Abstract: AIM: To observe the effects of Polysorbate 80 on basophilic cell leukemia RBL-2H3 cell degranulation and discuss the possible mechanism of anaphylactoid reaction.METHODS: RBL-2H3 cells were incubated with Polysorbate 80 for 60 min, and then the morphological changes of cells degranulation were observed by transmission electron microscopy, cell degranulation rate was detected by Alcian blue dye assay, Annexin V binding assay and β-hexosaminidase assay.RESULTS: Different concentrations of Polysorbate 80 can induce the typical morphological changes in RBL-2H3 cell with degranulation.Compared with the control group,the rates of degranulation and histamine release in Polysorbate 80 treated cells were significantly increased and dose-dependent.CONCLUSION: RBL-2H3 cell degranulation,histamine can be induced by single dose Polysorbate 80, and then induced anaphylactoid reaction, which may be one of the possible mechanisms of serious adverse induced by Polysorbate 80 injection for the first administration in clinic.

Key words: Pharmaceutical excipients, Polysorbate 80, RBL-2H3 cell, Degranulation, Anaphylactoid reaction