动物造模 z-bio 2022-11-05 468

　　Objective: To evaluate the allergic safety of hydroxyethyl starch 40 sodium chloride injection.

　　Methods: Active systemic anaphylaxis test, in vivo allergy index determination and screening, and passive skin anaphylaxis test were carried out to investigate the allergic safety of the samples.

　　Result: We conducted guinea pig systemic allergic reaction and passive skin allergy tests on 45 batches of hydroxyethyl starch 40 sodium chloride injection from 3 enterprises, and no allergic reaction occurred. By measuring and comparing the allergic indexes in plasma, histamine (HIS), IgG, IgM and IgE, it was found that there was no significant change in IgM and IgE among the groups; the histamine and IgG positive and negative groups and the sample groups There are differences.

　　Conclusion: It is suggested that the safety evaluation of hydroxyethyl starch 40 sodium chloride injection should include allergic reactions, and two allergic indicators, histamine and IgG, can be monitored during the clinical application of hydroxyethyl starch.