Poeppl Wolfgang, Rainer-Harbach Elena, Kussmann Manuel, Pichler Petra, Zeitlinger Markus, Wiesholzer Martin, Burgmann Heinz, Reznicek Gottfried
Military Medical Cluster East, Austrian Armed Forces, Vienna, Austria, and Division of Infectious Diseases and Tropical Medicine, Medical University Vienna, Vienna, Austria.
Department of Pharmacognosy, University of Vienna, Vienna, Austria.
Am J Health Syst Pharm. 2018 Oct 1;75(19):1467-1477. doi: 10.2146/ajhp170318.
Results of a compatibility and stability study of linezolid admixed in commercial peritoneal dialysis (PD) solutions stored at various temperatures are reported.
Test samples were prepared by adding linezolid i.v. injection (2 mg/mL) to infusion bags of 4 PD solutions (Extraneal, Nutrineal, Physioneal 40 Glucose 1.36%, and Physioneal 40 Glucose 2.27%, all from Baxter Healthcare Corporation). Assessments were conducted at various time points during storage of test samples at refrigeration temperature (6 °C) or room temperature (25 °C) for 14 days and at body temperature (37 °C) for 24 hours. Linezolid concentrations over time were determined by high-performance liquid chromatography, physical compatibility was determined by pH measurement and visual inspection, and antimicrobial activity was monitored by a disk diffusion method. The influence of solution warming by heating plate on drug stability was investigated.
Linezolid was stable in all tested solutions for 14 days at refrigeration and room temperatures and for 24 hours at body temperature. No linezolid adsorption to container material was detected. There were only minor variations in pH values, and visual inspection revealed no diluent abnormalities. With 1 exception, antimicrobial activity of >90% was retained in all PD solution samples for the duration of the study under all temperature conditions.
Linezolid injection 2 mg/mL remained stable and was compatible with the PD solutions studied for up to 2 weeks at refrigeration or room temperature and up to 24 hours at body temperature.
报告利奈唑胺在不同温度下储存于市售腹膜透析(PD)溶液中的相容性和稳定性研究结果。
通过将利奈唑胺静脉注射剂(2mg/mL)添加到4种PD溶液(均来自百特医疗保健公司的艾考糊精、Nutrineal、40葡萄糖1.36%的百特腹膜透析液和40葡萄糖2.27%的百特腹膜透析液)的输液袋中来制备测试样品。在测试样品于冷藏温度(6°C)或室温(25°C)下储存14天以及在体温(37°C)下储存24小时的不同时间点进行评估。通过高效液相色谱法测定利奈唑胺随时间的浓度,通过pH测量和目视检查确定物理相容性,并通过纸片扩散法监测抗菌活性。研究了加热板加热溶液对药物稳定性的影响。
利奈唑胺在所有测试溶液中于冷藏和室温下14天以及在体温下24小时均保持稳定。未检测到利奈唑胺对容器材料的吸附。pH值仅有微小变化,目视检查未发现稀释剂异常。除1例例外,在所有温度条件下的研究期间,所有PD溶液样品中均保留了>90%的抗菌活性。
2mg/mL利奈唑胺注射液在冷藏或室温下长达2周以及在体温下长达24小时均保持稳定,且与所研究的PD溶液相容。