Glascock J C, DiPiro J T, Cadwallader D E, Perri M
St. Joseph Hospital, Augusta, GA.
Am J Hosp Pharm. 1987 Oct;44(10):2291-3.
The stability of terbutaline sulfate injection repackaged in disposable plastic syringes and stored for a 60-day period under one of three conditions, dark at 4 degrees C, dark at 25 degrees C, and light at 25 degrees C, was studied. Terbutaline sulfate from 1-mg/mL ampuls was repackaged into 63 3-mL polypropylene syringes. Twenty-one syringes were protected from light by storage in ultraviolet-light-inhibiting bags in a dark cabinet. Twenty-one syringes were exposed to continuous fluorescent light at room temperature, and the remaining syringes were stored in the dark under refrigeration. Samples were visually inspected and assayed on days 0, 1, 4, 7, 14, 28, and 60 after repackaging. Drug concentrations were determined by a stability-indicating high-performance liquid chromatographic method. Terbutaline concentrations ranged from 89.2% to 98.5% of initial concentration. The contents of the light-exposed syringes had yellowed by day 60. Terbutaline sulfate in polypropylene syringes is stable for 60 days under refrigeration and at room temperature when protected from light, but substantial degradation and discoloration of the drug can occur when the syringes are not protected from light.
研究了硫酸特布他林注射液用一次性塑料注射器重新包装后,在三种条件之一(4℃黑暗环境、25℃黑暗环境、25℃光照环境)下储存60天的稳定性。将1mg/mL安瓿中的硫酸特布他林重新包装到63支3mL聚丙烯注射器中。21支注射器存放在黑暗橱柜中的防紫外线袋中以避光。21支注射器在室温下暴露于连续荧光灯下,其余注射器冷藏保存于黑暗环境中。在重新包装后的第0、1、4、7、14、28和60天对样品进行外观检查和分析。通过稳定性指示高效液相色谱法测定药物浓度。特布他林浓度范围为初始浓度的89.2%至98.5%。到第60天时,暴露于光照下的注射器内的内容物已变黄。聚丙烯注射器中的硫酸特布他林在冷藏和室温下避光时可稳定保存60天,但当注射器不避光时,药物会发生大量降解和变色。