基于高效液相色谱指纹图谱对党参及其配方颗粒的质量评价研究

Quality Evaluation of Codonopsis Radix and Its Formula Granules Based on HPLC Fingerprint

目的:建立党参与党参配方颗粒高效液相色谱法(HPLC)指纹图谱和指标成分含量同时测定方法,并对其质量进行评价。方法:采用高效液相色谱法,建立紫丁香苷、党参炔苷同时测定含量及指纹图谱方法。采用《中药色谱指纹图谱相似度评价系统(2012版)》进行相似度评价,确定共有峰。结果:建立的指纹图谱及多指标成分含量测定方法符合方法学考察要求,2个成分的含量均有不同程度的差异;指纹图谱共确定了25个共有峰,并指认了其中2个成分;10批不同厂家党参配方颗粒指纹图谱与对照图谱的相似度均>0.900。结论:所建指纹图谱特征性强且操作简便,可用于党参配方颗粒的质量控制。

Objective:To establish high performance liquid chromatography(HPLC)fingerprint of Codonopsis Radix and its formula granules and a simultaneous content determination method of their index components and conduct a comprehensive quality evaluation.Methods:HPLC was employed to develop a simultaneous content determination method for syringin and lobetyolin and establish a fingerprint.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012)was used to evaluate the similarity and determine the common peaks.Results:The established fingerprint and multi-index-component content determination method meet the requirements of methodological investigation,and the content of the two components is different in different degrees.A total of 25 common peaks were found in the fingerprint,and 2 of them were identified.The similarity between the fingerprints of 10 batches of Codonopsis Radix formula granules from different manufacturers and the control fingerprint was>0.900.Conclusion:The fingerprint has strong characteristics and is easy to operate,which can be used for the quality control of Codonopsis Radix formula granules.