奥美拉唑的工艺规程1.doc

奥美拉唑的工艺规程1.doc

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奥美拉唑生产工艺规程

编号：

SOP-MF-301-19

起草：

日期：

审阅：

日期：

审核：

日期：

审批：

日期：

执行日期：

分发部门：

生产部，设备部、办公室、质检部

目录

1.产品概述························································1

1.1通用名称······················································1

1.2化学名························································1

1.3中文别名······················································1

1.4汉语拼音······················································1

1.5英文名称·····················································1

1.6常见的商品名·················································1

1.7英文别称·····················································1

1.8分子式·······················································1

1.9分子量·······················································1

1.10结构式······················································1

1.11理化性质····················································1

1.12执行的标准··················································1

1.13临床用途····················································1

2.产品包装及规格··················································1

2.1包装··························································1

2.2包装规格······················································1

2.3规格··························································1

2.4储存··························································1

3.原辅料、包装材料质量标准········································1

3.1原辅料、成品质量标准·········································2

3.2包装材料·····················································4

3.3说明书·······················································4

4．化学反应式与工艺流程图··········································4

4.1化反应式·····················································4

4.2生产流程图···················································6

4.2.1工艺流程方框图··············································6

4.4.2设备流程图··················································9

5．工艺过程························································9

5.1配料比························································9

5.2操作工艺过程·················································10

5.3重点工艺控制点···············································11

5.4异常情况处理················································11

5.5注意事项·····················································11

6．中间体、半成品质量标准··········································12

6.1中间体的质量标准·············································12

6.2半成品布洛芬的质量标准·······································12

7．技术安全与防火··················································12

7.1技术安全·····················································12

7.2劳动保护与卫生安全··········································13

7.3洁净区环境监测要求··········································13

7.3危险化学品一览表·············································13

8．综合利用与三废治理···············································18

8.1.综合利用·····················································18

8.2三废治理·····················································18

9．操作工时与生产周期·············································18

10．劳动组织与岗位定员·············································19

11．设备一览表及主要设备生产能力··································19

11.1设备一览表··················································19

11.2主要设备生产能力···········································20

12．原材料、能源消耗定额和技术经济指标····························20

12.1能源消耗定额···············································20

12.2技术经济指标···············································20

13．物料平衡······················································20

14．附录··························································22

14.1物料平衡计算公式···········································23

14.2换算表······················································23

15．附页····························································23

1.1产品名称：

【中文名称】：

奥美拉唑

　　【简写拼音】：

AMLZ

　　【外文名】Omeprazole、Losec

【化学名称】5-甲氧基-2-{[（4-甲氧基-3，5-二甲基-2-吡啶基）-甲基]-亚磺酰基}-1H-苯并咪唑

1.2产品【结构式】

【分子式】C17H19N3O3S

　　【分子式量】345.42

1.3理化性质：

本品为白色或类白色结晶性粉末；无臭；遇光易变色。

本品在二氯甲烷中易溶，在甲醇或乙醇中略溶，在丙酮中微溶，在水中不溶；在0.1mol/L氢氧化钠溶液中溶解

1.12执行标准：

《中国药典》2010版第二部

批准文号:

国药准字H11020839

1.1临床用途：

药理作用：

适用于胃溃疡、十二指肠溃疡、应激性溃疡、反流性食管炎和卓-艾综合征（胃泌素瘤）

2.产品的包装及规格

2.1包装:

纸板桶；內衬材料：

PVC铝泊袋

2.2包装规格：

25kg/桶

2.3规格：

医药原料和中间体

2.4储存：

密封保存，阴凉干燥处保存

3.原辅料、包装材料质量标准

3.1原辅料、成品质量标准

物料名称

编号

规格

标准编号

质量指标

备注

包装规格

标准编号

包装材料

项目

指标

磷钨酸

水合肼

工业

HG-T3259-2004

外观

大于55%水合肼为无色透明发烟液体

腐蚀，怕晒药品，不与氧化剂，植物纤维混存

200KG/桶

GB/T191-2000

聚乙烯塑料桶或用内衬聚乙烯胆的铁桶

过氧化氢

工业

GB1616-2003

外观

无色透明液体

防止日光照射或受热，不能与易燃品和还原剂混运

不超过50KG/桶

GB191-2000

质量分数在50%以下采用深色高密聚乙烯桶

二氯甲烷

工业

GB4117-1992

沸点

蒸汽压

熔点

相对密度

水溶性

自然点

39.8℃

30.55kPa（10℃）

-95.1℃

1.3266（20/4℃）

20G/L（20oC）

640℃。

毒害品

250kg/桶

钢桶

硫酸镁

工业

HGT2680-2009

外观

白色或无色结晶颗粒或粉末

怕晒，怕雨，怕潮湿