3种盐酸氨溴索注射剂的稳定性比较

Stability study of three injections of ambroxol hydrochloride

目的:比较3种盐酸氨溴索注射剂(兰苏、沐舒坦和海天欣)的稳定性。方法:采用HPLC法测定盐酸氨溴索和有关物质的含量,考察3种盐酸氨溴索注射剂在高温条件下的质量变化。结果:在60℃放置10d,3种注射剂含量不变,海天欣中有关物质增加较前两者多。结论:兰苏和沐舒坦的稳定性优于海天欣。

Objective： To compare the stability of three injections of ambroxol hydrochloride （Mucosolvan, Lansu and Haitianxin）. Methods： The three injections of ambroxol hydrochloride and its related substances were quantified by HPLC. Their stabilities were investigated under the higher temperature. Results： When the three injections were stored at 60 ℃ for 10 days, the ambroxol concentrations remained unchanged, but the related substances of Haitianxin increased more than those of the other two injections. Conclusion： The stabilities of Lansu and Mucosolvan were better than Haitianxin.