目的考察雷公藤胃漂浮缓释制剂的体外释放行为,建立其质量评价方法。方法采用HPLC法进行释放介质指纹图谱分析,选择雷公藤内酯醇为参照峰,分别求出其他指纹峰与对照峰面积的线性相关方程,计算相对释放度及相似因子f2值。结果雷公藤胃漂浮缓释片和胃漂浮缓释微丸中的各成分在缓释的同时未能达到同步释放,而采用多元定时释药技术制备的雷公藤胃漂浮缓释胶囊中的各成分在缓释的同时达到了同步释放。结论以指纹图谱特征峰为指标可以更加科学全面地评价雷公藤缓释制剂的体外释放行为及其制剂的质量。

Objective To investigate the drug in vitro release behavior of gastric floating sustained release preparation of Tripterygium wilfordii and establish their quality evaluating methods. Methods HPLC was Employed to gain the fingerprints of releasing medium of preparations. Triptolide was selected as marker to calculate the linear equation concerning peak area then the relative drug release and f₂ similarity factor value were acquired.Results Various components in gastric floating sustained release tablets and pellets of T.wilf ordii could not release synchronously while sustained releasing but all of them in the gastric floating sustained release capsules of T. wilfordii prepared by using multiparticulate site-con-trolled release technology could release synchronously while sustained releasing. Conclusion The qualityand in vitro release behavior of gastric floating sustained release preparation of T.wilf ordii could be evaluated more scientifically and comprehensively by using HPLC fingerprints method.

福建省自然科学基金资助项目(2006J0116)