scholarly journals Quality Markers for Astragali Radix and Its Products Based on Process Analysis

2020 ◽  
Vol 11 ◽  
Author(s):  
Yuntao Dai ◽  
Dongbo Wang ◽  
Manjia Zhao ◽  
Lihua Yan ◽  
Chao Zhu ◽  
...  

Due to the complex nature of traditional medicines, quality control methods need to cover two aspects: compliance of raw materials with quality standards and process control. Astragali radix (AR), the roots of Astragalus mongholicus Bunge, was selected in this study as an example of a widely used traditional medicine in various formulations. Astragaloside IV (AG IV) and calycosin 7-O-β-D-glucoside (CG) are used as the markers for the quality control of AR and its products in the Chinese Pharmacopoeia. However, in the raw materials, malic acid esters of the CG and acetate esters of the astragaloside are easily decomposed into CG and AG IV during storage and processing of AR to make extracts for various preparations. The thermal stability of the isoflavonoids and astragalosides in decoction was studied. The level of CG and astragalosides (AG I/AG II/AG IV) was strongly affected by prolonged heat during processing, while calycosin was stable in the conditions. Also the major astragalosides in AR could fully converted into AG IV which eventually reaches a stable level under certain conditions. With calycosin and AG IV as marker components, practical, reproducible, and precise methods were established and applied to the quality analysis of AR from its raw materials to its intermediates and products. This study demonstrates that a full chemical profiles analysis of the whole manufacturing process (from “raw materials—intermediates/extracts—final product”) is important to identify quality markers (Q-markers) and even to establish proper analysis methods for traditional Chinese medicine products.

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.


2018 ◽  
Vol 64 ◽  
Author(s):  
N.V. Bespalova ◽  
M.M. Gomola ◽  
T.I. Yakovleva

The article is devoted to the urgent theoretical and practical problems of the quality control of the chocolate confectionery products in cafes and restaurants. The authors analyze the modern approaches to the quality control of the chocolate confectionery products. The practical recommendations can be useful for the process of selection of the high quality raw materials. The criteria for the quality control of the chocolate confectionery products have been given. Some ways to improve the quality of he chocolate confectionery products have been discussed.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (08) ◽  
pp. 5-6
Author(s):  
M. K. Raina ◽  

The therapeutic use of medicinal plants gained considerable momentum in the world during the past few decades. Traditional medicines, which are mostly based on the herbal raw materials growing in their respective regions, were used by over 70 percent of the world population as per WHO. The reason for their popularity was due to non-availability of modern medicines in the rural areas and also due to the unaffordability of modern medicines due to their high cost. Quality control of medicinal plants for use in these Traditional medicines has always been a challenge for the scientists working in this field. In our country, with the awareness growing among the people about the safety of Ayurvedic and Herbal medicines / cosmetics, the quality control testing of both raw herbal ingredients and finished formulations was seriously undertaken both by the academic / research institutions and the herbal drug manufacturers.


Molecules ◽  
2019 ◽  
Vol 24 (9) ◽  
pp. 1811
Author(s):  
Chunxia Zhao ◽  
Huan Liu ◽  
Peiqi Miao ◽  
Houen Wang ◽  
Heshui Yu ◽  
...  

Chinese medical preparation has complicated chemical constituents. Consequently, the proper quality control methods for these Chinese medical preparations have been great challenges to the traditional Chinese medicine modernization and internationalization. What components should be chosen for quality control is a big challenge in the development of traditional Chinese medicine. A new concept of “Quality Marker” was proposed by Liu et al. to solve this problem and established a new research paradigm for traditional Chinese medicine quality study. Several strategies were proposed by the researchers in traditional Chinese medicine, here, we used Shengmai injection as an example to discuss a strategy for selecting “Quality Markers” of Chinese medical preparation by the components transfer process analysis in the Shengmai injection manufacturing process. Firstly, a total of 87 compounds were identified or partially characterized in shengmai injection. Secondly, referenced to the quality control method in China pharmacopeia and considered the biomarkers in the original medicines and representative components in the manufacturing process, four ginsenosides in Panax ginseng (Hongshen), two compounds in Schisandra chinensis (Wuweizi), and a sugar from Ophiopogon japonicas (Maidong) were quantified. As a result, these seven representative compounds exhibited an acceptable transitivity throughout the Shengmai injection manufacturing process. Finally, combined with the active ingredients, components transfer process analysis, and comprehensive evaluation by “Spider-web” analysis, six compounds were selected as the quality markers for the quality control of Shengmai injection. Through this strategy of optimization for quality markers of Shengmai injection, we found that these six compounds could represent the main bioactive substances and be easily detected in the whole process of production. Furthermore, the quality control method was developed for quality assessment and control of these six quality markers in the Shengmai injection. The total content range of the selected quality markers in the 10 batches of the Shengmai injection is 13.844-22.557 mg/mL.


2020 ◽  
Vol 17 (1) ◽  
pp. 47-56
Author(s):  
Shun Liu ◽  
Xun Wang ◽  
Kaiping Zou ◽  
Wei Liu ◽  
Cunyu Li ◽  
...  

Background: Zishen Tongguan (ZSTG) capsules were prepared at the Affiliated Hospital of Nanjing University of Chinese Medicine and have been proven to be clinically effective for treating pyelonephritis and benign prostatic hyperplasia. However, the quality standards are not ideal; a comprehensive study of the “quality markers” (Q-markers), the chemicals inherent in traditional Chinese medicine and its preparations, has not been carried out. Experimental Methods: In this paper, a sensitive and specific ultra-high-performance liquid chromatographictandem mass spectrometry (UHPLC-MS/MS) method was developed for the simultaneous determination of eight potential Q-markers of ZSTG, including timosaponin A3, berberine, jatrorrhizine, phellodendrine, palmatine, mangiferin, neomangiferin, and timosaponin BII. A Kromasil 100-3.5 C18 column was used with a mobile phase of 0.2% formic acid with acetonitrile, and gradient elution at a flow rate of 0.2 mL/min was achieved in 13 minutes and used for separation. Detection was performed in positive/negative mode with multiple reaction monitoring (MRM). Results: The analytical method was validated in terms of the sensitivity, linearity, accuracy, precision, repeatability, stability and recovery. The method established here was successfully applied to study the potential Q-markers in 8 batches of commercial samples, which demonstrated its use in improving the quality control of ZSTG. Conclusion: The developed method had high repeatability and accuracy and was suitable for the simultaneous analysis of multiple Q-markers, which may provide a new basis for the comprehensive assessment and overall quality control of ZSTG.


2021 ◽  
Vol 11 (10) ◽  
pp. 4392
Author(s):  
Apolka Ujj ◽  
Kinga Percsi ◽  
Andras Beres ◽  
Laszlo Aleksza ◽  
Fernanda Ramos Diaz ◽  
...  

The use and quality analysis of household compost have become very important issues in recent years due to the increasing interest in local food production and safe, self-produced food. The phenomenon was further exacerbated by the COVID-19 pandemic quarantine period, which gave new impetus to the growth of small home gardens. However, the knowledge associated with making high-quality compost is often lacking in home gardeners. Therefore, the objective of this research was to find answers to the following questions: can the quality of backyard compost be considered safe in terms of toxicity and nutrient content? Can weed seed dispersion affect the usability of backyard compost? In general, can the circulation of organic matter be increased with the spread of home composting? In this study, 16 different house composts were analysed for stability, weed seed contamination, toxic elements, and nutrient content using analysis of variance. The results of the research showed that the quality properties of the composts (including their weed seed dispersion effect) were greatly influenced by the different techniques and raw materials used. The toxicity levels, as well as the content of macro and microelements, were within the parameters of safe-quality compost. The specific macronutrient (Ca, Mg) and micronutrient (Fe, Mn) contents of the tested composts have a similar and, in some cases, more favorable nutrient supply capacity in crop production than the frequently-used cow manure-based composts. With a plan of basic education on composting, there is potential to encourage farmyard composting.


Plants ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 1376
Author(s):  
Bomi Nam ◽  
Hyun-Jae Jang ◽  
Ah-Reum Han ◽  
Ye-Ram Kim ◽  
Chang-Hyun Jin ◽  
...  

The Dendrobium species (Orchidaceae) has been cultivated as an ornamental plant as well as used in traditional medicines. In this study, the chemical profiles of Dendrobii Herba, used as herbal medicine, Dendrobium in two different species, their hybrid, and the gamma-irradiated mutant lines of the hybrid, were systematically investigated via ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-QToF MS). Among the numerous peaks detected, 17 peaks were unambiguously identified. Gigantol (1), (1R,2R)-1,7-hydroxy-2,8-methoxy-2,3-dihydrophenanthrene-4(1H)-one (2), tristin (3), (−)-syringaresinol (4), lusianthridin (5), 2,7-dihydroxy-phenanthrene-1,4-dione (6), densiflorol B (7), denthyrsinin (8), moscatilin (9), lusianthridin dimer (10), batatasin III (11), ephemeranthol A (12), thunalbene (13), dehydroorchinol (14), dendrobine (15), shihunine (16), and 1,5,7-trimethoxy-2-phenanthrenol (17), were detected in Dendrobii Herba, while 1, 2, and 16 were detected in D. candidum, 1, 11, and 16 in D. nobile, and 1, 2, and 16 in the hybrid, D. nobile × candidum. The methanol extract taken of them was also examined for cytotoxicity against FaDu human hypopharynx squamous carcinoma cells, where Dendrobii Herba showed the greatest cytotoxicity. In the untargeted metabolite analysis of 436 mutant lines of the hybrid, using UPLC-QToF MS and cytotoxicity measurements combined with multivariate analysis, two tentative flavonoids (M1 and M2) were evaluated as key markers among the analyzed metabolites, contributing to the distinction between active and inactive mutant lines.


2015 ◽  
Vol 10 (6) ◽  
pp. 1934578X1501000 ◽  
Author(s):  
Giada Capecchi ◽  
Emanuele Goti ◽  
Elena Nicolai ◽  
Maria Camilla Bergonzi ◽  
Roberto Monnanni ◽  
...  

In this study HPLC analysis for the evaluation of carotenoids and DNA barcoding are reported for three different samples of Lycium cultivated in Tuscany (Italy). These two analytical methods can represent integrative methods for quality control of goji, giving also crucial information on the plant adaptation to different environments. Hence, carotenoids represent the quality markers proposed by the monograph of the European Pharmacopoeia, while DNA barcoding can differentiate between species and populations and is useful for the detection of the homogeneity of the samples.


Author(s):  
Kamyar Raoufi ◽  
Sriram Manoharan ◽  
Karl R. Haapala

Promoting excellence in sustainable manufacturing has emerged as a strategic mission in academia and industry. In particular, universities must prepare the next generation of engineers to contribute to the task of sustaining and improving manufacturing by providing appropriate types of sustainability education and training. However, engineering curricula are challenged in delivering educational training for assessing technical solutions from the three domains that define sustainability: economic, environmental, and social. In the research presented here, an educational framework is developed with an aim to improve student understanding of sustainable product design (PD) and manufacturing. The framework is founded on the analyze, design, develop, implement, and evaluate (ADDIE) model for instructional design. The developed framework is demonstrated using an example of a sustainable PD activity. This instructional design case study illustrates how engineering students would be able to investigate the impacts of raw materials, unit manufacturing processes, manufacturing locations, and design changes on product sustainability performance by integrating PD information and manufacturing analysis methods during the PD phase.


2019 ◽  
Vol 2019 (4) ◽  
pp. 119-126
Author(s):  
CH Bekmurotov ◽  

The article reviewed the certification and quality control of the technological process for the production of vegetable oil. There is a procedure for packaging, quality control of products, determination of quality indicators and quality control of finished products. The procedure for using refined cottonseed oil and its varieties, the requirements for placement and storage of vegetable oils, as specified in the regulatory documents, the quality control of vegetable oils and other solutions for cottonseed oil are provided. The gas analyzer shows a solution for measuring the amount of solution by painting the tubes of a mixture of gas and air in oil. Detailed information on the production of vegetable oils, the cost of raw materials, the level of fat content of cotton seeds and the methods used to produce oil from cotton seeds. Methods for certification of vegetable oils, types of quality control, methods of testing and quality determination are presented. It was shown that the procedure for refined production of cottonseed oils and their types, as well as the state of the product classification of products based on the method of producing vegetable oils for consumer purposes, analysis of the sequence of refined oils and refining processes.


Sign in / Sign up

Export Citation Format

Share Document