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目的:研究新西兰大耳白兔口服溴吡斯的明口腔崩解片和普通糖衣片后的药动学。方法:12只新西兰大耳白兔随机分为2组,分别口服给予溴吡斯的明口腔崩解片和市售普通片(60mg),反相离子对色谱法测定血浆药物浓度,用DAS2.1.1药动学软件计算药动学参数。结果:口腔崩解片和普通片均符合一室开放模型,Cmax分别为(1.81±0.09)mg.L-1和(1.71±0.03)mg.L-1;tmax分别为(2.25±0.27)h和(2.67±0.26)h;t1/2分别为(3.0±0.8)h和(3.27±0.18)h;AUC0-24分别为(15.8±0.5)mg.h.L-1和(14.85±0.17)mg.h.L-1;AUC0-∞分别为(16.1±0.6)mg.h.L-1和(15.14±0.19)mg.h.L-1;口腔崩解片相对生物利用度F0-24为106.19%,F0-∞为106.07%;经方差分析、双单侧t检验和非参数检验,两制剂在兔体内无显著性差异。结论:两种制剂生物等效。
OBJECTIVE: To study the pharmacokinetics of New Zealand white rabbits after oral administration of pyridostill orally disintegrating tablets and ordinary sugar tablets. Methods: Twelve New Zealand white rabbits were randomly divided into 2 groups. They were orally administered orally disintegrating tablets of pyridosch and common tablets (60mg) respectively. The plasma concentrations of drugs were determined by reverse phase ion chromatography (DAS2). 1.1 Pharmacokinetic software to calculate pharmacokinetic parameters. RESULTS: Oral disintegrating tablets and common tablets were in accordance with the open-chamber model. The Cmax values were (1.81 ± 0.09) mg.L-1 and (1.71 ± 0.03) mg.L-1, respectively; the tmax were (2.25 ± 0.27) h And (2.67 ± 0.26) h respectively; t1 / 2 was (3.0 ± 0.8) h and (3.27 ± 0.18) h respectively; AUC0-24 was (15.8 ± 0.5) mg.hL-1 and (14.85 ± 0.17) mg respectively. (16.1 ± 0.6) mg.hL-1 and (15.14 ± 0.19) mg.hL-1, respectively. The relative bioavailability of orally disintegrating tablets was 106.19% and F0-∞ was 106.07% .Analysis of variance, double unilateral t-test and nonparametric test showed that there was no significant difference between the two preparations in rabbits. Conclusions: Both formulations are bioequivalent.