烟酸辛伐他汀缓释微丸胶囊的制备工艺研究

Preparation of niacin-simvastatin sustained-release pellet capsules

目的对上市药品辛伐他汀烟酸缓释片Simcor进行工艺改进。方法以羟丙甲纤维素E10M作为烟酸丸芯骨架材料,采用挤出滚圆技术制备烟酸缓释微丸,再以羟丙甲纤维素E5为包衣材料,在烟酸缓释微丸上包覆辛伐他汀层含药层,制备烟酸辛伐他汀缓释包衣微丸胶囊。结果制得的缓释微丸胶囊体外释放度与参比制剂Simcor具有很好的相似性。结论本工艺改进实验为自主研发新型他汀类烟酸缓释制剂提供了可靠实验数据。

Objective To improve the process technology of the marketed drug, Niaspan/simvastatin named Simcor. Methods Extrusion-spheronisation method was used to prepare niacin sustained-release micro pills with the hydroxypropyl methylcellulose E10 M as the niacin pill core framework material. Then the simvastatin layer was coated on the surface of the pill core with HPMC E5 as the coating material. Results The in vitro release rate of sustained-release pellets was quite similar to that of Simcor. Conclusion This process improvement experiment lays a good foundation for the preparation of a new type of sustained-release statins nicotinic acid.