Botanical Dietary Supplements for Women's Health

UIC/NIH植物性膳食补充剂研究中心（“UIC/NIH植物中心”和“中心”）成立于1999年秋季，旨在解决植物性膳食补充剂（BDS）的标准化，质量，安全性和有效性问题。该中心采取了多学科的战略，以实现其基础和临床研究目标。参与的教师和合作研究者来自药学院的部门。药物化学与生药学与医学院系眼科和视觉科学，生物统计科。通过该中心的分包商协议，西北大学范伯格医学院妇产科系的教师也有代表。该中心的研究重点是据报道对妇女健康有潜在益处的植物药，并强调研究其安全性、功效和作用机制。对植物提取物进行严格的化学评价（项目1：代谢组学表征），然后进行体外和体内生物学试验。本中心将使用生物测定和动物模型研究常用植物药与雌激素的相互作用（项目2）。此外，在之前的中心临床试验中已经证明具有足够安全性特征的植物药将作为临床试验的候选药物，以评价其在处方药存在下的安全性和有效性特征（项目3）。这些试验将研究植物性药物黑升麻、红三叶草和啤酒花对伦理药物的影响，这些药物来自经过肝脏代谢的药物类别，经常被中年妇女使用。因此，在本资助周期内寻求更清晰的药物-植物相互作用的安全性特征。根据目前进行的第一阶段试验的预期安全性结果，该中心将为啤酒花的第二阶段试验寻求独立的资金。为了实现这一议程，以确定已经在化学和生物学上标准化的BDS的安全性，更新的BRC研究计划强调植物药对妇女健康的安全性，将围绕三个项目和四个核心组织：项目1：植物化学和协同作用的代谢组学表征，项目2：雌激素致癌作用的植物调节，项目3：代谢、安全性和有效性，核心A：管理和开发，核心B：植物完整性，核心C：生物测定和核心D：分析。本申请中提出的实验将极大地提高对植物药作用机制的科学理解，从而提高其在安全性分析方面的功效。

DESCRIPTION (provided by applicant): The UIC/NIH Center for Botanical Dietary Supplements Research ("UIC/NIH Botanical Center" and "Center") was established in the fall of 1999 to address issues of standardization, quality, safety and efficacy of botanical dietary supplements (BDS). The Center adopted a multi-disciplinary strategy to achieve its basic and clinical research goals. Participating faculty and co-investigators are drawn from the College of Pharmacy's Dept. of Medicinal Chemistry and Pharmacognosy & College of Medicine's Dept. of Ophthalmology and Visual Sciences, Biostatistics Section. Through the Center's subcontractor agreement, faculty with Northwestern University's Feinberg School of Medicine, Department of OBGYN are also represented. The Center focuses its studies on botanicals that are reported to have potential benefit for women's health, and emphasizes the study of their safety profiles, as well as efficacy and mechanism of action. Botanical extracts are subjected to rigorous chemical evaluations (Project 1: Metabolomic characterizations) followed by both in vitro and in vivo biological testing. The Center will study the interaction of frequently used botanicals with estrogen hormones using bioassay and animal models (Project 2). Additionally, botanicals which have already demonstrated an adequate safety profile during previous Center clinical trials will be candidates for a clinical trial to evaluate their safety and efficacy profile in the presence of prescription drugs (Project 3). The trials will study the impact of the botanicals black cohosh, red clover and hops on ethical drugs, from drug classes which undergo hepatic metabolism and are frequently used by mid-life women. Thus, a clearer safety profile of drug-botanical interactions is sought during this grant cycle. Based on an anticipated safety results from a currently conducted Phase I trial, the Center will seek independent funding for a Phase II trial of hops. In order to achieve this agenda for determining the safety of BDS that have been chemically- and biologically-standardized, the renewed BRC research program which emphasizes the safety of botanicals for women's health will be organized around three Projects and four Cores: Project 1: Metabolomic Characterization of Botanical Chemistry and Synergy, Project 2: Botanical Modulation of Estrogen Carcinogenesis, Project 3: Metabolism, Safety and Efficacy, Core A: Administrative and Development, Core B: Botanical Integrity, Core C: Bioassay & Core D: Analytical. The experiments proposed in this application will greatly enhance the scientific understanding of the mechanism of action of botanicals and therefore their efficacy within an enhanced view of safety profiling.