基于一测多评法的银杏叶分散片的溶出度研究

Dissolution of Yinxingye Dispersible Tablets by Quantitative Analysis of Multi-components with Single-marker

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 quantitative analysis method for determining the dissolution of Yinxingye dispersible tablets by quantitative analysis of multi-components with single-marker （QAMS）. Methods： A small glass method was adopted. Hydrochloric acid （0.1 mol L-1 ） was used as the dissolution medium, and the stirring speed was at 50 r min-1. HPLC-EISD with gradient elu- tion combined with QAMS was used to simultaneously determine the dissolution of 3 total flavonoids （artemisinin, quercetin and isorh- amnetin） and 4 total lactones （ginkgo esters and lactones a, b and c） in Yinxingye dispersible tablets. Results： Within a certain line- ar range, the relative correction factors （RCFs） of quercetin and isorhamnetin with the reference of artemisinin was 1. 873 and 0.324, respectively, and the RCFs of lactones a, b and c with the reference of ginkgo esters was 2. 280, 1. 659 and 1. 429, respectively, and the repeatability was good under the different experimental conditions. There were no significant differences between the calculated val- ues by QAMS and those by the external standard method in 5 batches of Yinxingye dispersible tablets, and the results showed that the RCFs was authentic. The dissolution uniformity of Yinxingye dispersible tablets was good in 0.1 mol L-1 hydrochloric acid. Conclu- sion： The method is simple, accurate and reproducible in the dissolution determination of Yinxingye dispersible tablets.