从风险角度浅析口服固体制剂生产工艺控制  

Risk Analysis of Production Process Control for Oral Solid Dosage Forms

作　　者：顾丽丽 GU Lili(Jiangsu Chia Tai Fenghai Pharmaceutical Co.,Ltd.,Yancheng 224100,China)

机构地区：[1]江苏正大丰海制药有限公司,江苏盐城224100

出　　处：《化工管理》2025年第4期154-158,共5页Chemical Management

摘　　要：口服固体制剂是制药工业中最常见的剂型之一,且口服固体制剂的应用依然在持续增长中。目前,常规口服固体制剂的生产工艺包括了粉碎、过筛、制粒、压片、包衣、分装等多个关键生产工序。如何保证所生产的产品质量始终能够稳定可靠,最大程度保证患者的用药安全。文章结合风险管理的思维和理念开展好药品生产生命周期中各阶段的工作,以实现不断提升生产管理水平,稳定产品质量的目的。Oral solid preparations are one of the most common dosage form in the pharmaceutical industry,the application of oral solid dosage forms continues to grow.At present,the production process of conventional oral solid preparations includes multiple key production processes such as crushing,screening,granulation,tablet pressing,coating,and packaging,how to ensure that the quality of the products produced can always be stable and reliable,ensure maximum medication safety for patients.This paper combines risk management thinking and concepts to carry out the work of each stage in the drug production lifecycle,to achieve continuous improvement of production management level,the purpose of stabilizing product quality.

关 键 词：口服固体制剂 生产工艺 风险控制 

分 类 号：R944.2[医药卫生—药剂学]