加替沙星滴眼液的制备与质量控制  

Preparation and Determination by HPLC of Gatifloxacin Eye Drops

作　　者：李群力[1] 蒋晓萌 

机构地区：[1]浙江金华职业技术学院医学院,浙江金华321000 [2]浙江尖峰药业有限公司,浙江金华321000

出　　处：《中国现代应用药学》2007年第4期330-333,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 探讨加替沙星滴眼液的处方、制备工艺和含量测定方法.方法 以乳酸为增溶剂、氢氧化钠为pH值调节剂、氯化钠调等渗、苯扎溴铵为防腐剂,制备加替沙星滴眼液;用HPLC法测定含量.结果 制备的加替沙星滴眼液在冷藏（2～4℃）、高温（60℃）、光照（4500lx）下及配制过程中含量稳定.结论 处方合理,工艺可行,制备的滴眼液性质稳定,含量测定方法准确可靠.OBJECTIVE To study the formulation and preparation procedire of Gatifloxacin eye drops and develop a high-perfomance liquid chromatography methods for the determination of the content. METHODS Gatifloxacin eye drops was prepared with lactate as solubilized agent, NaOH as regulator of pH value, NaCl as isotonic adjuster, and benzalkonium bromide as antiseptic. Its content was determined by HPLC. RESULTS Gatifloxacin eye drops was stable while coldened below 2 -4℃, Heated up 60℃ or radiated at 45001x. CONCLUSION The fomulation is reasonable. The preparation is feasible. Gatifloxacin eye drops is stable. The method of determination is sensitive and accurate.

关 键 词：加替沙星 滴眼液 含量测定 高效液相色谱 

分 类 号：R978.26[医药卫生—药品]