盐酸氨溴索注射液与3种支气管扩张剂配伍稳定性考察  

Compatible Stability of Ambroxol Hydrochloride Injection with Three Bronchodilators

作　　者：曹荣娟 李祥胜 李琪 孟祥云[1] CAO Rongjuan;LI Xiangsheng;LIQi;MENG Xiangyun(Hefei Second People′s Hospital,Hefei,Anhui,China 230001;Anhui Food and Drug Inspection and Research Institute,Hefei,Anhui,China 230051)

机构地区：[1]安徽省合肥市第二人民医院,安徽合肥230001 [2]安徽省食品药品检验研究院,安徽合肥230051

出　　处：《中国药业》2021年第18期45-50,共6页China Pharmaceuticals

基　　金：安徽省合肥市第二人民医院院级光华基金项目[院科教〔2015〕70号]。

摘　　要：目的考察3种医院常用支气管扩张剂分别与盐酸氨溴索注射液在0.9%氯化钠注射液中的配伍稳定性。方法将硫酸特布他林雾化液、吸入用硫酸沙丁胺醇溶液及吸入用异丙托溴铵溶液分别与盐酸氨溴索注射液在0.9%氯化钠注射液中按临床常用浓度配伍。采用高效液相色谱法测定3种配伍溶液中各成分的含量,考察其稳定性。结果3种配伍溶液8h内,外观均澄清透明,无色变,无气体、沉淀、浑浊产生,pH稳定,不溶性微粒数无明显变化。3种配伍溶液中,异丙托溴铵、盐酸氨溴索进样量分别在23.5~470.4ng和135.9~2718.0ng,沙丁胺醇、盐酸氨溴索进样量分别在21.9~438.2ng和133.7~2674.0ng,特布他林、盐酸氨溴索进样量分别在23.6~471.1ng和135.1~2702.0ng范围内与其相应峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2.0%,配伍溶液中各组分8h内含量的RSD均小于1.0%。结论硫酸特布他林雾化液、吸入用硫酸沙丁胺醇溶液及吸入用异丙托溴铵溶液均可与盐酸氨溴索注射液在0.9%氯化钠注射液中稳定配伍。Objective To investigate the compatible stability of three commonly used bronchodilators and Ambroxol Hydrochloride Injection in 0.9%Sodium Chloride Injection.Methods According to the common clinical concentrations,Terbutaline Sulphate Solution for Nebulization,Salbutamol Sulfate Inhalation Solution and Ipratropium Bromide Solution for Inhalation were combined with Ambroxol Hydrochloride Injection in 0.9%Sodium Chloride Injection.The high-performance liquid chromatography(HPLC)method was used to determine the content of each component in three compatible solutions and to investigate their stability.Results Within 8 h,the appearance of the three compatible solutions was clear and transparent without change in color,and no gas,precipitation or turbidity was produced,the pH was stable,and the number of insoluble particles had no obvious change.In the three compatible solutions,the linear ranges of ipratropium bromide and ambroxol hydrochloride were 23.5-470.4 ng and 135.9-2718.0 ng,the linear ranges of salbutamol and ambroxol hydrochloride were 21.9-438.2 ng and 133.7-2674.0 ng,the linear ranges of terbutaline and ambroxol hydrochloride were 23.6-471.1 ng and 135.1-2702.0 ng.The RSDs of precision,stability and repeatability tests were less than 2.0%,and the RSD of each component in the compatible solution within 8 h was less than 1.0%.Conclusion Terbutaline Sulphate Solution for Nebulization,Salbutamol Sulfate Inhalation Solution and Ipratropium Bromide Solution for Inhalation can be stably compatible with Ambroxol Hydrochloride Injection in 0.9% Sodium Chloride Injection.

关 键 词：硫酸特布他林雾化液 吸入用硫酸沙丁胺醇溶液 吸入用异丙托溴铵溶液 盐酸氨溴索注射液 0.9%氯化钠注射液 配伍稳定性 

分 类 号：R95[医药卫生—药学]