质量源于设计与高端制剂的开发和质量控制  

Development and Quality Control of High-End Pharmaceutical Preparations through Quality by Design

作　　者：胡雪丹 李菁[1] 孙敏捷[1] HU Xuedan;LI Jing;SUN Minjie(Department of Pharmaceutics,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国药科大学药剂学教研室,江苏南京210009

出　　处：《药学进展》2024年第2期134-142,共9页Progress in Pharmaceutical Sciences

摘　　要：质量源于设计(QbD)是基于科学和质量风险管理原则的方法,在药物设计和制造中发挥重要作用。随着制剂技术的革新,药物制剂向复杂、高效、个性化的方向发展。在高端制剂/药物递送系统的开发中,由于制剂复杂多变、研究人员经验有限,QbD的实施仍会遇到许多挑战。结合案例重点介绍了Qb D的主要元素、实施步骤及辅助工具,旨在强化对Qb D流程和工具的理解;举例介绍了Qb D在缓控释制剂、纳米制剂和生物技术产品开发及分析方法开发中的应用和优势。QbD方法同样有助于高端制剂的开发,并最终给制造商、监管机构和患者带来更大的利益。Quality by design(QbD)is a method based on principles of science and quality risk management,which plays an important role in drug design and manufacturing.With the innovation of preparation technology,pharmaceutical preparations are developing in the direction of complexity,efficiency and individuality.In the development of high-end pharmaceutical preparations/drug delivery systems,the implementation of QbD still encounters many challenges due to the complexity and variability of formulations and the researchers’lack of experience.Combined with the cases,the main elements,implementation steps and auxiliary tools of QbD are introduced,aiming to strengthen the understanding of QbD process and tools.In addition,the application and advantages of QbD in the development of sustained and controlled release preparations,nanomedicine and biotech products,as well as the development of analytical methods,are introduced.Foreseeably,QbD will also play an important role in the development of high-end pharmaceutical preparations,and will ultimately bring greater benefits to manufacturers,regulatory agencies and patients.

关 键 词：质量源于设计 风险评估 设计空间 缓控释制剂 纳米制剂 生物技术产品 

分 类 号：R943[医药卫生—药剂学]