口服固体制剂连续制造的研究进展  

Research Progress in Continuous Manufacturing of Oral Solid Dosage Forms

作　　者：袁春平[1,2] 时晔[1] 王健[1] 侯惠民[1] 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203 [2]国药集团广东环球制药有限公司,广东佛山528305

出　　处：《中国医药工业杂志》2016年第11期1457-1463,共7页Chinese Journal of Pharmaceuticals

摘　　要：连续制造作为先进生产模式应用于其他行业多年,能提高生产效率,降低生产成本,提高企业竞争力。现代制药产业也面临从传统的批式生产向连续制造模式转型的机遇与挑战。连续制药是通过计算机控制系统将各个单元操作过程进行高集成度的整合,增加物料在生产过程中的连续流动,原辅料和成品以同样速率输入和输出,实施过程分析技术(PAT)来保证最终产品质量。本文简述了口服固体制剂连续制造的概念与特点,综述了目前连续制药在国外的研究与发展状况,以及我国发展连续制药面临的挑战和机遇。As a well known innovative production concept, continuous manufacturing has been successfully used in industries for many years, which can increase productivity, reduce costs and improve company competitiveness. The modem pharmaceutical industry is facing the challenges and opportunities of transition from a traditional manufacturing approach based on batch-wise production to a continuous manufacturing model. Continuous pharmaceutical manufacturing consists of single unit process chains that are integrated by means of a computerized control system. This high degree of integration enables continuous flow of materials in process. Raw materials and products are at the same rate of input and output, and the implementation of process analysis technique （PAT） ensures the quality of the final product. The aim of this article is to review the concept and characteristics of continuous manufacturing of oral solid dosage forms and summarize the abroad research progresses, as well as the challenges and opportunities of continuous pharmaceutical manufacturing in China.

关 键 词：口服固体制剂 连续制造 连续制药 过程分析技术 综述 

分 类 号：R944.9[医药卫生—药剂学]