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目的观察大鼠对蛞蝓胶囊的长期毒性反应,为临床研究提供依据。方法按照成人每日用量,将给药组大鼠分为低剂量组175.0 mg.kg 1、中剂量组553.0 mg.kg 1、高剂量组1 750.0 mg.kg 1和对照组。连续灌胃给药26周,停药恢复4周,对一般情况进行观察,对体质量、进食量进行称量比较,对血液学指标、血液生化指标、尿常规进行检测,对脏器进行病理学检查和脏器系数比较。结果给药组与对照组比较,大鼠的一般状况、行为活动、进食量、体质量变化、外周血象、尿常规指标、血液生化指标、脏器系数以及病理组织学等均无统计学差异。结论蛞蝓胶囊大鼠长期毒性实验未见毒性反应,提示临床拟用剂量安全。
OBJECTIVE To observe the long-term toxicities of rats to Gansu capsule and to provide the basis for clinical research. Methods According to the daily dosage of adult, the rats in treatment group were divided into low dose group (175.0 mg.kg 1), middle dose group (553.0 mg.kg 1), high dose group (750.0 mg.kg 1) and control group. Continuous gavage for 26 weeks, stopping the recovery for 4 weeks, the general situation was observed, the body weight, food intake were compared, the hematological indicators, blood biochemical indicators, urine routine testing, organ disease Neutrophil examination and organ coefficient comparison. Results Compared with the control group, there was no significant difference in the general condition, behavioral activity, food intake, body weight, peripheral blood, urinalysis, blood biochemical parameters, organ coefficient and histopathology in the treated group and the control group. Conclusion Long-term toxicity test of rats in Xuyi capsule showed no toxic reaction, suggesting that the dosage should be safe in clinical practice.