雷公藤胃漂浮缓释片的制备和质量评价  

Preparation of gastric floating sustained-release tablets of Triperygium wilfordii and its quality evaluation

作　　者：张伟[1,2] 宋洪涛[1] 林方清[1,3] 

机构地区：[1]南京军区福州总医院药学科,福建福州350025 [2]福建中医学院药学系,福建福州350003 [3]厦门大学医学院药学系,福建厦门361005

出　　处：《中草药》2009年第2期210-214,共5页Chinese Traditional and Herbal Drugs

基　　金：福建省自然科学基金资助项目(2006J0116)

摘　　要：目的研制雷公藤胃漂浮缓释片,考察其漂浮和释药性能。方法采用粉末直接压片法制备雷公藤胃漂浮缓释片,以漂浮性能、雷公藤总二萜内酯的释放度为考察指标,进行处方筛选,并采用正交设计实验对处方进行优化。结果以羟丙基甲基纤维素(HPMCK4M)为骨架材料,十六醇为助漂剂,碳酸氢钠为产气剂,聚维酮为致孔剂,制备了一天给药两次的胃内漂浮型缓释片。该制剂在人工胃液中立即起漂,2h释放约30%,6h释放约60%,12h释放90%以上,满足12h释放要求,体外释药规律符合Higuchi方程,说明本缓释片属于药物扩散和骨架溶蚀混合控释机制。结论研制的雷公藤胃漂浮缓释片具有良好的漂浮性能和释药特性。Objective To prepare gastric floating sustained-release tablets of Triperygium wilfordii and study its behavior of floating and release characteristics. Methods The sustained-release tablets were prepared by direct powder compared to tablets technique. The floating and release of total diterpene-lactones were used as indicators to evaluate and optimize the formulation. Then the formulation was optimized by influential factors and orthogonal design test. Results The gastric floating sustained-release tablets which was taken orally twice one day, were prepared with HPMCK4M as matrix, cetyl alcohol as floating assistant, sodium bicarbonate as gas-producer, PVP as poremaking. The tablets released 30% in 2 h, 60% in 6 h, exceeding 90% in 12 h, the release behavior of the tablets was fitted to Higuchi equation,and it was properly characterized by the drug diffusion and bulk erosion mechanism. Conclusion Gastric float- ing sustained-release tablets of T. wilfordii prepared has good behavior of floating and release characteristics.

关 键 词：雷公藤胃漂浮缓释片 漂浮性能 雷公藤总二萜内酯 

分 类 号：R283.6[医药卫生—中药学] R286.02[医药卫生—中医学]