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时间:2018-09-13
《盐酸氨基葡萄糖两制剂人体生物等效性研究》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、万方数据中国药师2011年第14卷第3期chinaPhamacist201I,V01.14No.3盐酸氨基葡萄糖两制剂人体生物等效性研究林琳1乔逸2马忠英2杨林2杭太俊3文爱东2(1.解放军第522医院药剂科,河南洛阳471003;2.第四军医大学西京医院药剂科;3.中国药科大学分析化学教研室)摘要目的:比较两种氨基葡萄糖制荆的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服氨基葡萄糖颗粒(受试制剂)与氨基葡萄糖胶囊(参比制剂)0.75g,采用邻苯二甲醛/3.巯基丙酸衍生化后的LC-MS/MS法测定人血浆中氨基葡萄糖
2、浓度,用DAS2.1.1软件计算药动学参数和生物利用度。结果:1:7服氨基葡萄糖受试制剂与参比制剂后的人体药动学参数分别为:c~(10154-306)和(1026±470)ng·ml~,f~(2.40±1.20)和(2.80±1.37)h,tI/2B(1.24±0.53)和(1.20±0.32)h,AUCo.。(4504±l303)和(4315±l410)ng·h·ml’1,AUCa.。(4579±l275)和(4341±l407)ng·h·ml_1。受试制刑的相对生物利用度为(114.14-44.8)%。受试制刑AuG..的9
3、0%置信区间在参比制剂的等效范围内。结论:两种氨基葡萄糖制荆生物利用度等效。关键词氨基葡萄糖;药动学;生物等效性:高效液相色谱-串联质谱法中图分类号:R969.1文献标识码:A文章编号:1008-049X(2011)03-0335-04BioequivalenceofGlucosamineHydrochloridePreparationsinHealthyVolunteers“nLin‘。QiaoYi2,MaZhongyin92,YangLin2,HangTaijun3,WenAidon92(1.DepartmentofPhar
4、macy,522HospitalofPLA,HenanLuoyang471003.China;2.DepartmentofPharmacy,XijingHospital,FouahMilitaryMedicalUniversity;3.DepartmentofAnalyticalChemistry,ChinaPharmaceuticalUniversity)ABSTRACT0bjective:Toinvestigatethebioequivalenceoftwoglucosaminehydrochloridepreparatio
5、nsinheMthyvolunteers.Method:20healthymalevolunteerswereenrolledinarandomizedcrossoverstudyinwhichtheSUbjectswererandomlyassignedtore—ceivesingledoseof0.75gglucosaminehydrochloridegranule(testpreparation)orglueosaminehydroehioridecapsules(referencepreparation).Plasmac
6、oncentrationsofglucosaminehydrochlorideweredeterminedbyphthalaldehyde/3-mercaptopropionicaciddefivat·izationpuisneLC.MS/MSmethod.ThepharmacokineticparametersandbioequivalenceweretalcdatedwithDAS2.1.1software.Re-suit:Themainpharmacokineticparametersoftestandreferencep
7、reparationswereasfollows:C一(10154-306)and(10264-470)ng·ml~,l一(2.404-1.加)and(2.80±1.37)h,II脚(1.24-I-0.53)and(1.加±0.32)h,AUCo.。(45044-I303)and(4315±I410)ng·h·ml‘1,J4UCj.。(45794-1275)and(4341±I407)ng·h·ml’1.TherelativebioavailabilityofglucosaminehydroehloridegranulesWas
8、(114.1±44.8)%.The90%confidentialintervals(Ci)ofAUCo.。ofthetestpreparationWagamongthebioequivalentthresholdcomparedwiththatoftherefe
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