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J Pharm Biomed Anal

Title:		"Integration of non-targeted multicomponent profiling, targeted characteristic chromatograms and quantitative to accomplish systematic quality evaluation strategy of Huo-Xiang-Zheng-Qi oral liquid"
Author(s):		Li X; Wu M; Ding H; Li W; Yin J; Lin R; Wu X; Han L; Yang W; Bie S; Li F; Song X; Yu H; Dong Z; Li Z;
Address:		"College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China. State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China. College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, 301617, China; State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China. College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, 301617, China; State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China. Electronic address: hs_yu08@163.com. Chongqing Taiji Industry (Group) Co.,Ltd., 408000, China. Electronic address: dzlcdutcm@163.com"
Journal Title:		J Pharm Biomed Anal
Year:		2023
Volume:		20230911
Issue:
Page Number:		115715 -
DOI:		10.1016/j.jpba.2023.115715
ISSN/ISBN:		1873-264X (Electronic) 0731-7085 (Linking)
Abstract:		"Huo-Xiang-Zheng-Qi oral liquid (HXZQOL) is a well-known traditional Chinese medicine formula for the treatment of gastrointestinal diseases, with the pharmacologic effects of antiinflammatory, immune protection and gastrointestinal motility regulation. More significantly, HXZQOL is recommended for the treatment of COVID-19 patients with gastrointestinal symptoms, and it has been clinically proven to reduce the inflammatory response in patients with COVID-19. However, the effective and overall quality control of HXZQOL is currently limited due to its complex composition, especially the large amount of volatile and non-volatile active components involved. In this study, aimed to fully develop a comprehensive strategy based on non-targeted multicomponent identification, targeted authentication and quantitative analysis for quality evaluation of HXZQOL from different batches. Firstly, the non-targeted high-definition MS(E) (HDMS(E)) approach is established based on UHPLC/IM-QTOF-MS, utilized for multicomponent comprehensive characterization of HXZQOL. Combined with in house library-driven automated peak annotation and comparison of 47 reference compounds, 195 components were initially identified. In addition, HS-SPME-GC-MS was employed to analyze the volatile organic compounds (VOCs) in HXZQOL, and a total of 61 components were identified by comparison to the NIST database, reference compounds as well as retention indices. Secondly, based on the selective ion monitoring (SIM) of 24 'identity markers' (involving each herbal medicine), characteristic chromatograms (CCs) were established on LC-MS and GC-MS respectively, to authenticate 15 batches of HXZQOL samples. The targeted-SIM CCs showed that all marker compounds in 15 batches of samples could be accurately monitored, which could indicate preparations authenticity. Finally, a parallel reaction monitoring (PRM) method was established and validated to quantify the nine compounds in 15 batches of HXZQOL. Conclusively, this study first reports chemical-material basis, SIM CCs and quality evaluation of HXZQOL, which is of great implication to quality control and ensuring the authenticity of the preparation"
Keywords:		Authentication Characteristic chromatograms Huo-Xiang-Zheng-Qi oral liquid Quality evaluation Selective ion monitoring;
Notes:		"PublisherLi, Xuejuan Wu, Mengfan Ding, Hui Li, Wei Yin, Jiaxin Lin, Ruimei Wu, Xinlong Han, Lifeng Yang, Wenzhi Bie, Songtao Li, Fangyi Song, Xinbo Yu, Heshui Dong, Ziliang Li, Zheng eng England 2023/09/29 J Pharm Biomed Anal. 2023 Sep 11; 236:115715. doi: 10.1016/j.jpba.2023.115715"