年产一亿支二巯丙磺钠注射剂车间工艺设计.doc

年产一亿支二巯丙磺钠注射剂车间工艺设计 摘要：二巯丙磺钠注射剂常用于治疗汞中毒、砷中毒，为首选解毒药物。对有机汞有一定疗效。对铬、铋、铅、铜及锑化合物（包括酒石酸锑钾）均有疗效。实验治疗观察对锌、镉、钴、镍、钋等中毒，也有解毒作用。适应症少，毒性低是本品相对于其它解毒剂的优势所在。目前，国内对其生产工艺已日趋成熟，本次二巯丙磺钠注射剂的设计就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，空调净化系统及环境保护等。通过设计，使厂房符合GMP规范，且使生产工艺更加规范和严谨。 关键词：二巯丙磺钠注射剂;工艺流程;GMP;车间平面布置 With an annual output of 100 million 5 ml Sodium Dimercaptosilfonate Injections process design workshop Abstract: Sodium Dimercaptosilfonate Injections used in the treatment of mercury poisoning, arsenic poisoning, is the first choice of drug detoxification.?It has a certain effect on the organic mercury.?The effects of chromium, bismuth, lead, copper and antimony compounds (including potassium antimony antimony potassium) were effective.?Experimental observation on the treatment of zinc, cadmium, cobalt, nickel, polonium poisoning, also has a detoxifying effect.?Indications, low toxicity are the other advantages relative to where the antidote.At present, its domestic production technology has matured, the time of buflomedil hydrochloride injection design on the original production process on the basis of GMP reformation. Specific content includes: site selection, process flow, material balance, equipment design and selection, plant layout, air purification system and economic accounting. Through the design, so that the plant in accordSodium Dimercaptosilfonate Injections ； production process ；GMP ； Workshop layout? ance with GMP standard, and that the production of more normative and rigorous. Keywords: Sodium Dimercaptosilfonate Injections； production process ；GMP ； Workshop layout? 目录 TOC \o 1-3 \h \u 15976 引言 1 30541 第一章 设计指导思想和设计原则 3 15256 1.1 指导思想 3 9205 1.2.1 厂址选择 3 1168 1.2.2 工艺流程 3 10586 1.2.3 设备的选型 3 27672 1.2.4 制剂车间的布置 4 16831 1.2.5 空调净化系统 4 5017 第二章 生产工艺的选择 5 24652 2.1 一般规定 5 17242 2.2 工艺设计参数 5 20204 2.3 注射剂的配方 5 7536 28651 2.4 单元操作选择 5 18774 2.4.1.注射用水制备 5 27051 2.4.2 药液的配制 6 25948 2.4.3药液的滤过 6 29935 2.4.4药液的灌封 6