银杏叶分散片中萜类内酯含量测定方法的改进与溶出度的研究

Improvement of method for the content determination of terpene lactones and the dissolution in Ginkgo biloba L. dispersible tablets

目的建立对银杏叶分散片中萜类内酯含量测定的改进与溶出度的研究方法。方法采用HPLCELSD法测定其含量,以小杯法测溶出度,0.1 mol·L-1盐酸溶液为溶出介质。结果白果内酯在1.164~11.640μg、银杏内酯A在0.998~9.980μg、银杏内酯B在1.042~10.042μg、银杏内酯C在0.926~9.260μg内进样量浓度的对数值与峰面积的对数值线性关系良好,平均回收率分别为99.2%、99.3%、99.0%、99.7%。样品的溶出度均一性良好,在20 min时溶出量超过85%。结论改进的方法具有分析速度快,准确度高,重复性好等优点,可以用于实际样品含量的测定。

Objective To develop a method for the improvement and determination the content of terpene lactons and the dissolution in Ginkgo biloba L. dispersible tablets. Methods HPLC-ELSD method was used to determine the content of Ginkgo biloba L. dispersible tablets and the dissolution was adopted by 0.1 mol·L- 1 hydrochloric acid. Results The logarithm value of sample volume had a good liner earity with the logarithm value of peak area when the sample size of bilobalide and ginkgolide A, B and C was 1.164- 11.640 μg, 0.998-9.980 μg, 1.042- 10.042 μg, and 0.926- 9.260 μg, respectively. The average recovery was 99.2%, 99.3%, 99.0% and 99.7%. The dissolution of sample fulfilled the requirements and the content of dissolution was more than 85% during 20 min. Conclusion The method of improvement has a good advantage of time reduced, high accuracy and good reproducibility and can be used to determine the content of practical sample.