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比阿培南是一种新型经胃肠外吸收的碳青霉烯类抗生素,广泛用于治疗多种细菌感染。本试验建立了一种简便、有效、精确的固相萃取HPLC法测定人血浆中比阿培南的浓度。样品和内标物Vitamin B6经固相萃取后通过Capcell Pak C18柱进行分离。测定方法以0.05mol/L磷酸二氢钠(pH5.7)–甲醇(98:2,v/v)为流动相,流速为1.0mL/min,检测波长为300nm。比阿培南在0.04~50.00μg/mL浓度范围内线性关系良好,最低定量限可至0.04μg/mL,0.10、5.00和25.00μg/mL三个浓度的提取回收率均在70%左右。这种测定方法成功地应用于12名健康志愿者单次静脉滴注三剂量(150、300和600mg)比阿培南后的药动学研究。本方法具有良好的精密度和准确度,并且保证样品处理后的稳定性,因此能广泛应用于临床研究。
Biapenem is a novel parenteral carbapenem antibiotic that is widely used to treat a variety of bacterial infections. This experiment established a simple, effective and accurate solid phase extraction HPLC method for the determination of the concentration of biapenem in human plasma. The sample and internal standard Vitamin B6 were separated by Capcell Pak C18 column after SPE. The determination method was as follows: 0.05 mol / L sodium dihydrogen phosphate (pH 5.7) -methanol (98: 2, v / v) was used as the mobile phase at a flow rate of 1.0 mL / min and the detection wavelength was 300 nm. Biapenem had a good linearity in the range of 0.04-50.00μg / mL with the lowest limit of quantitation of 0.04μg / mL. The recoveries of three concentrations of 0.10, 0.005, 25.00μg / mL were all about 70%. This assay was successfully applied to the pharmacokinetic studies of a single intravenous infusion of three doses (150, 300 and 600 mg) of biapenem in 12 healthy volunteers. This method has good precision and accuracy, and to ensure the stability of the sample after treatment, it can be widely used in clinical research.