Henry D W, Repta A J, Smith F M, White S J
Am J Hosp Pharm. 1986 Jun;43(6):1492-5.
The stability of a propranolol hydrochloride suspension compounded from commercially available tablets was studied. Propranolol hydrochloride 10-mg tablets were triturated to a powder and incorporated into a commercially available suspension vehicle to yield a suspension with a theoretical propranolol hydrochloride concentration of 1 mg/mL. The suspension was divided into portions and stored in amber glass bottles at either room (25 degrees C) or refrigerated (2 degrees C) temperature for four months. The concentration of propranolol hydrochloride in the samples was determined by a stability-indicating, high-performance liquid chromatographic (HPLC) assay at 0, 30, 60, 90, and 120 days. Also at these times, the pH of the samples was measured, and the samples were inspected visually for evidence of microbial growth and ease of resuspension. The concentration of propranolol hydrochloride in the samples remained within 90% of the initial concentration throughout the study period. No important changes in the pH of the samples and no visible evidence of microbial growth were noted. This extemporaneous suspension of propranolol hydrochloride compounded from commercially available tablets is stable for at least four months when stored at room or refrigerated temperature.
对由市售片剂配制的盐酸普萘洛尔混悬液的稳定性进行了研究。将10毫克盐酸普萘洛尔片剂研磨成粉末，并加入市售混悬液载体中，制成理论盐酸普萘洛尔浓度为1毫克/毫升的混悬液。将混悬液分成若干份，分别储存在琥珀色玻璃瓶中，于室温（25℃）或冷藏（2℃）温度下保存四个月。在第0、30、60、90和120天，通过稳定性指示高效液相色谱（HPLC）法测定样品中盐酸普萘洛尔的浓度。同样在这些时间点，测量样品的pH值，并目视检查样品是否有微生物生长迹象以及再悬浮的难易程度。在整个研究期间，样品中盐酸普萘洛尔的浓度保持在初始浓度的90%以内。未观察到样品pH值有重要变化，也没有明显的微生物生长迹象。由市售片剂配制的这种临时盐酸普萘洛尔混悬液在室温或冷藏温度下储存时至少四个月是稳定的。
