基于监管科学的中药质量评价方法的整合研究思路和发展方向

Research approach and development trend of TCM quality evaluation method for multiple integration based on regulatory science

中药质量标志物(quality marker,Q-Marker)或生物标志物(quality biomarker,Bio-Marker)的确证需要整合多学科的技术方法,通过探索成分、活性与功效之间的多元整合模式,创新复杂体系质量属性的科学表达方式,建立能体现以中医理论为基础的中药质量属性的客观评价体系。聚焦中药临床价值,结合产品特色优势,揭示其科学内涵,强化其质量属性参数与科学监管的关联,通过“药材来源-制剂加工-药效评价-临床疗效”全过程的传递溯源可控性研究,构建中药复方整体质量一致性的监管体系,以期为中药质量控制方法的研发提供可借鉴的研究路径、科学依据和技术方法。此外融合大数据背景下的中药质量的信息技术与人工智能技术也是未来应该关注的发展方向,通过科学监管保障和提升中药品质,助力中药的高质量发展。

The identification of traditional Chinese medicine(TCM) quality markers or biomarker requires the integration of multidisciplinary techniques and methods. Through the innovation of the integrity expression of quality attributes of complex systems,the diversified integration mode of ingredients,activities and efficacy should be explored to embody the integrity of quality attributes based on TCM theory. In order to construct the overall quality evaluation system on the consistency for stabilizing and improving the product quality of TCM,the scientific issue and product advantages will be combined with the quality markers closely. Focusing on clinical value orientation,the correlation study between dose response and scientific supervision points for the quality attribute of TCM will be performed on the whole process of "resources-preparation-activity-efficacy". The benefits provide further insights on scientific basis and technical methods for the high-quality development of TCM quality control methods,and assist the innovation and cultivation of TCM products. Based on the regulatory science,the information technology and artificial intelligence technology integrating the quality of TCM under the big data may be a novel direction that should be paid attention to in the future.