重组人粒细胞刺激因子原液车间设计.docxVIP

PAGE 42 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 Workshop design of recombinant human granulocyte stimulating factor stock solution Abstract Recombinant 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 目录 TOC \o 1-3 \h \z \u 1前言 1 1.1粒细胞刺激因子作用机制 1 1.2重组人粒细胞刺激因子的应用 1 1.2.1肿瘤放化疗后的中性粒细胞减少 1 1.2.2动员外周造血干细胞 1 1.2.3辅助AIDS治疗 2 1.3国内外研究现状和发展趋势 2 1.4重组大肠杆菌高密度发酵 3 1.4.1培养基 3 1.4.2 pH值 3 1.4.3温度 4 1.4.4溶氧 4 1.4.5诱导方法 4 1.4.6补料方法 5 1.5层析技术 5 1.5.1离子交换层析 5 1.5.2疏水层析 5 1.5.3分子筛层析 5 1.6设计的目的和意义 6 2工艺路线 7 2.1重组人粒细胞刺激因子原液生产工艺 7 2.2重组人粒细胞刺激因子生产流程简述 7 2.2.1种子扩大培养及工程菌的发酵 7 2.2.2重组人粒细胞刺激因子原液提纯 8 2.2.3原液保存 9 2.3小结 10 3工艺计算 12 3.1基础数据 12 3.2生产过程中的物料衡算 12 3.2.1培养基物料衡算 12 3.2.2层析填料用量计算 14 3.2.3缓冲液物料衡算 15 3.3蒸汽用量 18 3.4生产用水量 20 3.4.1培养基及缓冲液配