PhytoAuthent: Molecular authentication of complex herbal food supplements for safety and efficacy

Ichim, Mihael Cristi; Crișan, Gianina; Ţebrencu, Carmen Elena; Boer, Hugo de

doi:10.3897/rio.3.e21710

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…Application of a DNA method only as a QC tool is not recommended due to the lack of specificity; DNA methods are recommended for detection of species substitution or falsification [83]. Constituents of interest or identity markers are not recommended to be applied as BIM of any herbs; this is also due to the lack of specificity.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Recent Development of Quality Control Methods for Herbal Derived Drug Preparations

Indrayanto

2018

Natural Product Communications

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Pharmaceutical industries should apply rigorous QC (quality control) to ensure the consistency, safety, and efficacy of their herbal derived drug-preparations. QC must be performed at every stage of the production line i.e. incoming raw materials, extractions, in-process control, finished products and keeping samples. Due to the complex nature of the chemical content of herbal drugs, two approaches to QC should be taken, that is quantitative determination of the selected marker(s) compound(s), and metabolite profiling. Contamination of herbal medicines by heavy metals, pesticides, toxic metabolites, microbial toxins, pathogenic microorganisms and other foreign matter should also be evaluated. A combination of chemical profiling and multivariate analysis (MVA) is recommended as the QC tool for the botanical identification method (BIM) of herbs, extracts, herb materials, and herbal drug preparations. Microscopic methods, DNA profiling or chemical marker(s) are not recommended for use as the sole BIM due to the lack of specificity. Only markers that meet certain criteria i.e. quality active (QA) markers can be utilized as a QC tool. The limit specification range of markers used as QC tools should be described in the analytical target profile (ATP). To gain reliable results of any analysis that has been performed at any QC laboratory, the analysis method must be validated according to the newest guidance. Sample detection limit of any toxic compound(s) should be lower than its cutoff value and MPL. The reliability of any results of analysis of a QC laboratory must be evaluated by using QC-samples for each series of measurements.

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Section: Conclusion and Recommendationsmentioning

confidence: 99%