决明山楂燕麦胶囊长期毒性实验研究

目的观察大鼠长期口服决明山楂燕麦所产生的毒性反应及其程度,为临床安全使用提供依据。方法以低剂量组1.6g/kg、高剂量组2.0g/kg的剂量给大鼠连续灌服决明山楂燕麦水溶液8周,对大鼠进行一般状况、血液学指标、血液生化指标、主要脏器指数和组织病理学观察和检测。结果低、高剂量组大鼠的一般状况、体质量、血液学指标、血液生化学指标及主要脏器系数与对照组比较差异无统计学意义;肉眼观察服药组心、肝、脾、肺、肾外观形态、颜色均无异常改变,光镜检查也未见各脏器组织结构和细胞形态异常。结论连续灌胃给予决明山楂燕麦8周,对大鼠无明显毒性,说明1.6g/kg、2.0g/kg剂量连续服用是安全的。该剂量分别相当于临床成人用量的40、50倍。

Long-term toxicity test of semen cassiae hawthorn oat capsules

Objective To provide basis for safe clinical use,and to observe the toxic reactions and degrees of semen cassiae hawthorn oat capsules in rats.Methods The semen cassiae hawthorn oat was orally given to rats for 8 weeks continuously at low（1.6 g/kg） and high（2.0 g/kg） dosages.The rats′ general physical state,hematological indexes,biochemical indexes,organ coefficients and histopatholo-gical changes were observed.Results There were no significant differences in the general state,weight changes,hematological indexes,biochemical indexes and organ coefficients in rats of low-and high-dosage group when compared with those of control group.Macroscopic observation of heart,liver,spleen,lung and kidney showed no changes of appearance,shape and color.Pathologic examination did not show any structural and cellular abnormalities of each organ.Conclusion The semen cassiae hawthorn oat capsule has no significant toxicity in rats for oral administration for 8 weeks continuously.It infers that dosages of 1.6 g/kg and 2.0 g/kg are safe for long-term taking.These two dosages are respectively equivalent to 40 and 50 times of clinical dosage for humans.