ARIZONA CENTER FOR PHYTOMEDICINE RESEARCH (ACPRX)

描述（申请人摘要）：膳食补充剂的使用 含有植物产品的食品在美国迅速扩张。而 公众使用这些产品来解决广泛的健康相关问题， 产品及其活性成分的安全性和有效性 被测试过了亚利桑那植物医学研究中心（Arizona Center for Phytomedicine Research） （ACPRx）将被建立以促进植物学的科学研究 作为膳食补充剂提供给公众，以提高质量 以及关于这些产品的科学信息的数量。在第一 五年来，ACPRx将集中精力研究 声称具有抗炎作用的几种植物药的安全性和有效性 作用并具体治疗关节炎或其他慢性 炎症性疾病。这些植物包括姜黄根茎（粉末 姜黄根）、生姜根茎（姜粉根）和树胶 乳香树脂（Boswellia serrata）。这三种植物药通常 建议关节炎患者在中西医结合诊所就诊， 亚利桑那大学医学院ACPRx的初始目标 将是解决活性化合物或化合物混合物的化学， 作用机制、口服生物利用度、药效学和 药代动力学植物药对生产的影响 抗炎介质将在体外以及在动物中进行评价 模型和离体人类受试者。研究部分将包括 三个项目由两个研究和三个行政核心支持。 项目1将通过以下方法分离和化学表征活性成分： 生物测定指导方法，进行生物化学研究， 三种植物药标准化的作用机制 项目2和3。 项目2将表征药代动力学（静脉给药后） 和胃肠道吸收动力学（绝对口服生物利用度， 吸收率）（作为功能剂量）以及 含有纯化学和活性成分的胶囊。药代动力学和 还将评估这些植物药之间的药效学相互作用。这些 实验将使用尤卡坦小型猪。项目3将描述 人体如何处理活性植物的药代动力学 成分及其抗炎活性的药效学。这 临床项目将进行I期临床试验， 植物药（来自商业上可获得的来源）单独和组合。 行政核心一将负责日常行政工作， 详细信息，调查人员之间的数据交换，容纳NAPIS数据库， ACPRx的方案协调、试点项目和评估。 行政核心2（信息收集和传播股）和3 （消费者和市场评估股）将作为消费者教育和 ACPRx的公共信息单位。研究核心1（植物学/农学）将 识别和鉴定植物成分，而核心2（分析 LC-MS-MS）将提供分析支持，包括去复制， 活性化合物鉴定、定量分析、生物利用度 药代动力学特征，以及动物体内代谢物的鉴定 还有人类未来，ACPRx将把研究扩展到其他领域。 植物性膳食补充剂，以帮助不仅消费者， 卫生保健从业人员。

DESCRIPTION (Applicant's Abstract): The use of dietary supplements containing botanical products is rapidly expanding in the United States. While the public is using these products for a wide range of health-related problems, the safety and efficacy of the products and of their active components have not been tested. The multidisciplinary Arizona Center for Phytomedicine Research (ACPRx) will be established to promote the scientific study of botanicals available to the public as dietary supplements in order to advance the quality and quantity of scientific information about these products. During the first five years, the ACPRx will concentrate its efforts on the research of the safety and efficacy of several botanicals purported to have anti-inflammatory actions and to be specific in the treatment of arthritis or other chronic inflammatory diseases. These botanicals include Curcuma longa rhizome (powdered turmeric root), Zingiber officinale rhizome (powdered ginger root) and the gum resin of Boswellia serrata (boswellia). The three botanicals are commonly recommended for arthritis patients seen at the Integrative Medicine Clinic at the University of Arizona College of Medicine. The initial goals of the ACPRx will be to address the chemistry of active compounds or mixtures of compounds, mechanisms of action, oral bioavailability, pharmacodynamics, and pharmacokinetics. The effect of the botanicals on production of anti-inflammatory mediators will be evaluated in vitro, as well as in an animal model and in human subjects ex vivo. The research component will consist of three projects supported by two research and three administrative cores. Project 1 will isolate and chemically characterize the active constituents by the bioassay-guided approach, conduct biochemical studies to establish mechanism(s) of action of produce standardization of the three botanicals for projects 2 and 3. Project 2 will characterize the pharmacokinetics (following intravenous dosing) and the gastrointestinal absorption kinetics (absolute oral bioavailability, rates of absorption) of commercial formulations (as a function dose) as well as capsules containing pure chemical and active components. Pharmacokinetic and pharmacodynamic interaction among these botanicals will also be assessed. These experiments will use the Yucatan minipig. Project 3 will characterize the basic pharmacokinetics of how the human body handles the active botanical constituents and the pharmacodynamics of their anti-inflammatory activity. This clinical project will perform Phase I clinical trials with each of the three botanicals (from commercially available sources) alone and in combination. Administration Core I will be responsible for the day-to-day administrative details, exchange of data among investigators, house the NAPIS database, program coordination, pilot projects and evaluation of the ACPRx. Administration Cores 2 (Information Collection and Dissemination Unit) and 3 (Consumer and Market Assessment Unit) will act as the consumer education and public information units for the ACPRx. Research Core 1 (Botany/Agronomy) will identify and authenticate botanical ingredients while Core 2 (Analytical LC-MS-MS) will provide analytical support including dereplication, identification, quantitative analysis of active compounds, bioavailability, pharmacokinetic profiles, as well as identification of metabolites in animals and humans. In the future, the ACPRx will expand its research to other botanical dietary supplements in order to help not only the consumer but also health care practitioners.