Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

Wang, Qingjun; Sun, Lei; Feng, Lin; Jin, Haiyan; Yu, Jingjie; Dai, Zhong; Ma, Shuang‐Cheng

doi:10.4236/cm.2016.72010

Cited by 11 publications

(6 citation statements)

References 25 publications

(14 reference statements)

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“…Many compounds which may be detected are not listed in the Chinese pharmacopeia; therefore, reference materials are not always readily available. To solve problems related to the availability of reference materials the NIFDC is preparing reference materials, and is currently launching a digital reference materials initiative (Wang et al, 2016). Secondly, the fast-changing list of common adulterants challenges STM development.…”

Section: Discussionmentioning

confidence: 99%

Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017

Huang

Gao

et al. 2019

Front. Pharmacol.

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Traditional Chinese medicines (TCMs) represent one form of complementary and alternative medicine. The popularity and complexity in production make them attractive and vulnerable to adulteration in stages ranging from planting to production. Adulteration refers to the addition of extraneous, improper, or inferior ingredients that should not be present in TCMs. To detect and combat adulterated TCMs, supplementary testing methods (STMs), which expand the capability of routine testing standards, have been applied in China since 2003. From 2003 to 2017, a total of 184 STMs for TCMs were approved by the Chinese national drug regulatory authority. By assessing these STMs, this research intends to identify those TCMs vulnerable to adulteration, to list common adulterants, and to characterize the techniques of analysis. The results show that adulteration of TCMs can be classified into three main categories: the addition of undeclared drugs/chemical substances, substitution with non-drug components, and the addition of foreign non-drug materials. The top five therapeutic areas of TCMs vulnerable to adulteration are diabetes, calm and sleep, sexual dysfunction, pain relief, and rheumatism. A total of 166 adulterants were detected in the adulterated TCM preparations and herbal products studied here, with 158 adulterants in TCM preparations and 43 in herbal products, with 35 adulterants in common. Each STM consists of different pharmaceutical analysis techniques, including tests for physical-chemical properties, chromatography, spectroscopic techniques, and mass spectrometry. The analytical methodology of STMs relies on the combination of these techniques, with HPLC ranking the highest percentage (76.1%) and physical-chemical techniques the lowest percentage (11.4%). This research shows that STMs have played a crucial role in combating adulterated TCMs. However, STMs represent merely a product testing-centered regulatory strategy. The inspection of cultivation and manufacturing processes should also be strengthened. More importantly, the awareness and self-discipline of TCM manufacturers in implementing good manufacturing practices and regulating the planting and cultivation of raw materials should be improved.

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Section: Discussionmentioning

confidence: 99%

Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017

Huang

Gao

et al. 2019

Front. Pharmacol.

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“…For improving the annotation process, re-ranking the annotations considering chemotaxonomic data was recently proposed (Rutz et al, 2019), and open-access spectral databases that also incorporate chemotaxonomic data should be further developed. In this direction, the concept of Digital Reference Standard (DRS) was proposed in the TCMs area (Wang et al, 2016b) and the platform MASST was launched in GNPS to fulfill this goal (Wang et al, 2020a). Furthermore, the automatic propagation of annotations in clusters has been proposed and could complement the approach used in this study (da Silva Ricardo et al, 2018).…”

Section: Improvement and Automation Of Processing Toolsmentioning

confidence: 99%

“…Furthermore, organizing HRMS/MS data by molecular networking (MN) brought a novel dimension to metabolite annotation ( Wang et al, 2016a ). As a way of classifying structurally related chemicals, MN is seen as a tool of interest for TCMs chemical investigation ( Hou et al, 2019 ) and has recently begun to be employed in TCM research to annotate single herb extracts ( Pan et al, 2019 ; Wang et al, 2019 ; Wang et al, 2020b ). Data processing step by open-source software, such as MZmine ( Pluskal et al, 2010 ) prior to MN has enabled the generation of so-called feature-based molecular networks (FBMN) ( Nothias et al, 2020 ) ( Table 1 ).…”

Section: Introductionmentioning

confidence: 99%

A Mass Spectrometry Based Metabolite Profiling Workflow for Selecting Abundant Specific Markers and Their Structurally Related Multi-Component Signatures in Traditional Chinese Medicine Multi‐Herb Formulae

et al. 2020

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In Traditional Chinese Medicine (TCM), herbal preparations often consist of a mixture of herbs. Their quality control is challenging because every single herb contains hundreds of components (secondary metabolites). A typical 10 herb TCM formula was selected to develop an innovative strategy for its comprehensive chemical characterization and to study the specific contribution of each herb to the formula in an exploratory manner. Metabolite profiling of the TCM formula and the extract of each single herb were acquired with liquid chromatography coupled to high-resolution mass spectrometry for qualitative analyses, and to evaporative light scattering detection (ELSD) for semi-quantitative evaluation. The acquired data were organized as a feature-based molecular network (FBMN) which provided a comprehensive view of all types of secondary metabolites and their occurrence in the formula and all single herbs. These features were annotated by combining MS/MS-based in silico spectral match, manual evaluation of the structural consistency in the FBMN clusters, and taxonomy information. ELSD detection was used as a filter to select the most abundant features. At least one marker per herb was highlighted based on its specificity and abundance. A single large-scale fractionation from the enriched formula enabled the isolation and formal identification of most of them. The obtained markers allowed an improved annotation of associated features by manually propagating this information through the FBMN. These data were incorporated in the high-resolution metabolite profiling of the formula, which highlighted specific series of related components to each individual herb markers. These series of components, named multi-component signatures, may serve to improve the traceability of each herb in the formula. Altogether, the strategy provided highly informative compositional data of the TCM formula and detailed visualizations of the contribution of each herb by FBMN, filtered feature maps, and reconstituted chromatogram traces of all components linked to each specific marker. This comprehensive MS-based analytical workflow allowed a generic and unbiased selection of specific and abundant markers and the identification of multiple related sub-markers. This exploratory approach could serve as a starting point to develop more simple and targeted quality control methods with adapted marker specificity selection criteria to given TCM formula.

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“…The platform of “digital standards of Chinese medicinal materials” developed by Chinese Pharmacopoeia Commission presents national standards and corresponding atlas and chromatograms in digital form, and provides statistical functions of quality standards in different national Pharmacopoeias [68] . The concept of digital reference standards (DRS) [69] has recently been proposed, substituting the qualitative and quantitative functions of physical RS in digital form. The ten characteristics corresponding to five aspects of DRS are shown in Fig.…”

Section: Elements Of “Ivarious” Standard Systemmentioning

confidence: 99%

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

Chen

Sun

Yuan

et al. 2017

Journal of Pharmaceutical Analysis

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An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks the top-design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named “iVarious”, was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the “iVarious” system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of “iVarious” integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

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Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

Cited by 11 publications

References 25 publications

Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017

Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017

A Mass Spectrometry Based Metabolite Profiling Workflow for Selecting Abundant Specific Markers and Their Structurally Related Multi-Component Signatures in Traditional Chinese Medicine Multi‐Herb Formulae

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

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