药用植物基因编辑种质创新应用与制度监管

药用植物资源是我国传统中医药学的重要组成部分，基因编辑技术能够在不引入外源基因的情况下进行基因组定点靶向突变，实现药用植物资源种质创新。CRISPR基因编辑技术是近年广泛应用的基因编辑技术，已在甜橙、铁皮石斛、罂粟、丹参、地黄、人参、灵芝、金针菇、竹黄、蛹虫草、茯苓等药用植物中研究和应用，构建了基因编辑体系，开展了活性成分关键基因与含量调控研究、表型性状关键基因与品质改良研究。中国、美国、日本、巴西、澳大利亚等国家陆续出台基因编辑种质创新相应的监管政策，促进了其产业化发展。建议进一步推进药用植物资源基因编辑种质创新基础研究、加强药用植物基因编辑后药物等效性评价、开展科普宣传和建立科学监管体系。

Application and Institutional Supervision of Gene Editing for Germplasm Innovation of Medicinal Plant Resources

Medicinal plant resources are an important part of Traditional Chinese Medicine, gene editing technology can realize site-specific targeted mutation of genome and innovation of medicinal plants germplasm without introducing other genes. CRISPR gene editing technology, the widely used gene editing technology in recent years, has been investigated and applied in medicinal plants resources, and a corresponding gene editing system has been constructed in Citrus sinensis, Dendrobium officinale, Opium poppy, Salvia miltiorrhiza, Rehmannia glutinosa, Panax ginseng, Ganoderma lucidum, Flammulina filiformis, Shiraia bambusicola, Cordyceps militaris, etc. Research on active components and content regulation of key genes, phenotypic traits, and quality improvement research of key genes, has been carried out in medicinal plants resources. China, the United States, Japan, Brazil, Australia, and other countries have successively issued corresponding regulatory policies for gene editing germplasm innovation, which promotes its industrialization. This paper proposes to further advance the basic research of gene editing germplasm innovation of medicinal plants resources, strengthen the research on drug equivalence after gene editing of germplasm, launch popular science publicity and establish a scientific supervision system.