舒更葡糖钠原料药的安全性检查法研究  

Safety Tests on Active Pharmaceutical Ingredients of Sugammadex Sodium

作　　者：李晓洁 汪玉馨 孟长虹 LI Xiaojie;WANG Yuxin;MENG Changhong(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019

出　　处：《药学与临床研究》2024年第4期316-320,共5页Pharmaceutical and Clinical Research

摘　　要：目的:对舒更葡糖钠原料药的豚鼠过敏反应检查、猫降压物质检查、大鼠升压物质检查、小鼠异常毒性检查的限值和方法进行考察。方法:取Hartley豚鼠48只,等分为8组,分别腹腔注射不同厂家不同浓度的舒更葡糖钠,观察豚鼠有无过敏反应症状;取健康狸花猫2只,分别静脉注射不同厂家不同浓度的舒更葡糖钠和磷酸组胺对照品溶液,比较供试品和对照品引起的猫血压下降的幅度;分别取Wistar、SD大鼠各1只,分别静脉注射不同厂家不同浓度的舒更葡糖钠和赖氨酸升压素对照品溶液,比较供试品和对照品引起的大鼠血压上升的幅度;取ICR小鼠40只,等分为8组,分别尾静脉注射不同厂家不同浓度的舒更葡糖钠,于48 h后观察小鼠的存活状态。结果:舒更葡糖钠原料药的豚鼠过敏反应检查项拟定限值为8 mg·kg^(-1);猫降压物质检查项拟定限值为20 mg·kg^(-1),大鼠升压物质检查项拟定限值为20 mg·kg^(-1);小鼠异常毒性检查项拟定限值为500 mg·kg^(-1)。结论:通过对舒更葡糖钠原料药的过敏反应、降压物质、升压物质和异常毒性检查方法学的研究和考察,为企业内控质量标准的制定和完善提供参考和依据。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 concentrations 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 formulated 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 response 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 suga

关 键 词：舒更葡糖钠 过敏反应 降压物质 升压物质 异常毒性 安全性检查 

分 类 号：R927.1[医药卫生—药学]