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1、ChineseJournalofNewDrugs2011, 20(4)320S02011M204Te王晓琳,女,硕士研究生,主要从事药代动力学研究。联系电话:(010)59971773,E-mail:。YT刘会臣,男,主任药师,主要从事临床药理学及药代动力学研究。联系电话:(010)59971772,E-mail:liu-。8S=:()g483rk5k1, 2,1(1航天中心医院临床药理室,北京 100049;2山东大学药学院,济南 250012)K1奥美拉唑是质子泵抑制剂类代表药物,临床上应用广泛。文中通过对国内 26篇奥美拉唑(盐)口服制剂人体生物等效性试验文献进行分析,探讨了试验内容、参
2、比制剂、受试者、生物样品采集及分析、药动学参数、上市后生物等效性再评价或监测等方面的问题和对策,以期为奥美拉唑(盐)口服制剂人体生物等效性研究和临床应用提供参考信息,并基于现有研究状况提出以下建议:开展食物影响研究、在受试者筛选时排除弱代谢者、参比制剂选择相同剂型的原创药、规范分析测定方法的确证并开展和加强奥美拉唑(盐)口服制剂的上市后生物等效性再评价或监测。1oM奥美拉唑;药动学;生物等效性ms| R975DS AcI| 1003-3734(2011)04-0320-05Problemsandcountermeasuresindomestichumanbioequivalencestudie
3、sfortheoralpreparationscontainingomeprazoleoritssaltWANGXiao-lin1, 2, LIUHui-chen1(1DepartmentofClinicalPharmacology, AerospaceCenterHospital, Beijing100049, China;2ColegeofPharmacy, ShandongUniversity, Jinan250012, China)AbstractOmeprazoleisarepresentativedrugoftheprotonpumpinhibitors(PPIs), andhas
4、beenap-pliedwidelyinclinicaltherapy.Here, wesummarized26domesticreferencesofhumanbioequivalenceresearchesfortheoralpreparationscontainingomeprazoleoritssalt.Theproblemsandcountermeasuresreferredtoexperimentcontents, referencepreparations, subjects, colectionandanalysisofbiologicalsamples, pharmacoki
5、neticparame-ters, andpost-marketingbioequivalencere-evaluationormonitoringweredescribedanddiscussed.Thegoalistoprovideusefulreferenceinformationforhumanbioequivalenceresearchandclinicalapplicationofomeprazoleoritssalt.Basedonthecurentresearchsituation, itisadvisabletocaryoutfood-efectbioequivalences
6、tudies, excludepoormetabolizersfromsubjectsinbioequivalencestudies, choosecorrespondingoriginaldrugsasreferenceprepara-tions, standardizebioanalyticalmethodvalidation, andperformpost-marketingbioequivalencere-evaluationormo-nitoring.Keywordsomeprazole;pharmacokinetics;bioequivalence0,4(protonpumpinh
7、ibitors,PPIs)VrM1%h,:TK,u;,.:5rB8M33rC.2006BS0M, 2006.15!,b,.:580#3rkJ.L05, 2007, 10(6):374-376.16,n=,V,;V,f8,.:580#3rJ.S0L,n,.:580#M3J.S0, 2001, 12(6):356-357.27l,.:5rB8=0J.0, 2001, 16(3):178-180.28a,l,0.:rB8=0J.SD0, 1997, 17(3):99-101.29,.:rAME#0J.0s, 1999, 19(5):300-303.30VAZ-DA-SILVAM, LOUREIROA
8、I, NUNEST, etal.Bioavail-abilityandbioequivalenceoftwoenteric-coatedformulationsofomeprazoleinfastingandfedconditionsJ.ClinDrugInvestig,2005, 25(6):391-399.31DELLAGRECAM, IESCEMR, PREVITERAL, etal.Degra-dationoflansoprazoleandomeprazoleintheaquaticenvironmentJ.Chemosphere, 2006, 63(7):1087-1093.编辑:杨青/接受日期:2010-12-20
