吸入用盐酸氨溴索溶液与5种临床常用平喘药物的配伍稳定性考察

Compatible Stability of Ambroxol Hydrochloride Solution for Inhalation with Five Anti-asthmatic Drugs

目的考察5种临床常用平喘药分别与吸入用盐酸氨溴索溶液的配伍稳定性。方法将硫酸特布他林雾化液、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及吸入用丙酸倍氯米松混悬液分别与吸入用盐酸氨溴索溶液按照临床剂量配伍组合。通过检测外观、pH和液相色谱峰面积,考察其配伍稳定性。结果7种配伍组合在6 h内,外观均无明显变化,pH值稳定,相对标准偏差(RSD)均在2%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%,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2%。结论吸入用盐酸氨溴索溶液可与5种临床常用平喘药稳定配伍,符合临床用药安全要求。

OBJECTIVE To investigate the compatible stability of five commonly used anti-asthmatic drugs and ambroxol hydrochloride solution for inhalation.METHODS According to the common clinical concentrations,terbutaline sulfate nebulizer solution,ipratropium bromide solution and budesonide suspension for inhalation,fluticasone propionate nebuliser suspension and beclometasone dipropionate suspension for inhalation were combined with ambroxol hydrochloride solution for inhalation.The appearance,pH value and peak areas of high performance liquid chromatography were measured to investigate the compatible stability.RESULTS No significant changes in the appearance and pH of all 7 combinations within 6 h,and the RSDs are all within 2%.In the established high performance liquid chromatography method,the linearity and specificity of the six components were satisfactory;the RSDs of precision,repeatability and stability were less than 2%,the spiked recovery rates were good,which all met the methodological requirements.The RSD of each component in the combinations within 6 h was less than 2%.CONCLUSION The ambroxol hydrochloride solution for inhalation could be stably compatible with five commonly used clinical antiasthmatic drugs,which could meet the requirements of clinical safety.