银杏叶提取物-蒺藜总皂苷缓释微丸的制备研究

Study on Preparation of Ginkgo Biloba Extract and Gross Saponin from Tribulus Terrastris Sustained Release Pellets

目的制备银杏叶提取物-蒺藜总皂苷(GBE-GSTT)缓释微丸。方法采用挤出制粒滚圆法制备素丸,以微球圆整度、堆密度、脆碎度和收率为指标,通过正交试验选出优化处方工艺,用乙基纤维素进行缓释包衣。结果缓释包衣微丸在1 h释放量约为20%,无明显突释现象;4 h释放量约为55%,8 h可达80%以上,基本符合中国药典对缓释制剂的要求。微丸体外释放符合一级动力学模型。结论本工艺制备GBE-GSTT缓释微丸可行,操作简便,质量稳定。

OBJECTIVE To prepare Ginkgo biloba extract and gross saponin from Tribulus terrastris（GBE-GSTT） sustained release pellets. METHODS Pellets were prepared by granulating extrusion spheronization method, and were further coated with ethyl cellulose. Degree of circularity, bulk density, friability and yield were selected as indicators to optimize theformulation and process by orthogonal test. RESULTS The pellets basically met the requirements of Pharmacopoeia of sustained-release preparations with the release profile of 20% at 1 h, 55% at 4 h and above 80% at 8 h respectively. The in vitro release of pellets fit the first-order kinetic model. CONCLUSION The process is feasible, simple and stable.