Citation: | Xiaoyan Lu, Yanyan Jin, Yuzhen Wang, Yunlong Chen, Xiaohui Fan. Multimodal integrated strategy for the discovery and identification of quality markers in traditional Chinese medicine[J]. Journal of Pharmaceutical Analysis, 2022, 12(5): 701-710. doi: 10.1016/j.jpha.2022.05.001 |
Y. Li, Y. Xie, Y. He, et al., Quality markers of traditional Chinese medicine: concept, progress, and perspective, Engineering 5 (2019) 888-894
|
F. Leong, X. Hua, M. Wang, et al., Quality standard of traditional Chinese medicines: comparison between European pharmacopoeia and Chinese pharmacopoeia and recent advances, Chin. Med. 15 (2020), 76
|
C.-X. Liu, S.-L. Chen, X.-H. Xiao, et al., A new concept on quality marker of Chinese materia medica: quality control for Chinese medicinal products, Chin. Tradit. Herb. Drugs 47 (2016) 1443-1457
|
C.-X. Liu, Y.-Y. Cheng, D.-A. Guo, et al., A new concept on quality marker for quality assessment and process control of Chinese medicines, Chin. Herb. Med. 9 (2017) 3-13
|
T.-J. Zhang, G. Bai, C.-Q. Chen, et al., Research approaches of quality marker (Q-marker) of Chinese materia medica formula based on “five principles”, Chin. Tradit. Herb. Drugs 49 (2018) 1-13
|
Z.-T. Li, F.-X. Zhang, C.-L. Fan, et al., Discovery of potential Q-marker of traditional Chinese medicine based on plant metabolomics and network pharmacology: periplocae Cortex as an example, Phytomedicine 85 (2021), 153535
|
G. Bai, T. Zhang, Y. Hou, et al., From quality markers to data mining and intelligence assessment: a smart quality-evaluation strategy for traditional Chinese medicine based on quality markers, Phytomedicine 44 (2018) 109-116
|
K. Sun, C. Su, W. Li, et al., Quality markers based on phytochemical analysis and anti-inflammatory screening: an integrated strategy for the quality control of Dalbergia odorifera by UHPLC-Q-Orbitrap HRMS, Phytomedicine 84 (2021), 153511
|
R. Länger, E. Stöger, W. Kubelka, et al., Quality standards for herbal drugs and herbal drug preparations-appropriate or improvements necessary? Planta Med. 84 (2018) 350-360
|
International Conference on Harmonisation, ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8 (R2), 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf. (accessed on 25 December, 2021)
|
International Conference on Harmonisation, ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10, 2008. https://database.ich.org/sites/default/files/Q10_Guideline.pdf. (accessed on 25 December, 2021)
|
X.-C. Gong, T. Chen, H.-B. Qu, Research advances in secondary development of Chinese patent medicines based on quality by design concept, China J. Chin. Mater. Med. 42 (2017) 1031-1036
|
X. Liu, W. Jiang, M. Su, et al., Quality evaluation of traditional Chinese medicines based on fingerprinting, J. Separ. Sci. 43 (2020) 6-17
|
Y.-H. Chen, J.-H. Bi, M. Xie, et al., Classification-based strategies to simplify complex traditional Chinese medicine (TCM) researches through liquid chromatography-mass spectrometry in the last decade (2011-2020): theory, technical route and difficulty, J. Chromatogr. A 1651 (2021), 462307
|
J.-Q. Zeng, J. Zhang, F.-Y. Zhang, et al., Critical quality attribute assessment of big brand traditional Chinese medicine: online NIR quality control research on boiling time during extraction process, China J. Chin. Mater. Med. 46 (2021) 1644-1650
|
J. Xue, Y. Shi, L. Ye, et al., Near-infrared spectroscopy for rapid and simultaneous determination of five main active components in rhubarb of different geographical origins and processing, Spectrochim. Acta Mol. Biomol. Spectrosc. 205 (2018) 419-427
|
H. Yao, P. Shi, Q. Shao, et al., Chemical fingerprinting and quantitative analysis of a Panax notoginseng preparation using HPLC-UV and HPLC-MS, Chin. Med. 6 (2011), 9
|
L. Wang, Z. Li, Q. Shao, et al., Dissecting active ingredients of Chinese medicine by content-weighted ingredient-target network, Mol. Biosyst. 10 (2014) 1905-1911
|
Z. Yang, Q. Shao, Z. Ge, et al., A bioactive chemical markers based strategy for quality assessment of botanical drugs: Xuesaitong injection as a case study, Sci. Rep. 7 (2017), 2410
|
Y. Zhong, J. Zhu, Z. Yang, et al., Q-marker based strategy for CMC research of Chinese medicine: a case study of Panax notoginseng saponins, Phytomedicine 44 (2018) 129-137
|
X. Yan, H. Fu, S. Zhang, et al., Combining convolutional neural networks and in-line near-infrared spectroscopy for real-time monitoring of the chromatographic elution process in commercial production of notoginseng total saponins, J. Separ. Sci. 43 (2020) 663-670
|
Y.F. Zhou, L.H. Zhou, F.L. Zhang, et al., The online control in the extraction of Panax notoginseng by using near infrared spectroscopy, Chin. Med. Mat. 42 (2019) 2367-2370
|
X.-Y. Wang, W.-L. Li, H.-B. Qu, Application of feedforward control strategy based on spectra of raw materials to optimize alcohol extraction process of Panax notoginseng, China J. Chin. Mater. Med. 43 (2018) 3127-3134
|
X. Lu, X. Lian, J. Zheng, et al., LC-ESI-TOF-MS-based metabolomic analysis of ginsenoside Rd-induced anaphylactoid reaction in mice, RSC Adv. 6 (2016) 19545-19554
|
Y.-Y. Cheng, B.-L. Zhang, T.-H. Fang, et al., Intelligent and lean manufacturing for Chinese medicine: theory and its applications, Chin. J. Chin. Mater. Med. 44 (2019) 5017-5021
|
H. Xu, Y. Zhang, P. Wang, et al., A comprehensive review of integrative pharmacology-based investigation: a paradigm shift in traditional Chinese medicine, Acta Pharm. Sin. B 11 (2021) 1379-1399
|
M. Liao, H. Shang, Y. Li, et al., An integrated approach to uncover quality marker underlying the effects of Alisma orientale on lipid metabolism, using chemical analysis and network pharmacology, Phytomedicine 45 (2018) 93-104
|
D. Li, B. Lv, D. Wang, et al., Network pharmacology and bioactive equivalence assessment integrated strategy driven Q-markers discovery for Da-Cheng-Qi decoction to attenuate intestinal obstruction, Phytomedicine 72 (2020), 153236
|
Z. Chen, M. Wang, Y. Yang, et al., Promotion of a quality standard for Porana sinensis Hemsl. based on the efficacy-oriented Effect-Constituent Index, Biomed. Chromatogr. 34 (2020), e4726
|
C. Li, C. Tu, Y. Che, et al., Bioassay based screening for the antiplatelet aggregation quality markers of Polygonum multiflorum with UPLC and chemometrics, J. Pharm. Biomed. Anal. 166 (2019) 264-272
|
Z. Jiang, J. Yang, Y. Wang, Discrimination and identification of Q-markers based on ‘Spider-web’ mode for quality control of traditional Chinese medicine, Phytomedicine 44 (2018) 98-102
|
X. Wu, H. Zhang, S. Fan, et al., Quality markers based on biological activity: a new strategy for the quality control of traditional Chinese medicine, Phytomedicine 44 (2018) 103-108
|
M.-Q. Huo, S. Peng, Y. Ren, et al., Discovery and application of traditional Chinese medicine efficacy markers based on systematic traditional Chinese medicine, China J. Chin. Mater. Med. 45 (2020) 3245-3250
|
P. Liu, H. Yang, F. Long, et al., Bioactive equivalence of combinatorial components identified in screening of an herbal medicine, Pharm. Res. 31 (2014) 1788-1800
|
X.-G. Liu, C.-Y. Cheng, J.-X. Wang, et al., A metabolic exposure-oriented network regulation strategy for the identification of effective combination in the extract of Ginkgo biloba L, J. Pharm. Biomed. Anal. 149 (2018) 151-159
|
L. Gong, H. Xu, L. Wang, et al., Identification and evaluation of the chemical similarity of Yindan xinnaotong samples by ultra high performance liquid chromatography with quadrupole time-of-flight mass spectrometry fingerprinting, J. Separ. Sci. 39 (2016) 611-622
|
Y.-Z. Liang, P.-S. Xie, K. Chan, Perspective of chemical fingerprinting of Chinese herbs, Planta Med. 76 (2010) 1997-2003
|
G.-L. Xu, M. Xie, X.-Y. Yang, et al., Spectrum-effect relationships as a systematic approach to traditional Chinese medicine research: current status and future perspectives, Molecules 19 (2014) 17897-17925
|
H.-B. Li, S.-H. Wu, J.-F. Tang, et al., Research progress on Q-biomarker of Chinese materia medica, Chin. Tradit. Herb. Drugs 50 (2019) 4556-4561
|
K. Li, J. Li, J. Su, et al., Identification of quality markers of Yuanhu Zhitong tablets based on integrative pharmacology and data mining, Phytomedicine 44 (2018) 212-219
|
R. Guo, X. Zhang, J. Su, et al., Identifying potential quality markers of Xin-Su-Ning capsules acting on arrhythmia by integrating UHPLC-LTQ-Orbitrap, ADME prediction and network target analysis, Phytomedicine 44 (2018) 117-128
|
H. Wang, H. Sun, A. Zhang, et al., Rapid identification and comparative analysis of the chemical constituents and metabolites of Phellodendri amurensis cortex and Zhibai dihuang pill by ultra-performance liquid chromatography with quadrupole TOF-MS, J. Separ. Sci. 36 (2013) 3874-3882
|
Y. Zhang, H. Xu, X. Chen, et al., Study on the application of intestinal absorption in vitro coupled with bioactivity assessment in Yuanhu Zhitong preparation, J. Med. Plants Res. 6 (2012) 1941-1947
|
Y. Zhang, H. Xu, X. Chen, et al., Simultaneous quantification of 17 constituents from Yuanhu Zhitong tablet using rapid resolution liquid chromatography coupled with a triple quadrupole electrospray tandem mass spectrometry, J. Pharm. Biomed. Anal. 56 (2011) 497-504
|
Y. Tao, H. Xu, S. Wang, et al., Identification of the absorbed constituents after oral administration of Yuanhu Zhitong prescription extract and its pharmacokinetic study by rapid resolution liquid chromatography/quadrupole time-of-flight, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 935 (2013) 1-9
|
P. Wang, T. Zhang, G. Yu, et al., Poly-pharmacokinetic strategy-delineated metabolic fate of bioactive compounds in a traditional Chinese medicine formula, Yuanhu Zhitong tablets, using parallel reaction monitoring mode, Phytomedicine 53 (2019) 53-61
|
H. Xu, Y. Tao, P. Lu, et al., A computational drug-target network for Yuanhu Zhitong prescription, Evid. Based Complement. Alternative Med. 2013 (2013), 658531
|
Z.-H. Li, N. Ai, L. Yu, et al., A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip, Sci. Rep. 7 (2017), 12243
|
H. Yao, B. Wu, Y. Cheng, et al., High throughput chemiluminescence platform for evaluating antioxidative activity of total flavonoid glycosides from plant extracts, Food Chem. 115 (2009), 380-386
|
E-H. Liu, L.-W. Qi, K. Li, et al., Recent advances in quality control of traditional Chinese medicines, Comb. Chem. High Throughput Screen. 13 (2010) 869-884
|
M.-R. Shen, Y. He, S.-M. Shi, Development of chromatographic technologies for the quality control of traditional Chinese medicine in the Chinese Pharmacopoeia, J. Pharm. Anal. 11 (2021) 155-162
|
U.S. Food and Drug Administration, Botanical Drug Development: Guidance for Industry. https://www.fda.gov/media/93113/download. (Accessed 28 February 2022).
|
European Medicines Agency, Guideline on Specification: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/traditional Herbal Medicinal Products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specifications-test-procedures-acceptance-criteria-herbal-substances-herbal-preparations_en.pdf. (Accessed 28 February 2022).
|
Q. Li, Z.-Y. Li, J. Zhang, et al., Xiyanping plus azithromycin chemotherapy in pediatric patients with Mycoplasma pneumoniae pneumonia: a systematic review and meta-analysis of efficacy and safety, Evid. Based Complement. Alternative Med. 2019 (2019), 2346583
|
G.-F. Wang, H. Xu, K. Liu, et al., Determination of total sulfonate of andrographolide in Xiyanping injection by differential spectrophotometry, Chin. J. Pharm. Anal. 28 (2008) 1680-1682
|
H.Z. Zhan. Study on Improving Quality Standards of Xiyanping Injection [master's Thesis]. [Nanchang]: Nanchang University; 2012
|
H.-Z. Zhan, W.-K. Chen, X.-W. Xiao, et al., HPLC simultaneous determination of four effective ingredients in Xiyanping injection, Chin. J. Pharm. Anal. 32 (2012) 140-143
|
S. Chen, J.S.W. Kwong, R. Zheng, et al., Normative application of Xiyanping injection: a systematic review of adverse case reports, Evid. Based Complement. Alternat. Med. 2018 (2018), 4013912
|
Q.-W. Yang, Q. Li, J. Zhang, et al., Crystal structure and anti-inflammatory and anaphylactic effects of andrographlide sulphonate E in Xiyanping, a traditional Chinese medicine injection, J. Pharm. Pharmacol. 71 (2019) 251-259
|
Y. Lin, C. Wang, Y. Hou, et al., The human mast cell line-1 cell membrane chromatography coupled with HPLC-ESI-MS/MS method for screening potentical anaphylactic components from Chuanxinlian injection, Biomed. Chromatogr. 31 (2017), e4015
|
W.-Y. Chen, Y.-S. Wang, C.-Y. Liu, etal, Comparison of pulmonary availability and anti-inflammatory effect of dehydroandrographolide succinate via intratracheal and intravenous administration, Eur. J. Pharmaceut. Sci. 147 (2020), 105290
|
B. Lin, H. Yang, Z. Liu, et al., Comparative study on fingerprint, anti-inflammatory effect and toxicity in vivo of Tripterygium polyglycosides tablets from various manufacturers, Chin. Pharmacist 22 (2019) 206-
|
R. Goldbach-Mansky, M. Wilson, R. Fleischmann, et al., Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial, Ann. Intern. Med. 151 (2009) 229-240, W49-51
|
Z. Liu, L. Ma, G.-B. Zhou., The main anticancer bullets of the Chinese medicinal herb, thunder god vine, Molecules 16 (2011) 5283-5297
|
M.-X. Su, W.-D. Zhou, J. Lan, et al., Rapid and sensitive analysis of multiple bioactive constituents in Tripterygium glycosides tablets using liquid chromatography coupled with time-of-flight mass spectrometry, J. Separ. Sci. 38 (2015) 804-812
|
X. Gao, X. Du, L. An, et al., Wilforine, the Q-marker and PK-maker of Tripterygium glycosides tablet: based on preparation quantitative analysis and PK–PD study, Phytomedicine 54 (2019) 357-364
|
X. Luo, X. Chen, X. Shen, et al., Rapid identification and analysis of the active components of traditional Chinese medicine Xiaoxuming decoction for ischemic stroke treatment by integrating UPLC-Q-TOF/MS and RRLC-QTRAP MSn method, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 1124 (2019) 313-322
|
Y. Lin, Y. Lv, J. Fu, et al., A high expression Mas-related G protein coupled receptor X2 cell membrane chromatography coupled with liquid chromatography and mass spectrometry method for screening potential anaphylactoid components in Kudiezi injection, J. Pharm. Biomed. Anal. 159 (2018) 483-489
|
G. Liang, J. Yang, T. Liu, et al., A multi-strategy platform for quality control and Q-markers screen of Chaiqin chengqi decoction, Phytomedicine 85 (2021), 153525
|
C. Zhao, H. Liu, P. Miao, et al., A strategy for selecting "Q-markers" of Chinese medical preparation via components transfer process analysis with application to the quality control of Shengmai injection, Molecules 24 (2019), 1811
|
M. Zhou, Y. Hong, X. Lin, et al., Recent pharmaceutical evidence on the compatibility rationality of traditional Chinese medicine, J. Ethnopharmacol. 206 (2017) 363-375
|
X. Fu, Q. Wang, Z. Wang, et al., Danggui-Shaoyao-San: new hope for Alzheimer's disease, Aging Dis. 7 (2015) 502-513
|
Y. Wang, G. Li, Y. Zhou, et al., The difference between blood-associated and water-associated herbs of Danggui-Shaoyao San in theory of TCM, based on serum pharmacochemistry, Biomed. Chromatogr. 30 (2016) 579-587
|
M. Jiang, S. Zhao, S. Yang, et al., An “essential herbal medicine”-licorice: A review of phytochemicals and its effects in combination preparations, J. Ethnopharmacol. 249 (2020), 112439
|
M. Wang, B. Liu, Y. Qi, et al., Effect of Glycyrrhiza uralensis saponins on acute toxicity of platycodins, Chin. J. Exp. Tradit. Med. Form. 14 (2008) 59-61
|
S.-Y. Cai, S.-W. Lv, Y.-H. Wang, et al., Solubility and apparent oil/water partition coefficient of glycyrrhizin and pachymic acid, Inform. Tradit. Chin. Med. 29 (2012) 118-121
|
J.-J. Shan, J.-S. Zou, T. Xie, et al., Effects of Gancao on pharmacokinetic profiles of platycodin D and deapio-platycodin D in Jiegeng, J. Ethnopharmacol. 170 (2015) 50-56
|
T.-J. Zhang, J. Xu, X.-P. Shen, et al., Relation of “property-response-component” and action mechanism of Yuanhu zhitong dropping pills based on quality marker (Q-marker), Chin. Tradit. Herb. Drugs 47 (2016) 2199-2211
|
Q. Xu, Z. Ouyang, Y. Chang, et al., Principal, assistant, compleaent, guide compatibility of Banxiahoupo decoction on contents of honokiol and magnolol, chin. J. Exp. Tradit. Med. Form. 14 (2008) 1-3
|