摘要：本文对阿奇沙坦水解和精制工段进行了工艺设计。根据前期对阿奇沙坦合成工艺的了解和初步对工艺流程的熟悉情况，结合了制药工程工艺设计、药事管理与法规等课程中的有关内容。主要通过对年产量25吨的阿奇沙坦进行物料衡算，得出所有生产中物料的质量、反应液及滤液的体积等条件。在物料衡算的基础上得出能量衡算表，综合以上两个条件做出符合生产实际情况的设备选型。在设备选型的过程中要考虑到生产合理性、经济实用性和综合可行性。为了符合生产适用性，对所选设备做出换热面积验证，以判断反应釜是否需要增加盘管来保证换热。最后，在2015版GMP的指导下，设计出车间平面图、设备布置图、及带控制点的工艺流程图三张工艺图纸。74979

毕业论文关键词： 水解工序；精制工序；物料衡算；车间布置

Process Design of Hydrolysis and Purification of 25t Azilsartan with an Annual Output

Abstract: This thesis mainly describes the design of the hydrolysis and refining of Azilsartan。 According to the previous understanding of the synthesis process of Azilsartan and the initial familiarity with the process, combined with the relevant content in pharmaceutical technology design, pharmaceutical administration and regulation courses。 The mass of all production materials, and the volume of the reaction liquid, filter liquor and other conditions are calculated mainly through the material balance of the annual output of 25 tons of Azilsartan。 The energy balance table is obtained on the basis of the material balance, and the equipment selection is accorded with the above two conditions。 In the process of equipment selection, the production rationality, economy and practicality, and comprehensive feasibility should be taken into account。 In order to meet the applicability of production, we verify the selected equipment to make heat transfer area to determine whether the reactor needs to increase the coil to ensure heat transfer。 Finally, under the guidance of the 2015 version of GMP, workshop plans, equipment layout, pipeline and instrument PID chart and other technical drawings are designed。

KeyWords:  hydrolysis process；refining process； material balance；workshop layout

目   录

1 绪论 1

1。1 设计依据 1

1。2 产品名称和设计规模 1

1。3 产品简介 2

1。4 原辅材料物性参数 2

2 工艺说明 4

2。1 工艺设计思路 4

2。2 工艺路线 4

2。3 工艺流程框图 6

2。4 工艺任务书 9

2。5 工艺流程叙述 10

2。6 质量控制 11

3 物料衡算 12

3。1 计算基准和相关数据 12

3。2 物料衡算 12

4 能量衡算 17

4。1 能量衡算目的 17

4。2 能量衡算依据 17

4。2。1 设备的热量平衡方程式 17

4。2。2 加热剂和冷却剂用量的计算 19

4。3 阿奇沙坦能量衡算 20

4。3。1 各种参与过程的物质的比热