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1、I300T/年头孢拉定原料药生产车间的工艺设计摘 要头孢拉定 (Cephradine, Velosef) 别名：先锋霉素 、头孢菌素 等。本品为第一代半合成头孢菌素，抗菌作用与头孢氨苄相似。头孢拉定是第一代头孢菌素类抗生素，该药是美国 squibb公司首先研制成功并生产的一个即可口服又可注射的头孢菌素。本品自问世以来，由于其优良的抗菌活性和药动学特点而被广泛应用于人医临床，适用于敏感菌引起的感染及预防多种术后感染。2002年农业部批准将头孢拉定用于兽医临床，初步显示其在兽因临床上应用价值非常大。本设计基于原料药车间的设计对头孢拉定生产做了个详细的研究，并对头孢拉定原料药车间做了初步的设计。本设
2、计以西宁市为厂址，根据实地情况和自然因素，经济因素规划了药厂的布局与面积。使得药厂具有自然、交通、人为的便利。根据西宁市的自然状况对药厂内部布局 做了规划，整个药厂具有生活区，生产区，行政区，配套设施区。车间的布局符合生产最优化的原则，并严格按照CMP 的要求进行设计，使得其能顺利进行头孢拉定原料药的生产。关键词：头孢拉定，初步工艺设计 ，原料药 IIPreliminary Design of Production Plant Process of 300 Tons of CefradineABSTRACTCephradine which has alias such as Vanguard
3、ADM VI, cephalosporins ,and so on. This product is the first generation of semi-synthetic cephalosporin. The result shows that the effect of antibacterial is similar with cephalexins. Cephradine is the first generation cephalosporin antibiotic, the drug is successfully developed first by the company
4、 of Squibb locates in US which produced the cephalosporins that can not only be taken orally but also be injected.Sinceit was developed, this product is widely used in human medicine clinical because of their excellent antibacterial activity and pharmacokinetic characteristics which applicable to go
5、ods caused by infection and prevention of a variety of postoperative infection. In 2002, Cephradine was approved to be used in the veterinary clinic by Ministry of Agriculture, and the initial valuedisplay in the animal due to the clinical application is very large. This design is a detailed study b
6、ased on the bulk drugs workshop designed to cephalosporins that pull scheduled production,and it is also a preliminary design about cephalosporin Rivet bulk drugs workshop.According to the situation on the ground and natural factors, economic factors, this design makes Xining City for the site and p
7、lans the layout and size of the pharmaceutical companies so that it will equipped with the pharmaceutical nature, transportation and human convenience. According to the natural situation in Xining City, the pharmaceutical internal layout plan that it should have entire pharmaceutical living area, pr
8、oduction area, administrative and ancillary facilities area. The layout of the workshop is in line with the principle of production optimization, and in strict accordance with the requirements of the CMP design. Smooth Cephradine production of bulk drugs.KEY WORDS: Cefradine，the preliminary process
9、design，bulk drugsIII目 录摘 要 .IABSTRACT .II1 简介 .11.1头孢拉定简介 .11.2头孢拉定市场分析 .11.3头孢拉定的发展前景 .21.4原料药的简述 .31.5 头孢拉定原料药车间初步设计.41.5.1 设计的指导思想 .41.5.2 设计依据 .41.5.3 设计内容和重点 .41.5.4 设计规模 .51.5.5 设计的目的和意义.52 生产工艺设计 .62.1 生产安排 .62.2 生产工艺流程 .62.3 生产工艺流程图 .72.4 物料衡算 .72.4.1 物料衡算依据 .72.4.2 总的物料衡算 .82.4.3 7ADCA 硅脂化的
10、物料衡算 .82.4.4 混合酸酐制备的物料衡算.82.4.5 缩合反应的物料衡算.82.4.6 水解反应的物料衡算.92.4.7 萃取的物料衡算 .102.4.8 过滤脱色的物料衡算.112.4.9 结晶反应的物料衡算.122.5 能量衡算 .122.5.1 能量衡算的目的 .132.5.2 热量平衡方程式 .132.5.3 缩合产物的能量衡算 .132.5.4 头孢拉定的能量衡算 .143 设备选型 .15IV3.1 设备选型步骤与原则 .153.2 选择设备 .163.3 设备型号 .163.3.1 蒸汽加热不锈钢反应釜.163.3.2 不锈钢缩合釜 .173.3.3 不锈钢水解釜 .173.3.4 不锈钢结晶罐 .173.3.5 列管式冷凝器 .183.3.6 泵 .
