03布洛芬的生产工艺规程.docx
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03布洛芬的生产工艺规程
文件编号
SOP―ＭＦ―321―00
药业有限公司现行文件
布洛芬生产工艺规程
起草人＿＿起草日期＿＿年＿＿月＿＿日
审阅人＿＿审阅日期＿＿年＿＿月＿＿日
审核人＿＿审核日期＿＿年＿＿月＿＿日
批准人＿＿批准日期＿＿年＿＿月＿＿日
分发部门：
生产部、设备部、办公室、质检部
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通用名称：
布洛芬
1.2化学名：
2-（4-异丁基苯基）丙酸
1.3其他名称：
拔怒风，异丁苯丙酸，异丁洛芬
1.4中文别名：
，异丁苯丙酸，异丁洛芬，芬必得，α-甲基-4-（2-甲基丙基）苯乙酸，芬必得
1.5汉语拼音：
Bu’luo’fen
1.6英文名称：
ibuprofen
1.7英文别名：
Algofen、Amersol、Andran、Apsifen、Brufen、Ebufac、Emodin、Infam、Motrin、Rurana
1.8分子式：
C13H18O2
1.9分子量：
206.28
1.10结构式：
1.11理化性质
1.11.1性状：
白色结晶性粉末。
不溶于水，易溶于乙醇、氯仿、乙醚、丙酮等有机溶剂及碱液中。
有异臭，无味。
1.11.2熔点：
74.5-77.5℃
1.11.3沸点：
157℃（4mmHg）
1.12执行标准：
《中国药典》2010版第二部
批准文号:
国药准字H11020839
1.13临床用途：
本品为非甾体抗炎药。
适用于缓解类风湿关节炎、骨关节炎、脊柱关节病、痛风性关节炎、风湿性关节炎等各种慢性关节炎的急性发作期或持续性的关节肿痛症状，无病因治疗及控制病程的作用。
治疗非关节性的各种软组织风湿性疼痛，如肩痛、腱鞘炎、滑囊炎、肌痛及运动后损伤性疼痛等。
急性的轻、中度疼痛如：
手术后、创伤后、劳损后、原发性痛经、牙痛、头痛等。
对成人和
儿童的发热有解热作用。
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
品名
标准批号
质量标准
异丁苯
SOP-QA-100-01
性状：
无色液体
沸点：
173℃
熔点：
-52℃
含量：
99%
乙酰氯
SOP-QA-100-02
性状：
无色发烟液体
蒸汽压：
12.1kPa/0℃
闪点：
4℃
熔点：
-112℃
含量：
99%
石油醚
SOP-QA-100-03
性状：
无色透明液体，有煤油气味
熔点：
-73℃
沸点：
40~80℃
闪点：
<-2℃
含量：
99%
三氯化铝
SOP-QA-100-04
性状：
白色或微带浅黄色的结晶粉末。
相对密度：
2.44g/cm^3
水不溶物：
≤0.05%
含量：
99%
5%稀盐酸
SOP-QA-100-05
性状;无色澄清液体
含量：
5%
4-异丁基苯乙酮
SOP-QA-100-06
性状：
液体
沸点：
124~130℃
含量：
99%
氯乙酸异丙酯
SOP-QA-100-07
性状：
无色透明液体
沸点：
149.5℃
相对密度：
升级会员 