银杏内酯滴丸质量控制方法探讨

Study of the Methods for Quality Control of Ginkgolides Drop Pills

目的:对银杏内酯滴丸的含量测定方法进行研究,同时对滴丸中主成分的提取条件进行筛选。方法:采用HPLC,C18柱,ELSD检测器,流动相为正丙醇-四氢呋喃-水(1∶25∶74),对分析方法进行了验证。结果:银杏内酯A进样量在2.45～12.25μg.mL-1范围内线性关系良好,银杏内酯B进样量在5.09～25.45μg.mL-1范围内线性关系良好,加样回收率分别为:99.06%和98.99%,样品溶液8h内稳定。结论:所建立的样品提取方法可行,分析方法专属性强、灵敏度高,测定结果准确、可靠,适用于银杏内酯滴丸的质量控制。

The study was emphasized on tests and assay of Ginkgolides drop pills,and it screened the extract conditions of the pills＇ main composition. The separation was performed in the C18 column and ELSD. The mobile phase consisted of propyl alcohol - methanol--water（ 1：25 ：74）. The calibration curves of Ginkgolides A were linear in the ranges of 2.45μg~ 12. 25 μg, The calibration curves of Ginkgolides B were linear in the ranges of 5.09μg -25.45μg, the recoveries were 99.06 % and98.99%. Samples were sta- ble in 8hrs. The results showed that：The extract way of the pills＇ main composition was reliable. The analysis approaches were proved to be accurate and reliable with high selectivity, sensitivity and reproducibility, and were suitable for the quality control of Ginkgolides drop pills