Abstract: Objective To establish in vivo and in vitro screening models for anaphylactoid reactions to evaluate the potential risk of anaphylactoid reactions to commonly used traditional Chinese medicine injections. Methods Based on the RBL-2H3 cell degranulation model and using the β-hexosaminidase (β-Hex) release rate as the index for evaluation, two dose groups (0.05 and 0.01 mL·mL^-1) were established to screen for the in vitro anaphylactoid reaction risk of five traditional Chinese medicine injections, including Bozhi glycopeptide, Toad venom, Danshen, Shengmai and Xingnaojing. An experimental model of ear blue staining in mice was also established, where the rate of blue staining and that of increase of Evans Blue (EB) were used as indicators. Bozhi glycopeptide (3.2 mL·kg^-1), Toad venom (16 mL·kg^-1), Danshen (16 mL·kg^-1), Shengmai (25 mL·kg^-1) and Xingnaojing (16 mL·kg^-1) were given at the maximum clinical dose before the possibility that the above injections could induce anaphylactoid reactions in vivo was evaluated. Results In vitro experiments showed that Danshen injection and Shengmai injection could induce the release of β-Hex at doses of 0.05 and 0.01 mL·mL^-1, so the difference was statistically significant compared with the negative control group (P<0.01). The results of in vivo mouse ear blue staining tests suggested that EB increased more significantly at the dose of 25 mL·kg^-1 in the Shengmai injection group than in the negative control group. Conclusion The RBL-2H3 cell model and the mouse ear blue staining model have proved to be well correlated and complementarity in the risk screening of anaphylactoid reactions to traditional Chinese medicine injections. The combination of the two models can provide a reference for research on post-marketing safety and for rational use of traditional Chinese medicine injections.

Key words: Traditional Chinese Medicine Injection, Anap-hylactoid Reaction, RBL-2H3 Cell, Ear Blue Staining Test, Mice