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目的:观察妇平胶囊对大鼠长期给药可能产生的毒性反应,评价其安全性,为临床用药提供指导。方法:将120只SD雌性大鼠随机分为溶媒对照组及受试药高、中、低3个剂量组:2.8、1.4、0.7g/kg,(分别相当于临床拟用剂量的62、31、15.5倍),每组30只。给药体积为1.0ml/100g,每天经口给大鼠灌服1次,每周6 d,连续灌胃给药6个月(24周),停药恢复4周。观察动物的一般体征状况、体质量、摄食量。给药中期(12周)、末期(24周)和恢复期(28周)每组分别剖杀1/3大鼠,检测血液学指标、血液生化学指标,进行系统尸检,计算脏器系数,检查脏器组织病理学。结果:给药期及恢复期各剂量组动物外观体征、行为活动等一般体征状况良好,体质量、摄食量增长正常,血液学、血液生化学虽有个别指标出现异常,但无剂量和时间的相关性,无毒理学意义。结论:妇平胶囊以相当于临床62倍的剂量对SD大鼠灌胃给药24周,未表现出明显的毒性作用,安全性良好。
OBJECTIVE: To observe the possible toxicity of Fu Ping capsule to rats for long-term administration, evaluate its safety and provide guidance for clinical medication. Methods: A total of 120 SD female rats were randomly divided into three groups: high dose, middle dose and low dose of test drug and control group (2.8,1.4,0.7g / kg, respectively) (equivalent to 62,31 , 15.5 times), each group of 30. The volume of administration was 1.0ml / 100g. The rats were orally dosed once a day for 6 days a week with continuous gavage for 6 months (24 weeks). The withdrawal was resumed for 4 weeks. Observe the general signs of animals, body weight, food intake. One-third of the rats in each group were sacrificed in the middle (12 weeks), the end of (24 weeks) and the recovery (28 weeks) of administration respectively. Hematological and blood biochemical indexes were measured and autopsy was performed. Check organ histopathology. Results: The physical signs and behavioral activities of the animals in the dosing period and recovery period were generally good. The body weight and food intake increased normally. There were some abnormalities in hematology and blood biochemistry, but no dose and time Relevance, non-toxicological significance. Conclusion: Fu Ping Capsule can treat SD rats intragastrically for 24 weeks at a dose equivalent to 62 times of that of the clinical ones, showing no obvious toxic effect and good safety.