Methodological Research on Abnormal Toxicity and Depressor Substance Tests of Sugammadex Sodium
Objective To establish methods for abnormal toxicity and depressor substance tests of sugammadex sodium.Methods Forty SPF mice were selected and randomly divided into five groups,with eight mice in each group.The mice in each group were injected 4 600,4 370,4 152,3 944,3 747 mg/kg sugammadex sodium via tail vein,and the mortality of the mice was observed within 72 h after administration.The median lethal dose(LD50)and its 95%confidence interval(CI)were calculated,the quarter dosage of the lower limit of 95%CI was selected for the abnormal toxicity test.One experimental cat was taken and injected 40,20,10 mg/kg sugammadex sodium via femoral vein,with 0.1 μg/kg histamine as the control.The carotid blood pressure of the experimental cat before and after administration was recorded,the reduction value was calculated,the limit of depressor substance test for sugammadex sodium was determined and verified.Results The LD50 of sugammadex sodium was 4 182.8 mg/kg,and the 95%CI was in the range of 3 988.1 to 4 409.4 mg/kg.All mice in three groups(five in each group)did not die within 48 h at the dosage of 1 000 mg/kg.The limit of depressor substance test was 10 mg/kg,the reduction value of blood pressure in experimental cat was not over 50%of that induced by histamine at this dosage,and the results of tests in three batches of samples were all in compliance with regulations.Conclusion The established methods can be used for the abnormal toxicity and depressor substance tests of sugammadex sodium.
sugammadex sodiumabnormal toxicitydepressor substancequality standard
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