Abstract

STANDARDIZATION OF HERBAL MEDICINE

Manoj Prajapati* and Awan Kumar Pandey

Abstract

Herbal medicine has been extensively practiced over the centuries in conventional as well as contemporary healthcare systems. Nonetheless, the absence of standardization in herbal preparations makes it a great challenge to maintain safety, efficacy, and quality. Standardization of herbal medicine employs different analysis-based, pharmacologybased, and regulatory methods aimed at ensuring bioactive component consistency, dosage, as well as therapeutic outcomes. Methods like chromatography, spectroscopy, and DNA barcoding are widely used to verify plant materials and identify adulterants. The WHO, FDA, and EMA have established guidelines for quality control of herbal products, but international harmonization is a problem. Although standardization procedures have been improved, differences in cultivation, processing, and storage conditions continue to influence the reproducibility of herbal medicine. Future studies should aim at refining quality assurance standards and combining indigenous knowledge with advanced analytical methods for increasing the validity of herbal remedies. The standardization of herbal products is very important to assure quality, safety, and efficacy. Such products are complex mixtures of bioactive compounds, and their compositions vary significantly with respect to plant species, growing condition, and processing methods. Standardization is a series of activities to ensure that the final building meets specific quality and purity standards. Such activities include botanical identification, chemical characterization, and quantification of marker compounds. Important for ensuring reproducibility of therapeutic effects of herbal products and prevention of adverse reactions, the regulation has its guidelines on standardization of herbal products given by global authorities such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). The importance of standardization in quality assurance is highlighted in this paper.

Keywords: Herbal products, standardization, quality control, safety, efficacy, botanical identification, chemical characterization, marker compounds.