citrinin

柑橘素
  • 文章类型: Journal Article
    含有红曲米(RYR)的食品补充剂(FS)主要用于降低血液中的脂质水平。负责生物活性的主要成分是monacolinK(MoK),化学结构与洛伐他汀相同的天然化合物。具有营养或生理作用的物质的浓缩来源以“剂量”形式作为食品补充剂(FS)销售。FS的“剂型”的质量特征在欧洲没有定义,而美国提供了一些质量标准。这里,我们对在意大利销售的含RYR的FS的片剂或胶囊的质量概况进行了评估,并进行了欧洲药典11版报道的两项测试。与USP报告的非常接近。结果突出了符合欧洲药典11版的剂型均匀性(质量和MoK含量)的变化。规格,而44%的测试样品崩解片剂所需的时间更长。还研究了MoK的生物可及性,以获得有关测试FS生物学行为的宝贵数据。此外,优化了citrinin(CIT)的测定方法,并将其应用于实际样品。分析的样品均未证明CIT污染(LOQ设置为6.25ng/mL)。考虑到FS的广泛使用,我们的数据表明,制造商和监管机构应更加重视,以确保上市产品的质量和安全消费。
    Food supplements (FS) containing red yeast rice (RYR) are largely employed to reduce lipid levels in the blood. The main ingredient responsible for biological activity is monacolin K (MoK), a natural compound with the same chemical structure as lovastatin. Concentrated sources of substances with a nutritional or physiological effect are marketed in \"dose\" form as food supplements (FS). The quality profile of the \"dosage form\" of FS is not defined in Europe, whereas some quality criteria are provided in the United States. Here, we evaluate the quality profile of FS containing RYR marketed in Italy as tablets or capsules running two tests reported in The European Pharmacopoeia 11 Ed. and very close to those reported in the USP. The results highlighted variations in dosage form uniformity (mass and MoK content) compliant with The European Pharmacopoeia 11 Ed. specifications, whereas the time needed for disintegrating tablets was longer for 44% of the tested samples. The bioaccessibility of MoK was also investigated to obtain valuable data on the biological behaviour of the tested FS. In addition, a method for citrinin (CIT) determination was optimized and applied to real samples. None of the analyzed samples demonstrated CIT contamination (LOQ set at 6.25 ng/mL). Considering the widespread use of FS, our data suggest that greater attention should be paid by fabricants and regulatory authorities to ensure the quality profile and the safe consumption of marketed products.
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