Anaizi N H, Swenson C F, Dentinger P J
Department of Pharmacy, University of Rochester (UR), NY, USA.
Am J Health Syst Pharm. 1997 Mar 1;54(5):549-53. doi: 10.1093/ajhp/54.5.549.
The stability of acetylcysteine in an extemporaneously compounded ophthalmic solution was studied. Acetylcysteine 10% ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was prepared and stored at 2-8 degrees C in clear, 15-mL, low-density polyethylene dropper bottles. At 0, 7, 14, 21, 28, 35, and 60 days, a 1-mL sample was removed from each bottle and analyzed for acetylcysteine concentration by high-performance liquid chromatography. Another set of 10% acetylcysteine solutions containing 0.025%, 0.050%, 0.075%, or 0.10% disodium edetate were prepared, stored at room temperature (23-25 degrees C), and analyzed at 0, 7, 15, 30, 40, and 50 days. In the solutions containing 0.025% disodium edetate, acetylcysteine was stable for 60 days at 2-8 degrees C but for less than 7 days at 23-25 degrees C. In the solutions containing 0.75% and 0.10% disodium edetate, acetylcysteine was stable for 40 and 50 days, respectively, at 23-25 degrees C. Acetylcysteine in a 10% acetylcysteine ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was stable for 60 days at 2-8 degrees C.
研究了乙酰半胱氨酸在临时配制的眼用溶液中的稳定性。制备了含0.025%依地酸钠和0.5%氯丁醇的10%乙酰半胱氨酸人工泪液基质眼用溶液，并储存在2 - 8℃的15毫升透明低密度聚乙烯滴管瓶中。在第0、7、14、21、28、35和60天，从每个瓶子中取出1毫升样品，通过高效液相色谱法分析乙酰半胱氨酸浓度。还制备了另一组含0.025%、0.050%、0.075%或0.10%依地酸钠的10%乙酰半胱氨酸溶液，储存在室温（23 - 25℃）下，并在第0、7、15、30、40和50天进行分析。在含0.025%依地酸钠的溶液中，乙酰半胱氨酸在2 - 8℃下可稳定60天，但在23 - 25℃下稳定时间不到7天。在含0.75%和0.10%依地酸钠的溶液中，乙酰半胱氨酸在23 - 25℃下分别可稳定40天和50天。含0.025%依地酸钠和0.5%氯丁醇的10%乙酰半胱氨酸人工泪液基质眼用溶液中的乙酰半胱氨酸在2 - 8℃下可稳定60天。
