兰索拉唑肠溶微丸胶囊的研制  

Preparation of Capsules Filled with Lansoprazole Enteric-coated Pellets

作　　者：简勇学 解兵亮 赵凯 周香莲 孙鹏 

机构地区：[1]江西欧氏药业有限责任公司,江西新余338004 [2]河北凯盛医药科技有限公司,河北石家庄050035

出　　处：《中国医药工业杂志》2013年第10期993-996,1071,共5页Chinese Journal of Pharmaceuticals

摘　　要：先制备兰索拉唑和磺丁基-β-环糊精的包合物溶液,再采用流化床底喷技术用该溶液对空白丸芯包衣得到载药微丸,再依次包隔离层(以无水碳酸钠为碱性调节剂增加药物稳定性)和肠溶层,制得肠溶微丸,装入1号胶囊得兰索拉唑肠溶微丸胶囊。自制微丸与市售品(达克普隆)内容物在40℃、相对湿度75%或光照[(4 500±500)lx]条件下放置10 d,外观、含量、有关物质和体外释放度等指标与0 d时相比无明显变化,且本品与市售品的各项质量指标相近。The blank pellets were coated with lansoprazole-sulfobutyl ether-β-cyclodextrin inclusion solution by fluidized bed bottom spray technology, and followed by coating with insulation layer （containing anhydrous sodium carbonate as an alkaline adjustment agent to increase the stability of lansoprazole） and enteric layer to obtain lansoprazole enteric-coated pellets. The enteric-coated pellets were encapsulated into hard gelatin capsules （size No. 1）. When the self- made pellets and the content of commercial product （Takepron） were stored under the condition of high temperature （40 ℃）, high humidity（relative humidity of 75%） or illumination [ （4 500±500）lx] for 10 d, the appearance, content, related substances and in vitro release had no obvious changes. And all above quality indexes of the self-made pellets were similar to Takepron.

关 键 词：兰索拉唑 包合物 磺丁基-β-环糊精 肠溶微丸 胶囊 稳定性 

分 类 号：R944.9[医药卫生—药剂学]