BOTANICAL DIETARY SUPPLEMENTS FOR WOMEN'S HEALTH

描述：(逐字摘自申请者的摘要)植物性膳食补充剂研究中心将由一个多学科的研究小组组成，他们将最初的工作重点放在研究用于治疗妇女健康的植物性药物的临床安全性和有效性，特别是更年期的治疗。其他研究将涉及作用机制、活性化合物的鉴定，以及这些植物中所含活性物种的代谢、生物利用度和药代动力学的表征。研究部分将由四个项目组成，将得到以下三个核心的支持：项目1.该生药学项目将与项目2合作开展植物膳食补充剂的标准化和活性化合物的结构鉴定。项目2将利用生物测定引导的分离分离活性化合物进行结构鉴定，然后将进行生化研究，以确定植物药对女性健康的作用机理(S)。项目3.在该项目期间，将开发和应用新的体外方法来研究植物中活性化合物的代谢、吸收和毒性。将对植物制剂的免疫毒性进行评估。项目4.本临床项目将对总状升麻和红三叶进行一期和二期临床试验。第一阶段的研究将集中于活性化合物的人体毒性、吸收、分布、新陈代谢和消除，第二阶段将评估缓解更年期症状的疗效。核心A.这个行政核心将促进调查人员之间的数据交流，协调数据存档，提供行政协助和统计支助，并将协调与咨询委员会的会议。核心B.教育和信息核心将负责制定生药学课程和实施研究生和博士后培训方案，实施互动在线学习和继续教育方案，为公众提供电话服务，以及搜索植物学信息数据库。核心C。LC-MS-MS核心将提供分析支持，包括：活性化合物的鉴定/分离和定量分析；生物利用度和药代动力学特征，以及尿代谢物的鉴定。有了这些研究设施，该中心将能够在未来扩大其努力，将用于更广泛的人类健康问题的其他植物药物的研究包括在内。

DESCRIPTION: (verbatim from the applicant's abstract) The Center for Dietary Supplements Research on botanicals will consist of a multidisciplinary team of investigators who will focus their initial efforts on the study of the clinical safety and efficacy of botanicals used to treat women's health with particular emphasis on therapies for menopause. Additional studies will address mechanisms of action, identification of active compounds, and characterization of metabolism, bioavailability and pharmacokinetics of active species contained in these botanicals. The research component will consist of four projects, which will be supported by three cores as follows: Project 1. This pharmacognosy project will carry out standardization of botanical dietary supplements and structure elucidation of active compounds using bioassay-guided fractionation in collaboration with Project 2. Project 2 will use bioassay-guided fractionation to isolate active compounds for structure elucidation, and then will carry out biochemical studies to determine the mechanism(s) of botanicals used for women's health. Project 3. Novel in vitro methods for the study of metabolism, absorption and toxicity of active compounds in botanicals will be developed and applied during this project. Immunotoxicity of botanical preparations will be evaluated. Project 4. This Clinical Project will carry out Phase I and Phase II clinical trials of black cohosh (Cimicifugae racemosa) and red clover (Trifolium pratense). Phase I studies will focus on human toxicity, absorption, distribution, metabolism and elimination of active compounds, and in Phase II, efficacy for the relief of menopausal symptoms will be evaluated. Core A. This Administrative Core will facilitate the exchange of data between investigators, coordinate data archiving, will provide administrative assistance and statistical support, and will coordinate meetings with the Advisory Committee. Core B. The Education and Information Core will be responsible for pharmacognosy curriculum development and the implementation of graduate and post-doctoral training programs, for the implementation of interactive on-line learning and continuing education programs, phone-in services for the public, and botanical information database searches. Core C. The LC-MS-MS Core will provide analytical support including: identification/dereplication and quantitative analysis of active compounds; bioavailability and pharmacokinetic profiles, and identification of urinary metabolites. With these research facilities in place, the Center will be positioned to expand its efforts in the future to include studies on other botanicals used for a wider range of human health issues.