盐酸西替利嗪的人体药代动力学研究

STUDY ON BIOEQUIVALENCE OF CETIRIZINE 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 ,10名健康成年男性受试者分别口服单剂量 2 0mg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 6 5± 0 55)h ,Cmax分别为 ( 6 13± 12 1 7)ng/ml和 ( 597± 119 8)ng/ml,AUC0～ 2 4分别为 ( 2 855 1± 52 8 3)h·ng/ml和 ( 30 16 4± 70 2 8)h·ng/ml,t1/2分别为 ( 11 5± 2 7)h和 ( 12 0±2 9)h ;片剂B相对A的平均生物利用度为 ( 10 0 2± 7 4 ) %。结论

Objective:To study the bioequivalence of Hydrochloride Tablets in healthy volunteers.Methods: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 sensitive HPLC assay was modified for determination of the drug levels in plasma.Results:The t max of tablets A and B were (1 72±0 39)h and (1 65±0 55)h,the C max (613±121 7)ng/ml and (597±119 8)ng/ml,(11 5±2 7)h and (12 0±2 9)h,AUC 0～24 (2 855 1±528 3)h·ng/ml and (3 016 4±702 8)h·ng/ml,respectively,and t1/2(11 5±2 7)h and (12 0±2 9)h.The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is no significant difference between the two products.Conclution:These two products are bioequivalent.