摘要
目的 研究健康家犬口服西替伪麻缓释片的药物动力学。方法 采用高效液相色谱法测定家犬交叉口服西替伪麻缓释片和新康泰克胶囊后的血药浓度 ,应用 3P97程序计算主要药代动力学参数 ,估算其相对生物利用度 ,并进行等效性检验。结果 西替伪麻缓释片的T12 、Cmax、Tmax、AUC0～ 2 4分别为 (2 97± 0 6 7)h、(1.2 11± 0 .4 19)mg/L、(3 33± 0 5 2 )h、(8 4 4± 2 37)mg/(h·L) ,新康泰克胶囊的上述参数分别为 (3 0 1± 0 4 4 )h、(1 315± 0 4 5 2 ) g/L、(3 5 0± 0 5 5 )h、(9 12± 2 4 1)mg/(h·L)。两制剂间的lnAUC0～ 2 4、lnAUC0～∞ 及lnCmax经方差分析和双单侧t检验发现 ,两制剂之间具有生物等效性。西替伪麻缓释片的相对生物利用度F0～ 2 4为 (10 3 7± 4 6 ) %。结论 西替伪麻缓释片在健康家犬体内具有缓释效果 ,与新康泰克胶囊生物等效。
Objective To study the pharmacokinetics of sustained release tablet of cetirizine/pseudoephedrine in dogs. Methods The plasma concentrations of cetirizine/pseudoephedrine sustained release tablet and CONTAC NT capsule were determined with HPLC in 6 dogs.The pharmacokinetic parameters and relative bioavailability and bioequivalent evaluation of two drugs were calculated.Results The pharmacokinetic parameters of cetirizine/pseudoephedrine sustained release tablet and CONTAC NT capsule were as follows:T 1/2 were (2.97±0.67) h and (3.01±0.44) h,C max were (1.211±0.419) mg/L and (1.315±0.452) mg/L,T max were (3.33±0.52) h and (3.50±0.55) h,AUC 0～24 were (8.44±2.37) mg/(h·L) and (9.12±2.41) mg/(h·L).The lnAUC 0～24,lnAUC 0～∞ and lnC max of the two drugs were bioequivalent with analysis of variance and double single test,the relative bioavailability of cetirizine/pseudoephedrine sustained release tablet was (103.7 ±4.6)%.Conclusion Cetirizine/pseudoephedrine has an effect of sustained release in dogs,and is bioequivalent to CONTAC NT capsule.
出处
《安徽医科大学学报》
CAS
2004年第4期264-267,共4页
Acta Universitatis Medicinalis Anhui
关键词
家犬
药代动力学
高效液相色谱法
西替利嗪
麻黄碱
cetirizine/pharmacokinetics
chromatography,high pressure liquid
ephedrine/pharmacokinetics
