奥美拉唑的工艺规程1.doc
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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
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