Application of DNA Barcoding for Quality Control of Herbal Drugs and Their Phytopharmaceuticals

Gesto-Borroto, Reinier; Medina‐Jiménez, Karina; Lorence, Argelia; Villarreal, Marı́a Luisa

doi:10.1007/s43450-021-00128-7

Cited by 17 publications

(9 citation statements)

References 124 publications

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“…Science-based quality standards, such as the up-to-date standards, may help to set appropriate quality attributes of DHSs between manufacturers, regulators, and other stakeholders when assessing their ingredients to ultimately homogenize the requirements, definition, and terminology of its categorization [ 50 , 51 ]. Additionally, emerging technologies such as DNA barcoding and next-generation sequencing can help to identify the origin of products, discriminate between similar species, and ensure reproducible results, thus improving research to establish a common reference standard between agencies [ 52 ]. Surveillance systems, such as China’s Adverse Drug Reaction Monitoring System and the FDA’s MedWatch program, have also provided important information regarding adverse events associated with DHSs [ 52 ].…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, emerging technologies such as DNA barcoding and next-generation sequencing can help to identify the origin of products, discriminate between similar species, and ensure reproducible results, thus improving research to establish a common reference standard between agencies [ 52 ]. Surveillance systems, such as China’s Adverse Drug Reaction Monitoring System and the FDA’s MedWatch program, have also provided important information regarding adverse events associated with DHSs [ 52 ]. Further to this, 4 out of the 11 countries in South-East Asia have established national systems for monitoring the safety of DHSs.…”

Section: Discussionmentioning

confidence: 99%

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Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

Kim

Suri

2022

J of Pharm Policy and Pract

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Background Over the last decade, the use of dietary and herbal supplements (DHSs) has expanded greatly across national healthcare settings for the prevention, management and/or treatment of a variety of health issues. Although regulatory policies for DHSs across different countries have been aimed towards evaluating safety and efficacy, performing quality controls, monitoring the manufacturing practices, and encouraging further research, significant safety issues have emerged from inappropriate regulatory classification, lack of suitable quality controls, and inadequate testing and labeling of these products. Therefore, the purpose of this scoping review was to identify facilitators and barriers to DHS regulation across different countries. Methods A scoping review was conducted and informed by the five-stage methodological framework proposed by Arksey and O’Malley and further enhanced by Levac et al. MEDLINE, EMBASE, AMED, and PsycINFO databases were systematically searched for eligible articles from database inception to September 29, 2020. Studies analyzing DHS regulatory frameworks were eligible for review. Relevant data from eligible articles were extracted and categorized into themes to provide a descriptive overview of the literature. Results Searches generated 4314 results, 1800 of which were duplicates, followed by 2472 that were excluded after screening the titles and abstracts of these articles. Of the remaining 42 full-texts, 15 eligible articles were included in this review. Themes identified include: (1) increased financial and human resources encouraging knowledge expansion as a facilitator to DHS regulation; (2) variances in DHS classification and regulatory requirements across countries as a barrier to DHS regulation, and (3) collaboration between various stakeholders (experts, policymakers, representatives of regulatory bodies, product companies and research institutions) facilitating DHS regulation. Conclusion The present scoping review identified facilitators and barriers to DHS regulation across different countries. We highlight that safety assessments of DHSs continue to be inadequate, and emerging technologies could potentially play a significant role in establishing common reference standards of herbal materials and products between regulatory agencies. Regulatory harmonization, increased scientific research, and collaboration could improve regulations globally through appropriate categorization and safe application of DHSs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

Kim

Suri

2022

J of Pharm Policy and Pract

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“…The researchers are currently interested in the other tool for botanical drugs authentication using genetic fingerprinting techniques. DNA barcoding enabled a rapid examination of the botanical drugs composition and was found to be an effective technique for authenticating dried and powdered plant materials for quality control purposes ( Gesto-Borroto et al, 2021 ). Tnah et al (2014) were the first to report the use of a genetic-based fingerprint technique to differentiate leaves of three M. pumilum varieties collected in the wild, followed by another investigation of botanical drug products containing M. pumilum ( Tnah et al, 2019 ) ( Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

Authentication of Marantodes pumilum (Blume) Kuntze: A Systematic Review

et al. 2022

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Botanical drug products consist of complex phytochemical constituents that vary based on various factors that substantially produce different pharmacological activities and possible side effects. Marantodes pumilum (Blume) Kuntze (Primulaceae) is one of the most popular Malay traditional botanical drugs and widely recognized for its medicinal use. Many studies have been conducted focusing on the identification of bioactive substances, pharmacological and toxicological activities in its specific varieties but less comprehensive study on M. pumilum authentication. Lack of quality control (QC) measurement assessment may cause different quality issues on M. pumilum containing products like adulteration by pharmaceutical substances, substitution, contamination, misidentification with toxic plant species, which may be detrimental to consumers’ health and safety. This systematic literature review aims to provide an overview of the current scenario on the quality control of botanical drug products as determined by pharmacopoeia requirements specifically for M. pumilum authentication or identification. A systematic search for peer-reviewed publications to document literature search for M. pumilum authentication was performed using four electronic databases: Web of Science, PubMed, Scopus and ScienceDirect for related studies from January 2010 to December 2021. The research studies published in English and related articles for identification or authentication of M. pumilum were the main inclusion criteria in this review. A total 122 articles were identified, whereby 33 articles met the inclusion criteria. Macroscopy, microscopy, chemical fingerprinting techniques using chromatography, spectroscopy and hyphenated techniques, and genetic-based fingerprinting using DNA barcoding method have been used to identify M. pumilum and to distinguish between different varieties and plant parts. The study concluded that a combination of approaches is necessary for authenticating botanical drug substances and products containing M. pumilum to assure the quality, safety, and efficacy of marketed botanical drug products, particularly those with therapeutic claims.

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“…DNA barcoding is an identification tool of different samples based on the molecular marker of conserved regions [ 27 , 28 ]. DNA Barcoding is widely used to identify and classify animal and plant species; unknown samples even previously described [ 29 , 30 ]. Moreover, DNA barcoding is used for quality control and identification of food authentication, for example, seafood, herbal plants, and crops [ 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

DNA Barcoding of Two Thymelaeaceae Species: Daphne mucronata Royle and Thymelaea hirsuta (L.) Endl

Alkaraki

Aldmoor

Lahham

et al. 2021

Plants

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Daphne mucronata Royle and Thymelaea hirsuta (L.) Endl both belong to the Thymelaeaceae family. Both species are used traditionally to treat several diseases along with various daily applications by Jordanian Bedouins. Traditionally, those species are identified through personal proficiency, which could be misleading due to human errors or lack of expertise. This study aims to investigate an effective DNA barcoding method to identify and characterize Daphne mucronata Royle and Thymelaea hirsuta plant species at the molecular level. Daphne mucronata Royle and Thymelaea hirsuta were collected from the ancient city of Petra in the Southern part of Jordan. Sequences of candidate DNA barcodes were amplified (rbcL, matK, and rpoC1), sequenced, and aligned to the blastn database. Moreover, the obtained sequences were compared with available sequences of related species at the GenBank database. Our results showed that DNA barcoding successfully identifies the two plant species using any of chloroplast genes (rbcL, matK, or rpoC1). The results emphasize the ability of DNA barcoding for identifying and characterizing different plant species through the recruitment of different barcode loci in molecular identification.

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Application of DNA Barcoding for Quality Control of Herbal Drugs and Their Phytopharmaceuticals

Cited by 17 publications

References 124 publications

Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

Authentication of Marantodes pumilum (Blume) Kuntze: A Systematic Review

DNA Barcoding of Two Thymelaeaceae Species: Daphne mucronata Royle and Thymelaea hirsuta (L.) Endl

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