年产.亿支ml芍甘口服液生产车间工艺设计

年产.亿支ml芍甘口服液生产车间工艺设计

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1、《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2.6亿支10mL芍甘口服液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2班,每班8h(2)药剂规格及原辅材料的消耗①规格:10mL/瓶②主要工序及原辅材料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

2、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········

3、··············································1二、生产工艺流程简述··········································22.1产品类型与规模··············································22.2包装形式·····················································22.3工艺流程框图与环境分区·······································22.4主要工

4、序简述·················································42.4.1提取····················································42.4.2浓缩····················································42.4.3醇沉····················································42.4.4回收乙醇····································

5、············42.4.5配液煮沸················································42.4.6冷藏静置················································42.4.7粗滤、精滤··············································42.4.8灌封···················································42.4.9灭菌··························

6、·························42.4.10检查··················································5三、物料衡算·······················································53.1计算条件···················································53.2计算过程····················································5四、主要设备选型说明··

7、··············································74.1生产设备选型原则············································74.2设备选型····················································74.2.1提取罐·················································74.2.2水提储液罐·············································74

8、.2.3蒸发浓缩罐·············································

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