摘要
目的对西替利嗪的两种制剂进行生物等效性评价。方法采用高效液相色谱法测定了20名健康男性志愿受试者随机交叉单剂量口服盐酸西替利嗪口腔崩解片(受试制剂)和普通片剂(参比制剂)后的不同时刻血浆中西替利嗪的浓度。采用DAS软件,计算盐酸西替利嗪两种制剂的药代动力学参数及评价两种制剂的生物等效性。结果20名健康受试者口服受试制剂和参比制剂后,血浆中西替利嗪的Tmax分别为(0.6±0.27)h和(0.9±0.32)h;Cmax分别为(644.5±108.4)ng.mL-1和(654.1±102.4)ng.mL-1;t1/2分别为(8.6±2.0)h和(8.9±3.6)h;AUC0-t分别为(4 944.3±750.4)ng.h.mL-1和(5 128.9±991.4)ng.h.mL-1;AUC0-∞分别为(5 535.8±941.1)ng.h.mL-1和(5 868.7±1519.7)ng.h.mL-1。受试制剂的相对生物利用度(98.1±14.9)%。以上参数统计学分析结果表明两种制剂无显著性差异。结论盐酸西替利嗪两种制剂体内生物作用等效。
Objective To evaluate the bioequivalence of two kinds of orally disintegrating tablets and conventional tablets of cetirizine hydrochloride. Methods Single doses of orally disintegrating tablets and conventional tablets of cetirizine hydrochloride were administered orally in 20 volunteers in an open, randomized, and crossover study of the pharmacokinetics and bioequivalence, and plasma concentrations of eetirizine hydrochloride were determined with HPLC. Results The pharmacokinetic parameters of test and control preparations were as follows. Tmax（0.6 ±0.27） and （0.9 ±0.32） h; Cmax（644. 5 ± 108. 4） and （654. 1 ± 102.4） ng· mL^-1; t1/2 （8.6 ±2.0） and （8.9 ±3.6） h; AUC 0-t（4 944.3 ±750.4） and （5 128.9 ±991.4） ng · h · mL^-1 ; AUC0-∞ （5 535.8 ±941.1） and （5 868.7 ± 1519.7 ） ng · h · mL^-1 The relative bioavailability of test formulation was （98.1 ± 14.9 ）%. The result of statistical analysis on above parameters showed that there was no significant difference between two preparations. Conclusion The two preparations were bioequivalent.
出处
《广东药学院学报》
CAS
2007年第5期522-524,共3页
Academic Journal of Guangdong College of Pharmacy
