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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 - GBE-GSTT sustained-release pellets. Methods Superexule was prepared by extrusion granulation spheronization method. The roundness, bulk density, friability and yield of microspheres were selected as indexes. The optimal prescription was selected through orthogonal test. clothes. RESULTS: The sustained-release coated pellets showed about 20% release at 1 h with no obvious burst release. The 4 h release volume was about 55%, and the 8 h was more than 80%, which basically met the requirements of the Chinese Pharmacopoeia . The in vitro release of pellets conforms to the first-order kinetic model. Conclusion The preparation of GBE-GSTT sustained-release pellets feasible, simple, stable quality.