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目的观察虎贞痛风胶囊对Wistar大鼠灌胃给药的长期毒性反应,评价其安全性,确定无毒反应剂量,为临床应用提供科学依据。方法采用长期毒性试验方法观察虎贞痛风胶囊对大鼠产生的毒性反应,给药剂量分别为5.0g/kg、2.50g/kg及1.25g/kg(相当于临床人拟定剂量的104,52及26倍)。结果给药90 d和停药后15 d,虎贞痛风胶囊对大鼠的一般情况、体重及摄入量、外周血象、肝肾功能、主要脏器系数及各主要脏器的病理组织学等检查,均无明显的蓄积性毒性反应,与对照组相比无差异。结论虎贞痛风胶囊在该剂量条件下使用安全。
Objective To observe the long-term toxicological response of Hu-Zhen Tong Feng Capsule to oral administration of Wistar rats, evaluate its safety, determine the dose of non-toxic reaction, and provide a scientific basis for clinical application. Methods Long-term toxicity test was used to observe the toxic reaction of Hu-Zhen Tong Geng Capsule to rats. The dosage was 5.0g / kg, 2.50g / kg and 1.25g / kg respectively (equivalent to 104, 52 and 26 times). Results The general condition, body weight and intake, peripheral blood, liver and kidney function, major organ coefficient and histopathology of major organ in HuZhen Gout Capsule after 90 d administration and 15 d after drug withdrawal Check, no significant accumulation of toxic reactions, no difference compared with the control group. Conclusion Hu-Zhen Tong Geng Capsule is safe to use under this dosage condition.