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1、342 C hina Pharm acy 2007 Vol.18 N o.5S02007M185*50=,V。Z_:50。:023-63849075。E -mail:qiany #YT:0=,q,pV。Z_:5030。:023-63847315。E-m ail:2:583r钱 妍*,赵春景#,张桂蓉,姜成丽(重庆医科大学附属第二医院,重庆市 400010)ms|R969.1DSMAcI|1001-0408(2007)05-0342-03K1目的:研究2种奥美拉唑肠溶胶囊的生物等效性。方法:20名健康男性志愿者随机分成2组,交叉口服受试制剂和参比制剂各40m g ,采用高效液相色谱法测定人血清中
2、奥美拉唑浓度,由DAS软件计算药动学参数及相对生物利用度。结果:受试制剂与参比制剂的t 1/2分别为(1.6850.866)、(1.6530.862)h , tm a x分别为(2.4250.693)、(2.2000.865)h ,Cm ax 分别为(0.8940.481)、(0.8650.342)g m L -1, AUC 0 10分别为(2.0411.446)、(2.0221.322)g h m L -1, AUC 0 分别为(2.1631.594)、(2.1251.507)g h mL -1,受试制剂的相对生物利用度为(100.317.4)%。结论:2种奥美拉唑肠溶胶囊具有生物等效性。1
3、oM奥美拉唑;药动学;高效液相色谱法;生物等效性:B&i,:0,4,hZ1H 2s8F0,9E9T0.05),受试制剂的相对生物利用度为(105.713.9)%。结论:2种制剂具有生物等效性。1oM盐酸伐昔洛韦;阿昔洛韦;药动学;生物等效性;高效液相色谱-荧光检测法BioequivalenceofValaciclovirHydrochlordideTablets inHealthyVolunteersSHAO Zhongying ,LI Kexin , LIU Lei(Dept.of Clinical Pharm acology , Beijing H ospital of Ministry
4、of PublicHealth ,Beijing 100730,China)SONG Lijie(College of Pharm acy ,Shandong University ,Ji nan 250012,C hina)ABSTRACT OBJECT IVE :To study the bioequivalence of valaciclovir hydrochlordide tablets in healt hy volunteers.M ETHO_DS :A total of 20 subject s w ere administered w ith single dose of t
5、est and reference preparations of valaciclovir hydrochlordidetablet s by a cross -over w ay.The blood concent ration of valacilovir and t he metabolite in vivo w ere determined by HPLC -fluoremet ry , and the pharmacokinetic param eters and t he bioequivalence w ere com puted using BAPP2.0 pharm aco
6、kinetic pro-gram.RES ULTS :The main pharmacokinetic param eters of the test preparation vs.the reference preparation of aciclovir tabletsw ere as follows :Cma x w ere(2.040.48)vs.(1.94 0.37)g mL -1, t ma x w ere(1.30.6)vs.(1.40.6)h , t 1/2 w ere(2.530.42)vs.(2.55 0.43)h , AUC 0 12 w ere(5.820.99)vs.
7、(5.54 0.84)g h mL -1, AUC 0 w ere(6.041.04)、(5.760.94)g h m L -1.No significant dif ference was found in pharm acokinetic parameters betw een two preparations by m ethodanalysis and paired t test(P 0.05).The bioequivalence of test tablets w as (105.7 13.9)%.CONCLUSION :The results ofstatistics analy
8、sis show that the test and reference tablets were bioequivalent.KEYWORDS Valaciclovir hydrochlordide ;Aciclovir ;Pharmacokinetics;Bioequiavailability ;HPLC -fluoromet rys(P 0.05)。N243r。M3AUC 0 t 、AUC0 9,sY(100.317.4)%(102.119.5)%。4)ky%MY|ZE)b,5=SrAME_b:i。TV,yZEe,+sL,n,等.:580#M3J.中国药房,2001,12(6):357. 37,$Wo,等.:580M3 J .中国现代应用药学杂志,2002,19(2):125. 4,等.SrB:#0 J .中国药理学与毒理学杂志,2003,17(1):51. 4?,.S:y0+ J.上海医科大学学报,2000,27(3):163.(l:2006-07-27:2006-09-08)
