产吨的替米沙坦原料药车间工艺的设计说明

摘要

本设计为年产15吨的替米沙坦车间工艺设计。在本设计中，我采用4-甲基-2-正丙基-1H-苯并咪唑-6-甲酸和N-甲基邻苯二胺为原料经过环缩合反应后，与4’-溴甲基联苯-2-甲酸甲酯发生取代反应，最后经过水解反应生成替米沙坦粗品的过程。该设计的主要步骤为环缩合、取代反应、和水解反应，产率依次为71.2％、82％和86％。根据任务书要求，设定301天为基准，替米沙坦的年产量为15吨。

在本设计中，我们先是通过查阅文献资料对替米沙坦和及其原辅料中间产品各种物性参数进行了查询和记录，然后，了解了它的临床用途、不良反应和各种药理毒理反应。然后根据设计绘制了工艺流程框图。其次，我们以反应釜为单位进行了物料衡算，并且列出了反应釜的进出物料平衡表。在以上基础上，完成物料衡算和设备选型，并绘制了带控制点的工艺流程图[1]。然后根据《药品生产管理规》等，并依据设计实际情况，进行了详细的劳动人员安排。最后根据生产中的废弃物的性质和排出量，制定了合理利用和“三废处理”办法。

【关键词】年产15吨的替米沙坦；物料衡算；热量衡算

Abstract

The design of 15 tons of telmisartan workshop process design.In this design, I use is 4 - methyl - 2 - propyl benzene and 1 h - imidazole - 6 - formic acid and N - methyl o-phenylendiamine as raw material after ring condensation reaction, and - bromine biphenyl, 4 '- 2 - methyl formate substitution reaction, finally after hydrolysis reaction of alcohol telmisartan process.The main steps of the design for the cyclic condensation, substitution reaction, hydrolysis reaction, and the yield was 71.2%, 82% and 86% in turn.According to the specification requirements, set for 301 days as a benchmark, telmisartan output of 15 tons.

In this design, we first through the literature data of telmisartan and its raw materials of various physical parameters in the query of the intermediate products and the records, then, to understand its clinical use, adverse reactions, and all kinds of pharmacology and toxicology.Then according to the design drawing the process flow diagram.Second, we in the reaction kettle has carried on the material balance, and lists the reaction kettle in and out of the material balance.On the basis of above, complete the material balance and equipment type selection, and draw a process flow chart with control points.Then according to the code for the pharmaceutical production management, etc., and according to the design of the actual situation, has carried on the detailed labor personnel arrangement.Finally, according to the nature of the waste in the production and discharge, formulate measures for reasonable utilization and "three wastes".

【key word】 Annual output of 15 tons of telmisartan;Material balance;Heat balance

摘要...................................................................... I Abstract ................................................................. II 第一章产品概述 (1)

1.1 基本信息、化学结构、性状与规格 (1)

1.1.1 产品名称 (1)

1.1.2 化学结构、分子式、分子量 (1)

1.1.3 性状与规格 (1)

1.2 产品药理毒理 (1)

1.3 适应症与不良反应 (2)

1.4 用法用量 (3)

1.5 禁忌 (3)

第二章生产工艺 (4)

2.1 生产工艺路线 (4)

2.2 生产工艺操作过程 (5)

2.2.1 环缩合反应式及操作步骤 (5)

2.2.2 取代反应式及操作步骤 (5)

2.2.3 水解反应式及操作步骤 (6)

2.2.4 包装 (6)

2.3 工艺流程框图 (7)

2.4“三废”处理及综合利用 (7)

2.4.1 废气 (7)

2.4.2 废水 (7)

2.4.3 废渣 (7)

第三章产品质量监测 (7)