复方盐酸左氧氟沙星滴眼液的稳定性试验研究

目的:考察复方盐酸左氧氟沙星滴眼液的稳定性。方法:采用高效液相色谱法同时测定3种主药(盐酸左氧氟沙星、盐酸萘甲唑啉及地塞米松磷酸钠)的含量,并进行包括强光照射试验、高温试验的影响因素试验及加速试验、长期试验的稳定性试验。结果:影响因素试验结果表明本品在该条件下性状发生了变化,颜色有所加深,3种主药的含量均呈下降趋势,但仍在合格范围内;加速试验和长期试验结果表明各项考察指标均无明显变化。结论:本品符合制剂稳定性的要求,但在贮存及运输过程中应避免高温及强光照射。

Study on the Stability of Compound Levofloxacin Hydrochloride Eye Drops

OBJECTIVE： To investigate the stability of Compound levofloxacin hydrochloride eye drops. METHODS ： The contents of 3 main components were determined by HPLC, such as levofloxacin hydrochloride, naphazoline hydrochloride and dexamethasone sodium phosphate. The influential factor test including highlight test and high temperature test, the stability test including accelerated test and long-term test were all conducted. RESULTS： Results of influential factor test showed that the property of the preparation was changed and the color of it was deepened under this condition; the contents of 3 main components were all decreased but in line with the standard. The samples were stable in accelerated test and long-term test. CONCLUSIONS： The preparation is up to the requirement of stability. It is important to protect the preparation from high temperature and high light in storage and transportation.