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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。
Objective: To observe the safety of phlegm softening tablets. Methods: The SD rats were randomly divided into 4 groups: low dose, middle dose and high dose of Huatanjianjian tablet and control group. The rats were treated with low dose of Huashenjianjian tablets (crude drug 13.7g / kg), middle dose 27.3g / kg), high dose (crude drug 54.6g / kg) and equal volume of distilled water in rats for 12 weeks and drug withdrawal for 2 weeks. Results: The general condition, behavioral activity, body weight, food intake, blood routine, blood biochemical indexes, organ coefficient and organs heart, liver, spleen, lung, Pathological examination of kidney, adrenal, thymus, testis and prostate, uterus and ovary showed no toxic reaction. Conclusion: Phlegm Softening Tablets in the clinical use of continuous use is safe.