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1、!2012!药物分析杂志ChinJPharmAnal2010,30(11)HPLC-MS/MS法测定人血浆中瑞舒伐他汀钙的浓度及生物等效性研究11231*严方,狄斌,张宏文,孙桂斌,杭太俊(1.中国药科大学药学院,南京210009;2.南京医科大学第一附属医院临床药物研究室,南京210029;3.南京正大天晴制药有限公司,南京210018)摘要目的:建立人血浆中瑞舒伐他汀钙的高效液相色谱-质谱(LC-MS/MS)测定方法,并评价瑞舒伐他汀钙片剂的药动学和人体生物等效性。方法:20名男性健康志愿者随机交叉口服瑞舒伐他汀
2、钙片受试制剂和参比制剂各10mg,采用HPLC-MS/MS测定血药浓度,以BAPP2.0软件计算其药动学参数,考察其生物等效性。结果:受试制剂与参比制剂瑞舒伐他汀钙-1t1/2分别为(7610)h和(7811)h,tmax分别为(4021)h和(4216)h,Cmax分别为(15778)ngmL和(167-1-1-1-1-194)ngmL,用梯形法计算所得的AUC分别为(14583)ngmLh和(14267)ngmLh,AUC分别为0-720-¥-1-1-1-1(14784)n
3、gmLh和(14470)ngmLh,以AUC0-72计受试制剂相对参比制剂生物利用度为(10240)%。结论:该方法重复性好,灵敏度高,瑞舒伐他汀钙片受试制剂和参比制剂具有生物等效性。关键词:瑞舒伐他汀钙;血药浓度;生物等效性;高效液相色谱-串联质谱中图分类号:R917文献标识码:A文章编号:0254-1793(2010)-11-2012-05HPLC-MS/MSstudyondeterminationofrosuvastatincalciuminhumanplasmaanditsbioequivalence112
4、31*YANFang,DIBin,ZHANGHong-wen,SUNGui-bin,HANGTai-jun(1.SchoolofPharmacy,ChinaPharmaceuticalUniversity,Nanjing210009,China;2.DepartmentofClinicalPharmacology,theFirstAffiliatedHospitalwithNanjingMedicalUniversity,Nanjing210029,China;3.NanjingChinaTianqingPharmac
5、euticalCo.,LTD,Nanjing210018,China)AbstractObjective:ToestablishanHPLC-MS/MSmethodforthedeterminationofrosuvastatincalciuminhumanplasma,andtostudythepharmacokineticsandbioequivalenceofrosuvastatincalciumtabletsinhumanvolunteers.Methods:Asingleoraldoseof10mgte
6、storreferencetabletswasgivento20malehealthyvolunteersinarandomizedcross-overdesign.TheconcentrationofrosuvastatincalciuminplasmawasdeterminedbyHPLC-MS/MS.PharmacokineticparameterswerecalculatedbyBAPP20software.Results:Themainpharmacokineticparametersoftestandr
7、eferencerosuvastatincalciumwereasfollowings:t1/2(7610)hand(7811)h,tmax(4021)hand-1-1-1-1(4216)h,Cmax(15778)ngmLand(16794)ngmL,AUC0-72(14583)ngmLhand-1-1-1-1-1-1(14267)ngmLh,AUC0-¥(14784)ngmLhand(14470)ngmLh.Therelativebioavailabilityoftestt
8、oreferencepreparationwas(10240)%accordingtoAUC0-72.Conclusion:Themethodisrepeatableandsensitive.Thetestandreferenceformulationswerebioequivalen.tKeywords:rosuvastati
