年产8千万支克矽平注射剂间工艺设计.doc

年产8千万支克矽平注射剂（规格:80mg/2ml）车间工艺设计 摘要：克矽平（(聚2一乙烯基吡啶氮一氧化物,P204）为治疗矽肺病用药，是一种分子结构中具有带强负电性氧原子的高分子药物，常见剂型为注射剂和喷雾剂。适用于各期矽肺病患者，对于早期和急性矽肺病患者疗效较好，可作为长期治疗使用药物。本品应用历史悠久，治疗效果显著。目前，国内对其原料药合成和制剂生产工艺已日趋成熟，本次克矽平注射液的设计就在原有的生产工艺基础上进行GMP规范化改进。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，使车间和生产工艺严格符合GMP规范。 关键词：克矽平注射液;工艺流程;GMP;车间设计 With an annual output of 80 million （Specification : 80mg/5 ml） PVNO?injection workshop process design Abstract: PVNO（Polyvinylpyridine-N-Oxide，P204) a drug for the treatment of silicosis, has a molecular structure with strong negatively chargeable oxygen atom of the macromolecular drug. The common dosage forms of PVNO are injections and sprays. PVNO applies to each period silicosis patients, has curative effect on both early and acute silicosis. It can be used as long-term treatment using drugs. The application of this product has a long history, with remarkable treatment effect. This time of PVNO injection design on the original production process is on the basis of GMP reformation. Currently, with the domestic production technology has become increasingly mature. This design of PVNO injection basis on the original production process improves on standardization compliance on GMP standard.Specific content includes: site selection, production process, material balance, design and selection of equipment, plant layout, air purification system and economic accounting. Through the design, to make the workshop and the production process are in rigorous with GMP standard. Keywords: PVNO Injections；Production Process；GMP；Workshop Design 目 录 TOC \o 1-2 \h \z \u 引言 1 注射剂概述 1 克矽平注射剂介绍 2 设计的目的、意义 2 1、设计指导思想和设计原则 4 1.1 指导思想 4 1.2 设计原则 4 2、生产工艺设计 6 2.1 GMP的一般要求 6 2.2 生产工艺设计参数 6 2.3 辅料选择 6 2.4 注射剂的配料比 6 2.5 克矽平注射剂生产工艺设计 7 2.6 主要单元操作选择 7 2.6.1 注射用水的制备 7 2.6.2注射剂容器处理制 8 2.6.3 调碳 8 2.6.4 注射剂的配制 9 2.6.5 注射剂的滤过 9 2.6.6 注射剂的灌封 9 2.6.7 注射剂的灭菌检漏 9 2.6.8 注射剂的灯检 9 2.6.9 擦瓶处理 10 2.6.10 注射剂的包装 10 2.7 质量控制 10 2.8