摘要
采用改进的高效液相色谱法 ,以盐酸羟嗪为内标 ,测定了 12名健康男性受试者口服盐酸西替利嗪胶囊和盐酸西替利嗪片后不同时刻血浆中西替利嗪的浓度 ,绘制了血药浓度 时间曲线 ,并求出两种制剂的主要药物动力学参数 :Cmax分别为 (90 5 7± 185 9)和 (777 1± 10 5 8)ng/mL ,Tmax分别为 (0 79± 0 2 6 )和 (0 90± 0 45 )h ,t1/ 2 分别为 (7 5 9± 1 2 9)和 (7 73± 1 46 )h ,AUC0→∞ 分别为 (6774 8± 10 5 9 1)和 (6 6 0 3 2± 12 5 7 6 )ng·h/mL .以AUC0→∞ 计算相对生物利用度 ,盐酸西替利嗪胶囊的相对生物利用度平均为 (10 4 0± 14 4) % .采用方差分析和双单侧t检验法进行生物等效性判断 ,结果表明 ,两种制剂生物利用度无显著性差异 (P >0 0 5 ) 。
The plasma concentrations of cetirizine in 12 healthy male volunteers after oral administration of cetirizine dihydrochloride capsules and cetirizine dihydrochloride tablets were determined by the improved HPLC, using hydroxyzine dihydrochloride as the internal standard.The plasma concentration time curves and major pharmacokinetic parameters of tests and reference preparation were obtained: C max were( 905 7± 185 9)and(777 1±105 8)ng/mL, T max were(0 79±0 26)and(0 90±0 45)h, t 1/2 were( 7 59± 1 29 )and( 7 73± 1 46)h , AUC 0→∞ were(6 774 8±1 059 1)and(6 603 2±1 257 6)ng·h/mL,respectively. According to AUC 0→ t ,the relative bioavailability of cetirizine dihydrochloride was (104 0±14 4)%. Results by ANOVA analysis and two side t test showd that there was no obvious difference in availability between the two preparations ( P >0 05), and the two preparations were bioequivalent.
出处
《沈阳药科大学学报》
CAS
CSCD
2000年第5期318-320,340,共4页
Journal of Shenyang Pharmaceutical University
基金
国家自然科学基金资助项目 !No.39625025
