Abstract

IntroductionHerbal medicines play an important role globally in the health care sector and in industrialised countries they are often considered as an alternative to mono‐substance medicines. Current quality and authentication assessment methods rely mainly on morphology and analytical phytochemistry‐based methods detailed in pharmacopoeias. Herbal products however are often highly processed with numerous ingredients, and even if these analytical methods are accurate for quality control of specific lead or marker compounds, they are of limited suitability for the authentication of biological ingredients.ObjectiveTo review the benefits and limitations of DNA barcoding and metabarcoding in complementing current herbal product authentication.MethodRecent literature relating to DNA based authentication of medicinal plants, herbal medicines and products are summarised to provide a basic understanding of how DNA barcoding and metabarcoding can be applied to this field.ResultsDifferent methods of quality control and authentication have varying resolution and usefulness along the value chain of these products. DNA barcoding can be used for authenticating products based on single herbal ingredients and DNA metabarcoding for assessment of species diversity in processed products, and both methods should be used in combination with appropriate hyphenated chemical methods for quality control.ConclusionsDNA barcoding and metabarcoding have potential in the context of quality control of both well and poorly regulated supply systems. Standardisation of protocols for DNA barcoding and DNA sequence‐based identification are necessary before DNA‐based biological methods can be implemented as routine analytical approaches and approved by the competent authorities for use in regulated procedures. © 2017 The Authors. Phytochemical Analysis Published by John Wiley & Sons Ltd.

Highlights

  • Herbal medicines play an important role in many industrialised countries as a complement and alternative to synthetic pharmaceuticals

  • Herbal product quality regulations vary between countries and together with a lack of standardised analytical methods (Locatelli et al, 2014; Locatelli and Celia, 2017; Melucci et al, 2017), complex processes for authentication and quality monitoring along their value chains are needed (Bent, 2008; Gertsch, 2009; Heinrich, 2015; Booker et al, 2015)

  • The Herbal Medicinal Products Committee (HMPC) is the European Medicines Agency’s (EMA’s) committee responsible for establishing monographs on the therapeutic uses and the safety of medicinal products, with the pharmacovigilance of the marketed herbal medicines being a regulatory requirement falling under the full responsibility of manufacturers and suppliers

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Summary

Introduction

Herbal medicines play an important role in many industrialised countries as a complement and alternative to synthetic pharmaceuticals. The global market for herbal products is projected to reach US$115 billion by 2020, with Europe leading the market (Global Industry Analyst, Inc., 2015). Their popularity is determined by consumers’ health concerns, cultural factors, and the belief that these are natural and safe (Lynch and Berry, 2007; Ipsos MORI, 2008). The production chains of regulated or unregulated herbal medicinal products result in different requirements at the various

National Pharmacovigilance
Regulatory status of herbal products
Quality issues and analytical challenges
Developments in analytical methods
Findings
DNA barcoding and metabarcoding
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