Michael P Lindenmaier, Matthew W Bernart, Josef A Brinckmann
{"title":"Advanced Methodologies for the Quality Control of Herbal Supplements and Regulatory Considerations.","authors":"Michael P Lindenmaier, Matthew W Bernart, Josef A Brinckmann","doi":"10.1002/pca.70000","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Herbal supplements and OTC herbal drugs enjoy wide popularity with consumers but their quality has been questioned by genomic methods of testing. Due to complex regulatory environments in Europe and North America, the quality assurance of herbal preparations depends on protocols, which can significantly differ between the respective national and supranational drug control agencies. Modern methods of analysis combine genetic testing (DNA barcoding) with advanced chromatographic techniques as well as traditional microscopic and macroscopic tests to detect adulterants and undesirable constituents of herbs, including alkylphenols, aristolochic acids, and pyrrolizidine alkaloids.</p><p><strong>Objective: </strong>This review will give an account of current trends in herbal drug analysis and explain the shortcomings of existing methodologies. The article will also discuss regulatory protocols, compendial methods and differentiate between dietary supplement testing regimens and the requirements for approved herbal drugs. The purpose of this review is to document current trends in genetic testing and reveal future developments in drug analysis to reduce the possibility of adulterations and assure the authenticity of herbal products.</p><p><strong>Results: </strong>Chemometric methods and orthogonal approaches aid in the deconvolution of chromatographic and spectral data while expanding databases for nucleotide sequences and mineable spectra support method development in herbal analysis.</p><p><strong>Conclusion: </strong>Genetic testing of herbal products has further increased the capabilities to detect minute adulterations, but such assays are only meaningful in combination with chromatographic and spectroscopic analysis. Despite the advancement of genomic testing, chemometrics, UHPLC and mass spectrometry, cost-effective quality control techniques such as HPTLC in conjunction with microscopic and macroscopic examination remain important particularly in regulated environments.</p>","PeriodicalId":20095,"journal":{"name":"Phytochemical Analysis","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytochemical Analysis","FirstCategoryId":"99","ListUrlMain":"https://doi.org/10.1002/pca.70000","RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Herbal supplements and OTC herbal drugs enjoy wide popularity with consumers but their quality has been questioned by genomic methods of testing. Due to complex regulatory environments in Europe and North America, the quality assurance of herbal preparations depends on protocols, which can significantly differ between the respective national and supranational drug control agencies. Modern methods of analysis combine genetic testing (DNA barcoding) with advanced chromatographic techniques as well as traditional microscopic and macroscopic tests to detect adulterants and undesirable constituents of herbs, including alkylphenols, aristolochic acids, and pyrrolizidine alkaloids.
Objective: This review will give an account of current trends in herbal drug analysis and explain the shortcomings of existing methodologies. The article will also discuss regulatory protocols, compendial methods and differentiate between dietary supplement testing regimens and the requirements for approved herbal drugs. The purpose of this review is to document current trends in genetic testing and reveal future developments in drug analysis to reduce the possibility of adulterations and assure the authenticity of herbal products.
Results: Chemometric methods and orthogonal approaches aid in the deconvolution of chromatographic and spectral data while expanding databases for nucleotide sequences and mineable spectra support method development in herbal analysis.
Conclusion: Genetic testing of herbal products has further increased the capabilities to detect minute adulterations, but such assays are only meaningful in combination with chromatographic and spectroscopic analysis. Despite the advancement of genomic testing, chemometrics, UHPLC and mass spectrometry, cost-effective quality control techniques such as HPTLC in conjunction with microscopic and macroscopic examination remain important particularly in regulated environments.
期刊介绍：
Phytochemical Analysis is devoted to the publication of original articles concerning the development, improvement, validation and/or extension of application of analytical methodology in the plant sciences. The spectrum of coverage is broad, encompassing methods and techniques relevant to the detection (including bio-screening), extraction, separation, purification, identification and quantification of compounds in plant biochemistry, plant cellular and molecular biology, plant biotechnology, the food sciences, agriculture and horticulture. The Journal publishes papers describing significant novelty in the analysis of whole plants (including algae), plant cells, tissues and organs, plant-derived extracts and plant products (including those which have been partially or completely refined for use in the food, agrochemical, pharmaceutical and related industries). All forms of physical, chemical, biochemical, spectroscopic, radiometric, electrometric, chromatographic, metabolomic and chemometric investigations of plant products (monomeric species as well as polymeric molecules such as nucleic acids, proteins, lipids and carbohydrates) are included within the remit of the Journal. Papers dealing with novel methods relating to areas such as data handling/ data mining in plant sciences will also be welcomed.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
