年产150万瓶氨甲苯酸氯化钠注射液生产车间设计.doc

年产150万瓶氨甲苯酸氯化钠注射液生产车间设计 中文摘要：此设计是针对中小型制药企业的生产车间设计，即年产150万瓶氨甲苯酸氯化钠注射液的生产车间设计。首先简要说明了该注射液的临床用途及规格等介绍，接着主要进行该药的配制方法、物料衡算、能量衡算、工艺选择、反应釜设备的计算及选型、车间布局等。工艺过程条件需经济合理，且必须符合GMP《药品生产质量管理规范》的要求。该设计还系统介绍了三废处理、经济衡算、生产能力及估算市场前景。并附有车间布置图、工艺流程图及主辅设备图。 关键词： 氨甲苯酸氯化钠注射液；物料衡算；工艺设计；车间布置 The production workshop design of annual 1.5 million bottles of PAMBA of sodium chloride injection Abstract：The design was aimed at middle-small scale enterprise of pharmaceutical, the annual output of 1.5 million bottles of P-Aminomethylbenzoic Acid (PAMBA) of sodium chloride injection of production process design. Firstly, it illustrated the clinical uses and specifications of the injection in briefly. And then it introduced the main method of preparation of the injection. At lost the material balance , the energy balance and process selection were calculated in the design, and the major equipments for the reactor jacket in mixturing were selected by equipments’ parameters and calculated data, the shop layout and so on. The process conditions required for economic rationality, and must comply with the GMP requirements. The production design has also introduced how to deal with the waste water,gas and material in brief, calculated the cost of production and profit , production capacity and estimated the market prospects. It enclosed drawing of workshop layout, diagram of process flow and a main equipment drawing and a supplementary equipment drawing. Key words: P-Aminomethylbenzoic Acid (PAMBA) sodium chloride injection; material balance; technological design; workshop layout 目录 499 前言 1 23065 第一章 产品概述 3 17788 1.1 氨甲苯酸结构式： 3 32707 1.2 注射液简介 3 5068 1.3 氨甲苯酸氯化钠的临床运用 4 9861 1.4 临床用药的注意事项 5 31632 第二章 指导思想和指导原则 6 10167 2.1 设计思想 6 26780 2.2 厂址的选择 6 16470 2.3 工艺流程 6 27294 2.4 设备的选型 6 5456 2.5 制剂车间的布置 7 7878 2.6 空调净化系统 7 4912 2.7 设计准备 7 15172 第三章 工艺选择 8 19459 3.1 工艺设计基本规范 8 29698 3.2 生产过程概述 8 19900 3.3 生产工艺流程 9 27159 3.4 处方的组成 9 31839 3.5 制作方法及工艺流程 9