Chen Xia-Lin, Geng Ting, Huang Wen-Zhe, Wang Zhen-Zhong, Xiao Wei
Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China.
State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China.
Zhongguo Zhong Yao Za Zhi. 2018 Apr;43(7):1404-1409. doi: 10.19540/j.cnki.cjcmm.20180312.006.
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.
银杏二萜内酯原料作为银杏二萜内酯葡甲胺注射液的原料,是从银杏叶中提取纯化得到的。分别建立了银杏二萜内酯原料的¹H-NMR含量测定方法和指纹图谱分析方法。采用¹H-qNMR对3批样品进行含量测定,结果与HPLC法基本一致。确定了24个质子峰为共有指纹峰,并利用对照品和NMR信息对指纹峰进行了鉴定。此外,采用¹H-NMR指纹图谱对10批样品进行分析,相似度均高于0.99,且共有峰与对照品进行了对照鉴定。该方法简便、快速,精密度、稳定性和重复性良好,可为银杏二萜内酯原料及其制剂的质量评价提供依据和新思路。