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美国药典委员会对维生素K的一种形式——甲萘醌-7的安全性评估。

US Pharmacopeial Convention safety evaluation of menaquinone-7, a form of vitamin K.

作者信息

Marles Robin J, Roe Amy L, Oketch-Rabah Hellen A

机构信息

US Pharmacopeial Convention's Dietary Supplements Admission Evaluations Joint Standard Setting Subcommittee, US Pharmacopeial Convention, Rockville, Maryland, USA. US Pharmacopeial Convention, Rockville, Maryland, USA.

出版信息

Nutr Rev. 2017 Jul 1;75(7):553-578. doi: 10.1093/nutrit/nux022.

DOI:10.1093/nutrit/nux022
PMID:28838081
Abstract

Vitamin K plays important biological roles in maintaining normal blood coagulation, bone mineralization, soft tissue physiology, and neurological development. Menaquinone-7 is a form of vitamin K2 that occurs naturally in some animal-derived and fermented foods. It is also available as an ingredient of dietary supplements. Menaquinone-7 has greater bioavailability than other forms of vitamin K, which has led to increasing sales and use of menaquinone-7 supplements. This special article reviews the chemistry, nomenclature, dietary sources, intake levels, and pharmacokinetics of menaquinones, along with the nonclinical toxicity data available and the data on clinical outcomes related to safety (adverse events). In conclusion, the data reviewed indicate that menaquinone-7, when ingested as a dietary supplement, is not associated with any serious risk to health or with other public health concerns. On the basis of this conclusion, US Pharmacopeia monographs have been developed to establish quality standards for menaquinone-7 as a dietary ingredient and as a dietary supplement in various dosage forms.

摘要

维生素K在维持正常血液凝固、骨矿化、软组织生理功能和神经发育方面发挥着重要的生物学作用。甲萘醌-7是维生素K2的一种形式,天然存在于一些动物源性和发酵食品中。它也作为膳食补充剂的一种成分提供。甲萘醌-7比其他形式的维生素K具有更高的生物利用度,这导致甲萘醌-7补充剂的销量和使用量不断增加。这篇专题文章综述了甲萘醌的化学性质、命名、膳食来源、摄入量水平和药代动力学,以及现有的非临床毒性数据和与安全性相关的临床结果数据(不良事件)。总之,所综述的数据表明,当作为膳食补充剂摄入时,甲萘醌-7与任何严重的健康风险或其他公共卫生问题均无关联。基于这一结论,美国药典已制定了专论,以确立甲萘醌-7作为膳食成分以及各种剂型膳食补充剂的质量标准。

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