银杏叶分散片的溶出度研究

Study on dissolution test of Yinxingye dispersible tablets

目的:建立银杏叶分散片的溶出度测定方法。方法:采用小杯法,以0.1mol·L-1盐酸溶液为溶出介质,转速75r.min-1测定溶出度,采用HPLC-ELSD法测定萜类内酯的溶出量。结果:白果内酯、银杏内酯A、银杏内酯B、银杏内酯C分离良好,线性范围分别为66.64～333.2mg·L-1(r=0.9996),33.6～168mg·L-1(r=0.9999),35.52～177.6mg·L-1(r=0.9993),33.44～167.2mg·L-1(r=0.9991);平均回收率分别为99.2%,98.4%,98.9%,98.1%。样品溶出度的均一性良好,在15min时的溶出度达到90%。结论:该方法简便、准确,重复性好,可用于该片剂的溶出度测定。

Objective：To establish a method of the dissolution test of Yinxingye dispersible tablets.Methods：Small glass-method was adopted.Using 0.1 mol·L-1hydrochloric acid as the dissolution medium,the speed rate was at 75 r·min-1,HPLC-ELSD method was used to determine the content of terpene lactones （bilobalide（BB） and ginkgolide A,B,C）.Results：The assay displayed a good linearity over the concentration range of 66.64 to 333.2 mg·L-1（r=0.9996） for bilobalide（BB）,33.6 to 168 mg·L-1（r=0.9999） for ginkgolide A,33.52 to 177.6 mg·L-1（r=0.9993） for ginkgolide B and 33.44 to 167.2 mg·L-1（r=0.9991） for ginkgolide C.The average recovery of bilobalide（BB） was 99.2%,ginkgolide A 98.4%,ginkgolide B 98.9% and ginkgolide C 98.1%.The dissolution of different batches of Yinxingye dispersible tablets fulfilled the requirements and had the similar nature.Conclusion：The method is simple,accurate and reproducible for the dissolution determination of terpene lactones in Yinxingye dispersible tablets.