甾体类药物发酵菌渣的无害化与资源化研究进展

我国为甾体类原料药的生产大国,微生物转化法生产甾体药物的过程中产生的发酵菌渣是一种非常宝贵的资源,但发酵菌渣中仍存在少量有毒的甾体类残留物,在我国被列入《国家危险废物名录》。目前,甾体药物发酵菌渣的处理仍存在一定困难,严重制约着制药企业的健康发展,为此很多研究者针对药物发酵菌渣的无害化与资源化途径开展了广泛的研究。从甾体类药物发酵菌渣的来源、污染属性及国家相关管理要求等方面入手,分别综述了目前包括水热处理、碱热处理、微波处理等预处理技术,燃料化、肥料化、材料化等资源化利用技术,焚烧处置、安全填埋等处置技术在内的甾体药物发酵菌渣无害化与资源化方面的研究现状与最新进展,并对不同处理处置技术的可行性与可操作性进行了综合分析,最后对该领域未来的研究方向进行展望。

RESEARCH PROGRESS ON HARMLESS AND RESOURCE UTILIZATION OF FERMENTATION RESIDUE OF STEROIDAL DRUGS

China is a major producer of steroidal APIs. The fermentation residue produced during the production of steroidal drugs by microbial transformation is a very valuable resource. However, there are still a small amount of toxic steroid residues in the fermentation residue, which is listed as national hazardous waste by the Ministry of Environmental Protection in China. At present, there are still some difficulties in the treatment of steroid drug fermentation residue, which has severely restricted the healthy development of pharmaceutical enterprises. For this reason, many researchers have conducted extensive research on the harmlessness and resource utilization of the residue. This paper starts with the source, pollution property and management requirements of steroid drug fermentation residue, and reviews its current research status and latest progress in the harmless and resource utilization, including pretreatment technologies such as hydrothermal treatment, alkali heat treatment and microwave treatment, resource utilization technologies such as fuel, fertilization and materialization, incineration, etc. The feasibility and operability of different treatment and disposal technologies were comprehensively analyzed, and finally the future research directions in this field were prospected.