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氨苄西林加头孢曲松在弹性输液装置中联合用于门诊胃肠外抗菌治疗的稳定性

Stability of Ampicillin plus Ceftriaxone Combined in Elastomeric Infusion Devices for Outpatient Parenteral Antimicrobial Therapy.

作者信息

Fernández-Rubio Beatriz, Herrera-Hidalgo Laura, Luque-Márquez Rafael, de Alarcón Arístides, López-Cortés Luis E, Luque-Pardos Sonia, Gutiérrez-Urbón José María, Fernández-Polo Aurora, Gil-Navarro María V, Gutiérrez-Valencia Alicia

机构信息

Unidad de Gestión Clínica de Farmacia, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS), 41013 Seville, Spain.

Unidad de Gestión Clinica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS), 41013 Seville, Spain.

出版信息

Antibiotics (Basel). 2023 Feb 22;12(3):432. doi: 10.3390/antibiotics12030432.

Abstract

Currently, ampicillin plus ceftriaxone (AC) is one of the preferred treatments for infective endocarditis. However, there is a lack of stability data for the combination of both drugs in elastomeric devices, so the inclusion of AC in Outpatient Parenteral Antimicrobial Therapy (OPAT) programs is challenging. The objective of the study was to determine the stability of AC in elastomeric pumps when stored at 8 ± 2 °C, 25 ± 2 °C, 30 ± 2 °C and 37 ± 2 °C using LC-MS/MS. The combination was diluted in 0.9% sodium chloride and the final concentrations were ampicillin 24 g/L plus ceftriaxone 8 g/L. Physical and chemical stability were evaluated at 12, 20, 24, 36 and 48 h after preparation. Stability was met at each time point if the percentage of intact drug was ≥90% of its respective baseline concentration and color and clearness remained unchanged. The drug combination was stable for 48 h when it was kept at 8 ± 2 °C. At 25 ± 2 °C and 30 ± 2 °C, they were stable for 24 h of storage. At 37 ± 2 °C, the stability criterion was not met at any time point. These results prove that AC could be included in OPAT programs using elastomeric infusion devices for the treatment of infections.

摘要

目前,氨苄西林加头孢曲松(AC)是感染性心内膜炎的首选治疗方法之一。然而,缺乏这两种药物在弹性体装置中联合使用的稳定性数据,因此将AC纳入门诊胃肠外抗菌治疗(OPAT)项目具有挑战性。本研究的目的是使用液相色谱-串联质谱法(LC-MS/MS)测定AC在弹性泵中于8±2℃、25±2℃、30±2℃和37±2℃储存时的稳定性。将该组合稀释于0.9%氯化钠中,最终浓度为氨苄西林24 g/L加头孢曲松8 g/L。在制备后12、20、24、36和48小时评估物理和化学稳定性。如果完整药物的百分比≥其各自基线浓度的90%且颜色和澄清度保持不变,则在每个时间点均符合稳定性要求。当该药物组合保持在8±2℃时,48小时内稳定。在25±2℃和30±2℃时,储存24小时稳定。在37±2℃时,在任何时间点均不符合稳定性标准。这些结果证明,AC可纳入使用弹性输液装置的OPAT项目用于治疗感染。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a3b4/10044682/95db4a88d7e6/antibiotics-12-00432-g001.jpg

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