年产5800万片地红霉素肠溶片的生产工艺设计.doc

年产5800万片地红霉素肠溶片的生产工艺设计 摘 要：本设计是年产5800万片的地红霉素肠溶片的生产工艺。文中对新一代大环内酯类抗生素—地红霉素的体内外抗菌作用、药代动力学特性、临床应用、肠溶剂等进行了介绍,对地红霉素肠溶片的生产工艺设计及所用的设备选型进行重点阐述。在工艺设计方面严格按照实际的工业生产需要和GMP规范的设计要求。在设备选型上根据物料衡算结果依次介绍并选用了合适的粉碎设备、筛分设备、制粒设备、干燥设备、压片机、包装机等。在车间布置以及空调方面严格贯彻规定，符合药厂规范。 关键词：地红霉素； 肠溶片； 工艺；设计 The production process design of annual production capacity of 58 million dirithromycin enteric-coated tablets ABSTRACT：The design is the production process of the annual output of 58 million dirithromycin enteric-coated tablets. The text is about a new generation of macrolide antibiotics – dirithromycin， in vitro and in vivo antibacterial effect, pharmacokinetic properties, clinical applications,enteric agents ,and focuses on the production process design and equipment selection of dirithromycin enteric-coated tablets. The process design is in strict accordance with the needs of industrial production and GMP design requirements.The quipment selection on the basis of the material balance results introduced in turn and select the appropriate grinding equipment, screening equipment, granulating equipment, drying equipment, tablet presses, packaging machines.The plant layout and the air conditioning implement the provisions strictly,comply with pharmaceutical standards. KEY WORDS：Dirithromycin；Enteric-coated tablets；Process；Design 目 录 引言---------------------------------------------------------------------------1 1.地红霉素----------------------------------------------------------------------------------------1 1.1地红霉素简介--------------------------------------------------------------------------1 1.2地红霉素的抗菌机制及临床应用--------------------------------------------------2 1.3地红霉素剂量及给药途径-----------------------------------------------------------3 1.4地红霉素的不良反应-----------------------------------------------------------------3 1.5地红霉素的优势-----------------------------------------------------------------------3 2.地红霉素的合成-------------------------------------------------------------------------------3 2.1红霉