药用辅料红糖的全波长融合指纹图谱研究
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摘要
目的研究并建立药用辅料红糖的紫外全波长融合指纹图谱。方法采用Durashell C18-AM色谱柱(4.6mm×250mm,5μm,100A),乙腈-0.1%三氟乙酸水作流动相,流速1.0mL/min,梯度洗脱,柱温25℃,采用PDA检测器进行210~400nm全波长检测,使用Waters Empower 3色谱数据软件对210~400nm紫外全波长数据进行融合,使用中药色谱指纹图谱相似度评价系统软件进行相似度分析。结果 35批药用辅料红糖的紫外全波长融合指纹图谱经相似度分析后共标出10个共有色谱峰,各批次的指纹图谱相似度均大于0.9,相似度良好。结论该方法稳定准确,重复性好,可以为制定药用辅料红糖指纹图谱的质量标准提供依据。
OBJECTIVE To research and establish the full wavelength fusion fingerprint of the brown sugar for pharmaceutical excipient.METHODS With a Durashell C18-AM column(4.6 mm×250 mm,5μm,100 A),gradient elution was performed by the mobile phase acetonitrile(A)-0.1%trifluoroacetic acid solution(B)at the flow rate of 1.0 mL/min.The column temperature was kept at 25℃.The detecting condition was performed with the photodiode array detector at the full wavelength from 210 nm to 400 nm.The data was fused by Waters Empower Chromatography Data Software and analysed with the similarity evaluation system for chromatographic fingerprint of chinese medicine.RESULTS There are 10 common peaks which were founded from fingerprints by similarity analysis,in the 35 batches of brown sugar for pharmaceutical excipient.The fingerprints provided credible similarities of brown sugars for pharmaceutical excipient which were greater than 0.9.CONCLUSION This method which is stable and accurate with good repeatability provides the basis for controlling the fingerprint of brown sugar for pharmaceutical excipient.
OBJECTIVE To research and establish the full wavelength fusion fingerprint of the brown sugar for pharmaceutical excipient.METHODS With a Durashell C18-AM column(4.6 mm×250 mm,5μm,100 A),gradient elution was performed by the mobile phase acetonitrile(A)-0.1%trifluoroacetic acid solution(B)at the flow rate of 1.0 mL/min.The column temperature was kept at 25℃.The detecting condition was performed with the photodiode array detector at the full wavelength from 210 nm to 400 nm.The data was fused by Waters Empower Chromatography Data Software and analysed with the similarity evaluation system for chromatographic fingerprint of chinese medicine.RESULTS There are 10 common peaks which were founded from fingerprints by similarity analysis,in the 35 batches of brown sugar for pharmaceutical excipient.The fingerprints provided credible similarities of brown sugars for pharmaceutical excipient which were greater than 0.9.CONCLUSION This method which is stable and accurate with good repeatability provides the basis for controlling the fingerprint of brown sugar for pharmaceutical excipient.
引文
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[2]苏敬.新修本草[M].太原:山西科学技术出版社,2013.
[3]陆游.老学庵笔记[M].西安:三秦出版社,2003.
[4]吴永章.异物志辑佚校注[M].广州:广东人民出版社,2010.
[5]陈亚军.新生化颗粒质量标准提升与指纹图谱研究[D].南京:南京中医药大学,2017.
[6]杨福安,王京娥.山东阿胶膏的研制[J].中成药研究,1986(3):6.
[7]张劲松,康桦,薛冬.产妇安口服液的药效学作用研究[J].中成药,2004,26(11):69-71.
[8]蔡俊安.山楂化滞丸中熊果酸的HPLC测定[J].中国中医药信息杂志,2011,18(5):49-50.
[9]国家药典委员会.中华人民共和国药典[M].北京:中国医药科技出版社,2015.
[10]国家药典委员会.中华人民共和国卫生部药品标准,中药成方制剂.第十二册[M].北京:中华人民共和国卫生部药典委员会,1997.
[11]国家药典委员会.中华人民共和国卫生部药品标准,新药转正标准.第十五册[M].北京:中华人民共和国卫生部药典委员会,1997.
[12]XIE P,CHEN S,LIANG Y,et al.Chromatographic fingerprint analysis—a rational approach for quality assessment of traditional Chinese herbal medicine[J].J Chromatogr A,2006,1112(1/2):171-180.
[13]PANG B,ZHU Y,LU L,et al.The applications and features of liquid chromatography-mass spectrometry in the analysis of traditional chinese medicine[J].Evid-Based Complement Alternat Med,2016,2016.
[14]WANG X,LI BQ,XU ML,et al.Quality assessment of traditional Chinese medicine using HPLC-PAD combined with Tchebichef image moments[J].J Chromatogr B,2017,1040:8-13.
[15]张丽,王智民,王维皓,等.作炮制辅料用姜汁的HPLC指纹图谱比较[J].中国中药杂志,2008,33(9):1010-1013.
[16]陆金兰,朱星宇,刘玲,等.中药炮制辅料米醋的指纹图谱研究[J].南京中医药大学学报,2017,33(5):463-469.