年产2.6亿支10mL芍甘口服液生产车间工艺设计.docVIP

年产2.6亿支10mL芍甘口服液生产车间工艺设计.doc

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《中药制剂设备与车间工艺设计课程设计》 设计成绩: 批 阅 人: 批阅日期: 设计题目:年产2.6亿支10mL芍甘口服液生产车间工艺设计 设计者: 陈维可 班 级: 12级中药制药 学 号: 046212154 指导教师: 潘林梅 设计日期: 2015.6.20—2015.6.30 南京中医药大学药学院 设计任务书 一、设计题目 年产2.6亿生产车间工艺设计a. 洗烘:瓶收率为98% b. 配液:收率99% c. 灌封:收率为99% d. 灭菌检漏:收率为98% e. 包装:内包收率为99.8%;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)设备选型(要求有洗瓶、灌封、灭菌检漏); (4)按GMP规范要求设计生产工艺流程图和车间工艺平面图; (5)编写设计说明书; 四、设计成果 (1)设计说明书一份 包括工艺概述、工艺流程及净化区域划分说明、物料衡算、设备选型及主要设备一览表、车间工艺平面布置原则、技术要求和说明。 (2)工艺流程图; (3)提取车间、制剂车间平面布置图(1∶100) 五、设计时间 设计时间为2周,从2015年6月20日至2015年7月1日 目录 一、绪论······················································1 二、生产工艺流程简述··········································2 2.1产品类型与规模··············································2 2.2包装形式·····················································2 2.3工艺流程框图与环境分区·······································2 2.4主要工序简述·················································4 2.4.1提取····················································4 2.4.2浓缩····················································4 2.4.3醇沉····················································4 2.4.4回收乙醇················································4 2.4.5配液煮沸················································4 2.4.6冷藏静置················································4 2.4.7粗滤、精滤··············································4 2.4.8灌封···················································4 2.4.9灭菌···················································4 2.4.10检查··················································5 三、物料衡算·······················································5 3.1计算条件···················································5 3.2计算过程····················································5 四、主要设备选型说明·································

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