Colsoul M L, Breuer A, Goderniaux N, Hecq J D, Soumoy L, Bihin B, Jamart J, Galanti L
CHU UCL Namur, Yvoir, Belgium.
Hosp Pharm. 2020 Jun;55(3):188-192. doi: 10.1177/0018578719836649. Epub 2019 Mar 12.
Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.
老年科使用含有劳拉西泮的输注液来控制老年人的焦虑症。目前，这些输注液由护理人员按需配制，但在集中服务中提前配制可提高配制质量和时间管理。本研究的目的是调查这种输注液在5±3°C下储存于聚丙烯注射器中的长期稳定性。然后，将获得的结果与劳拉西泮在室温下储存于注射器中、5±3°C下储存于玻璃瓶中以及室温下储存于玻璃瓶中的稳定性数据进行比较。在无菌条件下，将1 mL 4 mg的劳拉西泮稀释于23 mL 0.9%的氯化钠中，制备8支注射器和6瓶输注液。5支注射器和3瓶输注液储存于5±3°C，3支注射器和3瓶输注液储存于室温下30天。在储存期间，通过目视和显微镜检查定期检查颗粒外观或颜色变化。通过在3个波长（350 nm、410 nm、550 nm）处测量光密度（OD）来评估浊度。还评估了pH值的稳定性。在每个时间点通过配备220 nm紫外检测器的高效液相色谱法测量劳拉西泮浓度。4天后，5±3°C下注射器中的溶液出现物理不稳定：观察到晶体和350 nm处的OD下降。然而，pH值稳定。2天后，溶液被认为化学不稳定，因为注意到劳拉西泮浓度损失超过10%：95%的单侧置信下限低于初始浓度的90%。为评估温度和聚丙烯的影响，将结果与室温下注射器以及5±3°C和室温下玻璃瓶的结果进行比较。在所有条件下均观察到沉淀、350 nm处的OD下降和化学不稳定。5±3°C下注射器中的劳拉西泮溶液2天后不稳定。因此，提前配制似乎无法用于临床。储存条件（温度和形式）并不能提高稳定性。
