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.
出处
《中国药业》
CAS
2011年第7期36-37,共2页
China Pharmaceuticals
关键词
甲磺酸帕珠沙星
壳聚糖
滴鼻剂
制备
质量控制
pazufloxacin medilate
chitosan
nasal drops
preparation
quality control
