【摘要】 目的 建立复方臭灵丹合剂的HPLC特征图谱和多指标活性成分含量测定方法，结合化学计量学分析，完善该制剂的质量评价体系。方法 采用HPLC法建立15批复方臭灵丹合剂的特征图谱；测定7个活性指标成分的含量，结合聚类分析（CA）、主成分分析（PCA）、正交偏最小二乘法判别分析（OPLSDA）进行复方臭灵丹合剂的质量评价。结果 15批复方臭灵丹合剂特征图谱与对照图谱的相似度为0.946～0.999，确认了21个特征峰，并指认出12个成分。没食子酸、绿原酸、芦丁、槲皮苷、异绿原酸C、槲皮素、洋艾素7种成分含量分别为3.91～15.60μg/mL、4.72～12.64μg/mL、3.72～12.56μg/mL、7.21～19.14μg/mL、2.36～5.77μg/mL、0.86～3.18μg/mL、2.71～7.32μg/mL。化学计量学分析表明，根据质量差异可将15批复方臭灵丹合剂分为2类，且通过OPLS-DA筛选出槲皮苷、槲皮素、异绿原酸C、绿原酸、没食子酸5个差异质量标志物。结论 建立的复方臭灵丹合剂HPLC特征图谱及多指标成分含量测定方法科学合理，稳定可行，可用于该制剂的质量评价。更多还原

【Abstract】 Objective To improve the quality evaluation system of Compound Choulingdan Mixture(CCM)by HPLC characteristic chromatogram and multi-indicator active ingredient content determination combined with stoichiometric analysis. Methods The characteristic chromatogram of 15 batches of CCM and the contents of 7active ingredients were determined by HPLC. The cluster analysis(CA), principal component analysis(PCA), and orthogonal partial least square discriminant analysis(OPLS-DA) were combined to evaluate the quality of CCM.Results The characteristic chromatogram similarity of the 15 batches of CCM and the reference chromatogram were 0.946-0.999. A total of 21 characteristic peaks were identified and 12 ingredients were confirmed. The contents of gallic acid, chlorogenic acid, rutin, quercitrin, isochlorogenic acid C, quercetinand artemitin were determined. The contents of the above 7 ingredients in the 15 batches of CCM were 3.91-15.60 μg/mL,4.72-12.64 μg/mL, 3.72-12.56 μg/mL, 7.21-19.14 μg/mL, 2.36-5.77 μg/mL, 0.86-3.18 μg/mL, 2.71-7.32 μg/mL. The chemometric analysis showed that the 15 batches of CCM could be classified into 2 categories according to the quality difference, and 5 differential quality markers, namely quercitrin, quercetin, isochlorogenic acid C, chlorogenic acid and gallic acid were screened by OPLS-DA. Conclusion The established HPLC characteristic chromatographic method and multi-indicator content determination method of CCM are stable and feasible, and can be used for the quality evaluation of this preparation.更多还原