经典名方三化汤基准样品量值传递研究  

Study on quality value transmitting of benchmark samples of classical prescription Sanhua Decoction

作　　者：刘明松 邓亚伟 忻晓东 梁董茜 李春花 刘晓明 LIU Ming-song;DENG Ya-wei;XIN Xiao-dong;LIANG Dong-qian;LI Chun-hua;LIU Xiao-ming(College of Pharmacy,Hebei College of Traditional Chinese Medicine,Shijiazhuang 050200,China;Hebei Higher Education Institute Applied Technology Research Center on TCM Formula Preparation,Shijiazhuang 050090,China;Hebei Center for Drug Evaluation,Shijiazhuang 050090,China)

机构地区：[1]河北中医学院药学院,河北石家庄050200 [2]河北省中药组方制剂技术创新中心,河北石家庄050090 [3]河北省药品审评中心,河北石家庄050090

出　　处：《中草药》2023年第11期3501-3511,共11页Chinese Traditional and Herbal Drugs

基　　金：河北省省级科技计划资助(19272502D);2022年省属高校基本科研业务费专项项目(YXTD2022005)。

摘　　要：目的阐明三化汤基准样品的关键质量属性,建立其特征图谱并测定紫花前胡苷、柚皮苷、新橙皮苷、5种游离蒽醌、和厚朴酚与厚朴酚等指标成分,探究三化汤饮片-基准样品量值传递规律,为评价三化汤制剂奠定物质基础。方法通过文献考证,制备15批三化汤基准样品,采用UPLC建立特征图谱,计算其相似度并确定共有峰归属,结合指标成分及干膏转移率对基准样品进行量值传递分析。结果建立的15批三化汤基准样品相似度均大于0.98,特征图谱相似度良好,共指认26个共有峰,其中5个来自厚朴,6个来自枳实,5个来自羌活,10个来自大黄;指标成分紫花前胡苷、柚皮苷、新橙皮苷、厚朴酚与和厚朴酚、游离总蒽醌从饮片到基准样品平均转移率分别为(28.08±5.28)%、(45.07±5.35)%、(41.03±4.91)%、(3.32±0.92)%、(16.54±3.57)%,全处方干膏转移率为64.43%~76.39%。结论采用特征图谱结合多指标成分含量测定及出膏率等评价指标对经典名方三化汤基准样品进行了量值传递综合考察,为三化汤的质量控制和制剂开发提供了科学依据。Objective To elucidate the key quality attributes of the benchmark samples of Sanhua Decoction(三化汤),establish its characteristic chromatogram and determine the content of index components,including nodakenin,naringin,neohesperidin,five free anthraquinones,and magnolol and honokiol.The study explores the rules for the transfer of the Sanhua Decoction herbal pieces-benchmark sample,laying a material foundation for the later evaluation of Sanhua Decoction formulations.Methods Through literature research,15 batches of Sanhua Decoction reference samples were prepared.UPLC was used to establish a characteristic profile and calculate the similarity,and the common peaks were identified.The transfer analysis of the reference sample was conducted through the content determination of the index components and the transfer rate of the dry paste.Results The similarity of the 15 batches of Sanhua Decoction benchmark sample established was greater than 0.98,and the characteristic profiles were similar,with 26 common characteristic peaks identified,including five from Houpo(Magnoliae Officinalis Cortex),six from Zhishi(Aurantii Fructus Immaturus),five from Qianghuo(Notopterygii Rhizoma et Radix),and 10 from Dahuang(Rhei Radix et Rhizoma).The average transfer rates of the index components nodakenin,naringenin,neohesperidin,honokiol and magnolol,and total free anthraquinones from the decoction to the reference sample were(28.08±5.28)%,(45.07±5.35)%,(41.03±4.91)%,(3.32±0.92)%,and(16.54±3.57)%,respectively.The transfer rate of the whole formula dry paste ranged from 64.43%to 76.39%.Conclusion This study comprehensively investigated the transfer of the Sanhua Decoction benchmark samples using a characteristic chromatogram combined with content determination and dry paste rate evaluation,providing a scientific basis for the quality control and subsequent formulation development of Sanhua Decoction.

关 键 词：经典名方 三化汤 基准样品 量值传递 紫丁香苷 紫花前胡苷 芸香柚皮苷 柚皮苷 橙皮苷 新橙皮苷 芦荟大黄素 大黄酸 大黄素 和厚朴酚 异欧前胡素 厚朴酚 大黄酚 大黄素甲醚 

分 类 号：R283.6[医药卫生—中药学]