Advances in Fingerprint Analysis for Standardization and Quality Control of Herbal Medicines

Abstract

Herbal drugs or herbal medicines (HMs) have a long-standing history as natural remedies for preventing and curing diseases. HMs have garnered greater interest during the past decades due to their broad, synergistic actions on the physiological systems and relatively lower incidence of adverse events, compared to synthetic drugs. However, assuring reproducible quality, efficacy, and safety from herbal drugs remains a challenging task. HMs typically consist of many constituents whose presence and quantity may vary among different sources of materials. Fingerprint analysis has emerged as a very useful technique to assess the quality of herbal drug materials and formulations for establishing standardized herbal products. Rather than using a single or two marker(s), fingerprinting techniques take great consideration of the complexity of herbal drugs by evaluating the whole chemical profile and extracting a common pattern to be set as a criterion for assessing the individual material or formulation. In this review, we described and assessed various fingerprinting techniques reported to date, which are applicable to the standardization and quality control of HMs. We also evaluated the application of multivariate data analysis or chemometrics in assisting the analysis of the complex datasets from the determination of HMs. To ensure that these methods yield reliable results, we reviewed the validation status of the methods and provided perspectives on those. Finally, we concluded by highlighting major accomplishments and presenting a gap analysis between the existing techniques and what is needed to continue moving forward.

Suitability of botanical extracts as components of complex mixtures used in herbal tea infusions—challenges and opportunities

“…Confirmation of identity is critical to botanical quality testing, as is widely reflected in regulations governing the manufacture and marketing of dietary supplements and herbal medicinal products ( European Commission, 2003 ; United States Food and Drug Administration, 2022 ). The identity methods most cited within pharmacopoeias are of two types: macro/microscopic analysis and High Performance Thin Layer Chromatography (HPTLC) ( Noviana et al, 2022 ). While diagnostic anatomical and cellular features needed for macro/microscopic identification are not maintained through the process of extraction, a botanical extract’s chemical fingerprint acts as a link to the identity of the raw material.…”

“…In addition to identity testing of single ingredient extracts, HPTLC is a valued technique for determination of extract identity when combined with other herbal ingredients ( Reich and Frommenwiler, 2021 ; Frommenwiler et al, 2022 ; Noviana et al, 2022 ). An elderberry juice extract applied to a substrate of echinacea aerial parts to regulate particle size and mitigate hygroscopicity requires an identification method capable of distinguishing both herbal components of the combined ingredient.…”

Fingerprint and Multivariate Analysis of Apium Graveolens L. From Different Geographic with Spectroscopic ATR-FTIR

“…FTIR spectrum contains multivariate data in the form of absorbance in the range of wave numbers 4000 -650 cm -1 . 12 Each sample has a different spectrum identity, the spectrum has dominant peaks that show the differences in each sample. 8,12,13 ATR-FTIR spectroscopy method combined with multivariate analysis is highly recommended for qualitative or quantitative QC tools for individual or mixed herbal medicine.…”

Herbal Decoctions for the Levels of Sulfur Dioxide, Benzopyrene, and Mycotoxin from Traditional Korean Medicine Clinics: A Preliminary Study

“…According to the World Health Organization (WHO), in 2018, about 90% of member states and countries had regulations about herbal medicines [ 13 ]. Many countries have suggested guidelines on good manufacturing practices (GMP) and methods to standardize the quality of herbal medicines and to make them safe and efficient [ 14 ]. However, most guidelines of herbal medicine often follow rules for pharmaceutical products, foods, or food supplements without special consideration [ 12 ].…”

“…Safety concerns from contamination, heavy metals, and adulteration arise mainly from restricted quality control regulations and deficiency of internationally accepted standards [ 12 ]. Reproducible results demand the development, evaluation, and standardization of the latest methods of chemistry, biology, and pharmacology [ 14 ].…”