Spectrometric Validation of Botanical Materials and Reference Standards

描述（由申请人提供）：天然产物和天然衍生材料继续代表着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遗传学的起源，可以模糊化学结构和观察到的生物效应之间的相关性。因此，分析方法在确定有效原则和确定参考标准方面变得最为重要。这篇简明的摘要充分描述了植物性膳食补充剂（植物药）的现状，它代表了美国公众广泛销售和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）使用植物药，属于使用补充和替代医学（CAM）的人口的40%。能够全面评估植物制剂和相关天然产物完整性的新型分析技术需求量很大，并且有可能加速基础和临床科学的进展。该项目的总体目标是将目前天然产品的分析方法提升到一个新的水平，并在评估植物材料和参考标准的完整性方面实施新的技术水平。核磁共振（NMR）和连字符质谱（MS）的尖端方法的发展将为植物药的复杂性提供一种创新的方法，并改变目前最先进的天然健康产品的表征。为了实现这一目标，该项目将利用研究者专业知识（定量核磁共振[qNMR]，质谱技术的先驱），基础设施（一流的核磁共振设施）和跨学科研究环境（UIC生药学小组）的独特组合来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（qNMR、UHPLCQTRAP- MS），广泛应用于膳食补充剂的研究和生产工作流程。鉴于NCCAM/ODS/NIH对植物药的有效性和安全性以及FDA对“功能食品”安全性的广泛关注，这一方向的开创性研究尤其及时。新方法将首先针对前20种最广泛使用的植物中的10种建立。直接的结果是新的光谱平台技术，用于验证植物产品的来源、身份和临床完整性。产品完整性参数的保证是NIH/NCCAM/ODS在严格的科学背景下探索CAM的使命的核心。除了天然产品的完整性之外，项目成果还将对天然产品固有的复杂性提供新的利用，并促进跨学科生物医学研究，旨在使用于人类健康的植物药物合理化。

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.