年产5000万粒奥美拉唑肠溶胶囊生产车间工艺设计.rar

年产5000万粒奥美拉唑肠溶胶囊生产车间工艺设计


摘    要
奥美拉唑是一个国内外临床上广泛应用的质子泵抑制剂，是作用机制不同于H2受体拮抗剂的全新抗消化性溃疡药，比H2受体拮抗剂具有更强的抑制胃酸分泌作用，对溃疡的治愈率更高，速度更快。
消化性溃疡包括胃溃疡及十二指肠溃疡是一种常见病、多发病，总发病率约占人口总数的10％～20％。而药物治疗依旧是主要的治疗手段，奥美拉唑，可以特异性的作用于胃粘膜的壁细胞,降低壁细胞中的H+-K+-ATP酶的活性,使胃壁细胞内的氢离子不能转移到胃腔中,由于氢离子的缺乏而使胃酸的生成减少,从而起到治疗溃疡的作用。奥美拉唑剂量小，起效快，治愈率高，耐受性好，将其制成胶囊剂型，具有成分稳定，不易被污染 生物利用度高，密封性好，遮盖不良气味；崩解后在肠道直接吸收，无需溶解过程，吸收快等特点。已被有关刊物列入2000年时期的畅销药之一，具有广阔的市场前景。
本文参照国内制药现有水平，对奥美拉唑肠溶胶囊的生产车间进行设计，包括工艺流程设计、物料衡算、生产设备的选型、车间布置设计等。

关键词  奥美拉唑；肠溶胶囊；工艺流程；生产车间设计

Annual production capacity of 50 million omeprazole capsules production workshop process design
Abstract
Omeprazole is a widely used proton pump inhibitor in domestic and foreign clinical, and it is also a new anti-ulcer drugs which is different fr-om H2-recetor blockers in mechanism. Compared with H2-recetor blockers, it has a much stronger effect on inhibiting gastric acid secretion, higher recovery rate and faster.
Peptic ulcer which includes gastric ulcer and duodenal ulcer is a co-mmonly encountered disease and frequently-occurring disease. The disease rate is 10%～20% of the total population.However, the pharmacotherapy is still the main cure measures. Omeprazole can make a specific effect on the parietal cell of gastric mucosa , cutting down the activity of H+-K+-ATPase which is in parietal cell. And the hydrogen ions in the gastric pa-rietal cells cannot transfer to thegastral cavity. As lack of the hydrogen  ions, the generation of gastric acid dec-rease, and then achieve the object of curing the ulcer.
Omeprazole has lots of characters, such as small doses, work fast,   high recovery rate, and so on. And if make it into capsules, it will have much more characters, such as stable ingredient, hard to be polluted, high bioavailability, good leak tightness, covering the bad smell, absorbing in intestines directly and fast.It was list on some publication as a bestselling drugs in 2000 times. It has a wide market prospect.
In this paper, according to the current level of pharmaceutical, it was carri-ed by on Omeprazole Enteric-Coated Capsules production process  design and the design of its GMP production workshop, including process design, the calculation concerning the matierial balance, the selection of production equipment, the designing of the workshop and so on .

Key words: Omeprazole; Enteric-Coated Capsules; Technology process;            workshop design
目    录
摘    要 I
Abstract II
目    录 III
第1章 绪论 1
1.1 课题背景 1
1.2 抗溃疡药物研究进展 1
1.2.1 抑制攻击因子类药物 2
1.2.2 促进防御因子类药物 4
1.2.3 抗HP(幽门螺杆菌)感染的药物 5
1.2.4 联合用药 5
1.3 产品概述 6
1.3.1 产品名称、化学结构、理化性质、临床应用及药代动力学 6
第2章 生产工艺流程设计 7
2.1 生产工艺介绍 7
2.2 奥美拉唑肠溶胶囊制备工艺 8
2.2.1 丸芯制备 8
2.2.2 包衣 8
2.2.3 胶囊的充填 9
2.2.4 内包工序 10
第3章 物料衡算及设备选型 11
3.1 物料衡算 11
3.1.1 配制工序物料平衡 11
3.1.2 充填工序物料平衡 12
3.1.3 铝包工序物料平衡 12
3.1.4 奥美拉唑肠溶胶囊总物料衡算 13
3.2 生产设备选型 14
3.2.1 选择设备的原则 14
3.3 设备选型 15
3.3.1 粉碎 15
3.3.2 过筛 15
3.3.3 湿法制粒 15
3.3.4 包衣设备 16
3.3.5 充填设备 16
3.3.6 铝塑包装 17
第4章 生产车间设计 18
4.1 车间设计概述 18
4.1.1 设计目的 18
4.1.2 设计依据 18
4.1.3 胶囊剂车间GMP设计要点 20
4.1.4 设计原则 22
4.1.5 生产规模及生产制度 22
4.2 车间布置设计 22
4.2.1 基础资料 22
4.2.2 车间生产线布置 23
4.3 管道布置设计 23
4.3.1 管道设计的基础资料 23
4.3.2 管道设计的基本要求 24
第5章 工程建筑设计 25
5.1 车间建设对环境的影响 25
5.2 电力系统 25
5.3 采暖通风及空调净化系统 26
5.4 建筑具体细节要求的确定 26
5.5 相关工序特殊要求 27
5.5.1 备料室的设置 27
5.5.2 产尘的处理 27
5.5.3 关于车间排热、排湿及臭味的处理 27
5.5.4 参观走廊的设置 28
5.5.5 安全门的设置 28
结    论 29
致    谢 30
参考文献 31
附录A 32
附录B 41