Standardization of Medicinal Plants for the Sustainable Exploitation of Biodiversity

Abstract

A supply of consistent raw plant material provides the basis on which manufacturing controls act to yield reproducible herbal medicinal products. Therefore, it is important to enact standards and specifications in herbal monographs that cover botanical, chemical, pharmacognostic, and physical properties to authenticate and standardize medicinal plants to assure consistency of the raw material. An important part of this effort is to develop analytical methods for the qualitative and quantitative assessment of raw plant materials using appropriate chromatographic methods. For example, a chromatographic assay, such as liquid or gas chromatography, could be included in a monograph to determine the constituent(s) with known therapeutic activity or an active marker or multiple analytical markers. The harmonization of standards in different regions and countries is intended to coordinate the quality assessment and facilitate access to international markets for these products. Standards defined by regional herbal monographs and quality requirements enacted by a harmonized multinational regulatory environment would be in the best interest for the sustainable development of herbal and traditional medicines.