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机构地区:[1]武汉健民药业集团股份有限公司,武汉430052 [2]华中科技大学同济医学院药学院,武汉430030
出 处:《医药导报》2014年第1期20-23,共4页Herald of Medicine
摘 要:目的观察鳖甲煎丸对大鼠的毒性反应,确定其安全剂量,为拟定人用剂量提供参考。方法 SD大鼠60只,随机分为鳖甲煎丸低、高剂量组和对照组,每组20只,分别灌胃给予低、高剂量鳖甲煎丸药液(相当于生药5,10 g·kg-1)和纯化水2 mL,连续给予6个月。观察大鼠一般状况、体质量及进食量,给药结束及停药4周后检查血常规、血液生化学指标及脏器系数、组织病理学变化。结果鳖甲煎丸低、高剂量组大鼠一般状况、体质量、进食量、血常规、血液生化学指标及脏器系数与对照组比较均差异无统计学意义,亦未见异常组织病理学变化。结论鳖甲煎丸对大鼠血常规、血液生化学指标无明显影响,对脏器的长期毒性低,未发现毒性靶器官,长期服用安全。Objective To study the long-term toxicity of biejiajian pills in rats, determine the safe dose, and provide reference for human use. Methods Sixty SD rats were divided into low, high dose groups, and control group, respectively ( n=20 in each group) , biejiajian pills were orally administered to rats at the doses of 5 and 10 g ~ kg-~ daily for 6 months, while the control group was given with 2 mL of distilled water only. The general state, body mass and food intake were measured. By the end of the test and 4 weeks after drug withdrawal, blood routine, hematologic and biochemical examination, organ coefficient, and histopathology were tested. Results Compared with the control group, no significant differences in all checked items were found in the treatment groups. Conclusion Biejiajian pills have a low long-term toxicity on the organs, blood routine, hematologic and biochemical indicators. The organ specific toxicity of biejiajian pills is not found. Biejiajiart pill at tested doses is safe for oral use in rats.
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