荭叶心通软胶囊对大鼠的长期毒性研究.docVIP

荭叶心通软胶囊对大鼠的长期毒性研究 作者：何迅，李勇军，周雯，王爱民，兰燕宇，王永林‘ 【摘要】 　　目的： 观察荭叶心通软胶囊对大鼠的长期毒性。方法： 160只SD大鼠，随机分为高、中、低剂量组及空白对照组，雌雄各半，每日灌胃1次，连续给药26周,观察大鼠的一般状况、体重、摄食量和给药13、26周及停药后4周大鼠的血液学、血液生化学、凝血功能、脏器系数、解剖学及病理组织学改变的情况。 结果： 荭叶心通软胶囊高剂量组雌性大鼠给药13周总胆红素（TBIL）、给药26周肌酐（CREA）和TBIL、给药26周凝血酯原时间（PT）及高剂量组雄性大鼠给药26周Cl-浓度与对照组比较稍有差异，停药4周后即恢复正常，组织病理学检查无异常。其余各剂量组各项指标与对照组比较差异均无显著性。结论： 荭叶心通软胶囊在临床剂量范围内毒性小，使用安全。 【关键词】 毒性试验； 红蓼； 大鼠，Sprague-Dawley; 荭叶心通软胶囊； 长期毒性 　　［Abstract］ Objective: To study the long-term toxicity of Hongyexintong soft capsules to rats.Methods： One hundred and sixty SD rats were randomly divided into four groups （40 in each group）, and orally given the medicine with doses of 50, 25, or 12.5 g/kg of crude drug, or with bean oil of 0.5％CMC-Na （for control group） daily for 26 weeks.The physical status （body weight，growth rate and appetite）， hematological parameters, blood biochemistry, blood cotting, organ index, and tissue pathological changes of rats were checked in the 13th week,and 26th week of the administration and in four weeks after the stop of the administration. Results： All of the parameters tested did not differ from those of control group, except that blood level of total bilirubin （TBIL） of female rats in high dose group in the 13th week, blood creatinine level, blood TBIL level, and prothrombin time of male rats in high dose group in the 26th week were significantly higher than those of control group （Plt;0.05）, and that blood Cl-level of male rats in high dose group in the 26th week was lower than that of control group （Plt;0.05）. All the differences disappeared in 4 weeks after the drug withdrawal. No tissue pathological change was found. Conclusion： Hongyexintong soft capsules are safe in its clinical use with the recommended dosages. 　　［Key words］ toxicity tests; Polygonum orientale; rats,Sprague-Dawley; Hongyexintong soft capsules； long-term toxicity 冠心病心绞痛属于中医的胸痹心痛的范畴，为临床常见病、多发病，主要病机为心脉痹阻，即心脉运化失常，气血运行受阻，致使气结血凝而发生胸闷、心痛等症，故治宜活血化瘀、通