年产1000万瓶阿奇霉素萄葡糖注射液生产车间工艺设计.doc

年产1000万瓶阿奇霉素萄葡糖注射液（100ml, 阿奇霉素0.125g, 萄葡糖5.0g）生产车间工艺设计 摘要：阿奇霉素属于大环内酯类抗生素药物，其作用机制是通过阻碍细菌转肽过程来抑制其蛋白质的生成。阿奇霉素因为在酸性环境中稳定，半衰期长，并且感染部位血药浓度高，疗效明显，安全性和稳定性方面均有保障。现已广泛应用于临床。目前，阿奇霉素国内生产工艺已日趋成熟。本次阿奇霉素葡萄糖注射液的设计在原有的生产工艺基础上进行GMP改造。具体内容包括：厂址选择，生产工艺流程，物料衡算，设备的设计与选型，车间平面布置，空调净化系统及经济效益核算等。通过设计，使厂房符合GMP规范，使生产工艺更加规范和严谨。 关键词：阿奇霉素;葡萄糖注射液;车间平面布置;工艺设计 The design of annual output of 10 million bottles of azithromycin also glucose injection (10 million ml, azithromycin, 0.125 g also glucose 5.0 g) production workshop process Abstract: Azithromycin belongs to the large ring lactone class antibiotic drugs, its mechanism of action is a bacteria turn to suppress the formation of its protein peptide process. , azithromycin expanding clinical application because of azithromycin stability in acid environment, long half-life, and infection drugs concentration is high, the curative effect is obvious, are guaranteed in terms of security and stability. Now has been widely used in clinical. At present, the domestic to its production technology has been mature, the design of the azithromycin glucose injection in the original production technology based on GMP reform. The concrete content includes: site selection, production process, material balance, the workshop layout, equipment design and selection, air conditioning purification system and economic benefit calculation, etc. Through the design, make the factory conform to the requirements of GMP, and make the process more standardized and rigorous. Keywords: Azithromycin ; glucose injection ; workshop layout ; technological design 目录 引言 1.注射剂的概述……………………………………………………………………1 2.阿奇霉素的概述…………………………………………………………………1 3.阿奇霉素的市场前景分析………………………………………………………2 指导思想和设计原则 1.1 指导思想 .........................................................................................4 1.2 设计原则 .........................................................................................4 第二章 生产工艺流程的设计 2.1 一般规定 .......................................................................