生血胶囊的毒理学研究

目的本研究观察小鼠和大鼠口服生血胶囊的急性毒性和长期毒性反应,为临床用药提供参考。方法取健康小鼠和大鼠各30只,灌胃给药,2次/d,每次剂量分别为24和16 g/kg,给药后观察14 d,记录动物死亡及不良反应症状,取健康SD大鼠160只,随机分为低、中、高(0.5、2.5、5.0 g/kg)3个剂量组和一个对照组。灌胃,2次/d,每次10 ml/kg,连续26周。用药13周、26周和停药4周后分别取样进行血液学、血液生化学、脏器重量及重量指数,病理组织学检查。结果生血胶囊对小鼠和大鼠的口服最大给药量分别大于24和16 g/kg,该剂量是临床成人拟推荐用药剂量(0.08 g/kg)的240和160倍;长期毒性实验中各组大鼠的一般状况、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未见显著差异和异常改变;肉眼观察服药组心、肝、脾、肺、肾等脏器外观形态、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。结论在推荐临床剂量下服用生血胶囊是安全可靠的。

Toxicological Studies on Shengxue Capsules

Objective To observe the acute and chronic toxical reactions of Shengxue Capsules on mice and rats to suggest the reference dosage for humans.Methods Shengxue Capsules were ig administrated to mice and rats twice a day,24 and 16 g/kg,respectively.The mortality rate and drug toxicity were observed and recorded.During long-term toxicological studies,rats were given capsules by intragastric administration at the dosage of 0.5,2.5,5.0 g/kg,respectively,twice a day for 26 weeks.Hematology,blood biochemistry,measure weights and weight indexes,and pathological changes in major organs were examined at 13th week,26th week and 4 weeks after drug withdrawal.Results The maximum ig administration dosage was greater than 24 g/kg in mice and 16 g/kg in rats,240 and 160 times the clinical dosage in humans.Hematology,blood biochemistry,weights and weight indexex of rats were proved to be in the normal range and no pathologic changes in major organs were found.Conclusion Shengxue Capsules are safe at the prescribed dose.