摘要
目的建立高效液相色谱-质谱联用法同时测定人血浆中盐酸非索非那定和盐酸伪麻黄碱的方法,研究健康志愿者单剂量和多剂量口服非索伪麻缓释胶囊后非索非那定和伪麻黄碱在人体内的药动学。方法以苯乙双胍为内标,用C18柱,醋酸铵及乙腈组成流动相,血浆样品经乙腈沉淀蛋白萃取后,电喷雾离子化源,选择性正离子反应监测,测定血浆中盐酸非索非那定和盐酸伪麻黄碱的浓度。健康志愿者24名,随机抽取以研究单剂量和多剂量口服非索伪麻缓释胶囊的药动学。结果血药浓度在给药数次后第六天已达到稳态状态。2次/d服药可以维持体内波动较小的稳态血药浓度。单剂量或多剂量口服受试制剂,两组分药动学参数在性别间均无显著性差异(P>0.05)。ρmax、AUC0-40、和AUC0-∞药动学参数与剂量相关。结论所建方法预处理简单,重现性好,专属性强,灵敏度高,适合测定非索非那定和伪麻黄碱的血药浓度,可用于盐酸非索非那定和盐酸伪麻黄碱复方制剂的临床药代动力学研究。
Objective ALC-MS/MS method was established for the determination of fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release capsules were obtained in 24 healthy volunteers.Methods Phenformin was used as internal standard.A C18 column was used,with the mobile phase of acetonitrile ammonium acetate.ESI was applied and operated in positive ion selective reaction monitoring mode.The concentration of fexofenadine and pseudoephedrine in human plasma was determined by the method of LC-MS/MS with gradient elution.The pharmacokinetic profiles of oral single and multiple doses of fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120 mg extended-release capsules were obtained in a randomized.Results The plasma concentrations of fexofenadine hydrochloride and pseudoephedrine hydrochloride indicated that steady state was achieved on day 6 in the multiple-dose study.An extended-release effect of pseudoephedrine with the combination capsule formulations was observed in vivo.There are no difference between gender of its pharmacokinetic parameters（P 0.05）.The correlation between pharmacokinetic parameters,and dose were observed in this study.Conclusion The method was sensitive,specific,simple,and suitable for drug level monitoring in clinical pharmacokinetic study
出处
《中国医药指南》
2012年第36期2-5,共4页
Guide of China Medicine
