论文部分内容阅读
目的:建立一种测定人血浆中盐酸伊托必利血药浓度的反相高效液相色谱法,并用该法研究盐酸伊托必利颗粒的人体药物动力学。方法:采用外标法,血样经乙醚氢氧化钠混合溶剂提取后,以nucleosilC18250mm×4.6mm,5μm色谱柱为固定相,乙腈磷酸二氢钾为流动相,在257nm波长处定量检测。结果:血药浓度在10.0～1600.0ng·ml-1范围内线性关系良好,最低检测浓度为10.0ng·ml-1。日内、日间精密度RSD(%)均小于7%,低、中、高浓度(20,100,800ng·ml-1)的相对回收率分别为106.3%,104.6%,102.8%。用该法检测了20名健康受试者服用盐酸伊托必利颗粒后不同时间的血药浓度变化,并计算了有关药物动力学参数。结论:此方法简便、快速、精确,适用于伊托必利的血药浓度检测和药物动力学研究。
OBJECTIVE: To establish a RP-HPLC method for the determination of itopride hydrochloride in human plasma and to study the pharmacokinetics of itopride hydrochloride in human plasma. Methods: The external standard method was used. The blood samples were extracted with diethyl ether and sodium hydroxide. The mobile phase consisted of nucleosil C18 250 mm × 4.6 mm and 5 μm column with acetonitrile and potassium dihydrogen phosphate as mobile phase and quantitatively detected at 257 nm. Results: The linear range of plasma concentration ranged from 10.0 to 1600.0 ng · ml-1 with a minimum detectable concentration of 10.0 ng · ml-1. The intra-day and inter-day RSD (%) were less than 7%, and the relative recoveries were 106.3%, 104.6% and 102.8% for low, medium and high concentrations (20,100 and 800 ng · ml -1) respectively. The method was used to test the change of plasma concentration of 20 healthy volunteers after taking Itopride hydrochloride at different times, and the related pharmacokinetic parameters were calculated. Conclusion: This method is simple, rapid, accurate and suitable for the determination of drug concentration and pharmacokinetics of itopride.