Key principles and advanced approaches to quality assurance of phytopharmaceuticals
DOI:
https://doi.org/10.15574/SP.2023.134.7Keywords:
cough, quality assurance, phytoneering, phytopharmaceuticals, herbal medicinesAbstract
Due to the specificity of the composition and production of herbal medicines, ensuring their quality is particularly important, but at the same time an extremely difficult task.
Purpose - to review the key problems, principles and aspects of the quality of herbal medicines and generalize advanced approaches to ensure their quality using the example of a phytoneering drug for the treatment of cough in acute bronchitis and inflammatory diseases of the respiratory tract.
The concept of the quality of the phytoneering drug was considered and analyzed. The central role belongs to the well-founded choice of starting plant material, the use of cultivated subspecies of plants and own seed material, which is of critical importance for ensuring the optimal and stable phytochemical composition of the extracts. In addition, the quality of the phytoneering medicines is determined by strict compliance with the GACP guideline, a standardized production process in accordance with GMP using the latest patented technologies, leading procedures for continuous quality control and the possibility of analyzing the multicomponent composition of the obtained extracts. Thus, the concept of phytoneering provides a thorough and comprehensive methodological basis for establishing quality at each stage of the life cycle of the drug and the reproducibile and consistent quality of extracts from batch to batch. Together with a thorough evidence base of preclinical and clinical research all this is an absolute competitive advantage of the phytoneering medicine over other herbal drugs.
No conflict of interests was declared by the authors.
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