高产磷酸西格列汀片车间工艺设计

Process Design of High-Yield Sitagliptin Phosphate Tablets Workshop

摘要: 糖尿病是一类很严重的慢性代谢类疾病，糖尿病已构成21世纪全球公共卫生的重大挑战，我国糖尿病形势尤为严峻。而糖尿病的II型发病率占90%，磷酸西格列汀可以降低血糖水平，是目前治疗糖尿病的II型应用较多的药品。本文依据《药品生产质量管理规范(2010版)》(GMP)和《医药工业洁净厂房设计规范》等标准进行年产2亿片磷酸西格列汀片车间工艺设计，设计流程是根据生产工艺流程逐步展开车间工艺设计的，包括原辅料的选购、生产制度、工艺路线的确定、物料衡算、设备的选型、厂址选择及车间布局等。本设计车间的设计理念是减少交叉污染、提高生产效率、降低用人成本，确定了缩短工序之间的物料运输路线、功能间与辅助间结合的模块化组合车间布局。

Abstract: Diabetes is a serious chronic metabolic disease. Diabetes has become a major challenge to global public health in the 21st century, especially in China. The incidence of type II diabetes accounted for 90%. Sitagliptin phosphate can reduce the blood glucose level, which is the drug widely used in the treatment of type II diabetes. In this paper, the workshop process design of sitagliptin phosphate tablets with an annual output of 200 million tablets is carried out according to the standards such as “GMP (2010 Edition)” and the “Design Specification for Clean Workshop of Pharmaceutical Industry”. The design process is gradually carried out according to the production process, including the purchase of raw and auxiliary materials, production system, determination of process route, material balance, equipment selection, site selection and workshop layout. The design concept of the workshop is to reduce cross-pollution, improve production efficiency and reduce labor costs. It determines the modular combination workshop layout that shortens the material transportation route between processes and combines function and auxiliary rooms.