盐酸氨溴索溶液与5种常用雾化药物的配伍稳定性考察

Compatible stability of ambroxol hydrochloride solution for inhalation with 5 common nebulized drugs

目的考察吸入用盐酸氨溴索溶液与5种临床常用雾化药物的配伍稳定性。方法吸入用盐酸氨溴索溶液与硫酸沙丁胺溶液、吸入用异丙托溴铵溶液、吸入用布地奈德混悬液、丙酸氟替卡松雾化吸入用混悬液、吸入用丙酸倍氯米松混悬液配伍后,室温下于0、2、4、6 h观察配伍液的外观变化,测定其pH值,并采用高效液相色谱法测定配伍液中各成分百分含量。结果5种配伍组合在6 h内,外观均无明显变化,pH值稳定,RSD均在1.0%内。建立的高效液相色谱法中,6个成分的线性关系良好,专属性强,精密度、重复性及稳定性的RSD均小于2.0%,加样回收率良好,符合方法学要求,配伍组合中各成分6 h内峰面积变化RSD均小于1.0%。结论吸入用盐酸氨溴索溶液可与5种临床常用雾化药物稳定配伍,符合临床用药安全要求。

Objective To determine the compatibility stability of ambroxol hydrochloride solution for inhalation with 5 common nebulized drugs.Methods After ambroxol hydrochloride solution for inhalation was combined with salbutamol sulfate solution,ipratropium bromide solution,budesonide suspension,fluticasone propionate suspension and beclomethasone dipropionate suspension,the appearance changes of the mixtures at room temperature were observed at 0,2,4 and 6 h,respectively.The pH values were determined,and the percentage contents of each component in the mixed solutions were determined by high performance liquid chromatography.Results The appearance of the 5 combinations had no obvious change within 6 h,the pH values were stable,and the RSDs were within 1.0%.In the established high performance liquid chromatography method,the linearity and specificity of the 6 components were satisfactory,and the RSDs of precision,repeatability and stability were less than 2.0%.The spiked recovery were good,all meeting the methodological requirements.The RSD of the peak area change of each component in the compatibility combinations within 6 h were less than 1.0%.Conclusion The ambroxol hydrochloride solution for inhalation can be stably compatible with 5 common nebulized drugs,which can meet the requirements of clinical safety.