鼻泪道植入剂的制备及质量控制  

Preparation and Quality Control of Nasolacrimal Ducts Implants

作　　者：郭丰广[1] 郝吉福[1] 孝建华[2] 李菲[1] 武夏明[2] 宋涛[1] 崔吉兴[1] 

机构地区：[1]泰山医学院药学院,泰安市271016 [2]泰山医学院附属医院,泰安市271000

出　　处：《中国药房》2008年第25期1971-1972,共2页China Pharmacy

摘　　要：目的：制备鼻泪道植入刘并建立其质量控制方法。方法：以氧氟沙星为主药，聚乙烯醇、甘油为辅料制备鼻泪道植入剂；采用紫外分光光度法测定其中主药含量。结果：所制制剂为微黄色条状固体，鉴别、检查等均符合2005年版《中国药典》相关规定；氧氟沙星检测浓度的线性范围为5．0～15．0μg·mL^-1（r=0.9998），平均回收率为99．67％（RSD=0．62％，n=9）。结论：本制剂制备工艺简便可行，质量稳定可控。OBJECTIVE： To prepare nasolacrima implants and establish a method for their quality control. METHODS： Ofloxacin was taking as the main ingredient and polyvinyl alcohol （PVA） and glycerol were taking as the excipients to make the implants. UV spectrophotometry was applied to determine the content of the main ingredient. RESULTS： The implants prepared were in white solid bar, and its identification and test etc were all up to the standard stated in Chinese Pharmacopeia （2005 edition） . The linear range of ofloxacin was 5.0-15.0 μg·mL^-1（r = 0.999 8）, with the average recovery rate at 99.67% （RSD = 0.62% , n = 9） . CONCLUSION： The preparation process is simple and feasible, and the quality of the preparation is stable and controllable.

关 键 词：鼻泪道植入剂 氧氟沙星 质量控制 

分 类 号：R283.6[医药卫生—中药学] R927.2[医药卫生—中医学]