Gordon Ram Y, Cooperman Tod, Obermeyer William, Becker David J
Chestnut Hill Hospital, University of Pennsylvania Health System, Philadelphia, USA.
Arch Intern Med. 2010 Oct 25;170(19):1722-7. doi: 10.1001/archinternmed.2010.382.
Red yeast rice (RYR) is a widely available dietary supplement used by millions of patients as an alternative therapy for hyperlipidemia. It contains 14 active compounds called monacolins that inhibit hepatic cholesterol synthesis. Although studies have suggested that some formulations of RYR may be effective and safe for lipid lowering, monacolin levels are not standardized among marketed products and are generally not published on labels. We evaluated monacolin levels in 12 commercial RYR formulations and tested for citrinin, a mycotoxin that is nephrotoxic in animals.
Each formulation of RYR was labeled "600 mg/capsule" of active product. Analyses for monacolins and citrinin were performed between August 2006 and June 2008 using high-performance liquid chromatography with mass spectroscopy-mass spectroscopy detection. Laboratory analyses of RYR products were conducted by ConsumerLab.com, White Plains, New York.
There was marked variability in the 12 RYR products in total monacolins (0.31-11.15 mg/capsule), monacolin K (lovastatin) (0.10-10.09 mg/capsule), and monacolin KA (0.00-2.30 mg/capsule). Four products had elevated levels of citrinin.
We found striking variability in monacolin content in 12 proprietary RYR products and the presence of citrinin in one-third of the formulations tested. Although RYR may have potential as an alternative lipid-lowering agent, our findings suggest the need for improved standardization of RYR products and product labeling. Until this occurs, physicians should be cautious in recommending RYR to their patients for the treatment of hyperlipidemia and primary and secondary prevention of cardiovascular disease.
红曲米是一种广泛可得的膳食补充剂，数百万患者将其用作高脂血症的替代疗法。它含有14种名为莫纳可林的活性化合物，可抑制肝脏胆固醇合成。尽管研究表明某些红曲米制剂可能对降低血脂有效且安全，但市售产品中莫纳可林的含量并不标准，而且标签上通常也不公布。我们评估了12种市售红曲米制剂中的莫纳可林含量，并检测了桔霉素（一种对动物具有肾毒性的霉菌毒素）。
每种红曲米制剂的活性产品标签均为“600毫克/胶囊”。2006年8月至2008年6月期间，使用带质谱检测的高效液相色谱法对莫纳可林和桔霉素进行分析。红曲米产品的实验室分析由纽约州白原市的ConsumerLab.com进行。
12种红曲米产品在总莫纳可林（0.31 - 11.15毫克/胶囊）、莫纳可林K（洛伐他汀）（0.10 - 10.09毫克/胶囊）和莫纳可林KA（0.00 - 2.30毫克/胶囊）方面存在显著差异。四种产品的桔霉素含量升高。
我们发现12种专利红曲米产品中的莫纳可林含量存在显著差异，并且在三分之一的受试制剂中存在桔霉素。尽管红曲米可能有作为替代降脂剂的潜力，但我们的研究结果表明需要改进红曲米产品的标准化和产品标签。在此之前，医生在向患者推荐红曲米用于治疗高脂血症以及心血管疾病的一级和二级预防时应谨慎。
