Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles.
Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles.
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DOI：
10.3389/fnut.2021.780226
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发表时间：
2021
影响因子：
5
通讯作者：
Wu Q
中科院分区：
文献类型：
--
作者：
Lyu W;Rodriguez D;Ferruzzi MG;Pasinetti GM;Murrough JW;Simon JE;Wu Q
葡萄(Vitis Vinifera)中的生物活性膳食多酚已被用于膳食补充剂(DSS)中，目的是预防包括心血管和神经退行性疾病在内的多种疾病，并减少抑郁和焦虑。鉴于事先认识到DSS可能会受到来自目标生物活性物质纯度、鉴定、掺假和实际浓度的质量挑战，以确保消费者健康保护以及葡萄多酚DSS的质量和安全，本研究旨在为葡萄多酚DSS建立一种全面的质量控制(QC)方法，以支持人类临床研究。本研究采用不同的LC/UV-Vis/MS分析方法对葡萄籽多酚提取物(GSPE)、反式白藜芦醇(RSV)胶囊和协和葡萄汁(CGJ)及其原料药进行了分析。根据美国药典(USP)的规定，对GSPE和RSV胶囊的重量变化进行了评价。结果表明，各葡萄籽提取液(GSE)胶囊/CGJ胶囊的总多酚含量非常接近，均通过含量/重量均匀度检验。鉴于这些和许多植物产品因纯度、质量、掺假、一致性问题以及它们与每个葡萄衍生植物中复杂的化学成分的耦合而产生的复杂性，质量保证和确保葡萄衍生DSS良好均质和稳定并在特定浓度范围内包含已知和预期生物活性物质所需的步骤对任何研究研究，尤其是临床试验都是至关重要的。这些问题中的每一个都是至关重要的，以提供一个坚实的基础，在此基础上进行植物药临床试验，以实现可测量的精神健康结果，如减少抑郁和焦虑以及了解其潜在的生物学机制。
Bioactive dietary polyphenols in grape (Vitis vinifera) have been used in Dietary Supplements (DSs) with the aim to prevent numerous diseases, including cardiovascular and neurodegenerative diseases, and to reduce depression and anxiety. Given prior recognition that DSs can be quality challenged from the purity, authentication, adulteration, and actual concentration of targeted bioactives, to ensure consumer health protection as well as the quality and safety of grape polyphenol-based DSs, the present investigation was aimed at establishing a comprehensive quality control (QC) approach for grape polyphenol-based DSs in support of a human clinical study. In this study, the manufactured grape seed polyphenol extract (GSPE) and trans-resveratrol (RSV) capsules and Concord Grape Juice (CGJ) along with the corresponding original drug materials were analyzed using the developed different liquid chromatography/UV-visible spectroscopy/mass spectrometry (LC/UV-Vis/MS) methods. The weight variation of GSPE and RSV capsules was also evaluated according to the US Pharmacopeia (USP) tests. The results indicate that the total identified polyphenol content in each grape seed extract (GSE) capsule/CGJ is very similar and all GSE/RSV capsules pass the content/weight uniformity test. Given the complexity of these and many botanical products from the issues of purity, quality, adulteration, consistency, and their coupling to the complex chemistry in each grape-derived botanical, quality assurance and the steps needed to ensure grape-derived DSs being well homogeneous and stable and containing the known and expected bioactives at specific concentration ranges are fundamental to any research study and in particular to a clinical trial. Each of these issues is essential to provide a solid foundation upon which clinical trials with botanicals can be conducted with the goal of realizing measurable mental health outcomes such as reducing depression and anxiety as well as understanding of their underlying biological mechanisms.
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DOI：
10.1016/s0378-4347(97)00383-6
发表时间：
1997-11-21
期刊：
JOURNAL OF CHROMATOGRAPHY B
影响因子：
--
作者：
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通讯作者：
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影响因子：
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作者：
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影响因子：
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作者：
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DOI：
10.3390/antiox6030071
发表时间：
2017-09-15
期刊：
Antioxidants (Basel, Switzerland)
影响因子：
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作者：
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通讯作者：
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影响因子：
2.4
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