Department of Life and Environmental Sciences, Polytechnic University of Marche, 60131 Ancona, Italy.
Department of Clinical Sciences, Polytechnic University of Marche, 60131 Ancona, Italy.
Molecules. 2019 Feb 26;24(5):829. doi: 10.3390/molecules24050829.
Menaquinone-7 (MK7) is a member of the vitamin K family in which interest has considerably increased over the last decade, mainly due to its beneficial role in human health. MK7 can be produced by synthesis or fermentation, and its purity profile can differ depending on methodologies and extraction procedures. Finished formulations show a high heterogeneity of purity profiles, as well as frequent discrepancies in the nominal content, compared to the actual title. The present study compared purity profiles of different raw material and related them to their stability in normal (12 months/25 °C/60%RH) and accelerated conditions (6 months/40 °C/75% RH) in order to test their performance in the presence of different common excipients. Results showed higher purity profile results in enhanced stability, and this could explain title discrepancies found in finished products, which are present on the market worldwide.
甲萘醌-7（MK7）是维生素 K 家族的一员，在过去十年中，人们对其产生了浓厚的兴趣，主要是因为它对人类健康有益。MK7 可以通过合成或发酵生产，其纯度谱可能因方法和提取程序而异。成品制剂的纯度谱高度不均匀，与标称含量相比，经常存在差异。本研究比较了不同原料的纯度谱，并将其与在正常（12 个月/25°C/60%RH）和加速条件（6 个月/40°C/75% RH）下的稳定性相关联，以测试它们在不同常见赋形剂存在下的性能。结果表明，在稳定性增强的情况下，纯度谱更高，这可以解释在全球市场上存在的成品中发现的标题差异。
