School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia.
The Atomic Medicine Initiative, University of Technology Sydney, Sydney, NSW, 2007, Australia.
AAPS PharmSciTech. 2021 Feb 18;22(3):78. doi: 10.1208/s12249-021-01946-7.
Six Australian and five overseas complementary medicines (CM) and meal replacement shake products were analysed for potential adulteration with two common active pharmaceutical ingredients, caffeine and sibutramine, using thin-layer chromatography and mass spectrometry. The declared amount of caffeine in each product was also reviewed. Finally, the products were examined for heavy metal contamination using inductively coupled plasma-mass spectrometry. The results showed that there was no detected adulteration of either caffeine (for those products that did not list caffeine as an ingredient) or sibutramine in the 11 products; however, based on the product labels, one Australian and one overseas (two in total) CM product contained more than the maximum daily safety limit (400 mg) of caffeine. Potentially excessive lead and/or chromium was detected in six products, including four Australian products and two products purchased online. One Australian CM product appeared to contain these heavy metals at concentrations at, or exceeding, the safety limits specified in the United States Pharmacopeia or set by the World Health Organization. The overconsumption of caffeine and heavy metals has the potential of causing significant health effects in consumers.
对六款澳大利亚和五款海外的补充药物（CM）和代餐奶昔产品进行了分析，以检测两种常见的活性药物成分，即咖啡因和西布曲明，使用薄层色谱法和质谱法。还对每个产品中咖啡因的宣称含量进行了审查。最后，使用电感耦合等离子体质谱法对产品进行了重金属污染检测。结果表明，在 11 种产品中，没有发现咖啡因（对于那些没有将咖啡因列为成分的产品）或西布曲明的掺假；然而，根据产品标签，一种澳大利亚和一种海外（共两种）CM 产品含有超过最大日安全限量（400 毫克）的咖啡因。在六种产品中检测到潜在的过量铅和/或铬，包括四种澳大利亚产品和两种在线购买的产品。一种澳大利亚 CM 产品似乎含有这些重金属，浓度达到或超过美国药典或世界卫生组织规定的安全限量。消费者过量摄入咖啡因和重金属可能会对健康造成重大影响。
