陈夏霖;耿婷;黄文哲;王振中;萧伟;
CHEN Xia-lin;GENG Ting;HUANG Wen-zhe;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Parmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

• 1:江苏康缘药业股份有限公司
• 2:中药制药过程新技术国家重点实验室

摘要(Abstract)：

银杏二萜内酯原料是从银杏叶中提取纯化所得,是银杏二萜内酯葡胺注射液的原料。分别建立了银杏二萜内酯原料药的~1H-NMR含量测定和指纹图谱分析方法。采用~1H-NMR法对3批样品进行含量测定,并与高效液相测定结果进行比较,结果显示2种方法的检测结果基本一致。指纹图谱研究确定了24个质子峰作为共有指纹峰,并利用对照品及NMR信息对指纹峰进行了指认。10批样品的测定结果发现,其指纹图谱相似度均大于0.99。该研究建立的银杏二萜内酯原料药~1HNMR含量测定和指纹图谱分析方法,快速,便捷,且具有良好的精密度、稳定性和重复性,为银杏二萜内酯原料药及其制剂的质量评价提供依据以及新的思路。
Ginkgo diterpene lactone raw material,as a raw material for ginkgo diterpene lactone meglumine injection,is extracted and purified from ginkgo leaf.~1H-NMR content determination method and fingerprint analysis method were respectively established for ginkgo diterpene lactone raw material. Content determination was conducted in 3 batches of samples by using ~1H-qNMR,and then the results were basically consistent with the results in HPLC method. Twenty-four proton peaks were identified as common fingerprint peaks,and the fingerprint peaks were identified by using the control product and NMR information. Furthermore,10 batches of samples were analyzed by ~1H-NMR fingerprint. The similarities were all higher than 0. 99 and the common peaks were identified with the reference standards. This method is easy,fast,with good precision,stability and repeatability and could provide basis and new ideas for quality evaluation of ginkgo diterpene lactone raw material and its preparations.

关键词(KeyWords)： ~1H-NMR;含量测定;指纹图谱;银杏二萜内酯原料药;质量评价
~1H-NMR;quantitative analysis;fingerprint;ginkgo diterpene lactone raw material;quality evaluation

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2013ZX09402203)

作者(Author): 陈夏霖;耿婷;黄文哲;王振中;萧伟;
CHEN Xia-lin;GENG Ting;HUANG Wen-zhe;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Parmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

Email:

DOI: 10.19540/j.cnki.cjcmm.20180312.006

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