【摘要】 目的:观察化痰软坚片的使用安全性。方法:将SD大鼠随机分为4组,即化痰软坚片低剂量、中剂量、高剂量组及对照组,分别以化痰软坚片低剂量(生药13.7g/kg)、中剂量(生药27.3g/kg)、高剂量(生药54.6g/kg)及等体积蒸馏水连续对大鼠灌胃12周及停药恢复性2周。结果:给药12周与停药2周时各组大鼠的一般状况、行为活动、体质量、摄食量、血常规、血液生化指标、脏器系数及内脏器官心、肝、脾、肺、肾、肾上腺、胸腺、睾丸和前列腺、子宫及卵巢的病理组织学检查结果显示均未见毒性反应。结论:化痰软坚片在临床用药范围内连续使用是安全的。更多还原

【Abstract】 Objective: To observe the safety of Huatan Ruanjian tablets(for resolving phlegm and softening hard mass). Methods: Sprague-Dawley rats were randomly divided into low-,middle-,and high-dose Huatan Ruanjian tablet groups and control group to receive low-dose Huatan Ruanjian tablets(crude drug 13. 7g/kg),middle-dose Huatan Ruanjian tablets(crude drug 27. 3g/kg),high-dose Huatan Ruanjian tablets(crude drug 54. 6g/kg),and an equal volume of distilled water,respectively,by gavage for 12 weeks,followed by drug withdrawal for 2weeks. Results: During drug administration and drug withdrawal,these group showed no toxic reactions in terms of general status,activities,body weight,food intake,routine blood test results,blood biochemical parameters,organ coefficient,and histopathology of the heart,liver,spleen,lungs,kidneys,adrenal glands,thymus,testes,prostate,uterus,and ovaries. Conclusion: Continuous administration of Huatan Ruanjian tablets is safe within the clinical dose range.更多还原