基于关键质量属性与质量源于设计的化学药物质量控制研究进展

Research progress on quality control based on critical quality attribute and quality by design

我国化学创新药物产业正蓬勃发展,药物创新体系不断完善,国产创新药及高端制剂处于快速发展阶段,将为我国新药研发格局带来深刻变革。化学药物质量控制是药物研发的重点,是药品安全有效的前提。围绕化学药物产业发展战略,攻坚关键核心技术,要重视科技创新。结合当前国内外前沿理念及技术,未来我国化药制造将持续发展。从化药制造关键质量属性辨识、化药生产质量源于设计和化药质量控制与剂型改良3个角度展开论述,以近10余年国内外相关研究为参考,围绕化药产业发展战略,紧扣关键质量属性与质量源于设计理念对化药质量控制相关内容进行归纳总结,以期为化药质量控制提供方向和参考。

The chemical innovative drug industry of China is booming,the drug innovation system is constantly improving,and domestic innovative drugs and high-end preparations are in the stage of rapid development,which will bring profound changes to new drug research and development pattern of China.The quality control of chemical drugs is the key point of drug research and development,and is the premise of drug safety and effectiveness.Centering on the development strategy of the chemical drug industry,we should focus on scientific and technological innovation by tackling key core technologies.Combined with the current domestic and foreign cutting-edge concepts and technologies,chemical medicine manufacturing of China will continue to develop in the future.This paper discusses the identification of critical quality attributes,quality by design of chemical pharmaceutical production,chemical pharmaceutical quality control and dosage form improvement from three perspectives.Based on the relevant literature at home and abroad in the past decade,the relevant content of chemical pharmaceutical quality control is summarized around the development strategy of chemical pharmaceutical industry and closely related to the critical quality attribute and quality by design concept.In this paper,the identification of critical quality attribute,the concept of quality by design and the improvement of dosage form were reviewed in order to provide reference for the quality control of chemical drugs.