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目的:建立基于一测多评法的银杏叶分散片溶出度研究方法。方法:采用小杯法进行溶出度测定,以0.1 mol·L~(-1)的盐酸溶液为溶出介质,转速为50 r·min~(-1),采用HPLC-ELSD梯度洗脱结合“一测多评”法同时测定银杏叶分散片中3个总黄酮成分(山奈素、槲皮素、异鼠李素)和4个总内酯成分(白果内酯和内酯A、B、C)的溶出度。结果:在一定的线性范围内,山奈素与槲皮素及异鼠李素的相对校正因子分别为:1.873,0.324;白果内酯与内酯A、B、C的相对校正因子分别为:2.280,1.659,1.429。且在不同的实验条件下重现性良好。5批银杏叶分散片溶出度的“一测多评”法计算值与外标法测定值无显著差异,试验所得的校正因子可信;在0.1 mol·L~(-1)的盐酸溶液中,银杏叶分散片的溶出均一性良好。结论:该方法简便、准确,重复性好,可用于银杏叶分散片的溶出度测定。
OBJECTIVE: To establish a method for the study of dissolution of Ginkgo biloba dispersible tablets based on a multi-evaluation method. Methods: The dissolution rate was determined by the method of small cup. Using 0.1 mol·L ~ (-1) hydrochloric acid as dissolution medium, the rotation speed was 50 r · min ~ (-1) and the HPLC-ELSD gradient elution combined with " The results showed that the total flavonoids (kaempferol, quercetin, isorhamnetin) and four total lactone components in gingko leaf dispersible tablets were determined simultaneously (bilobalide and lactone A, B, C) dissolution. Results: In a certain linear range, the relative correction factors of kaempferol, quercetin and isorhamnetin were 1.873 and 0.324, respectively. The relative correction factors of bilobalide and lactone A, B and C were 2.280 , 1.659, 1.429. And in different experimental conditions, good reproducibility. There was no significant difference between the calculated values of dissolution of 5 batches of Ginkgo biloba dispersible tablets and those of the external standard method. The calibration factors obtained in this experiment were credible. When the concentration of 0.1 mol·L -1 hydrochloric acid Solution, gingko leaf dispersible tablet dissolution good uniformity. Conclusion: The method is simple, accurate, reproducible, and can be used for the determination of dissolution of Ginkgo biloba dispersible tablets.