年产300吨头孢拉定原料药车间的工艺设计.doc

PAGE VI PAGE V 300T/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Ⅵ、头孢菌素Ⅵ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 Preliminary Design of Production Plant Process of 300 Tons of Cefradine ABSTRACT Cephradine?which?has?alias?such?as?Vanguard?ADM?VI,?cephalosporins?Ⅵ,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?of?Squibb?locates?in?US?which?produced?the?cephalosporins?that?can?not?only?be?taken?orally?but?also?be?injected.Since?it?was?developed,?this?product?is?widely?used?in?human?medicine?clinical?because?of?their?excellent?antibacterial?activity?and?pharmacokinetic?characteristics?which?applicable?to?goods?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?value?display?in?the?animal?due?to?the?clinical?application?is?very?large. This design is a detailed study based 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 plans 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 si