文档介绍：药学论文-单次静滴注射用头孢噻肟钠舒巴坦钠注射液人体耐受性试验单次静滴注射用头孢噻肟钠舒巴坦钠注射液人体耐受性试验作者:罗新民,郭亚权,顾宜,王晓娟,王荣,白娟娟,元英进【关键词】注射用头孢噻肟钠;舒巴坦钠;耐受性;健康志愿者【Abstract】AIM:Toevaluatethesafetyofcefotaxime/:ordingtotheGoodClinicalPractice(GCP).Afterphysicalexaminationandlaboratorytestswereperformed,30healthyvolunteersweredividedrandomlyinto3groups,(cefotaxime/sulbactam:2g/1g),(cefotaxime/sulbactam:3g/)(cefotaxime/sulbactam:4g/2g),with10subjectsineachgroup(5maleand5female,agerange30to39years).Clinicalsymptoms,vitalsigns,routinebloodtests,ests,hepaticfunction,renalfunction,bloodelectrolytes,andelectrocardiogramwereobservedorexaminedbeforeandafterasingleintravenousinfusionadministrationofcefotaxime/:Afterasingleintravenousinfusionof3-6gcefotaxime/sulbactam,thevitalsigns,clinicalsymptomsandlaboratorytestswereallinthenormalrange,:Singleintravenousinfusionadministrationofcefotaxime/sulbactam(upto6g)in30Chinesehealthyvolunteersissafeandtolerable.【Keywords】cefotaxime;sulbactam;tolerance;healthyvolunteers【摘要】目的:在中国健康志愿者中评价单剂量静滴注射用头孢噻肟钠舒巴坦钠的安全性、:根据新药临床试验指导原则,将经体检及实验室检查,各项指标均在正常范围内的30名健康***(头孢噻肟钠2g和舒巴坦钠1g),();(头孢噻肟钠4g和舒巴坦钠2g)的3个剂量组,每组10名受试者,男女各半,年龄30,、生命体征、心电图、血常规、尿常规、肝功能、