摘要
目的建立高效液相色谱测定血浆中盐酸西替利嗪浓度的方法，并研究其药动学行为。方法18名受试者单剂量口服盐酸西替利嗪10mg后，采用HPLC法测定血药浓度，应用AIC法判别房室模型，并利用DAS软件计算药动学参数。结果血浆中西替利嗪在20．0～1000ng·mL^-1。线性关系良好（r=0．9981），平均回收率为103．4％，日内RSD≤7．79％．日间RSD≤12．8％。最佳房室模型为二室模型（Wi=1／C^2，AIC=-5．565），单剂量口服10mg盐酸西替利嗪后的药物动力学参数α为（2．73±7．66）h，β为（0．076±0．049）h，tmax为（0．88±0．34）h,t1/2β为（22．3±26．4）h，Cmax为（268±67．8）ng·mL^-1，AUC036为（1598±395）ng·h·mL^-1，AUC0为（1786±427）ng·h·mL^-1。结论该分析方法简单、快速、准确、精密度高，适用于人血浆中盐酸西替利嗪浓度的测定。盐酸西替利嗪的血浆药动学参数与国内外文献报道基本一致。
Objective To establish an HPI.C method for the determination of cetirizine hydrochloride in human plasma,and to study its pharmacokinetics. Methods Eighteen volunteers received a single oral dose of 10 mg cetirizine tablets and the plasma concentration of cetirizine hydrochloride was differentiated by HPLC method. The compartment model was differentiated by AIC method and DAS program was used to calculate the pharmaeokinetic parameters. Results The calibration curve was linear within 20.0-1 000 ng·mL^-1 （r=0. 998 1）, the recovery was 103. 4%, and the RSDs of intra-day and inter-day were 47.79% and 412.8%, respectively. The optimal compartment model fit the two- compartment model （Wi=1/C^2, AIC=- 5. 565）. The pharmacokinetic parameters of the volunteers after taking a single dose of 10 mg of cetirizine hydrochloride were as follows： α was （2.73±7.66） h^-1 , 13 was（0. 076±0. 049） h^-1 , tmax was （0.88±0.34） h, h 23 was （22. 3-4-26.4） h, Cmax was （268±67.8） ng·mL^-1 , AUC0-36 was （1 598±395） ng· h· mL^-1, and AUCm-∞ was （1 786±427） ng ·h ·mL^-1. Conclusion The method is suitable to determine the concentration of cetirizine hydrochloride in human plasma because it is rapid and sensitive. The pharmacokinetic parameters of cetirizine hydrochloride are similar to those reports home and abroad.
出处
《中南药学》
CAS
2009年第4期271-274,共4页
Central South Pharmacy
