蒙成药德都红花-7味散长期毒性试验探究.docVIP

蒙成药德都红花-7味散长期毒性试验探究 摘 要：目的：观察大鼠长期口服德都红花-7味散产生的毒性反应，为临床提供安全用药依据。方法：取wister大鼠，按体重随机分为空白对照组和德都红花-7味散低剂量组（1.34g·kg-1·d-1）、高剂量组（5.36g·kg-1·d-1），连续灌胃给药6个月，观察实验动物外观体征、体重、给药后的反应；检测血常规、凝血四项、血液生化指标；计算脏器指数，常规对主要脏器做he染色，观察组织形态学改变。结果：连续灌胃给药6个月和停药1个月后，给药组与空白对照组比较外观体征、行为活动、体重、脏器系数、血常规分析、凝血四项均无明显改变。生化检测中给药六个月后德都红花-7味散高剂量组ALT、AST、CRE与空白对照组比较明显下降，P＜0.05；停药后1个月生化检测CRE仍低于空白对照组，P＜0.05，其它检测项目均无明显改变。组织病理学检查各脏器均未发现明显的病理改变。结论：德都红花-7味散在临床剂量的120倍，即5.36g/kg内给予大鼠长期灌胃给药较安全，为临床用药提供了安全性依据。 关键词：蒙成药；德都红花-7味散；大鼠；长期毒性试验 中图分类号：R285.5文献标识码：A文章编号：1673-7717(2011)12-2761-04 Study on the Long-term Toxic Effect of Deduhonghua-7 Powder HAN Zhiqiang1，BA Tudeligen1，GAO Yufeng1,QING Yu1, NA Risu2，MU Qi2 (1. Affliated Hospital of Inner Mongolia University for the Nationalities, Tongliao 028007, Inner Mongolia, China； 2.Mongolia Medical College of Inner Mongolia University for the Nationalities，Tongliao 028000, Inner Mongolia, China) Abstract:Objective:To evaluate the long-term toxicity of Deduhonghua-7 powder on rats and to provide the scientific basis for its clinical usage.Methods: Wistar rats were randomly divided into control group and Deduhonghua-7 powder low dose group(1.34g·kg-1·d-1)、high dose group(5.36g·kg-1·d-1)，the rats were consecutively drenched Deduhong hua-7 powder for 6 months. The appearance of signs、body weight and reaction were observed after administration；blood、coagulation、blood biochemical indicators were tested organ index of the animals were calculated；conventional staining of HE dyed on major organs and histological changes were observed.Result: Consecutively medication for 6 months and 1 month after drug discontinuance, treated group compared with control group, there were no significant changes on appearance of the signs, behavior, body weight, organ coefficient, blood analysis, coagulation. Treated group compared with control group, ALT、AST、CRE in Deduhonghua-7powder high dose group was decreased obviously after administration for 6 months (P＜0.05). 1 month