Core 2 - Botanical Core

University Of Maryland Baltimore, Baltimore MD

Investigators

Linked publications & trials

Abstract

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