Brzezińska Joanna, Szewczyk Adrian, Brzezicha Justyna, Prokopowicz Magdalena, Grembecka Małgorzata
Department of Bromatology, Faculty of Pharmacy, Medical University of Gdańsk, Gen. J. Hallera Avenue 107, 80-416 Gdańsk, Poland.
Department of Physical Chemistry, Faculty of Pharmacy, Medical University of Gdańsk, Gen. J. Hallera Avenue 107, 80-416 Gdańsk, Poland.
Foods. 2021 Jul 22;10(8):1693. doi: 10.3390/foods10081693.
In the European Union, no specific requirements for the physicochemical parameters of dietary supplements have been established, contrary to the United States of America. This research aimed to assess the selected physical parameters of 31 commercially available beetroot-based dietary supplements in the form of tablets and capsules following the United States Pharmacopoeia (USP) guidelines and the Food and Drug Administration (FDA) recommendations. There was also estimated zinc and iron content by atomic absorption spectroscopy with flame detection. Results showed that nine products did not meet the USP requirements. Seven supplements needed more than 30 min to disintegrate. Two products in the form of tablets did not pass the friability test because of cracking. The hardness values varied significantly between manufacturers, demonstrating values from 59.1 to 455.8 N. The iron-enriched supplements differed significantly in iron content compared with the manufacturers' declaration (84.91-140.69%). Inappropriate quality of dietary supplements, which may constitute a potential risk to consumers, can be related to the lack of specific regulations in Europe; hence, similar to the USA requirements should be considered in the European Union. The work emphasizes the need to better control the quality of dietary supplements before they are introduced to the European market.
在欧盟,与美国不同,尚未对膳食补充剂的物理化学参数制定具体要求。本研究旨在按照美国药典(USP)指南和食品药品监督管理局(FDA)的建议,评估31种市售的片剂和胶囊形式的甜菜根基膳食补充剂的选定物理参数。还通过火焰检测原子吸收光谱法估算了锌和铁的含量。结果表明,有九种产品不符合USP要求。七种补充剂崩解时间超过30分钟。两种片剂形式的产品因开裂未通过脆碎度测试。不同制造商的硬度值差异显著,显示值在59.1至455.8牛顿之间。与制造商声明相比,富含铁的补充剂铁含量差异显著(84.91 - 140.69%)。膳食补充剂质量不佳可能对消费者构成潜在风险,这可能与欧洲缺乏具体法规有关;因此,欧盟应考虑采用与美国类似的要求。这项工作强调了在膳食补充剂进入欧洲市场之前更好地控制其质量的必要性。