年产1.7亿粒芍甘胶囊车间工艺设计.pdfVIP

目录 一、设计任务书；························3 二、绪论（简要说明所设计的制剂的性能、特点和用途等）；·····4 2.1胶囊剂的简介·······················4 2.1.1胶囊剂的性能·····················4 2.1.2胶囊剂的特点·····················4 2.1.3胶囊剂的用途·····················4 2.2芍甘胶囊的工艺简介····················4 2.2.1处方·························4 2.2.2制备工艺·······················4 2.2.3工艺流程·······················4 2.3设计目的·························5 2.4设计依据·························5 2.5设计原则·························5 2.6 GMP概述·························6 2.6.1概念·························6 2.6.2实施目的与意义····················6 2.7 硬胶囊的生产工艺过程···················6 三、生产工艺流程简述······················6 3.1产品类型与规模······················6 3.2包装形式·························6 3.3工艺流程框图与环境分区··················6 3.4主要工序简述·······················7 3.4.1煎煮·························7 3.4.2过滤·························7 3.4.3精制·························7 3.4.4制粒·························8 3.4.5灌装·························8 3.4.6包装·························8 四、物料衡算···························9 五、主要生产设备的选型······················10 5.1生产设备选型原则······················10 5.1.1 GMP对制药设备的要求·················10 5.1.2 设备选型概述·····················10 5.2主要设备选型·······················11 5.3设备选型及设备一览表···················15 6 、车间平面布置设计······················15 6.1车间平面布置设计的原则··················15 1 6.2技术要求和布置设计说明··················15 七、 束语（体会）；······················18 八、参考文献。（具体内容见设计任务书的要求）··········18 设计任务书 一、设计题目 年产1.7亿粒芍甘胶囊生产车间工艺设计 二、设计条件 （1）生产制度 年工作日：250天；1天1班，每班8 h （2）药剂规格及原辅材料的消耗 ① 规格：0.36 g/粒 ② 主要工序及原辅材料 a. 一步制粒：原料、糊精质量比为19∶17，收率为99% b. 装胶囊：收率为98% d. 包装：内包收率为99%；外包无损耗。 三、设计内容与要求 （1）确定工艺流程及净化区域划分； （2）物料衡算； （3）设备选