两性霉素B在50g·L-1葡萄糖注射液中稳定性考察

 目的：对两性霉素B(AmB)在50g·L^-1葡萄糖注射液中的稳定性进行实验考察。方法：将0.05，0.1,0.15g·^-13种浓度Am B的50g·L^-1葡萄糖注射液在8℃冷藏、25℃及34℃光照及避光5种贮存条件下放置24h，观察3种浓度稀释液的外观及含量变化。结果：5种贮存条件下放置24h，3种稀释液均无外观改变和明显的pH变化。与初浓度比较：在8℃冷藏贮存24h，3种稀释液的Am B含量下降小于2%，光照下25℃24h及34℃12h，AmB含量下降均已大于10%，25℃及34℃避光条件下24hAmB含量下降低于10%。结论：两性霉素B的50g·L^-1葡萄糖注射液在光照下不稳定。在避光条件下对通常的室温温度(25℃～34℃)则较稳定。临床使用Am B滴注时必须临时配制，避光滴注。

Stability of amphotericin B in 50 gL-1 dextrose injection

OBJECTIVE: To study the chemical and visual stability of amphotericin B in 50 gL-1 dextrose injection. METHODS: Amphotericin B 0.05, 0.1, 0.15 gL-1 in 50 gL-1dextrose injection were aseptically prepared and stored at 8 ℃, 25 ℃ and 34 ℃ under fluroescent light and protected from light. Amphotericin B concentration was tested at 0, 4, 8, 12, 24 h by HPLC. The admixtures were inspected visually and the pH was measured. RESULTS: The admixtures that stored under five conditions were no precipitation, turbidity, gas formation or color change and were no appreciable changes in pH. The mean amphotericin B concentration remained within 2% of the concentration at time zero under 8 ℃. Outside 10% of the concentration at time zero at 25 ℃ and 34 ℃ 12 h under the fluorescent light, the amphotericin B concentration remained within 10% of initial concentration up to 24 h at 25 ℃ and 34 ℃ under the condition of darkness. CONCLUSION: Amphotericin B in 50 gL-1 dextrose injection was not very stable when stored under the fluorescent light, and that was visually and chemically stable for room temperature (25 ℃～34 ℃) when stored protected from light. The admixture must be freshly prepared and intravenous injection protect from light.