Wiest D B, Maish W A, Garner S S, el-Chaar G M
College of Pharmacy, Medical University of South Carolina, Charleston 29425.
Am J Hosp Pharm. 1991 Nov;48(11):2430-3.
The stability of amphotericin B in 5%, 10%, 15%, and 20% dextrose injection was investigated. The dextrose solutions were prepared in triplicate from sterile water for injection and 70% dextrose injection and placed in empty 50-mL polyvinyl chloride bags. The pH of each solution was determined before amphotericin B was added to a concentration of approximately 100 micrograms/mL. The bags were stored at 15-25 degrees C and protected from light. Three 1-mL samples were taken from each bag at various times up to 24 hours. One sample was analyzed for precipitation and color and pH changes. Two samples were analyzed in duplicate by stability-indicating high-performance liquid chromatography. No visual changes were observed, and pH did not change substantially. The mean amphotericin B concentration was greater than 90% of the initial concentration at each sampling time. However, the drug concentration in 3 of the 27 samples from the admixtures with 10% dextrose injection and 5 of the 27 samples from the admixtures with 20% dextrose injection fell below 90% of the initial concentration. Amphotericin B 100 micrograms/mL was stable in 5%, 10%, 15%, and 20% dextrose injection when stored for up to 24 hours at 15-25 degrees C and protected from light.
研究了两性霉素B在5%、10%、15%和20%葡萄糖注射液中的稳定性。葡萄糖溶液由注射用水和70%葡萄糖注射液一式三份配制而成，置于50 mL空聚氯乙烯袋中。在加入两性霉素B使其浓度达到约100微克/毫升之前，测定每种溶液的pH值。袋子储存在15 - 25摄氏度，避光保存。在长达24小时的不同时间从每个袋子中取出三个1毫升的样品。一个样品用于分析沉淀、颜色和pH值变化。另外两个样品通过稳定性指示高效液相色谱法进行双份分析。未观察到外观变化，pH值也没有显著变化。在每个采样时间，两性霉素B的平均浓度大于初始浓度的90%。然而，在含10%葡萄糖注射液的混合液的27个样品中有3个以及含20%葡萄糖注射液的混合液的27个样品中有5个的药物浓度降至初始浓度的90%以下。当在15 - 25摄氏度避光保存长达24小时时，100微克/毫升的两性霉素B在5%、10%、15%和20%葡萄糖注射液中是稳定的。
