McNiff B L, McNiff E F, Fung H L
Am J Hosp Pharm. 1979 Feb;36(2):173-7.
The potency and stability of extemporaneous intravenous nitroglycerin (NTG) solutions prepared according to methods currently used in three hospitals were studied. Intravenous NTG solutions were prepared and packaged according to three hospitals' protocols. The NTG solutions varied in concentration (32 microgram/ml); source (one of two manufacturers' sublingual NTG tablets or 10% NTG adsorbate in lactose); and storage (ambient room temperature or refrigerated). The concentration of NTG in the i.v. solutions was determined spectrophotometrically. Nitroglycerin was found to be stable for at least 70 days when stored in glass containers, regardless of source, diluent (5% dextrose in water or normal saline) and storage temperature. The loss of NTG from solution, after storage for seven days in plastic i.v. bags, was greater when stored at room temperature (55%) than when refrigerated (30%). Adsorption was shown to be responsible for this phenomenon because intact drug was completely recovered from the plastic i.v. bags after methanol elution. The results of this study allow formulation of recommendations regarding the extemporaneous preparation of i.v. NTG solutions.
对按照三家医院目前使用的方法配制的临时静脉注射硝酸甘油(NTG)溶液的效力和稳定性进行了研究。静脉注射NTG溶液按照三家医院的方案进行配制和包装。NTG溶液在浓度(32微克/毫升)、来源(两家制造商的舌下NTG片剂之一或乳糖中的10%NTG吸附物)和储存条件(室温或冷藏)方面存在差异。通过分光光度法测定静脉注射溶液中NTG的浓度。结果发现,无论来源、稀释剂(5%葡萄糖水溶液或生理盐水)和储存温度如何,硝酸甘油储存在玻璃容器中时至少可稳定70天。在塑料静脉输液袋中储存7天后,溶液中NTG的损失在室温下储存时(55%)比冷藏时(30%)更大。吸附被证明是造成这种现象的原因,因为甲醇洗脱后,完整的药物从塑料静脉输液袋中完全回收。本研究结果有助于就静脉注射NTG溶液的临时配制制定建议。