前列宁胶囊毒理学研究

Toxicological Studies on Qianliening Capsule

[目的]对院内制剂前列宁胶囊进行急性毒性及长期毒性试验研究,为临床用药提供参考。[方法]应用最大耐受量(MTD)试验测定法对前列宁胶囊进行小鼠急性毒性实验;大鼠长期毒性试验连续12周灌胃给药,处死半数动物,其余动物停药进行恢复期观察2周。观察大鼠饮食、活动、体重、大小便、进食量、外观体征等情况,并进行血液、生化、病理学等检查。[结果]急性毒性实验未见明显毒性反应,MTD为133g/kg,相当于推荐临床用药量折合0.75g/kg的178倍。长毒试验结果提示,前列宁胶囊高、中、低各剂量组动物均未出现严重中毒表现,各脏器无病理性变化。[结论]前列宁胶囊急性毒性和长期毒性试验未见明显毒副作用,表明在推荐临床剂量下使用,具有较高的安全系数。

[Objective]To investigate possible acute and chronic toxicity of Qianliening capsule for clinical reference.[Methods]Maximal tolerate dose(MTD)test of twice administration a day was used for acute toxicological evaluation.The rats were treated with intragastrical garage(ig)administration for 12 weeks in the chronic toxicological study,then we sacrificed half of the animals and kept the others for 2 weeks reversal observation.Diet,activities,body weights,food-intakes and external appearances of the treated animals were observed and recorded.Haematological and blood biochemical parameters,and pathological examinations were undergone.[Results]No evident toxicity was observed in mouse acute toxicity test,the MTD was 133 g/kg twice a day,and it was about 178 times of the clinical recommended dose(0.75 g/kg).No severe toxic symptoms were examined in high,middle,or low dose group;No organic changes were observed in pathological tests.[Conclusion]Qianliening capsule is safe for i.g.administration in rats at the recommended clinical dose.