HPLC-MS/MS法测定人血浆中舒巴坦的含量及其在肾清除率增强危重患者中的药代动力学应用。

IF 0.9 4区 医学 Q4 PHARMACOLOGY & PHARMACY International journal of clinical pharmacology and therapeutics Pub Date : 2023-08-01 DOI:10.5414/CP204339
Sheng Hu, Bing Leng, Jinjiao Jiang, Lin Zhang, Nan Guo, Chengwu Shen
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引用次数: 0

摘要

目的:建立一种简便、快速、特异的高效液相色谱-串联质谱(HPLC-MS/MS)测定人血浆中舒巴坦的方法。材料与方法:反复给药头孢哌酮-舒巴坦(3 g, q8,静脉滴注,给药比例为2:1)后,观察舒巴坦在肾脏清除率增强的危重患者体内的药代动力学特征。以他唑巴坦为内标,采用LC-MS/MS法测定舒巴坦血药浓度。结果:该方法灵敏度为0.20 μg/mL,线性浓度范围为0.20 ~ 30.0 μg/mL。批内精密度(RSD%) < 4.9%,准确度偏差(RE%)在-9.9 ~ 1.0%之间;批间精密度(RSD%) < 6.2%,准确度偏差(RE%)在-9.2% ~ 3.7%之间。低、高质量控制(QC)浓度下的平均基质因子分别为96.8、101.0%。舒巴坦QCL和QCH的提取回收率分别为92.5%和87.5%。收集11例危重患者在0(给药前)、0.25、0.5、1、2、3、6和8小时(给药后)的血浆样本和临床资料。采用Phoenix WinNonlin软件进行非区室分析(NCA)测定药代动力学参数。结论:该方法可用于研究舒巴坦治疗危重病人的药动学。舒巴坦在肾功能增强组和肾功能正常组的主要药代动力学参数如下:半衰期分别为1.45±0.66和1.72±0.58 h,浓度-时间曲线下面积分别为59.1±20.1和111.4±23.2 μg × h/mL,稳态血浆清除率分别为18.9±7.5和9.32±2.03 L/h。这些结果提示,对于肾清除率增强的危重患者,应使用更高剂量的舒巴坦。
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An HPLC-MS/MS method for determination of sulbactam in human plasma and its pharmacokinetic application in critically ill patients with augmented renal clearance.

Objective: A simple, rapid, and specific method has been developed and validated to measure sulbactam in human plasma using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).

Materials and methods: The pharmacokinetic characteristics of sulbactam in critically ill patients with augmented renal clearance were investigated after the repeated administration of cefoperazone-sulbactam (3 g, q8, IV drip, combination ratio of 2 : 1). Sulbactam plasma concentration was determined using LC-MS/MS with tazobactam used as an internal standard (IS).

Results: The method was fully validated with a sensitivity of 0.20 μg/mL, the linear concentration was ranged from 0.20 to 30.0 μg/mL. The intra-batch precision (RSD%) was less than 4.9%, and the accuracy deviation (RE%) ranged from -9.9 to 1.0%; the inter-batch precision (RSD%) was less than 6.2%, and the accuracy deviation (RE%) ranged from -9.2% to 3.7%. The value of the mean matrix factor at the low and high quality control (QC) concentration was 96.8 and 101.0%, respectively. The extraction recovery for QCL and QCH of sulbactam were 92.5 and 87.5%,respectively. Plasma samples and clinical data were collected at 0 (pre dose), 0.25, 0.5, 1, 2, 3, 6, and 8 hours (post dose) from 11 critically ill patients. Pharmacokinetic parameters were determined by non-compartmental analysis (NCA) using Phoenix WinNonlin software.

Conclusion: This method was successfully applied to study the pharmacokinetics of sulbactam for critically ill patients. The main pharmacokinetic parameters of sulbactam in augmented renal function and normal renal function groups were summarized as follows: half-life, 1.45 ± 0.66 and 1.72 ± 0.58 hours, area under the concentration-time curve from 0 to 8 hours, 59.1 ± 20.1 and 111.4 ± 23.2 μg × h/mL, drug plasma clearance at steady state, 18.9 ± 7.5 and 9.32 ± 2 .03 L/h, respectively. These results suggested that a higher dose of sulbactam should be used in critically ill patients with augmented renal clearance.

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来源期刊
CiteScore
1.70
自引率
12.50%
发文量
116
审稿时长
4-8 weeks
期刊介绍: The International Journal of Clinical Pharmacology and Therapeutics appears monthly and publishes manuscripts containing original material with emphasis on the following topics: Clinical trials, Pharmacoepidemiology - Pharmacovigilance, Pharmacodynamics, Drug disposition and Pharmacokinetics, Quality assurance, Pharmacogenetics, Biotechnological drugs such as cytokines and recombinant antibiotics. Case reports on adverse reactions are also of interest.
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