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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。
OBJECTIVE: To observe the toxic reaction of long-term administration of dendrocytic safflower-7 in rats to provide safe basis for clinical use. Methods: Wister rats were randomly divided into two groups according to body weight: the control group, the low dose of safflower-sauces (1.34g.kg-1.d-1), the high dose of safflower-sauces (5.36g.kg-1 .d-1). The rats were given gavage for 6 months. The appearance, body weight and response of the animals were observed. Blood routine, blood clotting and blood biochemical parameters were measured. The organ index The hematoxylin-eosin staining was performed to observe the histomorphological changes. Results: There was no significant change in appearance signs, behavioral activity, body weight, organ coefficient, blood routine analysis and coagulation in the administration group compared with the blank control group after continuous gavage for 6 months and withdrawal for 1 month. After six months of biochemical test, the serum levels of ALT, AST and CRE in the Decoction-Safflower-7-Treated high dose group decreased significantly compared with the control group (P <0.05); the biochemical detection of CRE was still lower than that of the blank control group Control group, P <0.05, no significant changes in other test items. Histopathological examination did not find any significant pathological changes in various organs. Conclusion: The decoction of safflower-7 powder in the clinical dose of 120 times, or 5.36g / kg given to give long-term intragastric administration of rats safer, providing a safety basis for clinical medication.