摘 要

卡培他滨目前在市场上的主要剂型是片剂，其作为最新的氟化嘧啶药物，不仅具备特异的靶向性，而且对氟化嘧啶和其它化疗药物耐药的肿瘤仍然有效，十分有前景。本次设计的题目是《年产1000万片卡培他滨片剂的工艺与车间设计》。根据片剂的生产工艺和生产流程，卡培他滨片以卡培他滨为主药，以微晶纤维素、乳糖、交联羧甲基纤维素钠、3%羟丙甲纤维素水溶液、硬脂酸镁、滑石粉为辅料，设计出合理的处方，根据年产量计算原辅料的需求量以及每天的投料量。通过进行物料衡算和能量衡算之后，选择合适的设备，设计出合理的生产工艺及厂房布局。

关键词： 卡培他滨片；车间工艺；车间设计

abstract

At present,the main form of Capecitabine is tablet in the market, as the latest fluoride pyrimidine drugs, it not only have the specific targeting, but also fluoride pyrimidine and other chemotherapy drug resistance of tumor is still valid,it is very promising.The topic of this design is the process of annual output of 10 million pieces of capecitabine tablets and workshop design.According to the tablet production technology and production processes, the capecitabine tablets is given priority to with capecitabine, microcrystalline cellulose, lactose, 3% crosslinking sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose solution, magnesium stearate, talc powder as auxiliary materials, design a reasonable prescription,according the annual output to calculated the demand of raw materials and produce the inventory every day. Through carries on the material balance and energy balance, choose the right equipment, design a reasonable production process and factory layout.

Key words: Capecitabine Tablets; workshop process; workshop design

目 录

摘要................................................................................................................................I

Abstract..................................................................................................................... II

第1章 绪论..................................................................................................................1

1.1 设计的背景.........................................................................................................1

1.2 设计的目的和意义.............................................................................................1

第2章 设计方案..........................................................................................................3

2.1 卡培他滨片的相关事宜.....................................................................................3

2.1.1原料...............................................................................................................3

2.1.2 片剂种类的选择..........................................................................................3

2.1.3 产品方案......................................................................................................3

2.2 片剂生产车间的相关事宜.................................................................................3

2.2.1 片剂车间设计的要求..................................................................................3

2.2.2 生产工艺流程的选择..................................................................................4

第3章 生产工艺流程及洁净区的划分......................................................................5

3.1 生产工艺流程.....................................................................................................5

3.1.1 处方..............................................................................................................5

3.1.2 生产工艺流程简述......................................................................................5

3.1.3 生产工艺流程图..........................................................................................7

3.2 洁净区的划分.....................................................................................................7

3.2.1 GMP对厂房洁净等级的要求.......................................................................7

3.2.2 洁净区的划分..............................................................................................9

第4章 物料衡算和能量衡算....................................................................................10

4.1 物料衡算...........................................................................................................10

4.1.1 物料衡算清单............................................................................................10

4.1.2 各流程物料衡算........................................................................................10

4.1.3 包装材料衡算............................................................................................14

4.2 热量衡算...........................................................................................................14

4.2.1 素片干燥过程的热量衡算........................................................................14

4.2.2 包衣过程的热量衡算................................................................................17

第5章 设备选型与管道计算....................................................................................20

5.1 生产设备满足工艺要求的程度.......................................................................20

5.2 生产设备的选型说明.......................................................................................20

5.3 设备选型...........................................................................................................20

5.3.1 称量............................................................................................................20

5.3.2 粉碎............................................................................................................21

5.3.3 过筛............................................................................................................21

5.3.4 制湿粒........................................................................................................21