Core 2 - Botanical Core

这个植物核心的长期目标是建立一个质量保证计划，以提供 一种标准化的、质量有保证的中药制剂， 肠易激综合征（IBS）的治疗。为实现这一目标，本核心文件提议编制和 为项目2和3的合作者提供标准化的草药提取物用于动物和临床研究， 分别为此，应制定采购源材料的标准; 以及对单个草药和多组分配方的化学特征进行表征 提取物;以及提取物的质量控制分析和稳定性监测。的 提出的具体目标包括确认和标准化单个植物原料药的质量 材料.化学标准化用生物活性化合物或标记化合物的分离和鉴定 目的;制定复合配方的标准化程序;编制 用于动物研究的提取物和用于临床研究的标准化制剂的GMP生产;以及 监测标准化制剂的稳定性。 这些具体目标将通过以下方式实现。优质的天然植物药材将从可靠的 商业来源、其种植/采集来源以及记录的相关来源信息，以及 通过肉眼/感官和显微镜检查验证其鉴别， 药典标准，并根据需要通过DNA分析进行扩增。草药的样本将被测试 防止潜在的农药、有毒金属、微生物和霉菌毒素污染，以确保安全。 将建立组分草药的色谱（HPLC和/或LC-MS）图谱作为指纹图谱， 其将用作复合草药混合物以及其自身特性的参考点。到 为了帮助标准化，生物活性成分将通过EtOH的生物测定定向分级分离 (90%）的由复合配方中的草药制备的提取物。还将分离主要的标记化合物 从草药中提取。将鉴定生物活性或标记化合物/阐明结构 并用作定性（HPLC/LC-MS）标准化以及 复合配方的定量标准化。将为动物制备适当的浸提液 研究项目2。将与项目2和3合作， 在GMP条件下制备，用于项目3的临床研究。最后，产品的稳定性将是 从生产之日至临床研究期结束期间进行真实的实时监测。

The long term objective of this Botanical Core is to establish a quality assurance program in order to provide a standardized, quality assured herbal preparation of a traditional Chinese medicine formula to be used in the treatment of irritable bowel syndrome (IBS). To achieve this objective, this Core proposes to prepare and provide standardized herbal extracts for animal and clinical studies by collaborators in Projects 2 and 3, respectively. Toward this end, standards for the source materials to be acquired; the methods of preparation and characterization of the chemical profiles of the individual herbs and the multi-component formula extracts; as well as quality control analysis and stability monitoring of the extracts will be established. The specific aims proposed include validation and standardization of the quality of individual crude plant drug materials; the isolation and identification of bioactive or marker compounds for chemical standardization purposes; the development of standardization procedures for the composite formula; the preparation of extracts for animal studies and the GMP production of a standardized preparation for clinical studies; and the monitoring of the stability of the standardized preparation. These specific aims will be achieved as follows. Quality crude botanicals will be acquired from reliable commercial sources, their cultivation/collection origins and relevant sourcing information documented, and their identities authenticated by macroscopic/organoleptic and microscopic examinations with reference to pharmacopoeial standards, and augmented by DNA analysis as needed. Samples of the herbs will be tested for potential contamination with pesticides, toxic metals, microorganisms and mycotoxins to insure safety. Chromatographic (HPLC and/or LC-MS) profiles for the component herbs will be established as fingerprint, which will serve as reference points for the composite herbal mixture as well as for their own identities. To assist in standardization, bioactive constituents will be isolated by bioassay-directed fractionation of EtOH (90%) extracts prepared from herbs in the composite formula. Major marker compounds will also be isolated from adjunctive herbs as needed. The bioactive or marker compounds will be identified/structures elucidated and be employed as references in the qualitative (HPLC/LC-MS) standardization, as well as in the quantitative standardization of the composite formula. Appropriate extracts will be prepared for animal studies by Project 2. In collaboration with Projects 2 and 3, a formulation with a defined dose will be prepared under GMP condition for clinical studies by Project 3. Finally, the stability of the product will be monitored in real time from day of manufacture to the conclusion of the clinical study period.