中药分类通常是以药材自然属性作为依据,如分为植物药、动物药、矿物药等."真菌类中药"包括以子实体、菌核等入药的"药用真菌"和真菌的固体发酵产品--从古代的曲、酱、酒等至现代的"菌质"均属"真菌药物",已有千年以上药用史.但因生物分类学长期来误将真菌视为低等植物,故使"真菌类中药"也随着属于植物药,就既缺乏科学的归属更难以解释"真菌药物"的性质,从而将影响它产品的定位,脱离中药范畴,与那些在理念、工艺、应用上都有显著差异的现代其他各类生物制品统一定位.固体发酵是中药传统范畴内仅有的一项生物技术,它的发展受益于中医药理念、经验的指导,工艺与应用也具有中药特色,近期又接受应用现代中药的研发内容要求与实验方法,其下游工程也和现代中药提取、纯化技术一致,产品有合格质量标准,并按相关规定进行各期临床试验,因此它既有中药历史传统又符合现代中药的要求.虽然"真菌类中药"拥有研发潜力巨大、生产工艺多种、临床涉用面广等优势,且现代中药生物技术--固体发酵工程更已有显著的重要进展,但至今仍因缺乏科学归属与合理定位,而影响它的发展.现代生命科学已确认真菌并非植物,早已成立了真菌界Fungi,又与一些貌似真菌的真核生物如卵菌Oomyces、粘菌Slimemoulds等被统称为菌物Fungi,因此建议在中药范畴内正式冠名一类真菌为主的菌物药,以药用真菌和真菌药物即真菌的"固体发酵系列工程"所产各类菌质将成为重要支柱.本文同时介绍了菌质的历史、理念、工艺、应用等情况和已研发的三种代表性菌质的基本情况与方法.

Traditional Chinese medicine (TCM) is usually classified by the natural quality of medicinal materials, such as botanical medicine, animal medicine and mineral medicine. The fungal group of the TCM includes the medicinal fungi made of the fruit body and sclerotium, and the fungal medicine such as koji, sauce and liquor, which are solid fermentative products. Solid fermentative technique, with a long history of more than one thousand years, is the only biotechnique in the TCM industry. As the development of this technique has been guided by the TCM concepts and experience, while following the empirical approach of drug development supervision, fungal substrates not only reserve the special features of the TCM, but also meet the quality requirements. However, owing to the long-termwrong classification as a lower plant in taxonomy of biology, the fungal group of the TCM has been categorized into the plant medicine, which makes it separate from the TCM category and grouped into other biological products with different concepts, techniques and applications. Consequently, it is almost impossible to give an explanation to its characteristic. Although the fungal group has huge potential in research and development, as well as in clinical application, and significant progress has been made in the biotechnology of modern Chinese medicine (solid fermentation technology), the lack of proper ascription and orientation blocks its further development. In modern life science, fungi are no longer considered plants, and the Fungi Kingdom has already been estalished, which also covers such eukaryotes as oomyces and slimemoulds, which look like fungi. Therefore we suggest to establish a TCM category called Fungal Medicine. This new category will include both the medicinal fungi and the fungal medicine, covering all kinds of fungal substrates produced by solid fermentation engineering as the main body. This paper introduces the concept, techniques and application of the solid fermentation engineering, and gives a general description of three representative fungal substrates.