Abstract: Objective To research therapeutic index(TI) and the margin of safety factor(SF) of anti-inflammatory effect of Fructus Bruceae. Methods Establish tumidness model induced by daubing croton oil and granuloma model induced by subcutaneous injection of agar to explore acute and chronic anti-inflammatory effect of different components from Fructus Bruceae, and acute lethal dose test is also proceeded. Calculate ED50 and ED95 of anti-inflammatory efficacy and LD50 and LD5 of acute toxicity test of the different components from Fructus Bruceae. And then calculate the therapeutic index(TI) and safety factor(SF) of different components from Fructus Bruceae. Results The different components from Fructus Bruceae showed good anti-inflammatory effect and certain dose-effect relationship. The anti-inflammatory effect of alcohol extraction component was better than it of water extraction component. TI of anti-acute inflammatory effect of the water extraction component and the alcohol extraction component from Fructus Bruceae is 35.6207 and 25.3285, and SF is 7.8040 and 3.6645 respectively. And TI of anti-chronic inflammatory effect of the water extracts and the alcohol extracts from Fructus Bruceae is 47.6659 and 32.6431, and SF is 7.5494 and 4.2959 respectively. Conclusion The anti-inflammatory effect of the water extracts is greater than the alcohol extracts from Fructus Bruceae, but the margin of safety from alcohol extracts is greater than the water extracts from Fructus Bruceae. We should pay more attention to the occurrence of adverse reactions and strengthen drug monitoringin in the application of the water extracts from Fructus Bruceae.

Key words: Fructus Bruceae, anti-inflammatory, the margin of safety, therapeutic index, safety factor