【摘要】 目的:考察氢溴酸高乌甲素注射液及冻干粉的稳定性,为合理用药、剂型改进提供理论依据。方法:采用经典恒温加速、强光照射、高湿度试验法考察稳定性,氢溴酸高乌甲素的含量测定采用紫外分光光度法。结果:氢溴酸高乌甲素注射液在强光照射后含量呈较明显下降趋势,其降解速率常数约为恒温加速试验的2倍,溶液pH变化都不明显。冻干粉在强光照射时药物含量及其水溶液下降明显,而在高湿或加热环境中变化不大,高湿环境中放置10d吸湿百分率均值小于1%,粉末颜色及形状未见明显变化。结论:氢溴酸高乌甲素注射液主要对强光照射不稳定,高温对其稳定性的影响不明显;冻干粉的稳定性也主要受光照影响,对湿、热基本稳定。更多还原

【Abstract】 OBJECTIVE To investigate the stability of lappaconitine hydrobromide injection and freeze-dried powder to provide the theoretical basis for their rational usage and the improvent of preparation.METHODS The experiments on stability were conducted using constant temperature acceleration test,strong lighting,high temperature and high humidity test.The content of lappaconitine hydrobromide was determined by UV spectrophotometry.RESULTS Under strong light exposure,the content of lappaconitine hydrobromide had a obviously lowering trend,and the first-order rate constant was roughly twofold than that of constant temperature acceleration test,and the change of pH value was unobviously observed.Lappaconitine hydrobromide freeze-dried powder showed distinct changes in contents and pH under strong lighting,but changed little under high humid or heated conditions;the percentage of moisture absorption was less than 1% as being stored in high humidity for 10 d;no obvious change in its color and shape was observed.CONCLUSION Lappaconitine hydrobromide injection was unstable to strong light,but not sensitive to high temperature;Lappaconitine hydrobromide freeze-dried powder was also mainly influenced by strong light,basically stable to humidity and heat.更多还原