基于指纹图谱结合化学模式识别的桑菊饮传统汤剂与配方颗粒一致性评价研究

Study on consistency of traditional decoction and formula granules of Sangju Decoction based on fingerprint printing and chemical pattern recognition

目的比较桑菊饮中药饮片汤剂与配方颗粒的化学组成差异,为桑菊饮的质量评价提供方法。方法采用HPLC法建立桑菊饮传统汤剂和配方颗粒指纹图谱,从化学成分种类、指纹图谱相似度、化学模式识别分析、代表性指标成分含量4个方面分析桑菊饮传统汤剂和配方颗粒的化学组成差异。结果10批传统汤剂指纹图谱相似度均>0.988,标定出35个特征峰,指认其中12个共有峰(7号峰为新绿原酸、10号峰为绿原酸、11号峰为隐绿原酸、13号峰为1,3-二咖啡酰奎宁酸、17号峰为芦丁、19号峰为连翘酯苷A、20号峰为木犀草苷、24号峰为异绿原酸B、25号峰为3,5-O-二咖啡酰奎宁酸、31号峰为连翘苷、32号峰为蒙花苷、35号峰为甘草酸铵);配方颗粒指纹图谱相似度均>0.983,标定出29个特征峰。与传统汤剂相比,配方颗粒部分批次缺少14、26、27、30、32、34号峰,聚类分析、主成分分析、正交偏最小二乘判别分析均可区分二者。传统汤剂中指标性成分新绿原酸、绿原酸、隐绿原酸、1,3-二咖啡酰奎宁酸、连翘酯苷A、草苷、异绿原酸B、3,5-O-二咖啡酰奎宁酸、连翘苷、蒙花苷10个成分含量高于配方颗粒,配方颗粒中芦丁、甘草酸铵含量高于传统汤剂。结论桑菊饮配方颗粒与传统饮片汤剂存在成分种类及含量差异。指纹图谱与化学模式识别相结合的方式可有效评价桑菊饮传统汤剂与配方颗粒差异,为桑菊饮配方颗粒质量控制及临床合理应用奠定基础。

ObjectiveTo compare the chemical composition of decoction and granules of Sangju Decoction;To provide a method for quality evaluation of Sangju Decoction.Methods HPLC was used to establish fingerprints,and a comprehensive comparative study was conducted on the traditional decoction and formula granules of Sangju Decoction from four aspects:chemical composition type,fingerprint similarity,chemical pattern recognition analysis,and representative index component content.Results The fingerprint similarity of the 10 batches of traditional decoction was>0.988.35 peaks were identified and 12 peaks were identified as common peaks(neochlorogenic acid for peak 7,chlorogenic acid for peak 10,cryptochlorogenic acid for peak 11,1,3-dicaffeoylquinic acid for peak 13,rutin for peak 17,lenoside A for peak 19,lignan for peak 20,isochlorogenic acid B for peak 24,ammonium glycyrrhizate for peak 25).The fingerprint similarity of the formulation pellets was>0.983,and 29 characteristic peaks were identified.Compared with the traditional decoction,some batches of the granules lacked peaks 14,26,27,30,32 and 34,and clustering analysis(CA),principal component analysis(PCA),and orthogonal partial least squares discriminant analysis(OPLS-DA)could distinguish between the two.The contents of the 10O index components neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,1,3-dicaffeoylquinic acid,forsythia ester glycoside A,grass glycosides,isochlorogenic acid B,3,5-O-dicaffeoylquinic acid,forsythia glycosides,monkshood glycosides in the traditional soup were higher than that in the granules,and the contents of rutin and ammonium glycyrrhizate in the granules were higher than that in traditional decoction.Conclusions The content and composition of traditional decoction and formula granules of Sangju Decoction are significantly different.The combination of fingerprinting and chemical pattern identification effectively can effectively evaluate the difference between traditional decoction and formula granules of Sangju Decoction,which can lay a foundation for the quality control and rational clinical application of formula granules of Sangju Decoction.