格列吡嗪缓释微丸生产工艺改进研究

Study on the Improvement of Process Technology of Glipizide Sustained-Release Pellets

关键词:  格列吡嗪  缓释微丸  离心包衣锅  流化床

Key words:  glipizide  sustained-release pellets  centrifugal type coating-granulating machine  fluidized bed apparatus

摘要:

目的 将原格列吡嗪缓释微丸在离心包衣锅中进行上药、包衣改进到流化床中进行，提高生产效率，节约人工及能耗，同时产品各项指标达到质量标准要求。方法 不改变原有处方组成，通过2种生产工艺的上药率、体外释放度指标和生产效率的比较，采用正交试验优化生产工艺参数。结果 该产品的流化床工艺可行，各项指标达到原工艺的水平，且提高生产效率，节约人工及能耗。结论 流化床生产工艺优于离心包衣锅，适合格列吡嗪缓释微丸的生产。

Abstract:

OBJECTIVE To study drug-loading and coating process of glipizide sustained-release pellets by fluidized bed apparatus instead of by centrifugal type coating-granulating machine. METHODS Comparing drug-loaded rate, the release rate in-vitro and work efficiency of the two different kinds of process technology, the orhogonal design was used to optimize the manufacturing process, without any change of its prescription components. RESULTS The pellets produced by fluidized bed apparatus were coincident with the quality standard. Its work efficiency was improved and meanwhile its labor and energy consumption were lower than before. CONCLUSION The new process of preparing the pellets is better than the old one, and it is feasible to be applied to manufacture.