甲磺酸帕珠沙星壳聚糖滴鼻剂的制备与质量控制  

Preparation and Quality Control of Pazufloxacin Medilate Chitosan Nasal Drop

作　　者：李军[1] 杨慧玲[1] 董根山[2] 李金伟[2] 

机构地区：[1]郑州大学第一附属医院,河南郑州450052 [2]河南省人民医院,河南郑州450003

出　　处：《中国药业》2011年第7期36-37,共2页China Pharmaceuticals

摘　　要：目的研究甲磺酸帕珠沙星壳聚糖滴鼻剂的制备方法并建立其质量控制方法。方法以壳聚糖为增稠剂和增效剂、甲磺酸帕珠沙星为主药制备滴鼻剂,采用高效液相色谱法测定主药含量,并对其稳定性进行考察。结果该产品的处方和制备工艺简单,质量稳定,甲磺酸帕珠沙星质量浓度在20.0～80.0μg/mL范围内与峰面积线性关系良好,r=0.9999(n=6);平均回收率为98.62%,RSD为0.53%(n=9)。结论滴鼻剂可作为甲磺酸帕珠沙星制剂新品种的开发研究对象。Objective To study the preparation method of Pazufloxacin Medilate Chitosan Nasal Drop and to establish a quality control method for the suppository.Methods The nasal drop was prepared by using chitosan as thicken agent and synergist with pazufloxacin medilate as the principal agent.The content of pazufloxacin medilate was determined by HPLC.The stability of the preparation was also investigated.Results The preparation method was simple and stable.There was a good linearity of calibration curve of pazufloxacin medilate within the range of 20.0-80.0μg/mL（r=0.999 9,n=6）.The average recovery rate was 98.62%,and RSD was 0.53%（n=9）. Conclusion It is valuable to be further studied as a new preparation of pazufloxacin medilate.

关 键 词：甲磺酸帕珠沙星 壳聚糖 滴鼻剂 制备 质量控制 

分 类 号：R944.16[医药卫生—药剂学] R987[医药卫生—药学]