Development, Assessment, Improvement, and Standardization of Methods in Herbal Drug Research

About this Research Topic

Background

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This Research Topic is linked to the survey initiative developed by our Chief Editor Prof. Michael Heinrich and Dr. Banaz Jalil at UCL focused on Best Practice Guidelines for the Characterisation of Extracts used in Pharmacological, Clinical and Toxicological Research.

Please access the survey here (if you wish to participate, please do so before 15-October-2021).

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Herbal drugs (HD) and traditional medicinal plants have been used for centuries. The efficacy and toxicity of HD depend on their metabolites content. There are countless publications on HD, but unfortunately, most of them do not properly report chemical and biological aspects including the composition of the preparations. Therefore, the reliability of the data and thus the conclusions cannot be ascertained. Consequently, the products’ safety, pharmacological effects and efficacy cannot be assessed. Consequently, the application of HD as medicines remains rather limited, and has already been addressed in the journals ‘Four Pillars of best Practice’ (see also this article), which offers a wider perspective on this topic).

The most important step for developing modern drugs from HD is to study their bioactive metabolites including their chemical and pharmacological characterizations. Reproducibility requires the development, assessment, and standardization of chemical and biological methods based on the current state of the art. In general, the identity of (bioactive/toxic) metabolites in HD or biological fluids should be stated unambiguously using chromatographic and/or spectroscopic methods. The purity of the metabolite peak should be evaluated. Selectivity, linearity, accuracy, repeatability, intermediate precision, range, and robustness should be reported in quantitative analysis; mean ± confidence interval should be used, instead of mean ± (R)SD. For the analysis of toxic metabolite(s) in HD, the sample detection limit must be reported for each matrix.

The authentication of the cell lines and microorganisms should be reported. Z’-factor (standard/sample), the precision of EC50/CC50, and Selective index need to be evaluated in in vitro bioactivity studies of HD/isolated metabolites. Within and between run variations should be evaluated in in vivo studies. Null hypothesis significance testing should be avoided and replaced with the presentation of the effect sizes and their confidence intervals. CV of selected variables should be evaluated, unsupervised MVA model (PCA) should be assessed prior to performing supervised models (PLS, PLS-DA, SIMCA, etc.); cross-assessment and external-assessment data of the used models should be reported.

This Research Topic aims to attract innovative original contributions in new validated (chemical and biological) methods for HD research. We welcome Original Research and Review articles, focusing on the following subtopics, but not limited to:

• Method development and assessment of the chemical profiling as QC tools for HD-preparations.
• Discovery of the bioactive metabolite(s) and/or toxic metabolite(s) from HD and/or traditional medicinal plants.
• Development and assessment of the method of analysis for bioactive/toxic metabolites or chemical markers in HD-preparations.
• Development and assessment of the method of analysis for bioactive metabolites in biological fluids.
• Development and assessment of in vitro bioassay methods for the determination of a certain bioactivity effect.
• Development and assessment of in/ex vivo methods for the determination of a certain pharmacology effect.

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All the manuscripts submitted to the collection will need to fully comply with the Four Pillars of Best Practice in Ethnopharmacology (you can freely download the full version here).

We would like to drive the attention of the authors especially to Pillar 1 a):
Traditional context - The traditional context must be described in the introduction and supported with bibliographical primary references. This may be based on modern uses of a plant in general healthcare.

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Keywords: Herbal drugs, medicinal plants, validation methods, bioactive metabolites, toxic metabolites, metabolomics

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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