一测多评法同时测定舒血宁注射液中4种银杏内酯  

Simultaneous determination of four ginkgolides in Shuxuening Injection by QAMS

作　　者：游蓉丽[1] 林珊 杨晓宁 高治华 姚静 YOU Rong-li;LIN Shan;YANG Xiao-ning;GAO Zhi-hua;YAO Jing(Institute of Basic Medicine of Traditional Chinese Medicine Clinic,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shanghai State Institute of Pharmaceutical Industry,Shanghai 200433,China;Beijing Zhendong Guangming Pharmaceutical Research Institute Co.,Ltd.,Beijing 100085,China;Shanxi Zhendong Taisheng Pharmaceutical Co.,Ltd.,Datong 037010,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]上海医药工业研究院,上海200433 [3]北京振东光明药物研究院有限公司,北京100085 [4]山西振东泰盛制药股份有限公司,山西大同037010

出　　处：《中成药》2021年第7期1708-1712,共5页Chinese Traditional Patent Medicine

基　　金：2019年山西省重点研发计划(社发领域)项目(201903D321208)。

摘　　要：目的建立一测多评法同时测定舒血宁注射液(银杏叶提取物)中4种银杏内酯的含量。方法该药物续滤液的分析采用TSK gel ODS⁃100V色谱柱(150 mm×4.6 mm,3μm);流动相水⁃甲醇,梯度洗脱;体积流量0.6 mL/min;柱温30℃。以银杏内酯A为内标,建立其他3种银杏内酯的相对校正因子,测定其含量。结果白果内酯、银杏内酯A、银杏内酯B、银杏内酯C在各自范围内线性关系良好(r>0.9900),平均加样回收率97.86%~100.79%,RSD 2.45%~3.07%。一测多评法所得结果与外标法接近。结论该方法简便灵敏,重复性好,可用于舒血宁注射液的质量控制。AIM To establish a quantitative analysis of multi⁃components by single⁃marker(QAMS)method for the simultaneous content determination of four ginkgolides in Shuxuening Injection(Ginkgo Folium extract).METHODS The analysis of subsequent filtrate of this drug was performed on a 30℃thermostatic TSK gel ODS⁃100V column(150 mm×4.6 mm,3μm),with the mobile phase comprising of water⁃methanol flowing at 0.6 mL/min in a gradient elution manner.Ginkgolide A was used as an internal standard to calculate the relative correction factors of the other three ginkgolides,after which the content determination was made.RESULTS Bilobalide,ginkgolide A,ginkgolide B and ginkgolide C showed good linear relationships within their own ranges(r>0.9900),whose average recoveries were 97.86%-100.79%with the RSDs of 2.45%-3.07%.The results obtained by QAMS approximated those obtained by external standard method.CONCLUSION This simple,sensitive and reproducible method can be used for the quality control of Shuxuening Injection.

关 键 词：舒血宁注射液 白果内酯 银杏内酯A 银杏内酯B 银杏内酯C 一测多评 

分 类 号：R927.2[医药卫生—药学]