Johnson C E, Nesbitt J
College of Pharmacy, University of Michigan (UM), Ann Arbor 48109-1065, USA.
Am J Health Syst Pharm. 1995 Aug 15;52(16):1798-1800. doi: 10.1093/ajhp/52.16.1798.
The stability of ursodiol in an extemporaneous oral liquid formulation refrigerated at 4 degrees C for 35 days was studied. A suspension was prepared by opening commercially available 300-mg capsules of ursodiol, adding Glycerin, USP, to form a paste, and then adding Simple Syrup, NF. A control solution was prepared from analytical-grade ursodiol powder in simple syrup. The final concentration of ursodiol in both formulations was 60 mg/mL. Three samples of each preparation were stored in 2-oz, amber glass prescription bottles in the dark at 4 degrees C. Immediately after preparation and at 7, 14, 21, 28, and 35 days, samples were visually inspected, tested for pH, and assayed in duplicate by high-performance liquid chromatography. Stability was defined as the retention of more than 90% of the initial concentration. On day 35, the mean percentage of the initial ursodiol concentration remaining was 96.5% in the suspension made from powder-filled capsules, and 100.6% in the suspension made from analytical-grade powder. The color, odor, and pH of the samples did not change appreciably over the study period. An extemporaneously compounded oral liquid preparation of ursodiol in simple syrup was stable under the conditions studied for up to 35 days.
研究了熊去氧胆酸在4℃冷藏35天的临时口服液体制剂中的稳定性。通过打开市售的300毫克熊去氧胆酸胶囊，加入美国药典级甘油形成糊状物，然后加入美国国家处方集的单糖浆来制备混悬液。对照溶液由分析级熊去氧胆酸粉末溶于单糖浆中制备。两种制剂中熊去氧胆酸的最终浓度均为60毫克/毫升。每种制剂的三个样品储存在2盎司的琥珀色玻璃处方瓶中，于4℃黑暗处保存。制备后立即以及在第7、14、21、28和35天，对样品进行外观检查、pH测试，并通过高效液相色谱法进行双份测定。稳定性定义为初始浓度保留率超过90%。在第35天，由填充粉末胶囊制成的混悬液中熊去氧胆酸初始浓度的平均剩余百分比为96.5%，由分析级粉末制成的混悬液中为100.6%。在研究期间，样品的颜色、气味和pH没有明显变化。在研究的条件下，熊去氧胆酸在单糖浆中的临时复合口服液体制剂在长达35天内是稳定的。
