摘要
目的建立经典名方当归四逆汤物质基准的HPLC特征图谱及指标性成分含量测定方法,阐明当归四逆汤物质基准关键质量属性,为后续复方制剂的开发奠定基础。方法制备18批当归四逆汤物质基准,建立HPLC特征图谱,进行特征峰归属及相似度评价;测定指标性成分的含量,对物质基准进行量值传递分析。结果18批物质基准的特征图谱的相似度均大于0.90,共确定19个特征峰,分别来自方中当归(峰4、5、19)、桂枝(峰10、11、14)、白芍(峰6、9)、细辛(峰1、3、13、15、18)和炒甘草(峰7、8、12、16、17);各指标成分从饮片到物质基准的转移率分别为芍药苷78.47%~96.01%、甘草苷43.79%~94.62%、阿魏酸81.20%~131.24%、肉桂酸70.03%~106.75%、桂皮醛3.17%~5.50%、甘草酸31.08%~52.43%、细辛脂素9.63%~13.37%。结论采用特征图谱结合多指标性成分含量测定对当归四逆汤物质基准进行量值传递研究,该方法科学合理,为当归四逆汤物质基准的质量控制及复方制剂的开发提供科学依据。
Objective To establish the HPLC characteristic chromatogram and multi-index components determination for substance benchmark of Danggui Sini Decoction(DSD,当归四逆汤),which clarified the critical quality attributes,so as to lay a foundation for subsequent formulation development.Methods The substance benchmark of 18 batches of DSD was prepared based on ancient medical records.The characteristic chromatogram methodology was established to evaluate the origin and similarity of characteristic peaks,the components content and transfer rate were measured and the transfer analysis of substance benchmark was performed.Results The similarity of the 18 bathes of DSD material characteristic chromatogram were all greater than 0.90,and a total of 19 characteristic peaks were identified,which came from Danggui(Angelicae Sinensis Radix)(peaks 4,5,19),Guizhi(Cinnamomi Ramulus)(peaks 10,11,14),Baishao(Paeoniae Radix Alba)(peaks 6,9),Xixin(Asari Radix et Rhizoma)(peaks 1,3,13,15,and 18)and Chaogancao(fried Glycyrrhizae Radix et Rhizome)(peaks 7,8,12,16,and 17).The transfer rate of each index component from the decoction pieces to the substance benchmark was in the range of paeoniflorin 78.47%-96.01%,liquiritin 43.79%-94.62%,ferulic acid 81.20%-131.24%,cinnamic acid 70.03%-106.75%,cinnamaldehyde 3.17%-5.50%,glycyrrhizic acid 31.08%-52.43%;asarone 9.63%-13.37%.Conclusion In this study,the HPLC characteristic chromatogram combined with multi-index components determination were used to carry out the quantity value transfer analysis of the substance benchmark of DSD.The method is scientific and reasonable,and can provide scientific basis for the quality control substance benchmark and the development of compound preparations of DSD.
作者
许金国
梅茜
夏金鑫
赵晓莉
谢辉
毛靖
高红宁
李鹏
陆兔林
毛春芹
XU Jin-guo;MEI Xi;XIA Jin-xin;ZHAO Xiao-li;XIE Hui;MAO Jing;GAO Hong-ning;LI Peng;LU Tu-lin;MAO Chun-qin(College of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Nanjing Hailing Pharmaceutical Technology Research Co.,Ltd.,Nanjing 210023,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第21期6501-6509,共9页
Chinese Traditional and Herbal Drugs
基金
国家重点研发计划项目(2018YFC1707000)。
关键词
经典名方
当归四逆汤
物质基准
量值传递
当归
桂枝
白芍
细辛
炒甘草
芍药苷
甘草苷
阿魏酸
肉桂酸
桂皮醛
甘草酸
细辛脂素
质量控制
classical prescriptions
Danggui Sini Decoction
substance benchmarks
quality value transmitting
Angelicae Sinensis Radix
Cinnamomi Ramulus
Paeoniae Radix Alba
Asari Radix et Rhizoma
fried Glycyrrhizae Radix et Rhizome
paeoniflorin
glycyrrhizin
ferulic acid
cinnamic acid
cinnamaldehyde
glycyrrhizic acid
asarone
quality control
