银杏叶提取物注射液质量再评价研究  

Quality re-evaluation of extract from Ginkgo Biloba leaves injection

作　　者：黄昕[1] 李泮霖[1] 刘宏[1] 彭维[1] 吴忠[1] 苏薇薇[1] HUANG Xin LI Pan-lin LIU Hong PENG Wei WU Zhong SU Wei-wei(Guangdong Engineering and Technology Research Center for Quality and Efficacy Re-evaluation of Post-marketed TCM, Guangdong Key Laboratory of Tropical and Subtropical Plant Resources, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275)

机构地区：[1]中山大学生命科学学院广东省中药上市后质量与药效再评价工程技术研究中心广东省热带亚热带植物资源重点实验室,广州510275

出　　处：《中南药学》2016年第11期1153-1158,共6页Central South Pharmacy

基　　金：国家科技支撑计划课题(No.2012BAI29B09);广东省中医药局科研项目(No.20161050)

摘　　要：目的以银杏叶提取物注射液为研究载体,开展质量再评价研究,提高其质量控制水平。方法采用HPLC-DAD-ELSD串联技术,以Agilent zorbax SB C18(4.6 mm×250 mm,5μm)为色谱柱;以乙腈-四氢呋喃-0.1%甲酸溶液为流动相梯度洗脱,柱温25℃,流速1.0 m L·min-1;DAD检测波长254nm;ELSD N2压力3.5 bar,漂移管温度50℃,增益值11。结果构建了银杏叶提取物注射液的HPLCDAD-ELSD指纹图谱,将其水溶性成分、黄酮类成分和内酯类成分反映在一张色谱图上;采用对照品对照及UFLC-Triple TOF-DAD-MS/MS鉴定,确认和指认了指纹图谱25个共有峰中的20个成分,已知成分峰面积之和占共有峰总峰面积的90%以上。结论本研究提升了银杏叶提取物注射液的质量控制水平,具有推广应用价值。Objective To improve the quality control of extract from Ginkgo Biloba leaves injection（EGBLI） via quality re-evaluation. Methods The fingerprint was established by HPLC-DAD-ELSD. The chromatographic column was Agilent zorbax SB C18（4.6 mm×250 mm, 5 μm）. Acetonitrile-tetrahydrofuran-0.1% formic acid was used as the mobile phase with gradient elution. The column temperature was 25 ℃ and the flow rate was 1.0 m L·min-1. The DAD wavelength was 254 nm. The N2 pressure value of ELSD was 3.5 bar. The temperature of drift tube was 50 ℃ and the gain value was 11. Results The optimized fingerprint of EGBLI was used to monitor the water-soluble components, flavonoids and lactones simultaneously by one-step detection. Twenty components were identified by standard references and UFLC-Triple TOF-DAD-MS/MS. The identified peak areas accounted for more than 90% of the total peak areas. Conclusion This study improves the quality control of EGBLI, and provides a reference for the quality re-evaluation of other traditional Chinese medicines.

关 键 词：银杏叶提取物注射液 质量再评价 指纹图谱 二极管阵列检测器 蒸发光散射检测器 

分 类 号：R286[医药卫生—中药学]