Balayssac Stéphane, Danoun Saïda, Gilard Véronique, Martino Robert, Malet-Martino Myriam
Biomedical NMR Group, Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, 118 route de Narbonne, 31062 Toulouse cedex, France; Laboratoire IMRCP (UMR CNRS 5623), Université Paul Sabatier, 118 route de Narbonne, 31062 Toulouse cedex, France.
Biomedical NMR Group, Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, 118 route de Narbonne, 31062 Toulouse cedex, France.
J Pharm Biomed Anal. 2023 Apr 1;227:115283. doi: 10.1016/j.jpba.2023.115283. Epub 2023 Feb 9.
Ten POWER dietary supplements, chronologically called tabs, pills then caps, and advertised as 100% natural aphrodisiacs, were analyzed by H NMR from 2007 to 2022. They were all tainted by PDE-5 inhibitors. Eight different adulterants were identified (sildenafil (1), sildenafil analogues (6), and vardenafil analogue (1)). Their amounts ranged from 15 to 145 mg/capsule. Four supplements contained at least 100 mg/capsule of PDE-5 inhibitor or analogue, the maximal recommended dose of sildenafil. The nature of the adulterant has changed over time, probably to evade its detection by regulatory agencies routine screening tests. Despite several warnings and/or seizures from several European food and/or health authorities, the dietary supplement POWER is still on sale on the Internet, thus demonstrating the impossibility of controlling this market. Faced with this situation, the consumer should be better informed by establishing at the European level a public database of tainted dietary supplements on the model of that of the US Food and Drug Administration. It should indicate the product name, its photo, the adulterant name, and be easily accessible to everyone.
2007年至2022年期间,对10种名为“能量”的膳食补充剂进行了分析,这些补充剂按时间顺序依次被称为片剂、丸剂,然后是胶囊剂,并被宣传为100%天然壮阳药。通过核磁共振氢谱(¹H NMR)分析发现,它们均被磷酸二酯酶5(PDE - 5)抑制剂污染。共鉴定出8种不同的掺假物(西地那非(1种)、西地那非类似物(6种)和伐地那非类似物(1种))。其含量范围为15至145毫克/胶囊。有4种补充剂每胶囊含有至少100毫克的PDE - 5抑制剂或类似物,这是西地那非的最大推荐剂量。掺假物的性质随时间发生了变化,可能是为了逃避监管机构的常规筛查测试。尽管欧洲多个食品和/或卫生当局发出了多次警告和/或进行了查扣,但“能量”膳食补充剂仍在互联网上销售,这表明控制这个市场是不可能的。面对这种情况,应该在欧洲层面建立一个类似美国食品药品监督管理局的受污染膳食补充剂公共数据库,让消费者能够更好地了解相关信息。该数据库应标明产品名称、产品照片、掺假物名称,并且人人都能轻松访问。