Kintzel P E, Kennedy P E
Audie L. Murphy Memorial Veterans Hospital, San Antonio, TX 78284.
Am J Hosp Pharm. 1991 Feb;48(2):283-5.
The stability of amphotericin B in 5% dextrose injection was studied at concentrations used for administration through a central venous line. Amphotericin B 60, 80, and 100 mg was diluted in 50 mL of 5% dextrose injection; final mean +/- S.D. concentrations after adjustment for total volume were 0.92 +/- 0.01, 1.20 +/- 0.03, and 1.40 +/- 0.03 mg/mL, respectively. For each concentration, six admixtures were prepared; of these, three were stored at 25 degrees C and three at 6 degrees C. Amphotericin B concentration was tested at 0, 4, 12, 24, and 36 hours by stability-indicating high-performance liquid chromatography. The admixtures were inspected visually at each time point for precipitation, turbidity, gas formation, and color change, and the pH was measured. Concentrations of amphotericin B remained within 3% of initial concentrations at each time point at both storage temperatures. No precipitation, turbidity, gas formation, or color change was observed, and no changes in pH were measured. Amphotericin B in 5% dextrose injection was stable at concentrations of 0.92, 1.20, and 1.40 mg/mL when stored at 6 and 25 degrees C for up to 36 hours.
在通过中心静脉导管给药所使用的浓度下，研究了两性霉素B在5%葡萄糖注射液中的稳定性。将60、80和100mg两性霉素B稀释于50mL 5%葡萄糖注射液中；调整总体积后的最终平均±标准差浓度分别为0.92±0.01、1.20±0.03和1.40±0.03mg/mL。对于每种浓度，制备了6份混合液；其中3份在25℃储存，3份在6℃储存。通过稳定性指示高效液相色谱法在0、4、12、24和36小时检测两性霉素B浓度。在每个时间点对混合液进行外观检查，观察有无沉淀、浑浊、气体生成和颜色变化，并测量pH值。在两个储存温度下，每个时间点两性霉素B的浓度均保持在初始浓度的3%以内。未观察到沉淀、浑浊、气体生成或颜色变化，且未测量到pH值的变化。当在6℃和25℃储存长达36小时时，5%葡萄糖注射液中的两性霉素B在浓度为0.92、1.20和1.40mg/mL时是稳定的。
