BOTANICAL DIETARY SUPPLEMENTS FOR WOMEN'S HEALTH

描述：（从申请人的摘要中逐字摘录）膳食补充剂植物研究中心将由一个多学科的研究小组组成，他们将集中精力研究用于治疗妇女健康的植物药物的临床安全性和有效性，特别强调更年期的治疗。进一步的研究将涉及作用机制、活性化合物的鉴定、代谢特征、这些植物药中活性物种的生物利用度和药代动力学。研究部分将包括四个项目，这些项目将由以下三个核心提供支持：本生药学项目将与项目2合作开展植物性膳食补充剂的标准化工作，并利用生物测定引导分离技术对活性化合物进行结构鉴定。项目2将使用生物测定引导分馏法分离活性化合物以进行结构分析，然后进行生物化学研究以确定用于妇女保健的植物药物的作用机制。项目3。本项目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。将评估植物制剂的免疫毒性。项目4。本临床项目将开展黑升麻（Cimicifugae racemosa）和红三叶草（Trifolium pratense）的一期和二期临床试验。一期研究将侧重于活性化合物的人体毒性、吸收、分布、代谢和消除，二期研究将评估缓解更年期症状的功效。核心A.这一行政核心将促进调查人员之间的数据交换，协调数据存档，提供行政协助和统计支助，并协调与咨询委员会的会议。核心b：教育和信息核心将负责生药学课程的开发和研究生和博士后培训计划的实施，交互式在线学习和继续教育计划的实施，公众电话服务以及植物信息数据库的搜索。LC-MS-MS Core将提供分析支持，包括：活性化合物的鉴定/反复制和定量分析；生物利用度和药代动力学特征，以及尿液代谢物的鉴定。有了这些研究设施，该中心将能够在未来扩大其努力，包括对用于更广泛的人类健康问题的其他植物药物的研究。

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.