动物实验,羟乙基淀粉 z-bo 2020-08-28 501

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

　　Method: Use active systemic allergic reaction test, internal allergy index measurement and screening, and passive skin allergic reaction test methods to study the allergy safety of samples.

　　Result: The guinea pig's systemic allergic reaction and the passive skin allergic reaction of 45 batches of hydroxyethyl starch 40 sodium chloride injection from 3 companies were tested, but no allergic reaction occurred. By measuring and comparing the allergy indicators of plasma, histamine (HIS), IgG, IgM, IgE, it was found that IgM and IgE were between the groups (there was no significant change between the histamine and IgG positive and negative groups and the samples) group ) There is a difference.

　　Conclusion: It is recommended to include allergic reactions in the safety assessment of hydroxyethyl starch 40 sodium chloride injection. During the clinical application of hydroxyethyl starch, two allergic indicators can also be monitored, namely histamine and IgG.