质量源于设计在药物制剂设计中的应用  

Application of quality by design(QbD)in design of drug preparation

作　　者：丁水涵 王东凯[1] DING Shuihan;WANG Dongkai(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志（网络版）》2024年第3期83-89,共7页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：质量源于设计(Quality by Design, QbD)是指在可靠的科学和质量风险管理基础之上,预先定义好目标并强调对产品与工艺的理解及工艺控制的一个系统的研发方法。QbD理念强调产品的质量无法通过检验赋予,而应该通过设计赋予。在该理念指导下,制药工业应该将质量风险管理与产品和生产工艺深度结合,运用过程分析技术,建立适当的控制策略,促进产品在整个生命周期内持续改进和创新。The concept of QbD refers to a systematic research and development method based on reliable science and quality risk management,which defines the objectives in advance and emphasizes the understanding of products,processes and process control.The concept of QbD emphasizes that the quality of products should not be conferred by inspection,but should be conferred by design.Under the guidance of this concept,the pharmaceutical industry should deeply integrate quality risk management with products and manufacturing processes,apply process analysis techniques,establish appropriate control strategies,and promote continuous improvement and innovation throughout the products’whole life cycle.

关 键 词：质量源于设计 药物制剂设计 质量控制 

分 类 号：R94[医药卫生—药剂学]