药用棕色中硼硅玻璃安瓿与吸入用盐酸氨溴索溶液的相容性研究
Compatibility of medicinal brown medium borosilicate glass ampoule and the ambroxol hydrochloride solution for inhalation
李樾 1杨锐 1赵霞 1杨会英1
作者信息
- 1. 中国食品药品检定研究院,北京 100050;药用辅料质量研究与评价重点实验室,北京 100050
- 折叠
摘要
目的 考察药用棕色中硼硅玻璃安瓿与吸入用盐酸氨溴索溶液的相容性.方法 采用SEM、ICP-MS等方法,通过模拟试验及迁移试验研究药物与包装材料的相互作用,并根据毒理学研究资料评价相容性.结果 经加速稳定性试验放置6个月后,测得盐酸氨溴索溶液中Si、B等7种元素含量可见大于40％的上升率,但未超过每日最大允许摄入量,玻璃安瓿表面的侵蚀圆斑随加速放置时间延长而有所增多或增大;经长期稳定性试验放置24个月后,盐酸氨溴索溶液中元素含量、玻璃安瓿表面均未见明显变化.结论 加速稳定性试验提示药用棕色中硼硅玻璃安瓿与盐酸氨溴索溶液间存在相互作用的趋势,提示本品有效期应尽量缩短,并密切关注相互作用情况.
Abstract
Objective To determine the compatibility between medicinal brown medium borosilicate glass ampoule and ambroxol hydrochloride solution for inhalation.Methods SEM,ICP-MS and other methods were used to determine the interaction between drugs and packaging materials through simulation and migration experiments.The compatibility was evaluated according to toxicological research data.Results After 6 months of accelerated stability test,the changes of elements in ambroxol hydrochloride solution were measured.Seven elements such as Si and B increased more than 40％,but did not exceed the daily maximum allowable intake.The area or quantity of erosion spots on the surface of the glass ampoule increased with the extension of accelerated storage time.After 24 months of long-term stability test,there was no significant change in the elements in ambroxol hydrochloride solution and the surface of glass ampoules.Conclusion There tends to be interaction between medicinal brown medium borosilicate glass ampoule and ambroxol hydrochloride solution.The validity period of this product should be shortened as much as possible,and attention should be paid to the interaction.
关键词
吸入用盐酸氨溴索溶液/药用棕色中硼硅玻璃安瓿/相容性Key words
ambroxol hydrochloride solution for inhalation/medicinal brown borosilicate glass ampoule/compatibility引用本文复制引用
出版年
2024
NETL
NSTL
万方数据