伊血安在大鼠体内的长期毒性研究

Study of long-term toxicity of Yixuean in rats

目的研究伊血安的长期毒性。方法观察连续给予大鼠受试药物所产生的毒性反应,根据严重程度、靶器官、恢复和发展情况,确定无毒反应剂量。结果以原生药干膏ig给予151.2、67.2、33.6g(生药)·kg-1伊血安4周(日剂量分别为临床拟用量的108、48、24倍),3个剂量组的凝血时间均缩短,大剂量组的血清肌酐含量稍增高,其余均未见明显的毒性反应;停药观察2周后,上述改变均恢复至正常水平,未见明显的迟缓毒性反应。结论伊血安长期用药对大鼠无明显毒性,按临床拟用剂量、用药途径和疗程是安全的。

OBJECTIVE To investigate the long-term toxicity of Yixuean in rats.METHODS The long-term toxicity and severity occurred,target organ,recovery condition after successive administration of Yixuean in rats were observed.The safe dosage was determined.RESULTS Three tested dosage groups at 151.2,67.2,33.6 g·kg-1（108,48,24 times for clinical dosage） were set up for 4 weeks＇intragastric administration,respectively.The Clotting time was all shortened in three dosage groups and Sr of rats with high dosage was slightly increased.There were no other significant toxic reaction.The above changes were restored to normal levels at 2 weeks after drug withdrawal,and delayed toxicity reaction after drug withdrawal was not discovered.CONCLUSION Yixuean has no obvious toxicity in rats for long-term administration.