Strom J G, Kalu A U
Am J Hosp Pharm. 1986 Jun;43(6):1489-91.
The stability of diazepam in an extemporaneous suspension compounded from tablets was studied. A diazepam 1 mg/mL suspension was prepared by levigating diazepam 10-mg tablets with ethanol and propylene glycol and incorporating them into a suspension vehicle containing magnesium aluminum silicate and carboxymethylcellulose sodium with flavoring and sweetening agents. Samples of the suspension were stored in amber glass bottles at 5, 22, and 40 degrees C. At various times during the 60-day study period, samples were inspected visually for signs of caking or color change and evaluated for ease of pouring and redispersion. Also at those times, the concentration of diazepam in each sample was determined by a stability-indicating, high-performance liquid chromatography procedure. The concentration of diazepam in each sample was at least 90% of the initial concentration throughout the 60-day storage period. All samples remained homogeneous and showed no signs of caking or settling. A diazepam suspension compounded from tablets was found to be pharmaceutically acceptable and easily pourable and redispersible. The suspension is stable for at least 60 days at room or refrigerated temperature.
研究了由片剂配制的地西泮临时混悬液的稳定性。通过将10毫克地西泮片剂与乙醇和丙二醇研磨，然后将它们加入含有硅酸镁铝和羧甲基纤维素钠以及调味剂和甜味剂的混悬液载体中，制备了1毫克/毫升的地西泮混悬液。混悬液样品储存在5℃、22℃和40℃的琥珀色玻璃瓶中。在60天的研究期间的不同时间，对样品进行外观检查，看是否有结块或颜色变化的迹象，并评估其倾倒和再分散的难易程度。同样在这些时间，通过一种稳定性指示高效液相色谱法测定每个样品中地西泮的浓度。在整个60天的储存期内，每个样品中地西泮的浓度至少为初始浓度的90%。所有样品保持均匀，没有结块或沉淀的迹象。发现由片剂配制的地西泮混悬液在药学上是可接受的，易于倾倒和再分散。该混悬液在室温或冷藏温度下至少稳定60天。
