摘要：这次设计是对年产25吨缬沙坦的氢化还原工序的车间进行工艺设计，写设计说明书，并且绘画车间设计图工艺流程图设备布置图等。缬沙坦的氢化还原工序合成工艺生产是用N-正戊酰基缬氨酸甲酯作为起始原料发生氢化还原反应。

非无菌原料药车间设计要注意的要点主要是企业以缬沙坦的车间工艺生产路线对非无菌化学原料药缬沙坦的生产进行准确的物料衡算、节能的能量衡算以及车间工艺生产设备的选型，满足生产节能环保的要求。在进行物料衡算之后再进一步进行能量衡算，且对缬沙坦的车间设计中涉及到的主要设备进行设备选型，公用工程主管的管径计算，车间布置，平面设计，和查阅相关资料，行政法规执行及措施，三废处理。并对存在的问题做出总结，进一步绘制仪表流程图及工艺管道、车间设备布置图、车间平面布置图等设计图纸，人流物流布置图。

关键词:缬沙坦；生产工艺；车间布置；物料衡算；能量衡算；

Workshop Design for Annual Hydrogen Reduction Process of 25 Tonnes of Valsartan

Abstract

This design is to design the workshop for the hydrogenation reduction process of 25 tons of valsartan per year, to write the design specifications, and to draw the layout diagram of the workshop design flow chart and equipment layout. The hydrogenation reduction process of valsartan is produced by hydrogenation reduction using N-n-valerylproline methyl ester as a starting material.

The main points to pay attention to in the design of non-sterile APIs are the accurate material balance, energy-saving energy balance, and workshop processes for the production of non-aseptic chemical feedstock valsartan through the production line of Valsartan. Selection of production equipment to meet the requirements of energy saving and environmental protection. After the material balance is carried out, further energy balances are carried out, and the main equipment involved in the design of Valsartan's workshop is selected for equipment, the diameter calculation of public works supervisors, workshop layout, graphic design, and access to relevant information. , implementation of administrative regulations and measure , three waste treatment. Summarize the existing problems, and further draw the design drawings of the instrument flow chart and process piping, workshop equipment layout, workshop floor plan, and human logistics layout.

Keywords: Valsartan; Production process; Workshop layout; Material accounting; Energy accounting

目录

摘要 2

ABSTRACT 3

1绪论 8

1.1一款血管紧张素II受体拮抗剂治疗高血压类药物—缬沙坦 8

1.2国内缬沙坦的销售市场及研究发展情况 8

1.2.1国内市场情况 8

1.2.2国内临床研究情况 9

1.3缬沙坦现在的国际市场和发展情况 9

1.4.2018年缬沙坦行业研究 10

1.4.1缬沙坦行业发展关键因素和发展预测 10

1.4.2缬沙坦行业的客户需求分析 10

1.5车间设计指导说明 10

1.6设计研究的目的与意义 11

1.6.1设计研究的目的 11

1.6.2研究车间设计的意义 11

1.7车间设计研究的内容 11

2车间设计简单概述 12

2.1车间设计资料和依据 12

2.1.1设计的主要技术参考资料 12

2.1.2主要设计过程 12

2.2设计规模大小和产品名称 13

2.3缬沙坦的简介 14

2.4原料及中间体的主要用途、理化性质、规格 14

2.5厂址选择 15

3工艺说明 16

3.1工艺路线 16

3.2工艺流程框图 16

3.3车间设计任务书 18

3.4工艺流程叙述 18

4车间设计生产合理制度 20

4.1生产合理规划 20

4.2安排根据 20

4.3生产的时间安排 20

5物料衡算 21

5.1计算依据 21

5.2物料衡算 21

5.3物料衡算框框图 24

6能量衡算 25