Abstract: Objective To investigate the safety of Zhengqingfengtongning injection and evaluate the rationality of security project in the quality standards. Methods The safety of the Zhengqingfengtongning injection was studied with active systemic anaphylaxis(ASA), passive cutaneous anaphylaxis(PCA) in guinea pig, the depressor substance test in cat and muscle stimulation test in rabbit. Results ASA and PCA reaction didn't occur at the dose of 12.5 mg/ml; maximum concentration without blood pressure reduction was 0.125 mg/ml in cat; In rabbit muscle stimulation test,the response was less than level 2. Conclusion The results showed that Zhengqingfengtongning injection was safe for clinical use, and the safety project in quality standard was reasonable.

Key words: Zhengqinfengtongning injection, Safety evaluation, Anaphylaxis, Depressor substance, Muscle stimulation