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2 Drug Registration Department, National Medical Products Administration, Beijing 100037, China, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322631201945400130, articleId=1322631200745829184, tenantId=1146029695717560320, journalId=1302319053441957962, language=CN, title=质量属性导向的中药质量控制范式变革, columnId=1304140187961946198, journalTitle=中草药, columnName=专论, runingTitle=null, highlight=null, articleAbstract=中药质量控制经历了由经验鉴别、成分检测向多成分及整体控制不断深化的过程。随着现代药品质量科学、分析技术、生产方式和数据环境发展，质量研究面临的核心问题正在由“能够检测什么”进一步转向“什么真正关系产品质量并需要得到保证”。以关键质量属性（critical quality attributes，CQA）为核心，从临床定位和产品理解出发，提出“药品质量概貌-候选质量属性-CQA辨识-物料、过程及中间物料研究-关键物料属性（critical material attributes，CMA）/关键过程参数（critical process parameters，CPP）辨识-质量形成规律-质量状态评价-生命周期持续确认”的方法学框架；强调CQA关键性应由具体产品质量风险和相应证据支持，CMA和CPP应基于CQA牵引的全过程研究辨识，全过程研究应服务于关键控制而非项目叠加；进一步讨论整体评价的非补偿性边界、可靠测量、回顾性与前瞻性研究及真实生产数据在持续确认中的作用。认为中药质量控制由成分导向转向质量属性导向，并非否定既有分析技术和质量标准体系，而是将研究起点由“发现什么、能够测什么”进一步转向“什么真正重要、为什么重要、如何形成及如何持续保证”。这一范式变革仍需通过不同类型中药产品和真实商业化生产数据持续验证和完善。, authors=钱忠直¹, 于江泳², authorsList=钱忠直, 于江泳, authorCompany=1 国家药典委员会, 北京 100061;
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