Del Piano M, Morelli L, Strozzi G P, Allesina S, Barba M, Deidda F, Lorenzini P, Ballaré M, Montino F, Orsello M, Sartori M, Garello E, Carmagnola S, Pagliarulo M, Capurso L
Gastroenterology Unit, Maggiore della Carità Hospital, Novara, Italy.
Dig Liver Dis. 2006 Dec;38 Suppl 2:S248-55. doi: 10.1016/S1590-8658(07)60004-8.
Intestinal microflora has metabolic, trophic and protective functions, and can be modified in pathological conditions and by the exogenous administration of probiotics. Probiotics are defined as living microorganisms which resist gastric, bile, and pancreatic secretions, attach to epithelial cells and colonize the human intestine. In the last twenty years research has been focused on the identification of the role of planktonic flora and adhesive bacteria in health and disease, and on the requisite of bacterial strains to become probiotic product which can be marketed. Probiotics can be commercialized either as nutritional supplements, pharmaceuticals or foods, but the marketing as a pharmaceutical product requires significant time, complex and costly research, and the demonstration of a well-defined therapeutic target. This review examines the sequential steps of research which, from the identification of a possible probiotic strain, lead to its production and marketing, summarizing the whole process existing behind its development, through its growth in laboratory, the studies performed to test its resistance to human secretions and stability, microencapsulation technologies, and safety tests.
肠道微生物群具有代谢、营养和保护功能,在病理状态下以及通过外源性给予益生菌时可发生改变。益生菌被定义为能够抵抗胃、胆汁和胰腺分泌物,附着于上皮细胞并在人体肠道定殖的活微生物。在过去二十年中,研究集中于确定浮游菌群和黏附细菌在健康与疾病中的作用,以及成为可上市益生菌产品所需的细菌菌株条件。益生菌可作为营养补充剂、药品或食品进行商业化,但作为药品进行销售需要大量时间、复杂且成本高昂的研究,以及明确治疗靶点的证明。本综述考察了从鉴定可能的益生菌菌株到其生产和销售的研究步骤顺序,总结了其开发背后的整个过程,包括在实验室中的生长、测试其对人体分泌物的抗性和稳定性的研究、微囊化技术以及安全性测试。