摘要
目的研究小承气汤饮片物质基准的传递过程,建立小承气汤物质基准质量标准,为后续颗粒剂的开发奠定基础。方法制备15批小承气汤水煎液的冻干粉样品作为物质基准,测定其出膏率;建立指标性成分的含量测定方法学对指标性成分进行分析;建立特征图谱方法学进行特征峰的归属及相似度评价。结果15批小承气汤物质基准的出膏率均值为10.26%,物质基准中芦荟大黄素和大黄酚总质量分数及厚朴酚和辛弗林质量分数的均值分别为1.08、0.58、2.25 mg/g,物质基准特征图谱相似度均在0.9以上,出膏率、指标性成分含量和特征图谱可在饮片-物质基准中稳定传递。结论参考《古代经典名方中药复方制剂的申报资料要求(征求意见稿)》对小承气汤物质基准进行质量属性和量值传递研究,初步拟定小承气汤物质基准的质量标准,为类似方剂的开发研究提供思路。
Objective To study the inherent transfer process of material benchmark from decoction pieces of Xiaochengqi Decoction(小承气汤),establish the material benchmark quality standard of Xiaochengqi Decoction,so as to lay a foundation for the development of granules.Methods Fifteen batches of lyophilized powder samples of Xiaochengqi Decoction were prepared as the material benchmark,and paste-forming rate was determined;The content determination methodology of index components was established to analyze the index components;The specific chromatogram methodology was established to evaluate the origin and similarity of characteristic peaks.Results The average paste-forming rate of 15 batches of Xiaochengqi Decoction was 10.26%.The average contents of aloe emodin and chrysophanol,magnolol and synephrine were 1.08,0.58,and 2.25 mg/g,respectively.The similarity of material benchmark specific chromatograms was above 0.9.The paste-forming rate,index component content and specific chromatogram could be stably transferred in the material benchmark from decoction pieces.Conclusion In this paper,the quality attribute and quantity value transfer of Xiaochengqi Decoction material benchmark were studied by referring to the Requirements for Application Materials of Ancient Classic Traditional Chinese Medicine Compound Preparation(Draft),and the quality standard of Xiaochengqi Decoction material benchmark was preliminarily formulated,which provided ways for the development and research of similar prescriptions.
作者
齐琪
赵玥瑛
张晴
胡文均
申若男
刘雪纯
杜守颖
陆洋
白洁
QI Qi;ZHAO Yue-ying;ZHANG Qing;HU Wen-jun;SHEN Ruo-nan;LIU Xue-chun;DU Shou-ying;LU Yang;BAI Jie(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第10期2927-2937,共11页
Chinese Traditional and Herbal Drugs
基金
中央高校基本科研业务费专项资金资助(2018-JYB-XJQ004)。
关键词
经典名方
小承气汤
物质基准
量值传递
质量标准
特征图谱
芦荟大黄素
大黄酚
厚朴酚
辛弗林
classical prescriptions
Xiaochengqi Decoction
material benchmark
quality value transfer
quality standard
specific chromatogram
aloe emodin
chrysophanol
magnolol
synephrine
