益生菌安全性和有效性评价方法的研究进展

益生菌是指一类活的、摄入足够量就能够对人体产生有益作用的微生物，目前广泛应用于食品和饲料工业领域。随着市场上商品化益生菌的不断出现，如何评价一个菌株的安全性及有效性成为人们关注的问题。目前，益生菌的评价主要从安全性和有效性入手，安全性和有效性评价又包括体内和体外的评价。很多企业在开发益生菌产品时很少对菌株做出全面的安全性评价，而且各国研究者采用的评价指标和评价方法也不尽相同。对于有效性评价，同样也没有统一的评价标准。针对目前益生菌评价存在的问题，亟需建立一套完善的评价方法，对益生菌的安全性和有效性进行系统、科学地评价。作者从益生菌可能产生的潜在危害及功效方面出发，着重论述了益生菌的溶血性、毒力因子、抗生素抗性和产有毒代谢产物的体外安全性评价方法，耐酸、耐胆盐、耐人工胃肠液、胃肠黏膜黏附性和抑菌活性的体外有效性评价方法，及体内的安全性和有效性评价方法的研究进展，期望为建立完善的益生菌评价技术体系和标准提供参考。

Research Progress on the Evaluation Methods of Safety and Efficacy of Probiotics

Probiotics are live microorganisms. When they are administrated in adequate amounts, they can have beneficial effects on the host. They are widely applied in food fermentation and feed industry. With the appearance of commercial probiotics, more concerns are raised on the safety and efficacy evaluation of probiotics. At present, the evaluation of probiotics are mainly about the safety and efficacy, and both of them can be done in vivo and in vitro. When developing probiotic products, many companies rarely make a comprehensive safety evaluation of strains, and the evaluation index and methods used by various researchers from different countries are different. Besides, standards in efficacy evaluation of probiotics are not uniform either. In order to solve the problems of probiotics evaluation, it is necessary for evaluating the safety and effectiveness of the probiotics systematically and scientifically to establish a comprehensive evaluation method. From the aspects of potential harm and efficacy of probiotics, the authors summarizes recent developments in some aspects of safety evaluation in vitro including hemolytic, evaluation of virulence factors, antibiotic resistance and toxic metabolites-producing ability, in functional characteristics evaluation including resistance to acid and bile, tolerance to simulated gastrointestinal tract, adhesion capacity to gastrointestinal mucosa and epithelial cells, antimicrobial activity, and in safety and functional characteristics in vivo. The aim of this paper is to provide references to build a comprehensive technical system and standard of evaluation of probiotics.