含朱砂散剂清心散、益元散对大鼠的毒性研究

Toxicity Study on Qingxin Powder and Yiyuan Powder Containing Cinnabar in Rats

目的:考察清心散、益元散对大鼠脑功能、肝功能、肾功能的影响。方法:将24只雄性大鼠随机分为空白对照组、清心散组、益元散组、朱砂组,每组6只。按照大连市儿童医院临床使用疗程(5周)和2010版《中国药典》规定的成人最大日剂量0.5 g设计大鼠给药方案,各组大鼠分别灌胃给药35 d,末次给药后3 h取血清检测ALT、AST、BUN、Cr,取脑、肝、肾做组织病理学切片。结果:朱砂组、空白对照组、清心散组、益元散组ALT分别为67.40 IU/L、56.67 IU/L、57.17 IU/L、53.17 IU/L,朱砂组ALT显著升高(P<0.05),AST、Cr无显著变化;病理切片中朱砂组可见有炎性浸润,益元散组、清心散组未见对脑、肝、肾的明显影响。结论:清心散、益元散按成人最大日剂量换算给药,临床疗程5周内对大鼠脑、肝、肾的形态与功能未见明显不良影响,大鼠肝肾功能的各项指标未见显著变化。

Objective： To investigate the effects of Qingxin powder and Yiyuan powder on the function of brain, liver and kidney in rats. Methods： Twenty-four male rats were divided into the control group, the Qingxin powder group, the Yiyuan powder group and the cinnabar group （n = 6 each）. According to the clinical course （5 weeks） of Dalian Children＇s Hospital and the 2010 edition of the Chinese Pharmacopoeia, the adult maximum daily dose of 0.5 g design dosage regimen of rats. Rats were administrated with each drug respectively for thirty-five days. After then, blood samples were obtained; the ALT, AST, BUN and Cr were measured. The brain, liver and kidney were harvested to do pathological section. Results： The ALT of the four were 67.40 IU/L, 56.67 IU/L, 57.17 IU/L, 53.17 IU/L respectively （P〈0.05）, AST, Cr had no significant changes, The phlegmasia reaction were observed in pathological section of the cinnabar group. However, no obvious effect was observed on brain, liver and kidney in the Qingxin powder and Yiyuan powder group. Conclusions： Qingxin powder and Yiyuan powder did not markedly affect the function and form on brain, liver, and kidney in rats.