经典名方丁香柿蒂散的物质基准量值传递研究  

Research on quality value transfer of material benchmarks of classical prescription Dingxiang Shidi Powder

作　　者：李莹莹 刘凯洋 毕诗杰 徐真真 王泽文 赵亚楠 王梓安 张嘉宁 邹妍 张燕玲[1] LI Ying-ying;LIU Kai-yang;BI Shi-jie;XU Zhen-zhen;WANG Ze-wen;ZHAO Ya-nan;WANG Zi-an;ZHANG Jia-ning;ZOU Yan;ZHANG Yan-ling(Key Laboratory of Traditional Chinese Medicine Information Engineering,National Administration of Traditional Chinese Medicine,School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Shineway Pharmaceutical Group Ltd.,Langfang 065201,China)

机构地区：[1]北京中医药大学中药学院,国家中医药管理局中药信息工程重点实验室,北京102488 [2]神威药业集团有限公司,河北廊坊065201

出　　处：《中草药》2023年第21期7025-7033,共9页Chinese Traditional and Herbal Drugs

基　　金：国家自然科学基金面上项目(82073996);经典名方丁香柿蒂颗粒剂的合作开发研究(2017110031015575)。

摘　　要：目的建立经典名方丁香柿蒂散(Dingxiang Shidi Powder,DSP)特征图谱并测定指标性成分含量及出膏率,明确关键质量属性的传递规律,指导丁香柿蒂复方制剂的开发。方法制备17批DSP冻干粉作为物质基准样品,建立HPLC指纹图谱,并测定多指标性成分含量及干膏率,计算上述指标在饮片-水煎液-物质基准传递过程中的转移率。结果17批DSP物质基准的特征图谱相似度良好(均>0.90),标定了9个特征峰,对共有峰进行归属,1号峰来自丁香与柿蒂,2~8号峰来自丁香,9号峰来自生姜;指标性成分丁香酚、没食子酸、6-姜辣素在DSP物质基准中质量分数为2.09~3.88、0.60~1.11、0.05~0.10 mg/g;物质基准的出膏率在9.42%~17.49%。饮片到物质基准丁香酚、6-姜辣素的转移率分别为7.65%~14.29%、6.90%~32.90%,干膏率的传递率为6.88%~25.13%。结论DSP物质基准的关键质量属性可在饮片-水煎液-物质基准中稳定传递,初步建立了DSP物质基准的质量标准,为后续复方制剂的开发提供数据支撑。Objective Through establishing the the characteristic spectrum,as well as determining the paste yield and content of the index components of the classical prescription Dingxiang Shidi Powder(丁香柿蒂散,DSP),the transfer rule of the key quality attributes can be clarified and further guide the development of Dingxiang Shidi compound preparation.Methods A total of 17 batches of DSP freeze-dried powder were prepared as benchmark samples to establish characteristic spectrums;The content of index components and paste rate in the benchmark samples were determined,and the transfer rate of the above indicators in the process of pieces-decoction-material benchmark was calculated.Results The characteristic spectrum similarity of 17 batches of DSP was more than 0.90,and nine common peaks were calibrated.Peak 1 belonged to Dingxiang(Caryophylli Flos,CF)and Shidi(Kaki Calyx);Peaks 2—8 belonged to CF;Peak 9 belonged to Shengjiang(Zingiberis Rhizoma Recens).The mass fraction ranges of index components eugenol,gallic acid and 6-gingerol in DSP material benchmark were 2.09—3.88,0.60—1.11,0.05—0.10 mg/g,respectively;The paste rate range of the material benchmark was 9.42%—17.49%.The transfer rates of eugenol and 6-gingerol ranged from 7.65%to 14.29%,6.90% to 32.90%,respectively;The transfer rate of paste rate ranged from 6.88% to 25.13%.Conclusion The key quality attributes of the material benchmark of DSP can be transferred stably in pieces-decoction-material benchmark,and the quality standard of material benchmark of DSP was preliminarily established,which provides data support for the subsequent development of compound preparations.

关 键 词：经典名方 丁香柿蒂散 物质基准 量值传递 关键质量属性 HPLC 转移率 丁香 柿蒂 生姜 丁香酚 没食子酸 6-姜辣素 

分 类 号：R283.6[医药卫生—中药学]