Wood M J, Irwin W J, Scott D K
Department of Pharmaceutical Sciences, Aston University, Birmingham, U.K.
J Clin Pharm Ther. 1990 Aug;15(4):279-89. doi: 10.1111/j.1365-2710.1990.tb00386.x.
The shelf lives of doxorubicin, daunorubicin and epirubicin in infusion fluids were studied using high-performance liquid chromatographic (HPLC) methods. Doxorubicin and epirubicin were stable (loss in potency of less than 10%) for 24 and 20 days respectively, when dissolved in sodium chloride solution (0.9%; pH, 6.47) at 25 degrees C and stored in polyvinyl chloride (PVC) minibags, while daunorubicin was stable for at least 43 days. All three drugs were stable for at least 43 days in sodium chloride (0.9%; pH 6.47 and 5.20) and dextrose (5%; pH 4.36) at 4 and -20 degrees C. Repeated thawing and re-freezing of these solutions at ambient temperature did not cause degradation. All three drugs were stable for at least 43 days when reconstituted with Water-for-Injections BP and stored in polypropylene syringes at 4 degrees C.
采用高效液相色谱(HPLC)方法研究了阿霉素、柔红霉素和表柔比星在输液中的货架期。阿霉素和表柔比星分别在25℃溶解于氯化钠溶液(0.9%;pH值6.47)并储存在聚氯乙烯(PVC)小袋中时,24天和20天内保持稳定(效价损失小于10%),而柔红霉素至少43天保持稳定。这三种药物在4℃和-20℃的氯化钠(0.9%;pH值6.47和5.20)和葡萄糖(5%;pH值4.36)中至少43天保持稳定。这些溶液在室温下反复解冻和重新冷冻不会导致降解。用英国药典注射用水复溶并在4℃储存在聚丙烯注射器中时,这三种药物至少43天保持稳定。