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注射用泮托拉唑钠工艺研究
摘要：注射用泮托拉唑钠工艺根据处方要求，经过洗瓶、胶塞、配方、灌装、冷冻干燥、轧盖共6步工序制备得到，其工艺研究重点所在就是控制韦迪配制液、灌装半成品、冻干半成品等中间体质量，严格要求，把握设备操作方法，提高收率。我认为根据冻干粉针剂的特点再结合先进的技术和设备对本产品进行工艺研究，能更好的保证产品的质量。
关键词：注射用泮托拉唑钠 冻干粉针剂 工艺研究
目录
摘要··········································································1
关键词······································································
1.注射用泮托拉唑钠概述························································3
1.1品名·······································································3
1.2结构式·····································································3
1.3理化性质··································································``3
1.4药理毒理···································································3
1.5药代动力学·································································4
1.6临床应用···································································4
2.处方依据····································································4
2.1依据······································································4
2.2主药和辅料的作用···························································4
3.生产工艺····································································5
3.1工艺流程图·································································5
3.2主要生产操作·······························································6
3.3中间体过程质量控制·························································7
3.4岗位质量监控要点···························································8
4.原料及成品质量标准··························································9
4.1原料质量标准·······························································9
4.2成品质量标准······························································10
5.主要生产设备·······························································10
6.安全和劳动保护·····························································11
6.1安全······································································11
6.2劳动保护··························································
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