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按新药审批办法有关规定,本实验观察了冠心七味胶囊对大鼠的长期毒性。结果表明,冠心七味胶囊粉以0 .2g/kg .d(相当于成人每日临床用量的5倍)、1.0g/kg.d(相当于成人每日临床用量的2 5倍)、2 .0g/kg.d(相当于成人每日临床用量的5 0倍)连续给药3个月,无1例动物死亡;各组大鼠的一般状态、进食量、体重、血液学及血液生化各项指标、主要脏器生理及病理组织检查,均未见异常。结果提示冠心七味胶囊长期大剂量服用对动物的行为活动、生长发育、器官组织、血液系统等均无毒性作用,故以临床推荐的剂量使用是较安全的
According to the relevant provisions of the new drug approval method, this experiment observed the long-term toxicity of Guanxin Qiwei Capsule on rats. The results showed that Guanxin Qiwei capsule powder was 0.2g/kg.d (equivalent to 5 times of the daily clinical dosage in adults), 1.0g/kg.d (corresponding to 25 times of the daily clinical dosage in adults), 2 .0g/kg.d (equivalent to 50 times the daily clinical dose in adults) for 3 months without any animal death; General state, food intake, body weight, hematology, and blood biochemistry in each group No abnormalities were found in all indexes, physiology and pathological examination of major organs. The results suggest that Guanxin Qiwei capsules do not have toxic effects on behavioral behavior, growth and development, organ tissues, and blood system of animals after long-term high-dose administration. Therefore, it is safer to use the doses recommended by clinicians.