中药质量控制模式的现状分析与思考

Present Situation Analysis and Thinking on Quality Control Mode of Chinese Materia Medica

中药质量是保证中药临床应用安全有效的前提,中药质量标准化研究更是近年来实现中医药事业可持续发展的重中之重。目前,中药质量控制体系已经从单一化学评价向以临床疗效为导向的中药整体质量控制转变,但处方中药品标准仍存一定数量的中药饮片质量控制项缺乏或不完善等情况,使其在临床应用中的有效性与安全性难以保障。基于此,笔者从化学分析、生物评价及临床应用等角度对近年来中药质量控制模式及其创新理念进行分析和探讨,针对目前中药复杂体系整体质量控制中存在的问题,提出符合中医药特色的中药质量控制体系完善策略,以期为中药质量控制相关研究提供理论依据。

The quality of Chinese materia medica is the premise to ensure its safety and effectiveness in clinical application,and the standardization of Chinese materia medica quality is the most important to realize the sustainable development of traditional Chinese medicine(TCM).At present,the quality control system of Chinese materia medica has been transformed from a single chemical evaluation to the overall quality control guided by clinical efficacy.However,some quality control items of decoction pieces are still lacking or imperfect in the drug standard of prescription,which makes it difficult to guarantee the effectiveness and safety of Chinese materia medica in clinical application.Based on this,the quality control models and innovative ideas of Chinese materia medica were analyzed and discussed from the perspectives of chemical analysis,biological evaluation and clinical application in this paper.Aiming at the existing problems and actual needs in the control system of Chinese materia medica,this paper proposed the improvement strategies in accordance with the characteristics of TCM,in order to provide theoretical basis for the related research on quality control of Chinese materia medica.