Abstract: ObjectiveTo research therapeutic index(TI) and the margin of safety factor(SF) of anti-inflammatory effect of Radix et Rhizome Sophorae Tonkinensis. MethodsEstablish 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 Radix et Rhizome Sophorae Tonkinensis, 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 Radix et Rhizome Sophorae Tonkinensis. And then calculate the therapeutic index(TI) and safety factor(SF) of different components from Radix et Rhizome Sophorae Tonkinensis. ResultsThe different components from Radix et Rhizome Sophorae Tonkinensis 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 Radix et Rhizome Sophorae Tonkinensis is 34.0185 and 52.8432, and SF is 8.9965 and 16.3049 respectively. And TI of anti-chronic inflammatory effect of the water extracts and the alcohol extracts from Radix et Rhizome Sophorae Tonkinensis is 34.4115 and 53.8510, and SF is 8.5146 and 18.1641 respectively. ConclusionThe anti-inflammatory effect of the water extracts is greater than the alcohol extracts from Radix et Rhizome Sophorae Tonkinensis, but the margin of safety from alcohol extracts is greater than the water extracts from Radix et Rhizome Sophorae Tonkinensis. We should pay more attention to the occurrence of adverse reactions and strengthen drug monitoring in the application of the water extracts from Radix et Rhizome Sophorae Tonkinensis.

Key words: Radix et Rhizome Sophorae Tonkinensis, anti-inflammatory, the margin of safety, therapeutic index, safety factor