天钩降压胶囊的毒理学研究  

Experimental studies on toxic effects of Tiangou Jiangya capsule

作　　者：陈颖[1] 李玉洁[1] 杨庆[1] 翁小刚[1] 邹丽娟[1] 朱晓新[1] 

机构地区：[1]中国中医科学院中药研究所,北京100700

出　　处：《中国中药杂志》2011年第23期3358-3363,共6页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09103-403)

摘　　要：目的:观察天钩降压胶囊的急性毒性和长期毒性,以评估天钩降压胶囊用药的安全性。方法:以最大给药体积的天钩降压胶囊(0.345 g.mL-1)给予小鼠,24 h内分2次灌胃给药,连续观察14 d,记录动物外观、行为活动、精神状态、呼吸变化、中毒反应及死亡情况;存活小鼠每天记录体重及饲料量。用低、中、高剂量(32.4,64.8,129.6 g.kg-1,按生药计)的天钩降压胶囊灌胃给予大鼠,连续给药6个月,停药恢复1个月,分阶段观察大鼠的一般行为、体重增长、食量消耗、血液学及血液生化学指征、尿常规检查、心电图、系统尸解及组织病理学检查。结果:小鼠1 d内2次灌胃给予天钩降压胶囊的最大给药量为534.86 g.kg-1,相当于临床成人拟用日剂量(60 g.d-1)的534.86倍,未见明显的急性毒性反应。长期毒性实验中与同期对照组比较,天钩降压胶囊低、中、高3个剂量组动物行为活动、进食量、心电图等检查均未见异常;血液学指标、血液生化指标和尿液指标及病理组织学检查未发现存在与供试品有关的异常改变。结论:天钩降压胶囊低剂量为相对安全剂量;中、高剂量在6个月给药期内引起体重减少,在临床研究中应予以注意。Objective： To study the acute and chronic toxicity of Tiangou Jiangya capsule. Method： Tiangou Jiangya capsule was intragastrically administered to mice twice a day. The appearance, behavior, mental status, respiratory changes of mice and the number of poisoned and dead mice in each group were noted daily for 14 consecutive days. The amount of weight and feed of survived mice were recorded every day. The mice were divided into four groups： the treatment groups （minimum, middle, maximum dose of Tiangou Jiangya capsule） and the control group. After continuously orally administrated for 6 months, the rats＇ behavior, weight gain, food consumption, indications for hematology, blood biochemistry, urine analysis, electrocardiogram, systematic autopsy and histopathology were observed. The above physiological indexes were inspected again 1 month after cease of administration. Result： The oral acute toxicity study of Tiangou Jiangya capsule in mice revealed that the maximum dose is 534.86 g·kg^-1, which was 534.86 times the recommended human maximum dose in clinical practice. Compared with normal control group, no significant differences were observed in rats＇ behaviors, food-intake, electrocardiogram and relative examination indexes among the treatment groups. There was no difference of hematology, biochemistry test, urine and histopathology. Conclusion： The minimum dosage of Tiangou Jiangya capsule is relatively safe. It caused weight loss by administrated with the middle and maximum dose for 6 months, which should be paid attention in clinical studies.

关 键 词：天钩降压胶囊 急性毒性 长期毒性 

分 类 号：R285[医药卫生—中药学]