目的:建立银杏叶提取物(GBE)中黄酮醇苷和萜类内酯的含量测定方法,并对6个不同厂家GBE含量进行比较。方法:以HPLC-UV法测定黄酮醇苷的含量,流动相:甲醇-0.4%磷酸溶液(52∶48);检测波长:360nm。以HPLC-ELSD法测定萜类内酯的含量,流动相:甲醇-水,采用梯度洗脱程序:0-5min,40%-35%(A);5-12min,35%(A);12-14.5min,35%-40%(A);14.5-20min,40%(A);漂移管温度:65℃。结果:建立了测定GBE中黄酮醇苷和萜类内酯的方法,各成分间的分离度都〉1.5,精密度、稳定性、重复性、加样回收率均达到要求。黄酮醇苷的含量测定结果分别为3.87%、25.39%、25.35%、27.50%、26.09%、26.99%;萜类内酯的含量测定结果分别为6.39%、4.62%、6.02%、5.06%、5.32%、5.49%。结论:不同厂家GBE含量差异较大,1号、2号厂家含量达不到《中华人民共和国药典》规定标准,只有6号厂家的样品能够达到《美国药典》规定的标准。
Objective: To establish methods for determination of flavonol glycosides and terpene lactones in Ginkgo biloba extract(GBE), and to compare their content from 6 different pharmaceutical factories. Methods: The content of flavonol glycosides was determined by using HPLC-UV method, the mixture of 52% methanol and 48% phosphoric acid solution of 0.4% concentration(W/V) as mobile phase, the detection wavelength was 360 nm. The content of terpene lactones was detected by using HPLC-ELSD method, a mixture of methanol and water as mobile phase with a gradient elution program within 20 min, 0-5min, 40%-35%(A); 5-12 min, 35%(A); 12-14.5min, 35%-40%(A); 14.5-20 min, 40%(A). The temperature of drift tube was 65℃. Results: The methods for determination of flavonol glycosides and terpene lactones in GBE were established, and separation between the components was 〉1.5, precision, stability, repeatability, average recovery all meet the requirement. The content of flavonol glycosides is 3.87%, 25.39%, 25.35%, 27.50%, 26.09%, 26.99%; the content of terpene lactones is 6.39%, 4.62%, 6.02%, 5.06%, 5.32%, 5.49%. Conclusion: The content of GBE in different pharmaceutical factories has large differences. The content of GBE in No.1 and No.2 pharmaceutical factories could not reach standards of CP, and only No.6 could reach the standards of USP.