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作 者:高军[1] 王隶书[1] 陈昕 王超楠 GAO Jun;WANG Lishu;CHEN Xin;WANG Chaonan(Jilin Province Academy,Chinese Medicine,Changchun 130012,China;Experimental Center,Affiliated Hospital,Changchun University of Traditional Chinese Medicine,Changchun 130117,China)
机构地区:[1]吉林省中医药科学院,长春130012 [2]长春中医药大学附属医院实验中心,长春130117
出 处:《药学前沿》2025年第3期416-422,共7页China Pharmacist
基 金:吉林省科技发展计划项目(20230401058YY)。
摘 要:目的建立15批达原饮物质基准指纹图谱及多指标成分含量测定方法,研究量值传递规律,为经典名方达原饮的质量控制及评价提供参考。方法遵古考证制备15批达原饮物质基准样品,采用HPLC法建立达原饮指纹图谱及多成分含量测定方法,明确色谱峰归属及批次间相似度差异,通过指标性成分含量测定了解药材到物质基准量值传递规律,建立达原饮物质基准质量研究体系。结果15个批次达原饮物质基准指纹图谱以黄芩苷为参照峰通过相似度软件计算得相似度均>0.97,有24个共有峰,参照对照品图谱指认出12个色谱峰。含量测定以芍药苷、黄芩苷、汉黄芩苷成分含量较高,且转移率也较高,厚朴的转移率最低。结论指纹图谱结合多指标成分含量测定方法适用于达原饮物质基准的质量控制与评价,操作便捷,结合整体量值传递规律,为达原饮的质量控制和后续的制剂开发提供了科学依据。Objective To establish the benchmark fingerprint and multi-index component content determination methods for 15 batches of Dayuan drink,study the rules of value transfer,and provide reference for the quality control and evaluation of the classic formula Dayuan drink.Methods 15 batches of reference samples of Dayuan drink were prepared according to ancient research,and HPLC was used to establish the fingerprint and multi-component content determination method of Dayuan drink.The chromatographic peak attribution and similarity differences among batches were clarified.Through the content determination of indicative component,the transfer rules from medicinal herbs to reference substance values was understood,and a research system for the reference substance quality of Dayuan drink was established.Results The benchmark fingerprint spectra of 15 batches of Dayuan drink were calculated using similarity software with baicalin as the reference peak,and the similarity was>0.97.There were 24 common peaks,and 12 chromatographic peaks were identified based on the reference spectrum.The content determination showed that paeoniflorin,baicalin,and wogonoside were the higher content and had higher transfer rate,while the transfer rate of Magnolia officinalis was the lowest.Conclusion The fingerprint combined with multi-index component content determination method is suitable for quality control and evaluation of the substance benchmark of Dayuan drink.It is easy to operate and provides a scientific basis for the quality control and subsequent formulation development of Dayuan drink,combined with the overall value transfer rules.
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