葛芩粉的急性毒性和长期毒性研究

Experimental study on the acute toxicity and long-term toxicity of Geqinfen in rats

目的研究葛芩粉(GQF)的急性毒性和长期毒性作用。方法采用Bliss法研究葛芩粉对ICR小鼠的急性毒性,计算LD50。80只SD大鼠,随机均分为对照组和葛芩粉低、中、高剂量组,低、中、高剂量组的大鼠分别ig 0.6、2.4、3.6 g.kg-1葛芩粉,对照组给予等量蒸馏水,共30 d,观察给药期间大鼠的一般情况及可能出现的毒性反应。分别于停药及停药后2周各剖杀一半大鼠,观察血液生化学指标和血常规,称脏器重量,计算脏器系数,并作病理切片,观察组织形态学的变化。结果急毒实验表明:葛芩粉有一定的毒性,其LD50为15.576 g.kg-1(95%可信限为12.718～23.823 g.kg-1),折合为48.11 g.kg-1生药量。长毒实验表明:低、中剂量组大鼠的一般状况、重要脏器系数、血常规、血液生化学指标、脏器组织结构与对照组比较均未见明显异常;高剂量组的可见肝脏组织略有病变,其余脏器组织未见任何明显病理改变,各指标均未见异常;停药2周后,高剂量组的肝脏组织恢复正常,与对照组的比较差异无显著性。结论葛芩粉有一定的毒性,但病理变化具有可逆性,证明其毒性较小,使用时需要注意剂量及疗程。

OBJECTIVE To investigate the acute and long-term toxicity of Geqinfen（GQF）.METHODS The acute toxicity of GQF was observed by Bliss method and LD50 in ICR rats was calculated.In the long term toxicity,the 80 SD rats were divided into four groups at random,including three administration groups of different doses（0.6,2.4,3.6 g·kg-1） of GQF and the blank group for control giving distilled water for 30 days.The condition and toxic response of rats were observed and recorded.Half of the rats were killed when drug withdrawal and 2 weeks later respectively.Blood biochemistry,hematology,weights and tissue indexes,and the pathological change in major organs were explored.RESULTS The acute toxicity experiment showed that GQF had some toxicity,the LD50 was 15.576 g·kg-1（95%confidence limit was 12.718-23.823 g·kg-1）,equivalent to 48.11 g·kg-1 crude drug.The long term toxicity experiment showed that all the detected indexes were in normal range in low and middle dose groups compared with the control group;There were slight liver tissue lesions in high dose group,the rest of viscera had no any pathological changes,and other indexes were in normal range;After 2 weeks of the drug withdrawal,normal liver tissue could be seen in high dose group,and there were no significant differences compared with the control group.CONCLUSION The results suggest that GQF has low toxicity,but the pathological changes are reversible and attention should be paid to the dose and treatment.