阿司匹林复方片剂车间工艺设计课程

阿司匹林复方片剂车间工艺设计摘要阿司匹林是全世界应用最广泛的解热、镇痛和抗炎药物，也是比较和评价其他药物的标准制剂；阿司匹林复方片剂是一解热镇痛药物，其中阿司匹林和非那西丁均具有解热镇痛作用，咖啡因能够加强前两药缓解头痛的效果；片剂是国内外临床治疗中使用得最为广泛的剂型之一，它的化学稳定性较其他的剂型好，同时它具有携带方便、生产机械化程度高等优点；为了满足市场需求，本文对阿司匹林的车间与工艺进行了设计。

制剂的工艺流程是以保证实现处方的功能主治为目的，紧紧围绕功能主治的要求，对药物的处理原则、方法和程序所作的最差不多的规定。

它决定着制剂质量的优劣，也决定着该制剂大生产的可行性和经济效益，本设计采纳湿法制粒，然后进行压片、包衣和包装，在讲明书中对生产工艺做了详细的介绍，同时对生产所需的设备进行了选型。

生产规模为1.6亿片/年，在讲明书中对所需的物料、包材进行了衡算。

在设计中严格遵照《GMP》和《洁净厂房设计规范》等标准进行设计，车间布置设计时遵守设计程序，按照布局设计的原则，进行细致而周密的考虑，绘制了车间平面布置图，也对空调净化系统进行了相应的设计。

关键词：阿司匹林复方片剂，车间，工艺，设计，设备选型THE DESIGN OF ASPIRIN COMPOUNDTABLETS WORKSHOP PROCESSAspirin is the world's most widely used antipyretic, analgesic and anti-inflammatory drugs, but also more standard preparation and evaluation of other drugs. Aspirin Compound Tablets is an antipyretic and analgesic drug. In this compound tablets, aspirin and phenacetin haveantipyretic and analgesic effects, caffeine can enhance the effect of the first two drugs to relieve headaches. The tablet is one of the most widely used forms in the domestic and international clinical treatment. Its chemical stability is better than other formulations, and it is easy to carry and Produce by mechanical. In order to meet market demand, aspirin workshop and process are designed in this paper.The purpose of the preparation process is to ensure that achieve prescription Indications. It is the basic provision tightly around Indications requirements, principles of drugs, methods and procedures, and also determines the quality of the preparations, the feasibility and cost of thepreparation of large-scale production. In this paper, wet granulation is used. Then the tablets were compressed coated and packaged. The production process is described in detail in the specification. The production scale is 160 million per year. The necessary equipments used in production are selected. The desired materials and packaging materials are accounted in the specification. The workshop is designed in strict accordance with the "GMP" and "clean room design specifications and other standards. Detailed and careful consideration is used under compliance with the design process and in accordance with the principles of layout design at Workshop layout design. The workshop floor plan is draw. And the air purification system is designed.KEY WYORDS：aspirin compound tablets，Workshop，process，design，equipment selection目录第1章概述 (1)§1.1 阿司匹林的药理特性及临床应用 (1)§1.1.1 防治老年痴呆 (2)§1.1.2 防治糖尿病及其并发症 (2)§1.1.3 预防冠心病发作和中风 (3)§1.1.4 防治多种癌症 (3)§1.1.5 其它作用 (4)§1.2 片剂的介绍 (5)§1.2.1 片剂的优点 (5)§1.2.2 片剂的规格和质量 (6)§1.3 阿斯匹林复方制剂 (9)§1.4 设计指导思想和设计原则 (11)§1.4.1 指导思想 (12)§1.4.2 设计原则 (12)§1.4.3 厂址选择 (12)§1.4.4 总平面设计 (13)§1.4.5 工艺流程设计 (14)§1.4.6 相关工序的局部设计 (15)§1.5 可行性研究报告 (19)第2章工艺流程和处方设计 (19)§2.1 设计概述 (19)§2.1.1 设计依据 (20)§2.1.2 设计内容 (20)§2.1.3 设计原则： (21)§2.2 工艺流程介绍 (21)§2.2.1 粉碎 (22)§ 2.2.2筛分 (23)§ 2.2.3 混合 (24)§2.2.4 制粒 (24)§2.2.5 干燥 (24)§2.2.6 整粒，总混 (25)§2.2.7 压片 (25)§2.2.8 包装 (26)第3章物料衡算 (27)§3.1 概述 (28)§3.2 衡算依据 (28)§3.3 衡算过程 (29)第4章设备选型 (36)§4.1 粉碎 (37)§4.1.1 概述 (37)§4.1.2 粉碎的机理 (37)§4.1.3 粉碎机械的选用原则 (38)§4.1.5 粉碎设备选型 (39)§4.2.1 概述 (40)§4.2.2 筛分的目的 (41)§4.2.3 阻碍筛分的因素 (41)§4.2.4 筛分的设备选型 (42)§4.3 混合 (43)§4.3.1 概述 (44)§4.3.2 混合机理 (44)§4.3.3混合设备 (45)§4.4 制粒 (46)§4.4.1 制粒的目的 (46)§4.4.2 制粒的方法 (47)§4.4.3 湿法制粒机理 (48)§4.4.4 混合制粒机的选择 (48)§4.5 干燥 (50)§4.5.1概述 (50)§4.5.2 干燥原理 (50)§4.5.3 干燥设备选型 (51)§4.6 整粒 (52)§4.7压片 (53)§4.7.1 概述 (53)§4.7.2 压片机设备选型 (54)§4.8 包衣 (55)§4.9 包装 (56)§4.9.1 片剂包装的类型 (56)4.9.2 包装机的选择 (57)第5章车间平面布置图设计 (59)§5.1 车间设计的一般原则 (60)§5.2 片剂生产工序及区域划分 (60)§5.3 车间布置的总体要求 (60)§5.4 平面布置 (62)§5.5 车间平面布置图 (63)第6章生产车间空调净化系统的设计 (63)§6.1 设计参数 (64)§6.2 空调净化系统设计 (66)§6.2.1 空气过滤的机理 (66)§6.2.2 空气过滤器 (66)§6.2.3 空调净化系统 (67)§6.2.4 空调净化系统的设计方案 (68)§6.3 净化方案 (69)参考文献 (70)致谢 (76)。