重组人粒细胞刺激因子原液车间设计

重组人粒细胞刺激因子原液车间设计重组人粒细胞刺激因子原液车间设计摘 要重组人粒细胞刺激因子（recombinant human granulocyte stimulating factor，rhG-CSF）具有刺激中性粒细胞系增殖、分化和成熟以及激活血液中成熟中性粒细胞的功能，目前临床主要应用于抗肿瘤的放疗和化疗期间出现的不良反应，以及先天、后天中性粒细胞减少症。本文对重组人粒细胞刺激因子原液的生产工艺流程和内容进行研究，选取合适的生产工艺，根据生产要求确定与其相适应的设备，最终根据物料衡算确定设备参数进行设备选型，并结合 GMP 与制药行业标准对车间进行设计，绘制车间平面布置图。关键词：重组人粒细胞刺激因子；物料衡算；设备选型；车间设计北京理工大学珠海学院 2016 届本科生毕业设计Workshop design of recombinant human granulocyte stimulating factor stock solutionAbstractRecombinant human granulocyte stimulating factor has the function of stimulating the proliferation, differentiation and maturation of neutrophils and activating the mature neutrophils in blood. At present, it is mainly used in anti-tumor radiotherapy and chemotherapy, as well as congenital and acquired neutropenia. In this paper, the production process and content of recombinant human granulocyte stimulating factor stock solution were studied, the appropriate production process was selected, the corresponding equipment was determined according to the production requirements, and finally the equipment parameters were determined according to the material balance for equipment selection, and the production workshop was designed in combination with GMP and pharmaceutical industry standards, and the workshop layout was drawn.Keywords：recombinant human granulocyte stimulating factor; material balance calculation; equipment Selection; workshop design北京理工大学珠海学院 2016 届本科生毕业设计目录1 前言............................................................................................................................11.1...