scholarly journals Value the Unique Merit of HPTLC Image Analysis and Extending its Performance by Digitalization for Herbal Medicines Quality Control

Author(s):  
Pei Shan Xie Shuai Sun
Planta Medica ◽  
2021 ◽  
Author(s):  
Luiz C. Klein-Junior ◽  
Maira R. de Souza ◽  
Johan Viaene ◽  
Tania M. B. Bresolin ◽  
André L. de Gasper ◽  
...  

AbstractHerbal medicines are important options for the treatment of several illnesses. Although their therapeutic applicability has been demonstrated throughout history, several concerns about their safety and efficacy are raised regularly. Quality control of articles of botanical origin, including plant materials, plant extracts, and herbal medicines, remains a challenge. Traditionally, qualitative (e.g., identification and chromatographic profile) and quantitative (e.g., content analyses) markers are applied for this purpose. The compound-oriented approach may stand alone in some cases (e.g., atropine in Atropa belladonna). However, for most plant materials, plant extracts, and herbal medicines, it is not possible to assure quality based only on the content or presence/absence of one (sometimes randomly selected) compound. In this sense, pattern-oriented approaches have been extensively studied, introducing the use of multivariate data analysis on chromatographic/spectroscopic fingerprints. The use of genetic methods for plant material/plant extract authentication has also been proposed. In this study, traditional approaches are reviewed, although the focus is on the applicability of fingerprints for quality control, highlighting the most used approaches, as well as demonstrating their usefulness. The literature review shows that a pattern-oriented approach may be successfully applied to the quality assessment of articles of botanical origin, while also providing directions for a compound-oriented approach and a rational marker selection. These observations indicate that it may be worth considering to include fingerprints and their data analysis in the regulatory framework for herbal medicines concerning quality control since this is the foundation of the holistic view that these complex products demand.


2019 ◽  
Vol 57 (10) ◽  
pp. 944-949
Author(s):  
Ina Faraz ◽  
Arslan Ali ◽  
Faraz Ul Haq ◽  
Joseph Tchamgoue ◽  
Simeon F Kouam ◽  
...  

Abstract One of the major problems with the formulation of herbal medicines is the quality control of plant material to ensure its efficacy and safety. Quality control of medicinal plants requires analysis of many bioactive compounds present in the plant. C-alkylated flavonoids are an important bioactive subclass of flavonoids. A simple, rapid, sensitive and selective method is presented here for the quantification of bioactive C-alkylated flavonoids. This is the first quantitative method for analysis of C-alkylated flavonoids based on the multiple reaction monitoring (MRM) approach so far. This study focuses on method development for quantification of bioactive C-alkylated flavonoids. Quantification of a total of five C-alkylated flavonoids was done employing the MRM approach on an HPLC-QqQ-MS instrument. LODs and LOQs for quantified flavonoids were in the range of 0.41–1.32 and 1.23–3.96 ng/mL, respectively. Linear calibration curves between 25 and 1500 ng/mL were obtained with the regression coefficients of ≥0.996. Accuracy (% bias) and precision (% RSD) of the analyses were found to be less than 5%. Developed HPLC-ESI-MS/MS can be employed as a quality control method of plant raw materials.


Genes ◽  
2019 ◽  
Vol 10 (2) ◽  
pp. 122 ◽  
Author(s):  
Denis Omelchenko ◽  
Anna Speranskaya ◽  
Andrey Ayginin ◽  
Kamil Khafizov ◽  
Anastasia Krinitsina ◽  
...  

Plants are widely used for food and beverage preparation, most often in the form of complex mixtures of dried and ground parts, such as teas, spices or herbal medicines. Quality control of such products is important due to the potential health risks from the presence of unlabelled components or absence of claimed ones. A promising approach to analyse such products is DNA metabarcoding due to its high resolution and sensitivity. However, this method’s application in food analysis requires several methodology optimizations in DNA extraction, amplification and library preparation. In this study, we present such optimizations. The most important methodological outcomes are the following: 1) the DNA extraction method greatly influences amplification success; 2) the main problem for the application of metabarcoding is DNA purity, not integrity or quantity; and 3) the “non-amplifiable” samples can be amplified with polymerases resistant to inhibitors. Using this optimized workflow, we analysed a broad set of plant products (teas, spices and herbal remedies) using two NGS platforms. The analysis revealed the problem of both the presence of extraneous components and the absence of labelled ones. Notably, for teas, no correlation was found between the price and either the absence of labelled components or presence of unlabelled ones; for spices, a negative correlation was found between the price and presence of unlabelled components.


2018 ◽  
Vol 13 (12) ◽  
pp. 1934578X1801301 ◽  
Author(s):  
Gunawan Indrayanto

Pharmaceutical industries should apply rigorous QC (quality control) to ensure the consistency, safety, and efficacy of their herbal derived drug-preparations. QC must be performed at every stage of the production line i.e. incoming raw materials, extractions, in-process control, finished products and keeping samples. Due to the complex nature of the chemical content of herbal drugs, two approaches to QC should be taken, that is quantitative determination of the selected marker(s) compound(s), and metabolite profiling. Contamination of herbal medicines by heavy metals, pesticides, toxic metabolites, microbial toxins, pathogenic microorganisms and other foreign matter should also be evaluated. A combination of chemical profiling and multivariate analysis (MVA) is recommended as the QC tool for the botanical identification method (BIM) of herbs, extracts, herb materials, and herbal drug preparations. Microscopic methods, DNA profiling or chemical marker(s) are not recommended for use as the sole BIM due to the lack of specificity. Only markers that meet certain criteria i.e. quality active (QA) markers can be utilized as a QC tool. The limit specification range of markers used as QC tools should be described in the analytical target profile (ATP). To gain reliable results of any analysis that has been performed at any QC laboratory, the analysis method must be validated according to the newest guidance. Sample detection limit of any toxic compound(s) should be lower than its cut-off value and MPL. The reliability of any results of analysis of a QC laboratory must be evaluated by using QC-samples for each series of measurements.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20508-e20508
Author(s):  
Andreas H. Scheel ◽  
Gudrun Bänfer ◽  
Gustavo Bruno Baretton ◽  
Manfred Dietel ◽  
Rolf Diezko ◽  
...  

e20508 Background: Immunohistochemistry (IHC) of the PD-L1 protein has become a mandatory diagnostic test for NSCLC. We conducted a two-step round robin test to analyze interobserver- and interlaboratory-concordance of PD-L1 IHC and to compare four clinical trial assays (CTAs; 28-8, 22C3, SP264, SP142) and laboratory-developed tests (LDTs). Results of step-one showed that reproducible PD-L1 IHC scoring is feasible; here we present the data on interlaboratory concordance Methods: Interlaboratory-concordance was tested by a centrally prepared tissue-microarray containing 21 NSCLC specimens that was stained at ten sites using CTAs and LDTs. Assay-performance was assessed with a second tissue-microarray containing eleven cell-lines with defined PD-L1 expression. Slides were evaluated by central quality-control and image-analysis. Results: The four CTAs yielded reproducible IHC-stainings at all sites while the results of the LDTs were mixed: Six protocols showed appropriate IHC quality with staining patterns similar to 22C3 and 28-8 CTAs, five protocols yielded less DAB-deposits and reduced staining intensity. Interlaboratory-concordance of carcinoma cell scoring using the 6-step system was moderate (κ = 0.43-0.69) while the included cut-offs ≥1% and ≥50% showed substantial concordance for the CTAs (κ = 0.73-0.89) and moderate concordance for the LDTs (κ = 0.50). No significant differences in interlaboratory-concordance were found among the CTAs. However, differences in the resulting staining patterns were noticed: While 22C3 and 28-8 showed similar staining patterns, SP263 showed minor differences in some cases and SP142 showed distinct patterns. Conclusions: The data show that the PD-L1 CTAs can be reproducibly employed and scored at different sites. LDTs with staining patterns similar to the CTAs are possible yet have to be carefully calibrated to match the appropriate intensity-range. The choice of assay and the set-up of the IHC-protocol may strongly influence the resulting staining.


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