Spectrometric Validation of Botanical Materials and Reference Standards

描述(由申请人提供)：天然产品和天然衍生材料仍然是生物医学研究中的主要分析挑战。它们天生的化学复杂性是生物起源的，可能会模糊化学结构和观察到的生物效应之间的相关性。因此，在确定现行原则和确定参考标准方面，分析方法论变得最为重要。这份简明的摘要充分描述了植物性膳食补充剂(植物性药物)的现状，植物性膳食补充剂代表着广泛销售给美国公众和美国公众消费的天然健康产品。根据《2008年国家卫生统计报告》，几乎十分之一的人(3000万人)使用植物性药物，属于使用补充和替代医学(CAM)的40%的人口。可以全面评估植物制剂和相关天然产品完整性的新分析技术需求很高，可能会加速基础和临床科学的进步。该项目的广泛目标是将目前天然产品的分析方法提高到一个新的水平，并在植物材料和参考标准的完整性评估中实施一种新的最先进的方法。核磁共振(核磁共振)和联用质谱学(MS)尖端方法的发展将为研究植物药物的复杂性提供一种创新的方法，并改变目前在表征天然保健品方面的最先进水平。为了实现这一目标，该项目将利用研究人员专业知识(定量核磁共振技术的先驱、质谱学技能)、基础设施(一流的核磁共振设备)和跨学科研究环境(UIC生药学小组)的独特组合，解决草药制剂化学复杂性的基础研究问题。该项目将开发创新的光谱技术(Q核磁共振、UHPLCQTRAP-MS)，以广泛应用于膳食补充剂研究和生产工作流程。鉴于对NCCAM/ods/NIH倡导的植物性药物的有效性和安全性以及FDA倡导的“功能食品”的安全性的大量关注，在这一方向上的开创性研究尤其及时。新的方法将首先为前20种最广泛使用的植物药物中的10种建立。立竿见影的成果是新的光谱平台技术，用于验证植物产品的原产地、身份和临床完整性。产品完整性参数的保证是NIH/NCCAM/ods在严谨科学背景下探索CAM的使命的核心。除了天然产品的完整性之外，项目成果将为天然产品的内在复杂性提供新的杠杆，并促进旨在使用于人类健康的植物药物合理化的跨学科生物医学研究。 与公共健康相关：该项目寻求建立新的光谱技术来评估植物膳食补充剂的质量和完整性，植物膳食补充剂被美国公众广泛消费，也是一个主要的健康经济因素。使用磁共振(MR)和质谱学(MS)的综合尖端方法的开发将为植物学参考标准提供一种创新的方法，并可以改变目前在表征天然保健品方面的最先进水平。该项目将在伊利诺伊大学芝加哥分校(UIC)高度跨学科的生药学研究环境中建立一个独特的资源，并广泛提供给涉及植物药物和其他天然产品的转化性临床研究。

DESCRIPTION (provided by applicant): Natural products and nature-derived materials continue to represent major analytical challenges in biomedical research. Their innate chemical complexity is of biogenetic origin, and can obscure correlations between chemical structures and observed biological effects. Thus, analytical methodology becomes most important in the identification of active principles and the definition of reference standards. This concise summary fully characterizes the current situation of botanical dietary supplements (botanicals), which represent natural health products that are widely sold to and consumed by the U.S. public. According to the 2008 National Health Statistics Report, almost one in ten persons (30 mio.) use botanicals and belong to the 40% of the population who use complementary and alternative medicine (CAM). Novel analytical technologies that can comprehensively assess the integrity of botanical preparations and related natural products are in high demand and can potentially accelerate progress in basic and clinical sciences. The broad goal of this project is to advance the current analytical methodology for natural products to a new level and implement a new state-of-the-art in the assessment of the integrity of botanical materials and reference standards. The development of cutting-edge methods in nuclear magnetic resonance (NMR) and hyphenated mass spectroscopy (MS) will provide an innovative approach to the complexity of botanicals and transform the current state-of-the-art in the characterization of natural health products. In order to achieve this goal, the project will capitalize on the unique combination of investigator expertise (pioneers in quantitative NMR [qNMR], mass spectrometry skills), infrastructure (first-class NMR facility), and interdisciplinary research environment (UIC pharmacognosy group) to address the fundamental research problem of chemical complexity of herbal preparations. The project will develop innovative spectrometric technologies (qNMR, UHPLCQTRAP- MS) for broad implementation into dietary supplement research and production workflows. Groundbreaking research in this direction is especially timely in light of abundant concerns about the efficacy and safety botanicals as advocated by NCCAM/ODS/NIH, and the safety of "functional foods" as advocated by FDA. The new methodology will be initially established for 10 of the top-20 most widely used botanicals. The immediate outcome is new spectrometric platform technology for the verification of origin, identity, and clinical integrity of botanical products. Assurance of product integrity parameters is at the core of NIH/NCCAM/ODS' mission to explore CAM in the context of rigorous science. Going beyond natural product integrity, project outcome will provide new leverage on the inherent complexity of natural products, and foster interdisciplinary biomedical research aimed at the rationalization of the botanicals used for human health. Public Health Relevance: This project seeks to establish new spectrometric technologies for the assessment of the quality and integrity of botanical dietary supplements, which are widely consumed by the U.S. public and a major health economy factor. The development of integrated cutting-edge methodology using magnetic resonance (MR) and mass spectrometry (MS) will provide an innovative approach to botanical reference standards and can transform the current state-of-the-art in the characterization of natural health products. The project will build a unique resource to be maintained within the highly interdisciplinary pharmacognosy research environment at the University of Illinois at Chicago (UIC) and to be made broadly available for translational clinical research involving botanicals and other natural products.