Safety Tests on Active Pharmaceutical Ingredients of Sugammadex Sodium
Objective:To investigate the methods and limits of guinea pig allergic response test,cat depressor substance test,rat vasopressor substance test and mice abnormal toxicity test for sugammadex sodium.Methods:A total of forty eight Hartley guinea pigs were divided into eight groups,with six guinea pigs per group.The guinea pigs were intraperitoneally injected with sugammadex sodium which were formulated into different concentrations and from different manufactures.The allergic responses of guinea pigs were observed.Two healthy cats were intravenously injected sequentially with reference substance of histamine phosphate and sugammadex sodium samples,the latter were formulated into different concentra-tions and from different manufactures.The ranges of blood pressure drop caused by the samples and the reference substance were compared.A Wistar rat and a SD rat were intravenously injected sequentially with reference substance of lysine vasopressin and sugammadex sodium samples,the latter were formulated into different concentrations and from different manufactures.The ranges of blood pressure increase caused by the samples and the reference substance were compared.A total of forty ICR mice were divided into eight groups,with five mice per group.The mice were injected with sugammadex sodium,which were for-mulated into different concentrations and from different manufactures.After forty eight hours,the survive states of mice were observed.Results:For sugammadex sodium,the limit value of guinea pig allergic re-sponse test was 8 mg·kg-1,the limit value of cat antihypertensive substance test was 20 mg·kg-1,the limit value of rat vasopressor substance test was 20 mg·kg-1 and the limit value of mice abnormal toxicity test was 500 mg·kg-1.Conclusion:According to the methodology of allergic response test,antihypertensive substance test,vasopressor substance test and abnormal toxicity test on sugammadex sodium,this study can provide reference and basis for the formulation and improvement of quality standards of sugammadex sodium.
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