Abstract: AIM:To establish the allergic animal model of Shuanghuanglian Injection in order to explore the sensitizing substance caused type Ⅰ hypersensitivity by Shuanghuanglian Injection.METHODS:The Shuanghuanglian Injection and rabbit blood serum were used to incubate in vitro to prepare antigen, then the pure bleed Rabbits of New Zealand were immuned to prepare the antiserum of sensitizing substance in Shuanghuanglian Injection.And the potency and antibody specificity were detected by ELISA.RESULTS:A double sandwich ELISA was used to detect the antiserum potency, when the potency were 128 times diluted it was still positive.The indirect competitive ELISA was used to determine the serological specificity and the inhibitory curve was drawn.The regression equation was I =13.362lgC +50.503, the correlation coefficient(r) was 0.966 and the half-inhibition concentration(IC₅₀) was 0.92 mg/mL.CONCLUSION:A hypersensitivity animal model of Shuanghuanglian Injection was preliminary established, and can be used in investigation of the sensitizing substance in Shuanghuanglian Injection.

Key words: Shuanghuanglian Injection, hypersensitive animal model, antiserum, ELISA