动物造模 z-bio 2022-02-01 443

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

　　Method: Stop the active systemic allergic response test, internal allergy index measurement and screening, and passive skin allergic response test methods to investigate the allergic safety of the samples.

　　Result: We stopped the guinea pig systemic allergic reaction and passive skin allergic experiments on 45 batches of hydroxyethyl starch 40 sodium chloride injection from 3 companies, and there was no allergic reaction. After the allergic indicators in the plasma, the measurement and comparison of histamine (HIS), IgG, IgM and IgE were stopped, and it was found that IgM and IgE did not change significantly among the groups; the histamine and IgG positive group and the negative group and the sample group There are differences.

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