Ptachcinski R J, Walker S, Burckart G J, Venkataramanan R
Am J Hosp Pharm. 1986 Mar;43(3):692-4.
The stability and availability of cyclosporine from the oral dosage form when stored in plastic syringes were examined. Solutions of cyclosporine were stored in plastic syringes for 28 days at 25 degrees C. Half of the solutions remained in room light, and samples were obtained at 3, 6, and 12 hours and 1, 2, 3, 4, 5, 6, 7, 14, 21, and 28 days. The remaining samples were protected from light, and samples were obtained at 1, 3, 5, 7, 14, 21, and 28 days. Samples stored in plastic were compared with control solutions stored in the original amber bottle. All samples were analyzed for unchanged cyclosporine by high-pressure liquid chromatography. Cyclosporine was stable and completely available from the oral dosage form when stored in plastic syringes for up to 28 days. There was no difference in the stability of cyclosporine between the solutions exposed to room light and those protected from light. Solutions of the oral dosage form of cyclosporine may be stored in plastic syringes without protection from light for up to 28 days.
考察了环孢素口服剂型储存在塑料注射器中时的稳定性和可用性。将环孢素溶液在25℃下于塑料注射器中储存28天。一半溶液置于室内光照下,分别在3、6和12小时以及1、2、3、4、5、6、7、14、21和28天取样。其余样品避光保存,分别在1、3、5、7、14、21和28天取样。将储存在塑料中的样品与储存在原装琥珀瓶中的对照溶液进行比较。通过高压液相色谱法分析所有样品中环孢素未发生变化的含量。环孢素口服剂型储存在塑料注射器中长达28天时稳定且完全可用。暴露于室内光照的溶液与避光保存的溶液中环孢素的稳定性没有差异。环孢素口服剂型的溶液可储存在塑料注射器中,无需避光,长达28天。