注射用乳糖酸阿奇霉素与吸入用布地奈德混悬液的配伍稳定性考察

Study on the compatible stability of Azithromycin Lactobionate and Budesonide

目的考察注射用乳糖酸阿奇霉素与吸入用布地奈德混悬液配伍稳定性,以及两药与注射用盐酸氨溴索的配伍稳定性。方法参考临床用药方法,以0.9%氯化钠注射液为溶媒将注射用乳糖酸阿奇霉素与吸入用布地奈德混悬液、注射用盐酸氨溴索制备配伍溶液,采用液相色谱-串联质谱联用法(liquid chromatography-tandem mass spectrum,LC-MS/MS)测定法,考察3种药物在室温、冷藏(4℃)及避光保存条件下的含量、配伍溶液外观及其p H变化。结果配伍溶液保存2 d时,3种药物组分含量均不低于0 h时的95%,但保存3 d时,3种药物含量降低到0 h时的70%~90%,保存7 d时,药物含量均低于0 h时的50%。保存温度对含量变化无显著影响;配伍溶液保存7 d时,其外观无明显变化;配伍溶液保存3 d时,其p H无显著变化,但保存7 d时则显著降低。不同保存温度下阿奇霉素、布地奈德浓度均呈下降趋势,不同时点间差异有统计学意义(P<0.05),组间差异无统计学意义(P>0.05),组间·不同时点间交互作用差异无统计学意义(P>0.05)。结论注射用乳糖酸阿奇霉素与吸入用布地奈德混悬液、注射用盐酸氨溴索可作为外用制剂配伍使用,宜常温保存,滴鼻使用时间不宜超过3 d。

Objective To investigate the compatible stability of Azithromycin Lactobionate for injection with budesonide and ambroxol hydrochloride for injection. Methods Basing on clinical medication methods, azithromycin lactobionate, budesonide, ambroxol hydrochloride were prepared to compatibility solution with 0.9% sodium chloride injection. The contents of three drugs within 7 days were determined by liquid chromatography-mass spectrometry/mass speetrometry（LC-MS/MS）. The appearance and pH value of mixture were investigated. Results The contents of azithromycin lactobionate, budesonide and ambroxol hydrochloride changed less than 5% within 2 days, and the contents of three drugs was equal to 70%-90% of 0 h at 3 days, the contents of three drugs decreased significantly after 3 days, only less than 500/00 of 0 h. When azithromycin lactobionate and budesonide were put in different compatible solutions and stored at different temperatures, the concentration of azithromycin and budesonide were decreased. There was statistical significance difference between time points（P〈0.05）, but there was no significant difference between groups（P〉0.05）, and the interaction between groups and time（P〉0.05）.Conclusion Azithromycin lactobionate, budesonide and ambroxol hydrochloride are compatible, should be preserved at room temperature, and should not exceed 3 days for nose drops use.