Jacobson P A, Johnson C E, Walters J R
University of Michigan Medical Center (UMMC), College of Pharmacy, University of Michigan (UM), Ann Arbor, USA.
Am J Health Syst Pharm. 1995 Jan 15;52(2):189-91. doi: 10.1093/ajhp/52.2.189.
The stability of itraconazole in an extemporaneously compounded oral liquid formulation was studied. A suspension was prepared from the beads contained in commercially available 100-mg itraconazole capsules and sufficient Simple Syrup, NF, to make a final volume of 60 mL. The final concentration of itraconazole in the suspension was 40 mg/mL. Three identical volumes of each suspension were prepared and stored in 2-oz capped, amber glass prescription bottles and refrigerated at 4 degrees C (range, 2-6 degrees C). Immediately after preparation and at 7, 14, 21, 28, and 35 days, samples were visually inspected and assayed in duplicate by high-performance liquid chromatography; the pH of the samples was also determined. On day 35, the mean +/- S.D. percentage of initial itraconazole concentration remaining in the three suspensions was 95.3 +/- 2.2%. The color, odor, and pH of the samples did not change appreciably over the study period. Itraconazole 40 mg/mL in an oral liquid compounded from simple syrup and beads from capsules, stored in amber glass bottles, was stable for 35 days at 4 degrees C.
研究了伊曲康唑在临时配制的口服液体制剂中的稳定性。取市售100mg伊曲康唑胶囊中的珠子，加入足量的美国国家处方集（NF）单糖浆，制成最终体积为60mL的混悬液。混悬液中伊曲康唑的最终浓度为40mg/mL。制备三份相同体积的混悬液，置于2盎司带盖的琥珀色玻璃处方瓶中，在4℃（范围为2 - 6℃）冷藏。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，并通过高效液相色谱法进行双份测定；同时测定样品的pH值。在第35天，三种混悬液中剩余的初始伊曲康唑浓度的平均值±标准差为95.3±2.2%。在研究期间，样品的颜色、气味和pH值没有明显变化。由单糖浆和胶囊珠子配制而成的、浓度为40mg/mL的伊曲康唑口服液，储存在琥珀色玻璃瓶中，在4℃下35天内稳定。
