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夜咳灵口服液是我院自制制剂,主要成分盐酸异丙嗪,是常用的组胺H1受体拮抗剂,具有明显的抗过敏和镇静作用,临床用于治疗小儿过敏性咳嗽,疗效确切,不良反应小[1]。但在使用过程中发现该制剂易氧化变色,性质不够稳定。原先的含量测定方法紫外分光光度法[2]不能将主药与其在光照、高温等条件下产生的降解产物进行分离。因此本文建立了专属性强的高效液相色谱法,对原有处方及拟定处方进行含量、颜色对照试验,观察其稳定性。
Ye Ke Ling oral liquid is our hospital preparation, the main component of promethazine hydrochloride, is commonly used histamine H1 receptor antagonist, has obvious anti-allergic and sedative effects, clinical treatment of pediatric allergic cough, the exact effect, Adverse reactions small [1]. However, the use of the process found that the preparation of oxidative discoloration, the nature is not stable enough. The original content determination method UV spectrophotometry [2] can not be the main drug with its light, high temperature and other conditions generated degradation products were isolated. Therefore, this article established a highly specific high performance liquid chromatography, the original prescription and formulation of prescription content, color control test, observe its stability.