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Stability and degradation of hydroxysafflor yellow A and anhydrosafflor yellow B in the Safflower injection studied by HPLC-DAD-ESI-MSn

Li Fan, Run Pu, Hai-Yu Zhao, Xuan Liu, Chao Ma, Bao-Rong Wang, De-An Guo*   

  1. 1. State Key Laboratory of Natural and Biomimetic Drugs, Peking University Health Science Center, Beijing 100191, China
    2. National Institute for Radiological Protection, China CDC, Beijing 100088, China
    3. Shanghai Research Center for TCM Modernization, Shanghai Institute of Materia Medica, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 201203, China
  • Received:2010-10-19 Revised:2010-12-10 Online:2011-01-15 Published:2011-01-15
  • Contact: De-An Guo*

Abstract:

Safflower is a popular Chinese medicinal plant and Safflower injection is extensively used for the clinical treatment of cerebrovascular and cardiovascular diseases. In this study, HPLC-DAD-ESI-MSn was utilized to study the stability and degradation of the two major but chemically unstable bioactive compounds hydroxysafflor yellow A and anhydrosafflor yellow B, in Safflower injection. The impact of light irradiation, temperature, and pH on the stability of these two compounds were studied. The results showed that hydroxysafflor yellow A and anhydrosafflor yellow B could degrade at high temperature (>60 °C) or extreme pHs (pH≤3.0 or >7.0), but not under light irradiation. The common degradation product was p-coumaric acid. Chemical structures of the other degradation products were characterized by LC-MS. Hypothetical degradation pathways were proposed. In addition, ADP-induced platelet aggregation tests showed that the degradation of anhydrosafflor yellow B could reduce the anticoagulation activities of Safflower injection. Our results suggest that temperature and pH are critically important for the preparation and storage of Safflower injection.

Key words: Hydroxysafflor yellow A, Anhydrosafflor yellow B, p-Coumaric acid, Stability, Safflower injection, HPLC-DAD-ESI-MSn

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