盐酸西替利嗪片的人体药代动力学研究

Study on bioequivalence of Getirizine Hydrochloride Tablets

目的 用进口盐酸西替利嗪片 ( A)为对照品 ,评价片剂 B的相对生物利用度和生物等效。方法 采用随机交叉分组试验设计 ,1 0名健康成年男性受试者分别口服单剂量 2 0 mg测试品和对照品 ,采用HPLC法测定人血清中药物浓度进行生物等效性的研究。结果 对照品和测试品的 tmax分别为 ( 1 .72±0 .39) /h和 ( 1 .65± 0 .5 5 ) /h,cmax分别为 ( 6.1 3± 1 2 1 .7) ng/ml和 ( 5 97± 1 1 9.8) ng/ml,AUC0 - 2 4分别为( 2 85 5 .1± 5 2 8.3) h/( ng.ml)和 ( 30 1 6.4± 70 2 .8) h/( ng.ml) ,t1 /2分别为 ( 1 1 .5± 2 .7) h和 ( 1 2 .0± 2 .9) h;片剂 B相对 A的平均生物利用度为 ( 1 0 0 .2± 7.4) %。结论 测试片剂 B与对照片剂

Objective To study the bioequivalence Hydrochloride Tablets in healthy voIunteers Method In a randomized two way crossover design . 20mg single dose tablets A and B were respectively given to 10 male healthy volunteers.A rapid and senccitive HPLC assay was modified for determination of the drug levels in plasma Results The tmax,t1/2 and AUC0 24 of tablets A and B were (1 72±0 39)h and (1 65±0 55)h, (6 13±121 7)ng/ ml and (597±119 8)ng/ml, (11 5±2 7)h and(12 0±2 9)h, (2855 1±528 3)h/(ng ml) and (3016 4±702 8)h /(ng ml), respectively,The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is on signiticaant difference between the two products Concolusions The results suggested that these two products wete bioequivalent.