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1、中华现代中医学杂志JournalofChineseModernTraditionalChineseMedicine2008年第4卷第2期·97··论著·扎来普隆舌下喷雾剂在比格犬体内的相对生物利用度12311△王慧桃,郭艳芳,高永良,张淑秋,冷光【摘要】目的研究扎来普隆舌下喷雾剂在比格犬体内相对生物利用度。方法采用随机交叉试验设计,6条健康比格犬分别给舌下喷雾剂和分散片两种制剂各10mg,反相高效液相色谱法测定血浆中扎来普隆的浓度。结果比格犬在服用舌下喷雾剂和口腔分散片后扎来普隆的Cmax分别为(133.7±55.5)μg/L和(207.5±53.1)μg/L。tmax分别为(31±9
2、.2)min和(58.3±34.9)min,t1/2分别为(33.7±18.6)min和(31.2±15.2)min,AUCo-6h分别为(12340.6±6702.7)μg/(min·L)和(16303.7±3638.1)μg/(min·L)。AUC分别为(16390.4±14498)μg/(min·L)和(16906.8±4347.3)μg/(min·0-∞L)。扎来普隆舌下喷雾剂相对于分散片的生物利用度为(96.9±15.2)%。结论两制剂的各药动学参数间差异均无显著性(P>0.05),经双单侧t检验证实,两制剂具有生物等效性。【关键词】扎来普隆;舌下喷雾剂;生物利用度;比格犬;
3、反相高效液相色谱法【中图分类号】R-332【文献标识码】A【文章编号】1681-2476(2008)02-0097-05RelativebioavailabilityofzaleplonbysublingualsprayinhealthBeagledogWANGHui-tao,GUOYan-fang,GAOYong-liang,etal.DepartmentofPharmacy,ShanxiMedicalUniversity,Taiyuan030001,China【Abstract】ObjectiveTostudytherelativebioavailabilityofzaleplon
4、bysublingualsprayinhealthybeagledogs.MethodsInarandomizedcrossoverstudy,6healthybeagledogsweregivenadoseof10mgzaleplonbysublingualsprayordispersibletablets.ZaleplonconcentrationinplasmawasdeterminedbyaRP-HPLC.ResultsAfteradministrationofsublingualsprayanddispersibletablets,thepharmacokineticpara
5、metersasfollowed:Cmaxwere(133.7±55.5)μg/Land(207.5±53.1)μg/L,tmaxwere(31±9.2)minand(58.3±34.9)min,t1/2were(33.7±18.6)minand(31.2±15.2)min,AUCo-6hwere(12340.6±6702.7)μg/(min·L)and(16303.7±3638.1)μg/(min·L),AUC0-∞were(16390.4±14498)μg/(min·L)and(16906.8±4347.3)μg/(min·L)respectively.Therelativebio
6、availabilityofsublingualspraywas(96.9±15.2)%,com2paringwiththatofdispersibletablets.ConclusionThereisnosignificantdifferenceinpharmacokineticparame2tersbetweenthetwopreparations.Itisdemonstratedthatthetwopreparationsarebioequivalentbytwoone-sidettests.【Keywords】zaleplon;sublingualspray;bioavaila
7、bility;Beagledog;reversedphrasehighperformanceliquidchromatography(RP-HPLC)扎来普隆(zaleplon,商品名sonata)为美国与唑吡坦的作用机制相似,其特点是起效快,半衰期WyethAyerstLaboratoriesInc.研制的新型非苯二氮短,无宿醉现象,因而受到患者欢迎。本试验以扎来艹卓类催眠药,具有镇静催眠、肌肉松弛、抗焦虑和抗普隆分散片为参比制剂,研究了扎来
