Bigley F P, Forsyth R J, Henley M W
Am J Hosp Pharm. 1986 Nov;43(11):2803-9.
The stability of imipenem-cilastatin sodium (Primaxin, Merck Sharp & Dohme) in various intravenous fluids was determined after storage at 4 degrees C or 25 degrees C and after freezing. Samples of imipenem-cilastatin sodium were constituted with 100 mL of each of 17 i.v. fluids to concentrations of 2.5 mg/mL or 5.0 mg/mL of each drug component and stored in glass infusion bottles at constant room temperature (25 degrees C) or constant refrigerated temperature (4 degrees C). The concentration of each solution was determined immediately after constitution by a stability-indicating high-performance liquid chromatographic assay; the concentrations of both drugs were monitored in each i.v. fluid until the time that the concentration of either imipenem or cilastatin decreased to less than 90% of the initial concentration (t90). The exact value of t90 was determined for each solution by linear regression. The solutions were also assessed for changes in pH or color. Cilastatin sodium was more stable in all 17 i.v. fluids than imipenem. The stability of imipenem was dependent on the concentration of that drug in solution; solutions of imipenem 2.5 mg/mL were more stable than solutions of imipenem 5.0 mg/mL. The values of t90 for imipenem in solutions stored at 4 degrees C were greater than the values for solutions stored at 25 degrees C. Imipenem was most stable in 0.9% sodium chloride injection. The pH values of the solutions generally decreased during the study period.(ABSTRACT TRUNCATED AT 250 WORDS)
在4℃或25℃储存以及冷冻后,测定了亚胺培南-西司他丁钠(泰能,默克雪兰诺公司)在各种静脉输液中的稳定性。将亚胺培南-西司他丁钠样品用17种静脉输液中的每一种100 mL配制成每种药物成分浓度为2.5 mg/mL或5.0 mg/mL,并储存在玻璃输液瓶中,于恒定室温(25℃)或恒定冷藏温度(4℃)下保存。配制后立即通过稳定性指示高效液相色谱法测定每种溶液的浓度;在每种静脉输液中监测两种药物的浓度,直至亚胺培南或西司他丁的浓度降至初始浓度的90%以下(t90)。通过线性回归确定每种溶液的t90的确切值。还评估了溶液的pH值或颜色变化。在所有17种静脉输液中,西司他丁钠比亚胺培南更稳定。亚胺培南的稳定性取决于其在溶液中的浓度;2.5 mg/mL亚胺培南溶液比5.0 mg/mL亚胺培南溶液更稳定。4℃储存溶液中亚胺培南的t90值大于25℃储存溶液的值。亚胺培南在0.9%氯化钠注射液中最稳定。在研究期间,溶液的pH值通常会降低。(摘要截断于250字)