药剂专业毕业设计论文例文.doc

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毕 业论 文
论文题目：注射用泮托拉唑钠工艺研究
系 别：____ 药学系
专 业：_ 药物制剂技术_
班 级：__ 2008级4班 _
学 ·············································11
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、包装材料消耗定额····················································11
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冻干产品物料平衡·························································13
轧盖岗位物料平衡·························································13
灯检岗位物料平衡·························································13
包装岗位物料平衡·························································14
印刷性包装材料物料平衡···················································14
结论·········································································15
参考文献·····································································16
致谢·········································································
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注射用泮托拉唑钠工艺研究
朱荣花 指导周云
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
前言
冻干技术起源于19世纪20年代,在经历了几十年的起伏和徘徊后取得了长足发展。进入21世纪,真空冻干技术凭借其它干燥方法无法比拟的优势在医药界越来越受到人们青睐。其原理是在高真空状态下利用升华原理使预先冻结的物料中的水分不经过冰的融化,直接以冰态升华为水蒸汽被除去,从而达到冷冻干燥目的。冻干药品成海绵状,无干缩,体积大小几乎不变,含水分极少,再次使用时只需加入少量注射用水即可迅速溶解,相应包装后可在常温下长时间保存并方便运输。冻干技术的出现解决了热敏性物质易变性、失活、被氧化、易挥发性成分损失大的难题。药品的冻干技术在国内已经得到了一定的发展,冻干技术在针剂方面的应用不但提高了药品的质量还大大延长了药品的贮存期限,给医患双方都带来了极大的便利,具有良好的发展前景。因此,冻干粉针产品的工艺研究有潜力可挖。
1 注射用泮托拉唑钠概述
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
结构式
理化性质
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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。
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