Smith F M, Nuessle N O
Am J Hosp Pharm. 1982 Oct;39(10):1687-90.
The stability of diazepam injection repackaged in disposable glass syringes and stored at room and refrigerator temperatures was studied. Thirty-nine 1.5-ml syringes were filled with 1.1 ml diazepam injection 5-mg/ml. All syringes were stored in light-resistant bags on their sides so that the solution was in contact with the rubber stoppers on both ends. Samples were assayed with a stability-indicating HPLC method for diazepam and its degradation product, 2-methylamino-5-chloro-benzophenone (MACB), after 30, 60, and 90 days of storage at 30 degrees C and 4 degrees C. At 90 days, the diazepam injection stored at 4 degrees C retained 97.4 +/- 1.6% of its original potency; samples stored at 30 degrees C retained 92.4 +/- 1% of their original potency. Apparent sorption to rubber syringe components led to a decrease in the concentration of both diazepam and MACB. The decrease in diazepam was a function of storage time and temperature; however, the disappearance of MACB from the syringes was a function of only time. Diazepam injection is chemically stable as 5-mg doses in disposable glass syringes for 90 days when stored at 4 degrees C or 30 degrees C. However, refrigeration is recommended.
研究了用一次性玻璃注射器重新包装并在室温和冷藏温度下储存的地西泮注射液的稳定性。39支1.5毫升注射器中装入1.1毫升5毫克/毫升的地西泮注射液。所有注射器均侧面放置在避光袋中，使溶液与两端的橡胶塞接触。在30℃和4℃储存30、60和90天后，用地西泮及其降解产物2-甲基氨基-5-氯二苯甲酮（MACB）的稳定性指示HPLC方法对样品进行分析。在90天时，4℃储存的地西泮注射液保留了其原始效力的97.4±1.6%；30℃储存的样品保留了其原始效力的92.4±1%。对橡胶注射器部件的明显吸附导致地西泮和MACB的浓度降低。地西泮的降低是储存时间和温度的函数；然而，MACB从注射器中的消失仅是时间的函数。当在4℃或30℃储存时，5毫克剂量的地西泮注射液在一次性玻璃注射器中90天化学稳定。然而，建议冷藏。
