Department of Pharmaceutical and Pharmacological Sciences, University of Padova, Via Marzolo 5, 35100 Padova, Italy.
Unired srl, Via Niccolò Tommaseo 69, 35131 Padova, Italy.
Molecules. 2021 Apr 12;26(8):2222. doi: 10.3390/molecules26082222.
The use of dietary supplements for the prevention and management of diseases associated with excess of lipids is spreading in Western countries. Supplements containing red yeast rice (RYR) and extracts from species, characterized, respectively, by the active compounds monacolin K (MK) and berberine (BBR), are sold in pharmacies as over the counter medicines (OTC) and in regular markets without the need of medical prescription and medical surveillance. However, MK is chemically identical to lovastatin, a drug commonly used to treat hypercholesterolemia, and is characterized by the same mechanism of action, pharmacokinetic profile and toxicity. On the other hand, although BBR-containing supplements are considered to be well-tolerated and safe, they frequently show poor standardization of active ingredients, and this could lead to lack of effects. In this work, with the aim to give an overview on the potency of RYR- and BBR-containing supplements available on the Italian market, we analyzed a pool of supplements bought from both local pharmacies and markets. Results confirm the data already published by other authors, showing scarce standardization of bioactives and discrepancy between the doses of bioactives reported by the manufacturers and the amounts resulting from analysis of the same products. Overall, our data represent a further proof that a strict legislation regulating the production and marketing of dietary supplements and a close monitoring of these products by food and drug regulatory organs is mandatory.
在西方国家，使用膳食补充剂来预防和控制与脂质过量相关的疾病的做法正在普及。含有红曲米（RYR）和黄连（BBR）提取物的补充剂作为非处方药物（OTC）在药店销售，也在常规市场上销售，无需处方和医疗监督。然而，MK 与洛伐他汀化学性质相同，洛伐他汀是一种常用于治疗高胆固醇血症的药物，具有相同的作用机制、药代动力学特征和毒性。另一方面，虽然含有 BBR 的补充剂被认为耐受性良好且安全，但它们经常表现出活性成分标准化程度差，这可能导致缺乏效果。在这项工作中，为了概述意大利市场上可获得的含有 RYR 和 BBR 的补充剂的功效，我们分析了从当地药店和市场购买的一组补充剂。结果证实了其他作者已经发表的数据，表明生物活性物质的标准化程度很差，制造商报告的生物活性物质剂量与对同一产品进行分析得出的数量之间存在差异。总的来说，我们的数据进一步证明，必须严格监管膳食补充剂的生产和销售，并由食品和药品监管机构密切监测这些产品。
