【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
【机 构】
：
江西欧氏药业有限责任公司,河北凯盛医药科技有限公司,
论文部分内容阅读
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。
First, prepare a solution of lansoprazole and sulfobutyl-β-cyclodextrin inclusion complex, and then use a fluidized bed bottom spray technique to coat the blank pellet with the drug-loaded pellets, (Anhydrous sodium carbonate as a basic regulator to increase the stability of the drug) and enteric layer, enteric-coated pellets, No. 1 capsules were lansoprazole enteric-coated pellets. The contents of self-made pellets and commercial products (dulpron) were left for 10 days under the condition of 40 ℃, relative humidity 75% or illumination [(4 500 ± 500) lx], the appearance, content, related substances and in vitro release And other indicators compared with 0 d no significant change, and the quality of goods and commercial products similar to the indicators.
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