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 osteoarthritis. To achieve this objective, this Core proposes to prepare and provide standardized herbal extracts for animal and clinical studies in Projects 2 and 3, respectively. Toward this end, source materials will be acquired through good sourcing practices; 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 the acquisition of quality crude plant drug materials and the chemical profiling of the individual herbs; the isolation and identification of bioactiveor marker compounds for chemical standardization purposes; the development of standardization procedures for the composite formula; the preparation of extracts for animal studies and the production of a standardized preparation under GMP for clinical studies; and the monitoring of the stability of the standardized preparation.
These specific aims will be achieved as follows. Quality authenticated crude botanicals will be acquired from reliable commercial sources in China, their cultivation/collection origins and relevant sourcing information documented, and their identities authenticated by macroscopic/organoleptic and microscopic examinations with reference to pharmacopoeial standards with the assistance of collaborators in Beijing, China. 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 extracts prepared from the composite formula, and major marker compounds will be isolated from indi. The bioactividual herbs as necessary. Active 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 3. The stability of the product will be monitored in real time from day of manufacture to the conclusion of the clinical study period.
Showing the most recent 10 out of 33 publications
