宫血净胶囊毒理学研究

目的观察宫血净胶囊的急性毒性和长期毒性。方法（1）急性毒性试验：昆明种小鼠40只，用随机数字表法分成2组，每组20只，实验组用宫血净胶囊粉，采用最大给药法灌胃给药；对照组用等体积蒸馏水灌胃观察14d，记录小鼠的体重及毒性反应；（2）长期毒性试验：Wistar种大鼠80只，用随机数字表法分成4组，每组20只，3个实验组用宫血净胶囊生药81．6、49．0、24．5g／kg连续灌胃3个月；对照组用等体积蒸馏水灌胃停药14d后分另q称量大鼠体重、计算脏器系数、血液学指标、血液生化学指标并做病理组织学检查。结果宫血净胶囊的最大给药量为生药450g／kg，未见小鼠行为异常，体重增长正常。长期毒性试验：给药期间各组大鼠毛色、活动、二便、摄食、饮水与对照组比较差异无统计学意义（P〉0．05）；但大剂量组部分大鼠体重、血液学、血液生化学指标和脏器系数有异常变化，停药后，上述异常变化指标均恢复正常。给药期和恢复期重要脏器病理组织检查均未发现明显异常变化。结论宫血净胶囊的最大给药量为生药450g／ks；长期大剂量灌胃给予宫血净胶囊对大鼠有一定毒性，但停药后均恢复正常。该药按使用剂量和疗程给药是安全的。

Study on the Toxicity of Gongxuejing Capsule

Objective To observe the acute toxicity and long-term toxicity of Gongxuejing capsule. Methods （1） Acute toxicity test ：40 mice were divided into experimental group （n =20） and control group （n =20） according to random number table. Mice in experimental group administrated Gongxuejing capsule powder by maximum tolerance dose, while mice in control group administrated the same volume of distilled water by gavage. All the mice were observed 14 days and record the weight and toxicity reaction;（2） Long-term toxicity test：80 wistar rats were divided into four groups with each group of 20 rats according to random number table. The rats in experimental groups were given by gavage of Gongxuejing capsule at the dose of crude drug 81.6,49. 0,24. 5 g/kg for 3 month,after 14 days of drug withdrawal,the weight of rats,organ coefficient,hemotolngy parameters and histopathology examination were record or carried out. Results The maximum tolerance dose in mice was crude drug 450 g/kg,no abnormal behavior was found and the weight remains normal. In the long-term toxicity test,the coat color,action,urine and stool, feeding, drinking in rats of experiment group had no significant difference comparing with control group during the period of administration （P 〉 0. 05） ; but part of weight, organ coefficient, parameters of hemotology and biochemistry in rats of large dose group showed abnormal changes, the abnormal change of indexes were completely recovered after drug withdrawal. No obvious abnormal changes for the important organ of histopathology examination were found during the period of administration and recovery. Conclusion The maximum tolerance dose in mice is crude drug 450 g/kg;there is some long-term toxicity in rats by large dose intragastric administration of Gongxuejing capsule,but the changes could recovery completely after drug withdrawal;it is safe that within application dosage and course of Gongxuejing capsule.