PDF(Pubmed)
Abstract：
Diverse terms have been used in the literature to refer to the health benefits obtained from the administration of non-viable microorganisms or their cell fragments and metabolites. In an effort to provide continuity to this emerging field, the International Scientific Association of Probiotics and Prebiotics (ISAPP) convened a panel of experts to consider this category of substances and adopted the term postbiotic, which they defined as a \"preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.\" This definition does not stipulate any specific health benefit, finished product, target population or regulatory status. In this perspective article, we focused on postbiotics developed for pharmaceutical uses, including medicinal products and medical devices. We address how this field is regulated for products based on inanimate microorganisms, marketing considerations and existing examples of postbiotics products developed as cosmetics for the skin, for vaginal health, and as orally consumed products. We focus on the European Union for regulatory aspects, but also give examples from other geographical areas.
摘要：
文献中使用了不同的术语来指代从施用非活微生物或其细胞片段和代谢物获得的健康益处。为了给这个新兴领域提供连续性，国际益生菌和益生元科学协会（ISAPP）召集了一个专家小组来考虑这一类物质，并采用了“后生物”一词，他们将其定义为“无生命微生物和/或其成分的制剂，可赋予宿主健康益处。“这个定义没有规定任何具体的健康益处，成品,目标人群或监管状况。在这篇透视文章中，我们专注于为制药用途开发的postbiotics，包括医药产品和医疗器械。我们讨论了如何对基于无生命微生物的产品进行监管，营销考虑因素和作为皮肤化妆品开发的postbiotics产品的现有例子，为了阴道健康，作为口服产品。我们专注于欧盟的监管方面，但也给出了其他地理区域的例子。
