【摘要】 目的:建立高效液相色谱法测定盐酸伪麻黄碱(PSE)血药浓度的方法,研究洛芬伪麻片的人体药动学。方法:8名健康男性受试者单剂量口服洛芬伪麻片(含盐酸伪麻黄碱30mg)后,采用高效液相色谱法测定血浆中盐酸伪麻黄碱的浓度,色谱柱:DiamonsilTM C18柱(250mm×4.6mm,5μm),流动相:甲醇-0.02mol·L-1磷酸二氢钠(含0.005mol·L-1辛烷磺酸钠,磷酸调pH3.8)(45:55);流速:1mL·min-1;检测波长210nm。结果:线性范围20~1000ng·mL-1(r=0.9998),最低检测限为1.2ng,日内精密度(RSD)小于3.26%,日间精密度(RSD)小于4.89%,绝对回收率为75.76%~86.52%,PSE的主要药动学参数为:AUC0-∞为(1.83±0.60)μg·h·mL-1,Cmax为(279.52±92.46)ng·mL-1,tmax为(1.32±0.24)h,t1/2为(5.37±0.92)h。结论:本方法简便、快速、准确,可用于盐酸伪麻黄碱的血药浓度测定及药代动力学研究。更多还原

【Abstract】 Objective: To develop a RP-HPLC method to determine pseudoephedrine hydrochloride(PSE)in human plasma, and to examine the pharmacokinetic characteristics of the compound ibuprofen tablets in human. Methods: The compound ibuprofen tablets (contains 30 mg PSE) of single doses were orally administrated to 8 healthy Chinese male volunteers. The plasma concentrations of PSE were determined by RP-HPLC with DiamonsilTM C18 column (250 mm × 4.6 mm, 5μm). The mobile phase consisted of mathanol-0.02 mol·L -1 sodium dihydrogen phosphate (contains 0.005 mol·L -1 octane sulfonic sodium, adjust to pH 3.8 with phosphoric acid, 45 : 55) at the flow rate of 1 mL·min -1, and the detection wavelength was 210 nm. the main pharmacokinetic parameters were analysed by 3P97 program. Results: The calibration curve was linear in the range of 20 ~ 1 000 ng·mL -1 ( r = 0.999 8). The lower detection limit was 1.2 ng. The inter-day and intra-day RSD were 1ess than 3.26% and 4.89%, respectively. The methodology recovery was 75.76% ~ 86.52%. The main pharmacokinetic parameters of PSE were as follows: AUC0-∞ was (1.83 ± 0.60) μg·h·mL -1, Cmax was (279.52 ± 92.46) ng·mL -1, tmax was (1.32 ± 0.24) h,t1/2 was (5.37 ± 0.92) h. Conclusion: The established HPLC method is simple, specific, accurate, sensitive and applicable for pharmacokinetics study of PES.更多还原