甘乐胶囊大鼠长期毒性研究  

Research on Long-term Toxicity of Ganle Capsule in White Rat

作　　者：何光星[1] 张宁梅[2] 刘洁[1] 李秀婵[1] 

机构地区：[1]四川省中医药科学院,四川成都610041 [2]四川省疾病预防控制中心,四川成都610041

出　　处：《预防医学情报杂志》2008年第9期749-752,共4页Journal of Preventive Medicine Information

摘　　要：目的观察甘乐胶囊对大鼠所产生的毒性反应,为临床用药提供安全剂量。方法甘乐胶囊20.4、40.8、81.6g/kg(相当于临床剂量的15、30、60倍),连续给药6个月,观察对大鼠体重、心电图、血液细胞学、肝肾功能、系统尸解和脏器系数、组织形态学的影响。结果灌胃给药6个月小、中、大剂量组与对照组体重增长率分别为433.6%、407.8%、398.7%和414.4%,各剂量组体重与对照组比较差异均无统计学意义(P_均>0.05);仅见大剂量组(临床剂量60倍)肝功能指标ALT、AST明显降低(P<0.05、P<0.05)、TP明显升高(P<0.05);大剂量组动物肝、肾脏器系数增大(P<0.05、P<0.05)。给药6个月其他检查:心电图、血液细胞学、肾功能、系统尸解和主要脏器病理组织学检查各剂量组与对照组比较差异均无统计学意义(P_均>0.05)。结论甘乐胶囊40.8g/kg(相当于临床剂量30倍)以下剂量180 d灌胃大鼠无明显毒性反应,提示临床应用比较安全。但需注意在给药剂量较大时(临床剂量60倍)重点观察肝、肾方面的指标。objective To observe the toxicity of Ganle capsule on white rat, to provide the security dose for clinical usage. Method The effects of Ganle capsule on weight, electrocardiogram, hematology, function of liver and kidney, organ index, histomorphology were studied after giving the medicine to white rats for six months, with dosages of 20.4 g/kg 40. 8 g/kg, 81.6 g/kg, （corresponding to 15, 30, 60 times of clinical dosage）. Results Compared with the control, the weight of rats increased 6 months later but no statistical significance（ P 〉 0.05 ）. All the other indexes were also no significant differences. Conclusion Ganle capsule is no obvious toxicity on white rats and can be applied for clinical use.

关 键 词：甘乐胶囊 大鼠 长期毒性 

分 类 号：R289.5[医药卫生—方剂学]