【摘要】 目的:考察中药新药冰茶栓对动物的急性及长期毒性,为人临床有安全剂量提供参考。方法:急性毒性:小鼠腹腔注射冰茶栓处方药生理盐水溶液,Bliss法求得冰茶栓腹腔注射的LD50;长期毒性:大鼠以相当于成人拟临床用量35倍、70倍和140倍剂量直肠给予冰茶栓,给药及恢复期后处死动物,测定外周血象及血清生化,并进行系统解剖、病理检查、计算脏器指数。结果:(1)按Bliss法求得小鼠冰茶栓腹腔注射的LD50为2.665±0.209mg/kg;(2)大鼠以长期毒性试验中的三个剂量直肠给药30天后,与对照基质栓组比较,体重、摄食量、血液生化、脏器系数等指标未见差异性改变;病理学检查显示,大鼠直肠局部有机械性炎症,心肌、肝脏等组织有轻微病理改变,但具可逆性。结论:冰茶栓应用上述剂量时,未见有明显毒副反应,各项检测指标在给药组与对照组之间无显著差异,提示冰茶栓临床长期用药是安全的。更多还原

【Abstract】 Objective:To find out the acute and long-term toxicities of TCM suppository BingCha Shuan（BCS）in mice and rats.Methods:（Acute Toxicities）Fifty mice were randomized into five groups,each given different dose of BCS aqueous solution ip,the LD₅₀ of BCS in mice was obtained by the method of Bliss;（Long-term Toxicities）eighty rats（same number for both sexes）were divided into four groups,One group was a matched control,another three groups received BCS 1424 mg/kg.d^-1、712 mg/kg.d^-1 and 356 mg/kg.d^-1respectively for 30 days continuously.After then,the related parameters were measured.Results:（1）The LD₅₀ of BCS in mice was 2.665±0.209mg/kg;（2）Compared with the control,the parameters of the treated rats,such as weight,intake of food,biochemical assays of blood,index of internal organs,were not changed in normal rang;Pathomorphological examination showed that there were several mild pathological changes in the tissue of cardiac muscle and liver in only one or two animals,and all these toxic changes were reversible when the drugs had been withdrawed after 30 days.Conclusions:There were no obvious pathological changes in the tested animals after BCS administration.It is suggested that BCS may be safely prepared as a drug for clinical use.更多还原