Scheife A H, Grisafe J A, Shargel L
J Pharm Sci. 1982 Jan;71(1):55-9. doi: 10.1002/jps.2600710114.
The stability of intravenous nitroglycerin solutions prepared from either sublingual tablets or a 10% nitroglycerin-lactose adsorbate (powder) was examined under various conditions. Nitroglycerin concentration was measured by high-pressure liquid chromatography. Nitroglycerin stock solutions (0.8-1.0 mg/ml) prepared from tablets or powder in either 0.9% saline were stored upright in refrigerated multidose vials for 6 months without a significant decrease in concentration. Storage of the solutions at room temperature resulted in a 20% loss after 3 months. Intravenous nitroglycerin solutions (0.2 mg/ml) prepared from tablets or powder in 0.9% saline or 5% dextrose in water were stored in glass intravenous bottles at temperatures between 6 and 38 degrees for 24 hr with a maximum loss of 18%. Stability was not affected by light. Solutions in contact with rubber stoppers, plastic intravenous bags, or plastic administration sets exhibited decreased nitroglycerin concentration characteristic of sorption. Nitroglycerin concentrations decreased to a greater extent when the administration sets were equipped with plastic burets. Brief contact of nitroglycerin solutions with a plastic syringe did not result in decreased concentration. The stability of intravenous nitroglycerin solutions packaged in glass was not dependent on light, the vehicle, or the source of nitroglycerin. Contact with rubber or plastic surfaces should be minimized.
对由舌下片或10%硝酸甘油-乳糖吸附物(粉末)制备的静脉注射硝酸甘油溶液在各种条件下的稳定性进行了研究。通过高压液相色谱法测量硝酸甘油浓度。由片剂或粉末在0.9%盐水中制备的硝酸甘油储备溶液(0.8 - 1.0 mg/ml)直立储存在冷藏多剂量瓶中6个月,浓度无显著下降。溶液在室温下储存3个月后浓度损失20%。由片剂或粉末在0.9%盐水或5%葡萄糖水中制备的静脉注射硝酸甘油溶液(0.2 mg/ml)在6至38摄氏度的温度下储存在玻璃静脉瓶中24小时,最大损失为18%。稳定性不受光照影响。与橡胶塞、塑料静脉输液袋或塑料给药装置接触的溶液表现出硝酸甘油浓度因吸附而降低的特征。当给药装置配备塑料滴管时,硝酸甘油浓度下降幅度更大。硝酸甘油溶液与塑料注射器短暂接触不会导致浓度降低。包装在玻璃中的静脉注射硝酸甘油溶液的稳定性不取决于光照、载体或硝酸甘油的来源。应尽量减少与橡胶或塑料表面的接触。