注射用泮托拉唑钠工艺研究

毕业生姓名：（孙玉宣）学号：（11601217）

所学专业:（药物制剂）指导教师：（张萌）

2014 年05月

毕业论文任务书

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··································································11 7.原辅料、包装材料消耗定

额····················································11 8.物料平衡计算公

式 (12)

8.1理论收量的计

算 (1)

2 8.2灌装岗位物料平

衡 (12)

8.3 冻干产品物料平

衡 (13)

8.4 轧盖岗位物料平

衡 (13)

8.5 灯检岗位物料平

衡 (13)

8.6 包装岗位物料平

衡 (14)

8.7 印刷性包装材料物料平

衡···················································14 结

论·········································································15 参考文

献 (16)

1 注射用泮托拉唑钠概述

1.1 品名：注射用泮托拉唑钠

汉语拼音:zhusheyongpantuolazuona 商品名：韦迪

英文名称：Pantoprazde-sodium for Injection 1.2 结构式

1.3 理化性质

结构含有的两个OCH3,结构不稳定，高温条件下就能发生聚合。冻干粉针剂结构稳定。其溶解性很好，加水后溶解迅速而完全，几乎立即恢复原来的性状。

1.4 药理毒理

本品为胃壁细胞质子泵抑制剂，在中性和弱酸性条件下相对稳定，在强酸性条件下迅速活化，其pH依