Czigle Szilvia, Tóth Jaroslav, Jedlinszki Nikoletta, Háznagy-Radnai Erzsébet, Csupor Dezső, Tekeľová Daniela
Comenius University in Bratislava, Faculty of Pharmacy, Department of Pharmacognosy and Botany, Bratislava, Slovak Republic.
University of Szeged, Faculty of Pharmacy, Institute of Pharmacognosy, Szeged, Hungary.
Planta Med. 2018 Apr;84(6-07):475-482. doi: 10.1055/a-0581-5203. Epub 2018 Mar 5.
The aim of this study was to prove whether food supplements on the European market comply with pharmaceutical quality, and whether their composition satisfies the European Pharmacopoeia criteria. Medicinal products containing a standardised Ginkgo leaf extract are used for the improvement of cognitive impairment and quality of life in mild dementia. Further, Ginkgonis folium is used for the treatment of peripheral circulation disorders. Pharmacopoeial Ginkgo dry extract contains 22.0 - 27.0% flavonoids and 5.4 - 6.6% terpene lactones (ginkgolides, bilobalide). In addition to its widespread use as an herbal medicine (herbal medicinal product), the same extract can be an ingredient in food supplements. The content of active secondary metabolites was quantified in a number of European food supplements containing Ginkgo dry extract or Ginkgo leaf. Flavonoids were quantified using a modified pharmacopoeial HPLC-UV method, and terpene lactones (ginkgolides A, B, C, and bilobalide) using LC-MS/MS. Some Ginkgo leaf supplement samples were also analysed by microscopy. The quality of food supplements on the European market is dubious. In this paper, we present selected examples of several methods of adulteration and falsification, including higher/lower doses of Ginkgo dry extract or Ginkgo leaf than declared and the addition of undeclared extraneous materials. These examples reveal several patterns in the manufacturing of adulterated products.
本研究的目的是证明欧洲市场上的食品补充剂是否符合药品质量标准，以及其成分是否满足欧洲药典标准。含有标准化银杏叶提取物的药品用于改善轻度痴呆患者的认知障碍和生活质量。此外，银杏叶还用于治疗外周循环障碍。药典规定的银杏干提取物含有22.0 - 27.0%的黄酮类化合物和5.4 - 6.6%的萜类内酯（银杏内酯、白果内酯）。除了作为草药（草药药品）广泛使用外，相同的提取物还可以作为食品补充剂的一种成分。对一些含有银杏干提取物或银杏叶的欧洲食品补充剂中的活性次生代谢物含量进行了定量分析。黄酮类化合物采用改良的药典高效液相色谱-紫外法进行定量分析，萜类内酯（银杏内酯A、B、C和白果内酯）采用液相色谱-串联质谱法进行定量分析。一些银杏叶补充剂样品还通过显微镜进行了分析。欧洲市场上食品补充剂的质量令人怀疑。在本文中，我们列举了几种掺假和造假方法的实例，包括银杏干提取物或银杏叶的剂量高于或低于宣称剂量以及添加未申报的外来物质。这些实例揭示了掺假产品制造中的几种模式。
