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目的:建立测定银杏叶分散片中萜类内酯的溶出度测定方法。方法:用HPLC-ELSD法测定溶出液中萜类内酯的含量,用Hypersil ODS C18柱(200 mm×4．6 mm,5μm),正丙醇-四氢呋喃-水(1:15:84)为流动相,流速1．0 ml·min-1,用ELSD检测,溶出度测定方法用《中国药典》2005年版二部附录XC第三法,以0．1 mol·L-1盐酸溶液为溶剂。结果:白果内酯、银杏内酯A、银杏内酯B及银杏内酯C的线性范围分别为0．92-3．66,0．51-2．04,0．52-2．08μg和0．45-1．78μg,平均回收率分别为100．1％(RSD 0．7％),97．7％(RSD为1．1％),97．6％(RSD为1．1％),101．0％(RSD0．9％)。3批样品溶出度(限度)分别为97％,96％和98％％。结论:该方法简便、重复性好,可作为银杏分散片中萜类内酯的溶出度的测定。
Objective: To establish a method for the determination of dissolution of terpene lactones in Ginkgo biloba leaf dispersible tablets. Methods: The content of terpene lactones in the eluate was determined by HPLC-ELSD method using Hypersil ODS C18 column (200 mm×4.6 mm, 5 μm), n-propanol-tetrahydrofuran-water (1:15:84). Mobile phase, flow rate 1.0 ml·min-1, detected by ELSD, dissolution method using the “Chinese Pharmacopoeia” 2005 Second Edition Appendix XC third method, using 0.1 mol · L-1 hydrochloric acid solution as a solvent. Results: The linear ranges of ginkgolide, ginkgolide A, ginkgolide B and ginkgolide C were 0.92-3.66, 0.51-2.04, 0.52-2.08 μg and 0, respectively. For .45-1.78 μg, the average recoveries were 100.1% (RSD 0.7%), 97.7% (RSD 1.1%), and 97.6% (RSD 1.1%). 101.0% (RSD 0.9%). The dissolution (limit) of the three batches of samples were 97%, 96% and 98%, respectively. Conclusion: This method is simple and reproducible, and can be used as a measure of dissolution of steroidal lactones in Ginkgo biloba.