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目的:研究丹羚心舒75%乙醇提取物的长期毒性。方法:按GLP常规方法进行试验,丹羚心舒胶囊以10、14.5、21、30g/kg给大鼠连续灌胃30天,观察长期毒性试验结果。结果:所有动物外观、体征、行为活动均未见明显异常。动物饲料消耗量相似。给药30天中1周、2周、3周和4周给药组与对照组相比,超大剂量(30g/kg)和大剂量(21g/kg)组体重增长较慢。在各剂量组中,21、30g/kg药后可见流涎,药后20分钟动物少动,1h后活动正常。丹羚心舒4个剂量组大鼠血液细胞学检查、血液生化学检查均在正常值范围之内。解剖观察动物各器官组织的排列位置、颜色、质地等未见异常。除超大剂量和大剂量动物可见胃粘膜萎缩,结缔组织增生外,33个脏器中均无病理改变。给大鼠连续灌胃给药30天后停药恢复3周,外观、体征、行为活动均无明显异常,血液细胞学与对照组相比无统计学差异,血液生化指标正常;超大剂量和大剂量物少数动物可见轻度胃粘膜萎缩,余无其它病变。结论:丹羚心舒75%乙醇提取物10、14.5、21、30g/kg 30天灌胃给药,除超大剂量和大剂量可见胃粘膜水肿、萎缩之外,对动物体重增长、行为活动、血液细胞学、血液生化学及主要脏器组织等均未见明显影响,恢复21天后,各指标均正常,无延迟毒性。
Objective: To study the long-term toxicity of Tan Ling Xushu 75% ethanol extract. Methods: According to the conventional method of GLP, the rats were continuously gavaged with Danxinyuxin Capsule for 10, 14.5, 21 and 30 g / kg for 30 days. The long-term toxicity test results were observed. Results: All animals showed no abnormal appearance, signs and behavior. Consumption of animal feed is similar. The body weight of rats in the super-high dose (30g / kg) and high dose (21g / kg) groups were slower than that of the control group in the 1 week, 2 weeks, 3 weeks and 4 weeks after administration for 30 days. In each dose group, 21,30 g / kg drug can be seen after salivation, animals less animals 20 minutes after the action, normal activity after 1h. Dan Ling Xin Shu 4 doses of blood cytology, blood biochemical tests were within the normal range. Anatomical observation of animal organs and tissues arranged position, color, texture, etc. no exception. Except super-high-dose and high-dose animals showed gastric mucosal atrophy, connective tissue hyperplasia, 33 organs were no pathological changes. After 30 days of continuous gavage administration, the rats were resumed for 3 weeks and the appearance, signs and behavioral activities were not abnormal. There was no significant difference between the blood cytology and the control group, and the blood biochemical indexes were normal. The ultra-high dose and high dose A small number of animals showed mild gastric mucosal atrophy, I no other lesions. Conclusion: Dangxinsheshu 75% ethanol extract 10,14.5,21,30 g / kg gavage 30 days, except for large doses and large doses of visible gastric mucosal edema, atrophy, the body weight gain, behavioral activity, Blood cytology, blood biochemistry and major organs and other organizations had no significant effect, recovery 21 days, the indicators were normal, no delay in toxicity.