芪斛楂颗粒质量标准提升研究

Research on the Improvement of Quality Standard of Qihuzha Granules

目的:从不同产地和不同批次的原料药材中筛选出较优的原料药材,并建立芪斛楂颗粒的HPLC指纹图谱。方法:参考《中国药典》2015版及相关文献对陈皮、甘草、木瓜、等11味处方原药材进行成分检测和筛选,采用HPLC特征图谱技术,建立芪斛楂颗粒的指纹图谱分析方法,采用国家药典委员会中药色谱指纹图谱相似度评价系统软件(2012版)进行相似度分析。结果:通过对芪斛楂颗粒指标成分含量测定结果,筛选出较优的药材来源。芪斛楂颗粒的HPLC指纹图谱共确定了16个共有峰,指纹图谱相似度均在0.9以上,并指认出2个共有成分(甘草苷,橙皮苷)。结论:所建立的方法简便、重复性好、稳定性好,可为芪斛楂颗粒的质量标准提升提供依据。

Objective This subject selects the better raw medicinal materials from different origin different batches of raw materials.To establish the HPLC fingerprint of Qihuzha Granules.Methods Reference the“Chinese Pharmacopoeia”in the 2015 edition and the literature methods,the content of active ingredients in citri reticulatae pericarpium,glycyrrhizae radix et rhizoma,chaenomelis fructus,ete,have been measured.The HPLC characteristic spectrum technology was usedto analyze the characteristic spectrum ofQihuzha Granules.The similarity ofthe species wasevaluated by using software“Similarity Evaluation System for Chromatographic Fingerprint of TCM”published by the State Pharmacopoeia Commission(2012A version).ResultsIt has selected better medicines source through the results of measuring the content of the target composition.There were 16 common peaks in the HPLC chromatographic fingerprint of Qihuzha Granules,and 2 common components(Liquiritin,hesperidin)were identified.The similar degrees of 10 batches of samples were over 0.900.Conclusion This method is simple,repeatable,and stable.It provides basic data for improving the standand of Qihuzha Granules.