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Toxicol Res (Camb). 2020 May 21;9(3):323-330. doi: 10.1093/toxres/tfaa024. eCollection 2020 Jun.

Macromolecular substances as a dangerous factor in traditional Chinese medicine injections were determined by size-exclusive chromatography.

Toxicology research

Yue Li, Jinlian Duan, Heng Xia, Bin Shu, Weigang Duan

Affiliations

  1. Yunnan Provincial Key Laboratory of Molecular Biology for Sinomedicine, Yunnan University of Traditional Chinese Medicine, 1076, Yuhua Rd., Kunming 650500, China.
  2. Jiangsu Center for Safety Evaluation of Drugs, Nanjing Tech University, 30, South Puzhu Rd., Nanjing 211899, China.

PMID: 32670563 PMCID: PMC7329174 DOI: 10.1093/toxres/tfaa024

Abstract

Macromolecular substances in traditional Chinese medicine injections (TCMIs) are expected to be a main dangerous factor causing anaphylactic or anaphylactoid reaction. The main aim of the study was to verify the macromolecular substances' anaphylactic or anaphylactoid reaction in guinea pigs and establish a size-exclusive chromatographic method to detect them. The macromolecular substances from six TCMIs (Danshen injection, Dengzhanxixin injection, Honghua injection, Qingkailing injection, Shuanghuanglian injection and Shuxuening injection) were prepared by removing substances with molecular weight less than 10 kDa with an ultra-filter. The anaphylactic and anaphylactoid reactions caused by original TCMIs, injections rich in or free of macromolecules were assayed in guinea pigs. The relationship between the amount of the macromolecular substances and peak area of chromatogram was established by size-exclusive chromatography. Injections free of macromolecules were not likely to cause anaphylactic and anaphylactoid reactions, but injections rich in macromolecular substances were more likely to do so. If the macromolecular substances with molecular weight bigger than 10 kDa were removed, the signal of macromolecular substances in TCMIs was quantitatively reduced. All the results suggested that macromolecular substances in TCMIs are a dangerous factor causing safety problems, and the macromolecular substances can be quantitatively detected with size-exclusive chromatography.

© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Keywords: anaphylactic reaction; anaphylactoid reaction; macromolecular substances; size-exclusive chromatography; traditional Chinese medicine injection

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