乳酸左氧氟沙星氯化钠注射液与注射用盐酸氨溴索配伍稳定性考察

Compatible Stability of Levofloxacine Lactate and Sodium Chloride Injection Combined with Ambroxol Hydrochloride for Injection

目的考察乳酸左氧氟沙星氯化钠注射液与注射用盐酸氨溴索配伍后的稳定性。方法室温下观察乳酸左氧氟沙星氯化钠注射液与注射用盐酸氨溴索配伍后的外观及pH变化。采用高效液相色谱(HPLC)法,测定配伍后0~24 h内左氧氟沙星及盐酸氨溴索的含量。结果乳酸左氧氟沙星氯化钠注射液与注射用盐酸氨溴索质量浓度分别在39. 19~391. 90μg/mL和5. 99~59. 94μg/mL范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于1%;配伍后的溶液24 h内稳定,其中左氧氟沙星含量在1. 920 7~1. 921 8 g/L之间,盐酸氨溴索含量在0. 286 6~0. 288 4 g/L之间。结论乳酸左氧氟沙星氯化钠注射液与注射用盐酸氨溴索可配伍应用。

Objective To investigate the compatible stability of Levofloxacine Lactate and Sodium Chloride Injection combined with Ambroxol Hydrochloride for Injection. Methods The appearance and pH value of the mixture of Levofloxacine Lactate and Sodium Chloride Injection and Ambroxol Hydrochloride for Injection were observed at room temperature. The contents of levofloxacin and ambroxol hydrochloride in 0 - 24 h after compatibility were determined by HPLC. Results Levofloxacine Lactate and Sodium Chloride Injection and Ambroxol Hydrochloride for Injection showed good linear relationship with peak area in the ranges of 39. 19 - 391. 90 μg / mL and 5. 99 - 59. 94 μg / mL,respectively. RSDs of precision,stability and repeatability tests were all less than 1%. The compatible solution was stable within 24 h,and the content of levofloxacin was in the range of 1. 920 7 - 1. 921 8 g / L,and the content of ambroxol hydrochloride was in the range of 0. 286 6 - 0. 288 4 g /L. Conclusion Levofloxacine Lactate and Sodium Chloride Injection can be compatible with Ambroxol Hydrochloride for Injection.