（毕业论文 字数：2990 页数：3）摘要: 目的:观察复方抗癫Ⅰ号胶囊对大鼠的长期毒性,为临床安全用药提供依据。方法:将大鼠随机分为4个组,3个剂量组分别按9g/kg、4.5g/kg、1.5g/kg连续灌胃给予复方抗癫Ⅰ号60天,对照组给予同体积蒸馏水。停药后继续观察3周,测试大鼠体重、血液学指标、血液生化学指标、脏器指数及病理组织学变化。结果: 主要血液学指标均在正常范围;主要生化学指标与对照组基本一致(P>0.05),解剖主要脏器未见明显肉眼可见的病理性改变;主要脏器系数值与对照组比较无明显差异。结论:复方抗癫Ⅰ号在临床推荐剂量下有一定的安全性。

关键词：复方抗癫Ⅰ号胶囊,长期毒性

Study on long-term toxicity of compound anti-epilepsy capsuleⅠ in rats

Abstract Objective: To observe the long-term toxicity of compound anti-epilepsy capsuleⅠand provide reliable safety data for clinical use. Method: the experiment rats were randomly chosen to form four groups, three of which were given the investigation drug at the dosage of 9g/kg,4.5g/kg and 1.5g/kg respectively for consecutive 60 days and the control group was administered distilled water as placebo. 3 weeks after drug ceased, studies on body weight, hematological changes, and blood biochemistry and possible pathological changes of the organs were performed. Results: Major hematological changes were within the normal physiological range in the experimental groups and the obtained biochemical data showed little deviation from the control group (P>0.05). Conclusion: Compound anti-epilepsy capsuleⅠtaken at the recommended dosage has a safe clinical application.

Keywords: compound anti-epilepsy capsuleⅠ, long-term toxicity

目录

1 实验材料
2 实验方法
3 结果
4 结论与讨论

1 实验材料
1.1 实验动物 健康SD大鼠，鼠龄8-10周，雌雄各半。合格证号:医动字06-058号。
1.2 受试药物 复方抗癫Ⅰ号胶囊，规格：100mg；批号:060418。使用前将本品分别制成浓度为0.45g/ml、0.225g/ml、0.075g/ml的溶液。
1.3 空白对照品 蒸馏水。
1.4 生化测定试剂盒 丙氨酸氨基转移酶、总蛋白、白蛋白、尿素氮、肌酐生化试剂盒由北京北化康泰临床试剂有限公司生产；总胆红素、血糖生化试剂盒由四川迈克科技有限公司生产；总胆固醇试剂盒由温州东瓯生物工程有限公司生产；血红蛋白试剂盒由上海伊华临床医学科技有限公司生产。均在有效期内。
1.5 仪器 UV-200紫外分光光度计，日本岛津公司生产。PB302型电子天平，瑞士梅特勒公司生产。DT多功能电子天平，常熟市衡器厂生产。OLYMPUS H02112型显微镜，日本奥林巴斯公司生产。