年产1000万瓶己酮可可碱葡萄糖注射液生产车间工艺设计.doc

年产1000万瓶己酮可可碱葡萄糖注射液生产车间工艺设计 摘要:己酮可可碱[3]葡萄糖注射液具有多种药理作用，其主要药理作用是有剂量地降低血液粘稠度、提高红细胞变形性、改善白细胞血液流变特性等，其在临上主要作为血管扩张剂，用于周围血管性疾病的治疗。目前，己酮可可碱葡萄糖注射液的生产工艺[5]渐渐成熟，它的设计就是在原有的工艺设计基础上进行了GMP改造。具体的内容包括以下几个方面:厂址的选择、工艺流程、物料衡算、设备选型、车间平面布置、空调净化系统等。通过设计，使厂房符合GMP规范，并且使生产工艺更加规范和严谨。 关键词： 己酮可可碱；注射剂；生产工艺设计；车间平面布置 The design of annual output of 10 million bottles of hexanone theobromine glucose injection production workshop process Abstract: Hexanone theobromine and glues injection has many pharmacological effects , the main pharmacological effect is dose to reduce blood viscosity , improve erythrocyte defomability and improve leukocytes blood rheologicao characteristics , its clinically as a vasodilator , mainly used for the treatment of peripheral vascular disease . At present , the hexanone theobromine glucose injection production technology mature gradually , the design of it is in the original process design on the basis of the GMP reform . Specific content includes the following aspects: site selection , process flow , material balance , equipment selection , shop layout , air purification system and so on . Through the design , make the factory conform to the requirements of GMP , and make the process more standardized and rigorous. Keywords: Hexanone theobromine Injection Manufacturing process Workshop layout design 目录 TOC \o 1-3 \h \u 1744 前言 1 31545 1.1 概述 1 5696 1.2 己酮可可碱 2 26388 1.3 设计的目的和意义 3 11987 第2章 指导思想和设计原则………………………………………………………..4 2327 2.1 指导思想 4 1334 2.2 设计原则 4 2.2.1 工艺流程…………………………………………………………………………4 2.2.2 设备的选型…………………………………………………………………...…4 2.2.3 空调净化系统………………………………………………………………..….5 20931 2.3 设计准备 5 17485 第3章 生产工艺 6 3.1生产工艺的基本要求…………………………………………………………………6 29959 3.2 生产过程概述 6 23435 3.3 生产工艺流程 6 20261 3.4 注射用水的制备 7 7833 3.5 注射液容器的处理 7 4706 3.6 注射液的过滤 8 3.7 注射液的灌封…………………………………………………………………………..9 3.8 注射液的灭菌…………………………………………………………………………..9 3.9 灯检……………………………………………………………………………………9 11720 3.10 印字包 9 3.11