年产一亿颗盐酸多奈哌齐胶囊的生产车间设计 摘要：盐酸多奈哌齐是属于第二代乙酰胆碱酯酶抑制剂，它能可逆性地抑制乙酰胆碱酯酶所引起的乙酰胆碱水解，从而增加受体部位的乙酰胆碱酯含量，进而增强乙酰胆碱的生理作用。临床上作为治疗阿尔兹海默症的首选药物。本设计从可行性出发，设计了年产一亿颗盐酸多奈哌齐胶囊剂的工艺流程、物料衡算、设备选型、平面布置等。本着符合GMP要求、可操作性的角度出发，设计有一般中小型制药厂所需具备的简单、经济、合理、安全等优良性质。通过此次设计，使所学理论知识运用到实际设计中来，大大锻炼了学生能力。 关键词：盐酸多奈哌齐；工艺流程；物料衡算；生产设备；车间布置 窗体顶端 Abstract: do
nepezil hydrochloride belo
ngs to the seco
nd ge
neratio
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nhibitor that reversibly i
nhibit the hydrolysis of acetylcholi
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ncreasi
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ng the physiological role of acetylcholi
ne. As the drug of choice for the treatme
nt of Alzheimer's disease cli
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n starti
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n process o
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ndred millio
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nual do
nepezil hydrochloride capsules, material bala
nce, equipme
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n the GMP requireme
nts, operatio
nal poi
nt of view, the desig
n of most small a
nd medium pharmaceutical required of simple good
nature of eco
nomic, reaso
nable, a
nd security. With this graduatio
n project, so that the theory of k
nowledge i
nto actual desig
n to greatly exercise the stude
nts' ability.窗体底端 窗体顶端 Abstract: do
nepezil hydrochloride belo
ngs to the seco
nd ge
neratio
n acetylcholi
nesterase i
nhibitor that reversibly i
nhibit the hydrolysis of acetylcholi
ne caused by acetylcholi
nesterase, thereby i
ncreasi
ng acetylcholi
ne receptor sites ester co
nte
nt, thus e
nha
nci
ng the physiological role of acetylcholi
ne. As the drug of choice for the treatme
nt of Alzheimer's disease cli
nically. This desig
n starti
ng from feasibility, desig
n process o
ne hu
ndred millio
n a
n
nual do
nepezil hydrochloride capsules, material bala
nce, equipme
nt selectio
n, layout a
nd so o
n. I
n the GMP requireme
nts, operatio
nal poi
nt of view, the desig
n of most small a
nd medium pharmaceutical required of simple good
nature of eco
nomic, reaso
nable, a
nd security. With this graduatio
n project, so that the theory of k
nowledge i
nto actual desig
n to greatly exercise the stude
nts' ability.窗体顶端 窗体顶端 A
n a
n
nual output of o
ne hu
ndred millio
n do
nepezil hydrochloride capsules productio
n workshop desig
n Pharmaceutical E
ngi
neeri
ng 2011 Ze
ng Fei Ya
n I
nstructor: Xiao Xi
nro
ng窗体底端 A workshop desig
n about a
n
nual output of o
ne hu
ndred millio
n do
nepezil hydrochloride capsules Abstract: do
nepezil hydrochloride belo
ngs to the seco
nd ge
neratio
n acetylcholi
nesterase i
nhibitor that reversibly i
nhibit the hydrolysis of acetylcholi
ne caused by acetylcholi
nesterase, thereby i
ncreasi
ng acetylcholi
ne receptor sites ester co
nte
nt, thus e
nha
nci
ng the physiological role of acetylcholi
ne. As the drug of choice for the treatme
nt of Alzheimer's disease cli
nically. This desig
n starti
ng from feasibility, desig
ns the process flow ,material bala
nce, equipme
nt selectio
n a
nd layout of o
ne hu
ndred millio
n a
n
nual do
nepezil hydrochloride capsules.With the GMP requireme
nts a
nd operatio
nal poi
nt of view, the desig
n co
ntai
ns that the most small a
nd medium pharmaceutical require simple, eco
nomic, reaso
nable, a
nd security good
nature. With this graduatio
n project, the theory of k
nowledge i
nto actual desig
n greatly exercise the stude
nts' ability. Keywords: Do
nepezil hydrochloride; Process flow; Material bala
nce; Productio
n equipme
nt; Pla
nt layout 窗体底端 窗体底端 目录 一、概述1 1.1胶囊剂的概述1 1.2盐酸多奈哌齐胶囊剂的概述1 二、指导思想和设计原则3 2.1指导思想3 2.2设计原则3 2. 2.1厂区的选择和布置3 2. 2.2工艺流程3 2.2.3设备的选型4 2.2.4制剂车间的布置4 2.2.5空调净化系统4 三、生产工艺5 3.1工艺规定5 3.2工艺设计参数5 3.3工艺设计6 四、生产工艺的物料衡算10 4.1物料衡算10 4.2物料工艺流程15 4.3物料平衡表16 图4-2各组分物料流程图17 五、主要设备选型19 5.1主要设备选择19 5.1.1粉碎19 5.1.2筛分20 5.1.3混合21 5.1.4制粒22 5.1.5干燥23 5.1.6填充24 5.1.7抛光25 5.1.8包装26 5.2主要设备选型一览表： 28 六、车间布置设计30 6.1车间区域布置30 6.2车间总体布置31 6.2.1粉碎、筛分车间平面设计32 6.2.2称量配料车间平面设计32 6.2.3混合车间平面设计32 5.2.4制粒车间平面设计32 6.2.5干燥车间平面设计32 6.2.6填充车间平面设计33 6.2.7包装车间平面设计33 6.2.8车间布置表33 6.3车间布置图35 七、空调净化系统设计36 7.1净化系统概述36 7.2设计参数36 7.3净化系统设计37 八、环境保护39 8.1环境保护至关重要39 8.2制剂生产污染的特点39 8.3三废的处理39 九、谢辞41 参考文献42