The application of metabolomics for herbal medicine pharmacovigilance: a case study on ginseng

2016 ◽  
Vol 60 (5) ◽  
pp. 429-435 ◽  
Author(s):  
Elly Crighton ◽  
Ian Mullaney ◽  
Robert Trengove ◽  
Michael Bunce ◽  
Garth Maker

Herbal medicines are growing in popularity, use and commercial value; however, there remain problems with the quality and consequently safety of these products. Adulterated, contaminated and fraudulent products are often found on the market, a risk compounded by the fact that these products are available to consumers with little or no medical advice. Current regulations and quality control methods are lacking in their ability to combat these serious problems. Metabolomics is a biochemical profiling tool that may help address these issues if applied to quality control of both raw ingredients and final products. Using the example of the popular herbal medicine, ginseng, this essay offers an overview of the potential use of metabolomics for quality control in herbal medicines and also highlights where more research is needed.

1994 ◽  
Vol 12 (8) ◽  
pp. 711-724 ◽  
Author(s):  
P. A. Miller ◽  
M. F. Barth ◽  
D. W. van de Kamp ◽  
T. W. Schlatter ◽  
B. L. Weber ◽  
...  

Abstract. The National Oceanic and Atmospheric Administration (NOAA) has completed the installation of a 30-site demonstration network of wind-profiling radars in the central United States. The network is being used to demonstrate and assess the utility of wind profiler technology in a quasi-operational environment, and to help define operational requirements for possible future national networks. This paper describes two automated quality control methods designed to remove erroneous winds from the hourly network data. Case study examples and statistical evaluation of the performance of each method are also presented.


2020 ◽  
Vol 9 (3) ◽  
pp. 171-176
Author(s):  
Nurul Retno Nurwulan ◽  
Wilcha Anatasya Veronica

A good quality control system is important to be implemented to increase productivity and minimize defects in products. One of the quality control methods is failure mode and effect analysis (FMEA). This study uses the FMEA to identify the causes of the defects and recommend the prevention methods to overcome the causes of the defects in an Indonesian paper mill. The risk priority number (RPN) is calculated by multiplying the severity, occurrence, and detection of the failures that have been determined. Unsymmetrical and tainted products are the most dominant defects in the paper mill. An inappropriate machine setting is the cause of unsymmetrical products with the highest RPN of 343. The second highest RPN is problems with bleaching machines that caused tainted products with an RPN value of 216. This study offers suggestions to Indonesian paper mill to prevent and minimize defective products. 


2021 ◽  
Vol 19 ◽  
Author(s):  
Thomas Brendler ◽  
Josef A. Brinckmann ◽  
Ulrich Feiter ◽  
Nigel Gericke ◽  
Lucy Lang ◽  
...  

: Modern-day regulatory systems governing conditions for how health products enter national markets constitute a barrier of access for traditional herbal medicines on an international level. Regulatory intentions are focused on ensuring consumers are being provided with safe, efficacious and high-quality products that, however, collaterally limit opportunities for traditional herbal medicinal products, especially those that do not already have a long-standing tradition of use established in the respective national marketplaces. This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant – Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] aerial parts – fares internationally in today’s regulatory environments. It is argued that inadvertent regulatory favoritism combined with the lack of means for adequate protection of intellectual property may obstruct innovation by creating an almost insurmountable economical hurdle for successful product development and introduction of botanicals from developing countries into most of the world’s health product markets.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Soo-Hyun Sung ◽  
Ji-Eun Han ◽  
Ji-Yeon Ryu ◽  
Angela Dong-Min Sung ◽  
Jung-Youn Park ◽  
...  

Abstract Background An external herbal dispensary (EHD) is a type of pharmacy that provides various types of personalized herbal medicines (PHMs) to other traditional Korean medicine (TKM) institutions. Such dispensaries were legalized by the Ministry of Health and Welfare (MoHW) in 2008 in South Korea. The purpose of this study is to understand the current status of the EHD facilities and their quality controls and compare them with the good manufacture practice (GMP) guidelines to contribute to the establishment of the safety and quality control criteria for PHMs. Methods We contacted 107 EHD representatives or people in charge of the preparation of PHMs (TKM pharmacists) and invited them to complete a survey questionnaire; of the total, 81 responded. The survey questionnaire was developed in 3 stages: drafting, revision by external experts, and final editing. It consisted of 20 questions covering 3 sections: basic characteristics of EHDs, facility, and quality control. The survey was hosted online from December 2017 to January 2018 as guided by the MoHW. Results The completion rate was 75.7% (n = 81). In terms of facilities, the five facilities (water supply, manufacture, pest control, hygiene management and warehousing) that corresponded to the legal requirements of EHD were mostly equipped, but the types of facilities and equipment differed. Two facilities (sterilization and cross-contamination that were not legally required for EHD were found to have mostly pharmacopuncture-EHD (P-EHD), but hardly any herbal medicine-EHD (H-EHD). In our findings regarding quality control of non-medicinal herbs, sensory evaluation that included checks for foreign bodies and deterioration were conducted. In terms of the quality control of herbal medicines, residual pesticides and heavy metals tests were performed and for pharmacopuncture, pH, salinity, sterility, and endotoxin tests along with gross examination were performed. In the end, we found that 6 of the 38 standard items as required by the Korea GMP were suitable. Conclusions In this study, detailed information for each existing EHD law was determined through a nationwide questionnaire. Moreover, the basis for its reflection in additional legal standards should be introduced so that safe herbal medicine can be prepared in EHDs.


Author(s):  
Deepak Sharma ◽  
Suresh Kumar ◽  
Sandeep K. Thakur

2021 ◽  
Vol 12 ◽  
Author(s):  
Steven B. Woodley ◽  
Rhys R. Mould ◽  
Meliz Sahuri-Arisoylu ◽  
Ifigeneia Kalampouka ◽  
Anthony Booker ◽  
...  

Quality control has been a significant issue in herbal medicine since herbs became widely used to heal. Modern technologies have improved the methods of evaluating the quality of medicinal herbs but the methods of adulterating them have also grown in sophistication. In this paper we undertook a comprehensive literature search to identify the key analytical techniques used in the quality control of herbal medicine, reviewing their uses and limitations. We also present a new tool, based on mitochondrial profiling, that can be used to measure medicinal herbal quality. Besides being fundamental to the energy metabolism required for most cellular activities, mitochondria play a direct role in cellular signalling, apoptosis, stress responses, inflammation, cancer, ageing, and neurological function, mirroring some of the most common reasons people take herbal medicines. A fingerprint of the specific mitochondrial effects of medicinal herbs can be documented in order to assess their potential efficacy, detect adulterations that modulate these effects and determine the relative potency of batches. Furthermore, through this method it will be possible to assess whole herbs or complex formulas thus avoiding the issues inherent in identifying active ingredients which may be complex or unknown. Thus, while current analytical methods focus on determining the chemical quality of herbal medicines, including adulteration and contamination, mitochondrial functional analysis offers a new way of determining the quality of plant derived products that is more closely linked to the biological activity of a product and its potential clinical effectiveness.


2020 ◽  
Author(s):  
Lizhen Yu ◽  
Fengjiao Bu ◽  
Xuebin Shen ◽  
Ying Xiong ◽  
Yong Fan ◽  
...  

Abstract Background Green and economic conversion of spirostanol saponins in the plant is considered as an attracting area in pharmaceutical applications. We aimed to provide a practical paradigm named limewater-based conversion of spirostanol saponins (LCSS), meanwhile, a widely-used traditional Chinese herbal medicine, Paridis Rhizoma (PR), was selected as a case study. Methods Based on single factor experiments, response surface methodology (RSM) using a Box-Behnken design (BBD) was employed to optimize processing time, limewater concentration and solvent volume to obtain a maximum total saponins yield from PR. H1299, A549 and HeLa cell lines was carried out to check pharmacological effect of Crude Paridis Rhizoma (CPR) and Processed Paridis Rhizoma (PPR), and the technology was reconfirmed by another herbal medicine, Anemarrhenae Rhizoma (AR). Results The optimal conditions were: processing time of 24 h, limewater concentration of 0.12% limewater and solvent volume of 60 mL/30 g. Under these conditions, the contents of polyphyllin VII, polyphyllin II, dioscin, gracillin, and polyphyllin I had 1.131 ± 0.448, 1.835 ± 0.479, 1.430 ± 0.550, 1.761 ± 0.571 and 1.668 ± 0.360 times increasing in four batches of PR, which was responsible for the increasing of total spirostanol saponins (TSS) in PPR. In addition, the extracts of PPR exhibited stronger antitumor potential than that of CPR on H1299, A549 and HeLa cell lines based on MTT test and cell scratch test. The efficiency of proposed LCSS was then reconfirmed by Anemarrhenae Rhizome (AR), indicating its capacity in broader application. Conclusion This study depicted a LCSS strategy that may have great potential in achieving effective and economic improvement of spirostanol saponin accumulation in herbal medicines.


2021 ◽  
Vol 10 (2) ◽  
pp. 156-165
Author(s):  
Razieh Mirzaeian ◽  
Farahnaz Sadoughi ◽  
Shahram Tahmasebian ◽  
Morteza Mojahedi

In recent years, there has been a renewed interest in the use of herbal medicines. Quality control and safety are two critical principles to be considered in the production process of herbal medicines. This review study aimed to investigate the condition of the countries other than Iran in terms of observing the safety principles, quality control, and meeting the standard of herbal drug use. In this systematic review, references were selected using the search terms "health-care quality" and "challenges of herbal medicine usage" from the databases "Web of Science" and "PubMed" published between 2000 and 2019. To select the resources among the selected literature, confirmation was accomplished by two researchers and Cohen’s kappa coefficient (κ). The selected papers were classified based on publication year, journal, country, reference standards, regulation, toxicity evaluation, quality control, efficacy, safety, and adverse effects in herbal medicine. From 1532 retrieved papers, 27 papers with an estimated Cohen’s kappa coefficient of 0.81 were confirmed and included in the study. Based on the analysis, the main findings of the papers were thematically classified into seven subcategories as follows: reference standards in herbal medicine, regulation of herbal medicinal products, toxicity evaluation for herbal products, quality control of herbal medicine, efficacy, adverse effects of herbal medicine, and safety. Given the significance of the effects of herbal medicines on health care quality, it is essential to codify guidelines on the proper use of these drugs.


Sign in / Sign up

Export Citation Format

Share Document