HPLC-ELSD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 HPLC-ELSD

作　　者：胡梦婷 王若柳 佟美鸿 康宁 王书芳[1] HU Meng-ting;WANG Ruo-liu;TONG Mei-hong;KANG Ning;WANG Shu-fang(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Heilongjiang ZBD Pharmaceutical Co.,Ltd.,Hulin 158400,China)

机构地区：[1]浙江大学药学院,浙江杭州310058 [2]黑龙江珍宝岛药业股份有限公司,黑龙江虎林158400

出　　处：《中成药》2021年第6期1425-1428,共4页Chinese Traditional Patent Medicine

基　　金：国家中药标准化项目(ZYBZH-C-HLJ-13);“重大新药创制”科技重大专项(2019ZX09201005)。

摘　　要：目的建立HPLC-ELSD法同时测定舒血宁注射液(银杏叶)中4种银杏内酯的含量。方法该药物乙酸乙酯提取液的分析采用Agilent ZORBAX SB-C_(18)色谱柱(250 mm×4.6 mm, 5μm);流动相甲醇-四氢呋喃-水(20∶10∶75);体积流量1.0 mL/min;柱温30℃。结果银杏内酯A、B、C、J在各自范围内线性关系良好(r>0.990 0),平均加样回收率91.2%~98.6%,RSD 3.8%~5.7%。75批样品中各银杏内酯含量差异明显,RSD 18.4%~28.0%。结论该方法准确可靠,重复性好,可用于舒血宁注射液的质量控制。不同厂家该制剂质量不稳定,应加以关注。AIM To establish an HPLC-ELSD method for the simultaneous content determination of four ginkgolides in Shuxuening Injection(Ginkgo Folium).METHODS The analysis of ethyl acetate extract of this drug was performed on a 30℃thermostatic Agilent ZORBAX SB-C18 column(250 mm×4.6 mm,5μm),with the mobile phase comprising of methanol-tetrahydrofuran-water(20∶10∶75)flowing at 1.0 mL/min in a gradient elution manner.RESULTS Ginkgolides A,B,C and J showed good linear relationships within their own ranges(r>0.9900),whose average recoveries were 91.2%-98.6%with the RSDs of 3.8%-5.7%.The contents of various ginkgolides demonstrated obvious differences in seventy-five batches of samples with the RSDs of 18.4%-28.0%.CONCLUSION This accurate,reliable and reproducible method can be used for the quality control of Shuxuening Injection.The unstable quality of this preparation from different manufacturers should be paid attention to.

关 键 词：舒血宁注射液 银杏内酯A 银杏内酯B 银杏内酯C 银杏内酯J HPLC-ELSD 

分 类 号：R927.2[医药卫生—药学]