复方鞘蕊苏颗粒毒理学研究

目的对新药复方鞘蕊苏颗粒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）试验测定法对复方鞘蕊苏颗粒进行小鼠急性毒性实验；大鼠长期毒性试验每天灌胃1次，连续8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，单日两次给药MTD为160g／kg（折合生药量为300g／kg），相当于推荐临床用药量折合生药量1．125g／kg的267倍．长毒试验结果提示，复方鞘蕊苏颗粒高、中、低各剂量组动物均未出现严重中毒表现，受试药与对照组比较，主要表现为对肝脏代谢功能的可逆性影响，对各脏器无病理性器质变化．结论复方鞘蕊苏颗粒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该药是安全的．

Toxicological Studies on Compound Qiao Rui Su Granules

Objective To investigate possible acute and chronic toxicity of compound qiao rui su granules 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 gavage （ig） administration once everyday for 8 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 160 g/kg twice a day （amount to 300 g/kg raw herbs） , and it was about 267 times of the clinical recommended dose （1.125 g/kg）. The results of repeated administrations in rats demonstrated： （1） No severe toxic symptoms were examined in high, middle, or low dose group; （2） Hepatic metabolism functions in qiao rui su treated groups were significantly higher than control group, and this change was reversible; （3） No organic changes were observed in pathological tests. Conclusion Compound qiao rui su granule is safe for i.g. administration in rats at the recommended clinical dose.