加替沙星眼用凝胶的人血浆暴露水平分析

发布时间：2018-04-25 00:30

本文选题：加替沙星 + 眼用凝胶　；参考：《中国药学杂志》2015年15期

【摘要】：目的定量分析人血浆中加替沙星的浓度,研究加替沙星眼用凝胶连续7 d给药后加替沙星在健康男性受试者体内的暴露特点。方法建立人血浆中加替沙星的LC-MS-MS定量分析方法 ,并对该方法的特异性、灵敏度、精密度与准确度、基质效应、回收率、稳定性等进行考察;测定10名男性健康受试者连续7 d滴用加替沙星眼用凝胶后不同时间点血浆样品中加替沙星的浓度。结果 LC-MS/MS定量分析人血浆中加替沙星的线性范围为2~500 ng·m L-1;在5、10、50和400 ng·m L-1浓度水平的准确度(RE)在±15.0%以内,批内精密度(RSD)在1.47%~2.61%之间,批间精密度(RSD)在1.79%~13.1%之间,基质效应、回收率、特异性、稳定性等进行考察均满足要求。受试者连续给药后所有血浆样品中加替沙星的药物浓度均低于定量下限(2 ng·m L-1)。结论本实验建立了灵敏、准确的加替沙星定量分析方法 ,受试者连续7 d滴用加替沙星眼用凝胶后在所有血浆样品中加替沙星的药物浓度均低于定量下限(2 ng·m L-1)。
[Abstract]:Objective to quantitatively analyze the concentration of gatifloxacin in human plasma and to study the characteristics of gatifloxacin exposure in healthy male volunteers after gatifloxacin was administered for 7 days. Methods the LC-MS-MS quantitative analysis method of gatifloxacin in human plasma was established, and the specificity, sensitivity, precision and accuracy, matrix effect, recovery rate and stability of the method were investigated. The concentrations of gatifloxacin in plasma samples of 10 healthy male subjects were determined at different time points after gatifloxacin gel was used for 7 days. Results the linear range for quantitative analysis of gatifloxacin in human plasma by LC-MS/MS was 2 500 ng mL -1, the accuracy of concentration of 1050 and 400 ng mL -1 of gatifloxacin was within 卤15.0%, the precision of intra assay was between 1.47% and 2.61%, the precision of between-assay was between 1.7913%, the matrix effect, recovery rate, and recovery rate of gatifloxacin in human plasma were 1.7913. 1% and 1.79 ng mL ~ (-1), respectively. The investigation of specificity and stability met the requirements. The drug concentration of gatifloxacin in all plasma samples was lower than the lower limit of 2 ng mL ~ (-1) after continuous administration of gatifloxacin. Conclusion A sensitive and accurate method for quantitative analysis of gatifloxacin was established in this study. The concentration of gatifloxacin in all plasma samples was lower than 2 ng mL ~ (-1) of gatifloxacin in all plasma samples after intravenous gatifloxacin gel was used for 7 days.
【作者单位】：天津药物研究院释药技术与药代动力学国家重点实验室;湖北大学生命科学学院;
【分类号】：R969.2

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