ARIZONA CENTER FOR PHYTOMEDICINE RESEARCH (ACPRX)

说明(申请人摘要)：膳食补充剂的使用 含有植物产品的产品在美国正在迅速扩张。而当 公众正在使用这些产品来治疗一系列与健康相关的问题， 产品及其活性成分的安全性和有效性尚未得到证实 已经测试过了。亚利桑那州多学科植物医学研究中心 (ACPRx)将成立以促进植物学的科学研究 提供给公众作为膳食补充剂，以提高质量 以及有关这些产品的科学信息的数量。在第一次 五年内，ACPRx将集中精力研究 几种据称具有抗炎作用的植物药的安全性和有效性 并在治疗关节炎或其他慢性疾病方面具体化 炎症性疾病。这些植物药包括姜黄根茎(粉末状 姜根)、生姜(姜粉)和口香糖 锯缘乳香树脂(Boswell Lia)这三种植物药通常是 推荐到中西医结合诊所就诊的关节炎患者，网址为 亚利桑那大学医学院。ACPRx的最初目标 将解决活性化合物或化合物混合物的化学问题， 作用机制、口服生物利用度、药效学和 药物动力学。植物性药物对黄瓜生产的影响 抗炎介质将在体外和动物体内进行评估。 模型和人体外受试者。研究部分将包括 由两个研究和三个行政核心支持的三个项目。 项目1将通过以下方式分离活性成分并对其进行化学表征 以生物化验为导向的方法，进行生化研究以建立 三种植物药生产标准化的作用机制(S) 项目2和项目3。 项目2将描述药物动力学(静脉给药后) 胃肠吸收动力学(绝对口服生物利用度， 吸收速率)商业制剂(作为功能剂量)以及 含有纯化学成分和活性成分的胶囊。药动学和药动学 还将评估这些植物性药物之间的药效相互作用。这些 实验将使用尤卡坦微型猪。项目3将描述基本的 人体处理活性植物的药代动力学 其抗炎活性的成分和药效学。这 临床项目将对这三个项目分别进行I期临床试验 植物药(来自商业来源)单独或联合使用。 行政核心我将负责日常行政工作 细节，调查人员之间的数据交换，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)将担任消费者教育和 ACPRx的新闻单位。研究核心1(植物学/农学)将 鉴定和鉴定植物成分，而核心2(分析性 LC-MS-MS)将提供分析支持， 活性化合物的鉴定、定量分析、生物利用度、 动物体内的药代动力学及代谢物的鉴定 和人类。未来，ACPRx将把它的研究扩展到其他 植物性膳食补充剂，不仅有助于消费者，也有助于 卫生保健从业者。

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.