周小梅, 管咏梅, 刘丽丽, 臧振中, 朱卫丰, 张锐, 陈振华. 质量源于设计理念在脂质立方液晶开发中的应用J. 药学学报, 2026, 61(2): 441-452. DOI: 10.16438/j.0513-4870.2025-0072
引用本文: 周小梅, 管咏梅, 刘丽丽, 臧振中, 朱卫丰, 张锐, 陈振华. 质量源于设计理念在脂质立方液晶开发中的应用J. 药学学报, 2026, 61(2): 441-452. DOI: 10.16438/j.0513-4870.2025-0072
ZHOU Xiao-mei, GUAN Yong-mei, LIU Li-li, ZANG Zhen-zhong, ZHU Wei-feng, ZHANG Rui, CHEN Zhen-hua. Application of the quality by design concept in the development of lipid-based cubic liquid crystallineJ. Acta Pharmaceutica Sinica, 2026, 61(2): 441-452. DOI: 10.16438/j.0513-4870.2025-0072
Citation: ZHOU Xiao-mei, GUAN Yong-mei, LIU Li-li, ZANG Zhen-zhong, ZHU Wei-feng, ZHANG Rui, CHEN Zhen-hua. Application of the quality by design concept in the development of lipid-based cubic liquid crystallineJ. Acta Pharmaceutica Sinica, 2026, 61(2): 441-452. DOI: 10.16438/j.0513-4870.2025-0072

质量源于设计理念在脂质立方液晶开发中的应用

Application of the quality by design concept in the development of lipid-based cubic liquid crystalline

  • 摘要: 以质量源于设计(quality by design, QbD) 理念作为药物研发设计基本原则已成为行业共识。本文在回顾制药QbD设计步骤的基础上, 深入探讨QbD在脂质立方液晶开发中的应用, 详细分析了脂质立方液晶设计中目标产品质量概况、关键质量属性、关键物料属性、关键工艺参数、风险评估及因素筛选、实验设计、设计空间及控制策略等QbD要素, 旨在深入挖掘QbD理念融合运用, 为脂质立方液晶制剂的开发提供参考。

     

    Abstract: It has become an industry consensus to take the concept of quality by design (QbD) as the basic principle of drug development design. On the basis of reviewing the design steps of pharmaceutical QbD, this paper deeply discusses the application of QbD in the development of lipid-based cubic liquid crystalline, and analyzes in detail the QbD elements in the design of lipid-based cubic liquid crystalline, such as quality target product profile, critical material attributes, risk assessment and factor screening, critical material attributes, critical process parameters, experimental design, design space and control strategy, etc. The purpose of this study is to deeply explore the integration and application of QbD concepts and provides a reference for the development of lipid-based cubic liquid crystalline preparations.

     

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