Poor chemical and microbiological quality of the commercial milk thistle-based dietary supplements may account for their reported unsatisfactory and non-reproducible clinical outcomes
Poor chemical and microbiological quality of the commercial milk thistle-based dietary supplements may account for their reported unsatisfactory and non-reproducible clinical outcomes
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DOI：
10.1038/s41598-019-47250-0
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发表时间：
2019-07-31
影响因子：
4.6
通讯作者：
Stranska-Zachariasova, Milena
中科院分区：
文献类型：
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作者：
Fenclova, Marie;Novakova, Alena;Stranska-Zachariasova, Milena
基于草药的膳食补充剂越来越受欢迎。从牛奶蓟（水飞蓟）提取物，经常用于治疗肝脏疾病。然而，关于这些非处方制剂的功效、组成以及安全性存在严重的担忧。因此，本研究的目的是调查2016年至2017年期间从美国和捷克市场购买的26种基于水飞蓟的膳食补充剂的成分以及化学和生物安全性。该研究的重点是确定活性成分的组成，以及分析可能的污染物，包括：真菌毒素，植物生物碱和农药残留，以及微生物纯度。采用先进的U-HPLC-HRMS技术进行高通量分析。在个别奶蓟制剂中观察到水飞蓟素含量的巨大差异，通常与制造商提供的信息相反。此外，还证明了水飞蓟素含量的显著批间差异。在所有测试的奶蓟制剂中，检测到大量和高浓度的真菌毒素和几种农药，以及大量存在的微生物污染，这表明存在严重的安全问题。总之，我们的研究结果强烈表明，需要严格控制的组成，化学污染物，以及用于治疗肝脏疾病的商业奶蓟提取物的微生物纯度。这些制剂的定义不佳以及生物活性物质的污染不仅可能导致临床观察结果的不一致，而且可能是基于草药的饮食有害物质诱导的肝损伤的原因。
Herbal-based dietary supplements have become increasingly popular. The extract from milk thistle (Silybum marianum), is often used for the treatment of liver diseases. However, serious concerns exist regarding the efficacy, composition, as well as the safety of these over-the-counter preparations. Therefore, the aim of the present study was to investigate the composition as well as chemical and biological safety of 26 milk thistle-based dietary supplements purchased from both the U.S. and Czech markets between 2016 and 2017. The study was focused on a determination of the composition of active ingredients, as well as analyses of possible contaminants including: mycotoxins, plant alkaloids, and pesticide residues, as well as the microbial purity. High-throughput analyses were performed using advanced U-HPLC-HRMS techniques. Large differences in the silymarin content were observed among individual milk thistle preparations, often in contrast with the information provided by the manufacturers. In addition, substantial inter-batch differences in silymarin content were also demonstrated. In all milk thistle preparations tested, large numbers and high concentrations of mycotoxins and several pesticides, as well as the substantial presence of microbiological contamination were detected, pointing to serious safety issues. In conclusion, our results strongly indicate the need for strict controls of the composition, chemical contaminants, as well as the microbiological purity of commercial milk thistle extracts used for the treatment of liver diseases. Poor definition of these preparations together with contamination by biologically active substances may not only account for the inconsistency of clinical observations, but also be responsible for possible herbal-based dietary supplements-induced liver injury.