壮尔颗粒的毒理学实验研究  

Study on the Toxic Effective of Zhuang’er Grandules

作　　者：李红[1] 宋铁玎[2] 王捷 李丽 陈英[2] 张铭[2] 

机构地区：[1]辽宁中医药大学,辽宁沈阳110032 [2]辽宁中医药大学附属医院,辽宁沈阳110032 [3]国家新药安全评价中心,辽宁沈阳110021

出　　处：《辽宁中医杂志》2006年第7期871-872,共2页Liaoning Journal of Traditional Chinese Medicine

基　　金：沈阳市科技委员会重点项目(1032041-1-04)

摘　　要：目的:考查动物灌胃给予壮尔颗粒的急性毒性和长期毒性。方法:以最大浓度、最大容积的壮尔颗粒给予小鼠,求出最大给药量;大鼠分壮尔颗粒高、中、低剂量组,对照组,连续灌胃13周,停药恢复期2周。观察实验期间大鼠的行为活动、外观体征、体重、摄食量的变化,给药末和恢复期末两次解剖,检测血液常规、血液生化、脏器系数,观察组织器官病理学变化。结果:24h最大给药剂量为72g/kg壮尔颗粒(相当于生药264g/kg,为临床有效剂量31倍);长期毒性实验,壮尔颗粒对大鼠经口给药的高剂量为24.0g/(kg·d)壮尔颗粒(相当于生药88g/(kg·d),为临床有效剂量的15.3倍),无明显毒性反应。结论:壮尔颗粒安全可靠。Objective ： To study both the acute and chronic toxic effect of Zhuang＇ er Grandules. Methods ： After the maximal density and capacity administering rats by garage, we gained the maximal dose ; There were 4 groups of high, middle, lower dosage of Zhuang＇ er Grandules and the control group. During continuously feeding rats orally for 13 weeks and recovering 3 weeks,we observed rats＇ behavior, appearance, body weight, appetite. After feeding and recovering,the haematological and biochemical markers, coefficient of the main organs and pathological examinination of the rats were investigated . Results： The maximal dose was 72g/（ kg · d） Zhuang＇ er Grandules according with 264g/kg crude materials,respectively 31 times as much as the clinical dosage. The experiment of chronic toxicity showed that the high dosage of 24.0 g/（ kg · d） Zhuang＇ er Grandules led to no remarkable toxic effect. Conclusion： Zhuang＇ er Grandules is absolutely safe.

关 键 词：壮尔颗粒 急性毒性 长期毒性 

分 类 号：R285.5[医药卫生—中药学]