不同棕色玻璃安瓿对盐酸氨溴索注射液光稳定性的影响

摘要

Objective To compare the stability of Ambroxol Hydrochloride Injection in different brown glass ampoule under the light test and determine the best form of packaging. Methods Through the light test,determining the ambroxol hydrochloride and impurities by HPLC,to study the stability of Ambroxol Hydrochloride Injection packaging by brown low &neutral borosilicate glass ampoule and carton. Results Ambroxol Hydrochloride Injection packaging by brown neutral boro-silicate glass ampoule was consistent with the low brown borosilicate glass ampoule and carton packaged under the light test. Ambroxol Hydrochloride Injection individually packaged by brown low borosilicate glass ampoule was significantly dif-ferent,and the unknown monoimpurity was over the reporting limits after 48 h exposured. Conclusion Brown neutral boro-silicate glass ampoule or low borosilicate glass ampoule and carton can be used as Ambroxol Hydrochloride Injection packa-ging materials,but light exposure time should not exceed 24 h for brown low borosilicate glass ampoule packaging Ambroxol Hydrochloride Injection.%目的：比较光照影响因素试验中不同棕色玻璃安瓿对盐酸氨溴索注射液稳定性的影响，确定最佳包装形式。方法棕色中性、低硼硅玻璃安瓿以及附加外包装纸盒的盐酸氨溴索注射液分别进行光照试验，采用高效液相色谱法测定盐酸氨溴索和有关物质的含量，考察药物稳定性。结果棕色中性硼硅玻璃安瓿与棕色低硼硅玻璃安瓿+纸盒包装的盐酸氨溴索注射液光稳定性试验结果基本一致。棕色低硼硅玻璃安瓿单独包装的盐酸氨溴索注射液光稳定性试验结果有明显差异，且暴露48 h 后未知单杂超过报告限度。结论棕色中性硼硅玻璃安瓿或棕色低硼硅玻璃安瓿+纸盒可作为盐酸氨溴索注射液的包装材料，但棕色低硼硅玻璃安瓿包装的盐酸氨溴索注射液光照暴露时间不宜超过24 h。