Schlesser Vincent, Hecq Jean-Daniel, Vanbeckbergen Danielle, Jamart Jacques, Galanti Laurence M
Medical Laboratory.
Int J Pharm Compd. 2002 Sep-Oct;6(5):391-4.
Cefepime is often used in antibiotic infusions for the hospitalized patients. Using intravenous solutions of cefepime prepared in advance can be efficient, but little information is available about the stability of that antibiotic after freezing followed by microwave thawing. The purpose of this study was to investigate how freezing, long-term storage, and microwave thawing can affect the stability of cefepime in 5% dextrose injection. The stability of 5 polyvinyl chloride bags of solution containing 2g of cefepime per 100 mL of 5% dextrose injection was studied after the bags had remained frozen for 1 month at -20 deg C, were thawed in a microwave oven with a validated cycle, and were stored at 4 deg C. The concentration of cefepime was measured by high-performance liquid chromatography by means of a reversed phase column, a mobile phase consisting of 10% acetonitrile and pentane sulfate buffer, and ultraviolet detection at 254 nm with a diode array detecor. Visual inspection was also conducted, and pH measurements were obtained. No color change or precipitation in the solution was observed. Cefepime remained stable for 11 days. During this period, the 95% lower confidence limit of the estimated regression line of the concentration-time profile remained above 90% of the initial concentration and the pH value increased slightly without affecting chromatographic parameters. Within those limits, cefepime may be prepared in advance by a centralized intravenous admixture service; it may be frozen and then thawed in a microwave before use in clinical units.
头孢吡肟常用于住院患者的抗生素输注。使用预先配制的头孢吡肟静脉溶液可能会很有效，但关于该抗生素在冷冻后经微波解冻的稳定性信息却很少。本研究的目的是调查冷冻、长期储存和微波解冻如何影响头孢吡肟在5%葡萄糖注射液中的稳定性。对5袋每100 mL 5%葡萄糖注射液含2g头孢吡肟的溶液进行稳定性研究，这些袋子在-20℃冷冻1个月后，在经过验证的微波炉程序中解冻，并在4℃储存。通过高效液相色谱法测量头孢吡肟的浓度，采用反相柱，流动相由10%乙腈和戊烷磺酸盐缓冲液组成，并用二极管阵列检测器在254nm处进行紫外检测。还进行了目视检查并测量了pH值。溶液中未观察到颜色变化或沉淀。头孢吡肟在11天内保持稳定。在此期间，浓度-时间曲线估计回归线的95%置信下限保持在初始浓度的90%以上，pH值略有升高，但不影响色谱参数。在这些限制范围内，头孢吡肟可由集中式静脉药物配置服务预先配制；它可以冷冻，然后在临床单位使用前在微波炉中解冻。
