[关键词]
[摘要]
中药质量均一、稳定是确保临床用药安全有效的核心要素,受中药材原料质量、生产设备与工艺稳定性和质量标准控制体系等因素影响。中药材及饮片作为中药制剂生产的起始原料,处于产业链前端,其质量评价与控制对中药质量提升具有引领作用。通过总结中药材及饮片质量波动的评价控制方法和遗传成因,探讨基于药用植物分子遗传学和本草基因组学的DNA条形码内变异等遗传多态性方法以评价和控制中药材及饮片质量均一性的可行性,包括增强基原品种鉴定的正确性及控制批内/批间化学质量波动等策略,从品种选育、栽培、加工、投料等前期环节进行质量均一性控制,参与保障中药材及饮片质量稳定,促进中药质量均一、稳定,推动中医药大健康产业可持续发展。
[Key word]
[Abstract]
The quality uniformity and stability of traditional Chinese medicine (TCM), which affected by numerous factors including the diverse sources of Chinese medicinal materials (CMMs), stability in pharmaceutical equipment and processes, and the imperfections of quality standards, are the foundation to ensure the safety and efficacy of their clinical applications. As the starting raw materials, CMMs are the forefront of production chain, its quality evaluation and control play a key role in improving the quality of TCM. By summarizing the evaluation and control methods and genetic causes of quality fluctuations of CMMs and decoction pieces, the feasibility of genetic polymorphism methods such as DNA barcode inner-variants based on medicinal plant molecular genetics and herbgenomics to evaluate and control the quality uniformity of CMMs and decoction pieces. The strategies are proposed to enhance the accuracy of germplasm origin identification and control the chemical quality fluctuations within and between batches, focusing on quality uniformity control on TCM germplasm, cultivation, processing, material input, and production inspection, with view to promoting the uniformity and stability of CMMs and decoction pieces and driving the sustainable development of TCM health industry.
[中图分类号]
R282
[基金项目]
国家重点研发计划(2023YFC3504000);山西省科技创新人才团队专项资助项目(202204051001030)