国产与进口盐酸氨溴索片的人体生物等效性研究.doc

国产与进口盐酸氨溴索片的人体生物等效性研究国产与进口盐酸氨溴索片的人体生物等效性研究上海第二医科大学26ActaUnb'etskafisMedicimdisSecondacSmnghai【文章编号】0258—5898(2002)叭一03国产与进口盐酸氨溴索片的人体生物等效性研究戈升荣,安富荣,,曹惠明,王平全(上海第二医科大学仁济医院临床药学研究室,上海200001)【摘要】目为评价国产与进『=_『盐酸氨溴索片的物等效性方法9名健康男性志愿者随机交义,?448O4和236355?44886rig-h/ml;【分别为21176?7()71ng/m]和22653?3459ng/m];分别为222?165和182?08h;t]/2ke分别为6o8=102h和627=066h方差分析表明两种片剂各参数之间无显着性差异(P>O05),积单侧,检验表明二者具有生物等效性国产片的相对生物利甩虞为(g956t1065)%(以AUG计算)结论国产与进口盐酸氨溥索片具有生物等效性【关键词】盐酸氨演索;生物利用度;生物等效性【中图分类号】R915【文献标识码】ABioequivalenceofDomesticandImportedAmbroxolHydrochlorideTabletsinHealthVoltmteersGESheng-rong,ANFu-tong,YUANJing,etal(Departme~ltClinicalPharmacy,RenalHospital,SSMU,Shahai200001,China)【Abstract】~gIeoraladministrationof90mgdomesticandimportedambroxolhydrochloridetableksw'to9healthymalevolunteersintherandomizedcrossoverstudyAhighperformancel~heconcentrationofarnbroxolhydrochlorideinhumanplasn-——ministrationof90ragdomeslieandimlxqrtedtabletswereasfo[1ows:AUCwere234042?44804and236355?44886ng?h/m[;mw-ere21176??[;tmwere222?=066h,?080h;1were608?tainedfirotlltwof0rmulatkmswerecontparedby't