Hoey L L, Vance-Bryan K, Clarens D M, Wright D H, Konstantinides F N, Guay D R
Department of Pharmacy Practice, University of Minnesota, Minneapolis, USA.
Ann Pharmacother. 1996 Apr;30(4):343-6. doi: 10.1177/106002809603000403.
To determine the stability of lorazepam over a 24-hour period when prepared in polyvinyl chloride (PVC) bags at initial concentrations of 0.08 and 0.5 mg/mL.
Each concentration was studied at room (21 degrees C) and refrigerator (4 degrees C) temperatures in dextrose 5% (D5W) and NaCl 0.9% solutions. Duplicate test solution admixtures were prepared for each lorazepam concentration, diluent, and temperature. At 0, 1, 4, 8, and 24 hours, duplicate samples were obtained for visual inspection, pH determination, and concentration determination by stability-indicating, reverse-phase HPLC analysis. Compared with baseline, peaks for lorazepam degradation products were not found on any of the study chromatograms.
In D5W and NaCl 0.9% solutions, lorazepam loss in excess of 10% by HPLC analysis occurred for concentrations of 0.08 and 0.5 mg/mL at 1 and 4 hours, respectively.
These data suggest that significant loss of lorazepam occurs as the probable result of sorption to PVC bags when admixed in both D5W and NaCl 0.9% solutions at 21 and 4 degrees C.
测定劳拉西泮在初始浓度为0.08和0.5mg/mL时，于聚氯乙烯（PVC）袋中配制24小时期间的稳定性。
在室（21℃）温和冷藏（4℃）温度下，分别在5%葡萄糖（D5W）和0.9%氯化钠溶液中研究每种浓度。针对每种劳拉西泮浓度、稀释剂和温度制备两份测试溶液混合物。在0、1、4、8和24小时时，获取两份样品用于目视检查、pH测定以及通过稳定性指示反相高效液相色谱分析进行浓度测定。与基线相比，在任何研究色谱图上均未发现劳拉西泮降解产物的峰。
在D5W和0.9%氯化钠溶液中，通过高效液相色谱分析，浓度为0.08mg/mL和0.5mg/mL的劳拉西泮分别在1小时和4小时时损失超过10%。
这些数据表明，当在21℃和4℃下于D5W和0.9%氯化钠溶液中混合时，劳拉西泮显著损失可能是吸附到PVC袋上的结果。
