指纹图谱及多成分定量结合化学模式识别法评价不同厂家消炎利胆片质量

Quality Evaluation of Xiaoyanlidan Tablets from Different Habitats by Fingerprint and Multi-Component Quantification Combined with Chemical Pattern Recognition

目的 基于HPLC指纹图谱、多成分定量与化学模式识别相结合的方法,对不同厂家消炎利胆片的质量进行评价,为其质量控制、生产工艺研究提供依据。方法 采用HPLC,流动相为乙腈-0.1%甲酸水溶液进行梯度洗脱,检测波长为225 nm,柱温为室温,对32批消炎利胆片样品进行指纹图谱分析,41批消炎利胆片样品的7个成分进行含量测定,应用主成分分析(Principal component analysis,PCA)、聚类分析(Cluster analysis,CA)、正交偏最小二乘判别分析(Orthogonal partial least squares discriminant analysis,OPLS-DA)对消炎利胆片的质量进行整体性评价。结果 消炎利胆片的32批样品的HPLC指纹图谱相似度为0.818-0.998,通过无监督模式CA、PCA将样品分为3类,结合有监督模式OPLS-DA分析得出3号峰(4-甲氧基-5-羟基铁屎米酮)、4号峰(穿心莲内酯)、11号峰(脱水穿心莲内酯)为样品质量差异的标志峰。41批样品中,6批不含3号峰(4-甲氧基-5-羟基铁屎米酮),9批不含8号峰(4,5-二甲氧基铁屎米酮)。结论 不同厂家的消炎利胆片的成分含量存在一定差异,其质量控制应注意药材的来源、药用部位、生产工艺。HPLC指纹图谱与化学模式识别相结合可整体性的评价消炎利胆片的质量,该方法的建立为其质量控制研究提供参考。

Objective The quality of Xiaoyanlidan tablets from various manufacturers was assessed using HPLC fingerprinting, multi-component quantification, and chemical pattern recognition to offer a foundation for quality control and production process study. Methods HPLC was used. The mobile phase was acetonitrile-0.1% formic acid aqueous solution for gradient elution. The detection wavelength was 225 nm and the column temperature was room temperature.The fingerprints of 32 batches of Xiaoyanlidan tablets were analyzed, and the contents of 7 components of 41 batches of Xiaoyanlidan tablets were determined by principal component analysis(PCA), cluster analysis(CA), orthogonal partial least squares discriminant analysis(OPLS-DA) was used to evaluate the quality of Xiaoyanlidan tablets. Results The similarity of HPLC fingerprints of 32 batches of Xiaoyanlidan tablets was 0.818-0.998. The samples were divided into three categories by unsupervised mode CA and PCA. Combined with supervised mode OPLS-DA analysis, peak 3(4-Methoxy-5-hydroxycanthin-6-one), peak 4(Andrographolide) and peak 11(Dehydroandrographolide) were the marker peaks of sample quality difference. Among the 41 batches of samples, 6 batches did not contain peak 3(4-Methoxy-5-hydroxycanthin-6-one) and 9 batches did not contain peak 8(4,5-Dimethoxycanthin-6-one). Conclusion There are some differences in the content of components of Xiaoyanlidan tablets from different manufacturers. Attention should be paid to the source of medicinal materials, drug parts and production technology in its quality control. The combination of HPLC fingerprint and chemical pattern recognition can integrally evaluate the quality of Xiaoyanlidan tablets. The establishment of this method provides a reference for its quality control research.