化学原料药多功能车间工艺设计1.pdf

武汉工程大学 望舒 国药工程杯 摘要 原料药多功能车间不同于传统的原料药车间，它可以同时或分期生产不同品 种的多种原料药。多功能车间的建设可以满足小批量、多品种的生产要求，应对 市场的迅速变化。另外，从整体上而言，多功能车间在设备和土地上更节约，使 生产成本降低。 本文针对硫辛酸、依非韦伦、缬沙坦三种原料药设计一个多功能车间，设计 规模为每种药品 25t/a，按照 GMP 标准，对车间的设计依据、设备选择、车间布 置以及工艺路线论证、工艺流程设计，劳动保护、安全生产与 “三废”处理等一 系列工程问题作了详细的介绍，并附有设计图纸和表格。 关键词：原料药、多功能车间、硫辛酸、依非韦伦、缬沙坦 1 武汉工程大学 望舒 国药工程杯 Abstract Multifunction workshop is different from traditionnal API workshop, it can simultaneously produce a variety of pharmaceutical raw materials or phases of different varieties. Multifunctional building workshop to meet small quantity and variety of production requirements, respond quickly to market changes. In addition, from on the whole, more versatile workshop on conservation and land equipment, reduce production costs. In this paper, lipoic acid, efavirenz, valsartan three kinds of pharmaceutical raw materials to design a multi-purpose workshop, designed to scale to each drug 25t / a, in accordance with the GMP standards, based on the plants design, equipment selection, plant layout and process route demonstration, process design, labor protection, production safety and the three wastes treatment and a series of engineering problems were described in detail, together with the design drawings and tables. Keywords: pharmaceutical raw materials, multi-plant, lipoic acid, efavirenz, valsartan 2 武汉工程大学 望舒 国药工程杯 目 录 第一篇 多功能生产车间 硫辛酸设计说明书 前言1 第一章 概述 2 1.1 产品的名称、结构、理化性质