益生菌来自健康声明的挑战
本文介绍了全世界不同国家和地区关于健康声明应用的法律规范。健康声明必须依据科学的证据, 提供这些证据需要一个漫长而昂贵的过程, 而且必须解决一系列的挑战。应用体内、体外不同的方法, 筛选和鉴定益生菌。体外研究一般用于筛选目的, 获得被测菌株特异性功能等信息, 以及评估它们的安全性。差强人意的前期筛选、有限的体外实验及不合适的动物模型经常导致体外结果和体内可行性之间相互矛盾。益生菌最终必须通过适当设计的人体临床研究得到验证。通过实验证据来鉴定益生菌和证实它们在临床试验中的效果, 比其他的功能性食品更具挑战, 因为这些效果是由活的微生物所介导的, 并且微生物本身的状态也会影响这些效果。本文逐一回顾了益生菌健康声明的具体步骤。
This paper reviewed the laws and regulations of health claims applications by worldwide. A common element of those is that substantiation of claims should be based on scientific evidences. Providing such evidences requires a long and expensive procedure, while a number of challenges have to be addressed. Different in vitro and in vivo methods are applied for screening and characterizing the putative probiotic strains. In vitro studies are generally useful for screening purpose and for gaining information on specific functional properties of the tested strains, as well as for assessing their safety. Poor prior selection, limited capacity of in vitro tests, and unsuitable animal models often contribute to contradictions between in vitro findings and in vivo feasibility. Although these tests may be useful as assessment tools, probiotics must be validated by properly designed human clinical studies. The experimental evidence to identify probiotic microorganisms and to demonstrate their efficacy in clinical trials is more challenging than for other potential functional foods, because effects are mediated by living microorganisms and may therefore be influenced by the status of these microorganisms. This paper reviewed the crucial steps of substantiation of health claims associated with probiotics with special emphasis on the related challenges.
标题：益生菌来自健康声明的挑战
英文标题：Challenges of probiotic from the health claims
作者：
余萍 汉臣氏(沈阳)儿童制品有限公司
李雪龙 沈阳斯佳生物制药有限公司
中文关键词:益生菌,健康声明,挑战,
英文关键词:probiotic,health claims,challenges,
发表日期：2016-07-05
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