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目的评价ig瑞格列汀对小鼠自主活动及协同睡眠的影响,以发现潜在非期望药理作用。方法将小鼠随机分为4组,包括对照组和瑞格列汀10、20、40 mg/kg组,单次ig给予溶媒或供试品,进行小鼠自主活动次数测定和协同睡眠影响分析。结果 ig给药后,各组动物均未见异常,未出现行动迟缓、活动不协调等反应。不同剂量组之间动物自主活动次数无明显差异。在接受戊巴比妥钠注射后,与对照组动物相比较,供试品给药组动物的入睡率无显著性差异。结论 ig瑞格列汀在40 mg/kg及其剂量以下对小鼠自主活动无显著性影响,与阈下催眠剂量的戊巴比妥钠合用无明显协同催眠作用。研究结果为临床进一步评价其安全性奠定了基础。
Objectives To evaluate the effect of ig-repaglinide on autonomic activity and synergetic sleep in mice in order to find out the potential undesired pharmacological effects. Methods The mice were randomly divided into 4 groups, including the control group and repaglinide 10, 20, 40 mg / kg group, single ig given vehicle or the test sample, the number of spontaneous activity in mice and collaborative sleep impact analysis . Results ig administration, no abnormalities in each group of animals, did not appear sluggish, incoordination and other reactions. There was no significant difference in the number of autonomic activities between different dosage groups. After receiving sodium pentobarbital injection, there was no significant difference in the rate of falling asleep in the animals administered the test compound compared with the control animals. Conclusions ig Retagliptin has no significant effect on the spontaneous activity of mice under the dose of 40 mg / kg and no significant synergistic hypnosis with subliminal hypnosis dose of sodium pentobarbital. The results provide a basis for clinical further evaluation of its safety.