Szajewska Hanna, Fordymacka Anna, Bardowski Jacek, Górecki Roman K, Mrukowicz Jacek Z, Banaszkiewicz Aleksandra
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, 01-184 Warsaw, Poland.
Med Sci Monit. 2004 Sep;10(9):BR346-50. Epub 2004 Aug 20.
The purpose of our study was to investigate both qualitatively and quantitatively the microbial content of probiotic products licensed for medicinal purposes.
MATERIAL/METHODS: Microbiological analysis was performed on five different brands of probiotic products that claimed to contain lactobacilli and/or bifidobacteria. The species were determined based on phenotypic characters, using API 50CH, API 20A, and API rapid ID 32A kits. Bacterial strains belonging to the Bifidobacterium genus were further identified using genotypic methods (amplification of specific DNA fragments by PCR and analysis of their nucleotide sequences). The products were also analyzed for pathogenic bacteria. The number of microorganisms contained in four of the products was determined using the plate-count method and the most-probable-number method. The actual and claimed content of probiotic products was analyzed statistically.
Microbiological and genetic analysis showed that, in terms of quality, only three of the five products contained the bacterial strains claimed on the label. None of the tested products contained pathogens. Quantitative analysis demonstrated that 57 of 64 samples (89% [95% CI: 81-97]) contained bacterial counts at the cell densities (doses) claimed on the label.
Our study demonstrates unsatisfactory qualitative microbiological specification in the tested products. However, there was good quantitative agreement with the labeling. Our findings indicate that regulations governing the labeling of probiotic products are urgently required.
我们研究的目的是对已获药用许可的益生菌产品的微生物含量进行定性和定量调查。
材料/方法：对五个不同品牌声称含有乳酸杆菌和/或双歧杆菌的益生菌产品进行微生物分析。使用API 50CH、API 20A和API快速鉴定32A试剂盒，根据表型特征确定菌种。使用基因分型方法（通过聚合酶链反应扩增特定DNA片段并分析其核苷酸序列）进一步鉴定属于双歧杆菌属的细菌菌株。还对产品中的病原菌进行分析。使用平板计数法和最大可能数法测定其中四种产品所含微生物的数量。对益生菌产品的实际含量和声称含量进行统计学分析。
微生物学和基因分析表明，在质量方面，五个产品中只有三个含有标签上声称的细菌菌株。所有测试产品均未含有病原菌。定量分析表明，64个样本中有57个（89%[95%可信区间：81 - 97]）所含细菌数量达到标签上声称的细胞密度（剂量）。
我们的研究表明，测试产品的微生物质量标准不尽人意。然而，在数量上与标签有良好的一致性。我们的研究结果表明，急需制定有关益生菌产品标签的法规。
