Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (4): 216-220.

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Research Progress in Analytical Methods of Allergenic Components in Injection

ZANG Qing-ce1, JIN Hong-tao2, ABLIZ Zeper1,3, HE Jiu-ming1,*   

  1. 1State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050,China;
    2New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China;
    3Centre for Bioimaging and Systems Biology, Minzu University of China, Beijing 100081, China
  • Received:2018-05-29 Revised:2018-05-29 Online:2018-04-20 Published:2018-05-29

Abstract: Injection has been frequently reported to cause anaphylaxis. Establishing sensitive, effective and practical analytical methods for safety evaluation and quality control of injection can help to improve the safety of injection in clinical applications. In this review, we summarize the main analytical techniques for the determination of allergenic components in injection, including liquid chromatography-mass spectrometry, cell membrance chromatography and enzyme-linked immunosorbent assays, and discuss the applications, limitations and trends of these analytical techniques, hoping to provide reference for the improvement of the safety of injections.

Key words: injection, allergenic components, analytical method, quality evaluation

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