银杏叶片溶出度研究

Study on Dissolution of Ginkgo Biloba Tablets

目的:探讨银杏叶片溶出度测定方法及溶出动力学,为评价和控制药品质量提供方法和参数。方法:采用转篮法,100 r·min^(-1),自身对照紫外分光光度法测定不同厂家银杏叶片在人工胃液和人工肠液中累积溶出百分率。并进行溶出动力学拟合,提取威布尔分布溶出参数进行统计学处理。结果:银杏叶片在人工胃液和人工肠液中溶出参数有所区别但无显著性差异(P>0.01),不同厂家的银杏叶片溶出参数有显著性差异(P<0.05)。结论:建议在银杏叶片质量标准中增加溶出度项目;自身对照法做为银杏叶片体外溶出度测定方法操作简便可行。

Objective： To determine the dissolution rate of ginkgo biloba tablets in vitro and provide methods for evaluatiing and improving the quality . Method： The rotating-basket method was used, simulated gastric fluid and simulated intestinal fluid was applied as dissolution medium respectively, the cumulative dissolution percentage was determined by UV. The dissolution parameters was obtained by Weibull distribution model. Result： According to statistics, the dissolution rate of ginkgo biloba tablets in simulated gastric fluid and simulated intestinal fluid have no significant difference （P 〉 0.01 ） in vitro. Two manufactures were differed significantly from one another in their dissolution （P 〈 0.01 ） . Conclusion： It will be necessary to bring the dissolution determination method into the quality control standard for improving the quality of Ginkgo biloba tablets. It is convenient feasible by self contrast method to determine the dissolution rate of ginkgo biloba tablets.