PDF(Pubmed)
Abstract：
Dietary supplements containing red yeast rice (RYR), a fermentation product of the fungus Monascus purpureus grown on white rice, remain popular in Europe as proclaimed cholesterol-lowering aids. The cholesterol-lowering effects are due to the occurrence of monacolin K, which is often present as a mixture of monacolin K lactone (MK) and as monacolin K hydroxy acid (MKA). MK is structurally similar to the cholesterol-lowering medicine lovastatin. Recently, due to safety concerns linked to the use of statins, the European Commission prohibited RYR supplements with a maximum serving exceeding 3 mg of total monacolins per day. Moreover, the amount of the mycotoxin citrinin, potentially produced by M. purpureus, was also reduced to 100 µg/kg. Evidently, manufacturers that offer their products on the European market, including the online market, must also be compliant with these limits in order to guarantee the safety of their products. Therefore, thirty-five different RYR supplements, purchased from an EU-bound e-commerce platform or from registered online pharmacies, were screened for their compliance to the European legislation for citrinin content and the amount of total monacolin K. This was conducted by means of a newly developed LC-MS/MS methodology that was validated according to ISO 17025. Moreover, these supplements were also screened for possible adulteration and any contamination by micro-organisms and/or mycotoxins. It was found that at least four of the thirty-five RYR supplements (≈11%) might have reason for concern for the safety of the consumer either due to high total monacolin K concentrations exceeding the European predefined limits for total monacolins or severe bacterial contamination. Moreover, three samples (≈9%) were likely adulterated, and the labeling of six of the seventeen samples (≈35%) originating from an EU-based e-commerce platform was not compliant, as either the mandatory warning was missing or incomplete or the total amount of monacolins was not mentioned.
摘要：
含有红曲米（RYR）的膳食补充剂，一种生长在白米上的紫红曲霉的发酵产物，在欧洲仍然很受欢迎，被称为降低胆固醇的艾滋病。降低胆固醇的作用是由于monacolinK的发生，其通常作为monacolinK内酯(MK)和monacolinK羟基酸(MKA)的混合物存在。MK在结构上与降胆固醇药物洛伐他汀相似。最近,由于与使用他汀类药物相关的安全问题，欧盟委员会禁止RYR补充剂，其最大剂量超过每天3毫克的总monacolins。此外，霉菌毒素桔霉素的量，可能是由PurpureusM.产生的，也减少到100微克/千克。显然,在欧洲市场提供产品的制造商，包括在线市场，还必须符合这些限制，以保证其产品的安全性。因此,三十五种不同的RYR补充剂，从欧盟电子商务平台或注册的网上药店购买，对其符合欧洲法规的柑橘素含量和总monacolinK的量进行筛选。这是通过根据ISO17025验证的新开发的LC-MS/MS方法进行的。此外，还对这些补充剂进行了可能的掺假和微生物和/或真菌毒素污染的筛查.已发现，三十五种RYR补充剂中至少有四种（≈11％）可能有理由担心消费者的安全，这是由于高的monacolinK总浓度超过了欧洲预定的总monacolin限值或严重的细菌污染。此外，三个样本(约9%)可能掺假，来自欧盟电子商务平台的十七个样本中的六个（约35%）的标签不合规，因为强制性警告缺失或不完整，或者没有提到monacolins的总量。
