质量源于设计在制剂设计中的应用研究进展  

Quality by Design in the application research progress of formulation design

作　　者：皮桐昊 代英辉[2] 王东凯[1] PI Tonghao;DAI Yinghui;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 [2]沈阳药科大学中药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志（网络版）》2022年第4期129-138,共10页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：质量源于设计在制剂的设计过程中发挥到关键性的作用,使得最终的制剂产品安全有效,质量可控。本文以国内28篇文献为依据,对质量源于设计在制剂设计中的应用进行了概述和总结,阐述了质量源于设计(quality by design,QbD)的概念并探讨了其在药物制剂设计过程中发挥的作用;对QbD的总体研究思路以及其在固体制剂、液体制剂设计中的应用进行了概述并阐述了QbD理念在中药缓控释制剂的研发思路;最后总结了QbD理念在制剂设计中的应用前景并进行了讨论。质量源于设计理念在制剂设计中的应用是一种科学有效的新方法,具有很高的研究价值,具有着极其重要的作用。Quality by design(QbD)plays a key role in the design process of formulations,making the final product safe,effective and quality controllable.Based on 27 domestic documents,this article summarizes the applications of QbD in formulation design,expounds the concept of QbD,and discusses its use in the process of drug production and development.The general research ideas of QbD and its application in the design of solid and liquid formulations are summarized,and the concept of QbD in the research and development of Chinese medicine sustained and controlled release formulations are explained.Finally,the application prospect of QbD concept in formulation design is summarized and discussed.The application of QbD in formulation design is a new scientific and effective method with high research value and very important role.

关 键 词：质量源于设计 固体制剂的设计 液体制剂的设计 中药缓控释制剂的设计 

分 类 号：R94[医药卫生—药剂学]