College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
Am J Health Syst Pharm. 2011 Jan 1;68(1):69-72. doi: 10.2146/ajhp100214.
The stability of extemporaneously prepared acetylcysteine 1% and 10% solutions for treatment of meconium ileus was evaluated.
Acetylcysteine 1% (10-mg/mL) and 10% (100-mg/mL) solutions were prepared by mixing 3 and 10 mL, respectively, of commercially available 20% acetylcysteine solution with a sufficient quantity of bacteriostatic 0.9% sodium chloride for injection to make a final volume of 60 mL. Three identical samples of each concentration were prepared, placed in 2-oz amber plastic prescription bottles, and stored at 20-25 °C. Samples were assayed in duplicate using high-performance liquid chromatography and inspected for changes in color, odor, and pH immediately after preparation and at 7, 14, 30, 60, and 90 days. Stability was defined as retention of at least 90% of the initial concentration.
At least 90% of the initial concentration of acetylcysteine was retained in both formulations for 60 days. No appreciable change from the initial pH occurred in the acetylcysteine 1% or 10% solution during the first 60 days, but there was a notable change in pH after 90 days in both formulations. Neither solution was stable at day 90. There was no detectable change in color at 90 days; however, the odor of hydrogen sulfide was more pungent than on previous study days.
Extemporaneously prepared solutions of acetylcysteine 1% (10 mg/mL) and 10% (100 mg/mL) prepared with bacteriostatic 0.9% sodium chloride for injection were stable for at least 60 days when stored in plastic amber bottles at room temperature.
评估用于治疗胎粪性肠梗阻的临时配制的乙酰半胱氨酸 1%和 10%溶液的稳定性。
通过将 3 和 10 mL 的商业 20%乙酰半胱氨酸溶液分别与足够数量的抑菌 0.9%氯化钠注射用混合，以制成最终体积为 60 mL，来制备 1%（10-mg/mL）和 10%（100-mg/mL）的乙酰半胱氨酸溶液。每个浓度制备 3 个相同的样品，将其放置在 2 盎司琥珀色塑料处方瓶中，并在 20-25°C 下储存。立即在制备后以及在第 7、14、30、60 和 90 天，使用高效液相色谱法对每个浓度的两个样品进行重复测定，并检查颜色、气味和 pH 的变化。稳定性定义为保留至少 90%的初始浓度。
在两种制剂中，乙酰半胱氨酸的初始浓度至少保留 60 天。在最初的 60 天内，乙酰半胱氨酸 1%或 10%溶液的初始 pH 值没有明显变化，但在两种制剂中，90 天后 pH 值发生了明显变化。在第 90 天，两种溶液均不稳定。在 90 天时，颜色没有明显变化；然而，硫化氢的气味比之前的研究日更刺鼻。
当在室温下储存在塑料琥珀色瓶中时，用抑菌 0.9%氯化钠注射用制备的临时配制的乙酰半胱氨酸 1%（10 mg/mL）和 10%（100 mg/mL）溶液至少在 60 天内稳定。
