目的 :观察雷公藤叶提取物 β-环糊精包合物的动物长期毒性。　 方法 :采用小剂量 ( 5mg/ kg)、中剂量 (大鼠 15mg/ kg、犬 10 mg/ kg)和大剂量 (大鼠 35mg/ kg、犬 15mg/ kg) ,连续灌胃(口服 )给药 3个月。　 结果 :小剂量对大鼠和犬均不表现毒性 ;中剂量有一定毒性 ,停药后可恢复正常 ;大剂量对动物心、肝、肾、肺等多种脏器呈现显著的病理损害 ,停药后可以恢复 ,未见延迟性不良反应。　 结论 :本品在治疗量范围内是安全的 Objective : To observe the long-term toxicity of Tripterygium wilfordii leaf extract β-cyclodextrin inclusion complex. METHODS: Low-dose (5 mg/kg), middle-dose (rat 15 mg/kg, canine 10 mg/kg) and large-dose (rat 35 mg/kg, canine 15 mg/kg), continuous gavage (orally) 3 months. RESULTS: Small doses did not show toxicity to rats and dogs; moderate doses had certain toxicity and could return to normal after discontinuation; large doses showed significant pathological damage to various organs such as heart, liver, kidney, lung, and other organs. After the drug can be restored, no delayed adverse reactions. Conclusion : This product is safe within the therapeutic range