Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (10): 1195-1200.
DOI: 10.19803/j.1672-8629.20230228

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Research progress in key technologies for quality control of snake venom hemocoagulase drugs

LIU Bo1,2, GUO Yunxiao1,2,3,△, LIU Lisha1,2, FAN Huihong1,2,*   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China;
    3School of Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 210009, China
  • Received:2023-04-13 Online:2023-10-15 Published:2023-10-16

Abstract: With the wide application of snake venom hemocoagulase in clinical practice in recent years, better quality of its products is required. However, constrained by the complexity of the products and related technologies, it becomes increasingly difficult for the key quality control technologies, especially quality control projects such as structural characterization, purity analysis and potency, to meet the requirements of increasingly stringent quality control. By referring to domestic and foreign pharmacopoeias and the latest research progress in other proteinic drugs, this article summarizes the structural characteristics, purity and potency determination methods of snake venom hemocoagulase drugs before future developments are predicted. It is hoped that this article can be of referential value for the improvement of levels of quality control of hemocoagulase drugs.

Key words: hemocoagulase, quality control, primary structure, advanced structure, purity, activity, snake venom

CLC Number: