年产15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，我采纳 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与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 de...