基于指纹图谱和多成分含量测定的护肝解毒汤标准煎液量值传递研究

Study on Quality Value Transmitting of Standard Decoction of Hugan Jiedu Decoction(护肝解毒汤)Based on Fingerprint and Multicomponent Content Determination

目的:建立护肝解毒汤标准煎液的指纹图谱及多指标成分含量测定方法,为其标准煎液及制剂的质量评价研究提供参考。方法:采用HPLC法结合中药色谱指纹图谱相似度评价系统,对15批护肝解毒汤标准煎液进行指纹图谱、相似度分析及共有峰的指认,并建立煎液中5种指标性成分的同时检测方法,计算各成分的转移率。结果:15批标准煎液指纹图谱相似度>0.90,有22个共有峰,对照品比对出绿原酸、葛根素、芍药苷、甘草素、落新妇苷、黄藤苷、盐酸小檗碱、五味子醇甲、黄柏酮、梣酮10个成分,15批标准煎液中绿原酸、葛根素、落新妇苷、盐酸小檗碱、五味子醇甲的转移率分别为48.26%~63.80%、20.30%~31.50%、28.24%~39.11%、2.89%~5.60%、13.51%~21.85%。结论:采用指纹图谱、出膏率及指标性成分含量测定相结合的模式,对护肝解毒汤标准煎液的量值传递过程进行分析,可初步拟定护肝解毒汤标准煎液的质量标准,为其后续新药开发及相关制剂的质量控制提供依据。

Objective:To establish a fingerprint and multi index component content determination method for the standard decoction of Hugan Jiedu decoction,in order to provide reference for the quality evaluation research of its standard decoction and preparation.Methods:According to HPLC combined with a similarity evaluation system for traditional Chinese medicine chromatographic fingerprints,Fingerprints,similarity analysis and identification of common peaks were performed on 15 batches of standard decoction of Hugan Jiedu decoction.A simultaneous detection method was established for 5 indicator components in the decoction,and the transfer rate of each component was calculated.Results:The similarity of the fingerprint spectra of 15 batches of standard decoctions was over 0.90,with 22 common peaks.The control samples were compared and 10 components were identified,including chlorogenic acid,puerarin,paeoniflorin,iquiritigenin,astilbin,gartanin,berberine chloride hydrate,gomisin A,obacunone and fraxinellone.The transfer rates of chlorogenic acid,puerarin,astilbin,berberine chloride hydrate,and gomisin A in the 15 batches of standard decoctions were 48.26%-63.80%,20.30%-31.50%,28.24%-39.11%,2.89%-5.60%,and 13.51%-21.85%respectively.Conclusion:The combination of fingerprinting,extraction rate and determination of the content of the indicator components was used to analyze the quantitative transfer process of the benchmark samples of the Hugan Jiedu decoction,which can initially formulate the quality standard of the benchmark samples of Hugan Jiedu decoction and provide reference for its future development of new drugs.