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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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