摘要
目的制备左氧氟沙星原位胶化滴眼剂并建立其质量控制方法。方法以氯化钠为渗透压调节剂、海藻酸钠为增稠剂、羟苯乙酯为防腐剂,制备左氧氟沙星原位胶化滴眼剂,用高效液相色谱法测定含量。结果制得的液体为无色或浅黄色澄明液体,pH为5.57,鉴别、检查结果均符合2005年版《中国药典(二部)》中的相关规定,含量测定的线性范围为9.39～62.60μg/mL,平均回收率为99.27%,RSD为2.92%(n=6)。结论左氧氟沙星原位胶化滴眼液处方合理,质量符合要求。
Objective To prepare insitu gelling of Levofloxacin Hydrochloride Eye Drops and to establish its quality control method. Methods The insitu gelling of Levofloxacin Hydrocbloride Eye Drops was prepared with sodium chloride as buffer to regulate the pH value and osmotic pressure and with sodium polymannuronate as thickener. The content of levofloxacin bydrochloride was determined by high performance liquid chromatography（HPLC）. Results The sustained- release eye drops were colorless or yellow limpid liquid. Its test and identification results all conformed to the related stipulation stated in Chinese Pharmacopeia （2005 edition）. There was the good linear relationship within the concentration range of 9.39- 62.60 μg/mL for levofloxacin hydrochloride, and its average recovery rate was 99.27%, RSD was 2.92% and pH was 5.57. Conclusion The preparative method is simple and feasible. The quality of insitu gelling of Hydrochloride Levofloxacin Eye Drops is stable and controllable.
出处
《中国药业》
CAS
2010年第7期38-39,共2页
China Pharmaceuticals
