AUTHENTICATION AND QUALITY ASSESSMENT OF BOTANICALS AND BOTANICAL PRODUCTS USED IN CLINICAL RESEARCH

Fundamental in the clinical assessment of herbal drugs is the need for the full characterization of the botanical and/or the botanical product being investigated. This article provides an overview of how botanical raw materials and finished products need to be characterized in order to maximize the potential for clinical efficacy, minimize the potential for adulteration, and ensure the ability for reproducibility in future testing of the same agent. Addressed will be issues of physical and chemical characterization of botanicals using a model established by the American Herbal Pharmacopoeia. This characterization includes the botanical, macroscopic, and microscopic identification for the physical characterization of plants and the application of validated qualitative (HPTLC) and quantitative (e.g. HPLC) analytical methods for chemical characterization. Other quality control parameters, including harvest times, processing conditions, and application of good manufacturing practices, will be discussed, as will the complexity of compound herbal drugs, challenges in the approval of herbal drugs, and the need for authenticated botanical and chemical reference standards for the testing of herbal drugs.