摘要
Abstract
This article provides an in-depth analysis of the provisions related to quality uniformization treatment in traditional Chinese medicine(TCM)manufacturing,as outlined in the Special Provisions on the Supervision and Administration of TCM Manufacturing(Draft for Public Comment)issued by the National Medical Products Administration.The regulation permits quality uniformization of raw materials and intermediates,aiming to address inter-batch variability,enhance product quality consistency,and ensure clinical safety and efficacy.The article systematically evaluates the scientific rationale,operational feasibility,and potential risks of quality uniformization in TCM from three key perspectives.The findings indicate that,considering the complex composition of TCM products,quality uniformization is underpinned by robust theoretical foundations and practical precedent,offering effective stabilization of pharmacologically active substances.Technically,advances in analytical characterization and engineering implementation make such processes increasingly viable.Despite potential risks-including challenges in quality traceability and the possibility of non-compliant practices-these can be effectively managed through rigorous quality management systems,robust digital traceability mechanisms,and strengthened regulatory oversight.When implemented scientifically and regulated prudently,quality uniformization offers strong support for the high-quality development of the TCM industry and can accelerate its modernization and global integration.关键词
中药生产/质量均一化/复杂成分/药效物质基础/科学支持/数学建模/工程实施/监管风险Key words
traditional Chinese medicine manufacturing/quality uniformization/complex constituents/active substances/scientific support/mathematical modeling/engineering implementation/regulatory risks分类
医药卫生
