摘要
目的 :以苯扎溴铵为抑菌剂 ,氯化钠为渗透压调节剂 ,聚乙烯吡咯烷酮 (PVP)为增粘剂 ,制备左旋氧氟沙星缓释滴眼剂。方法 :含量测定采用高效液相色谱法 ;稳定性实验以60℃～90℃之间每5℃为1个梯度进行考察。结果 :加样回收率高 ,日内、日间相对标准偏差均<3 %。预测有效期为1 5年。家兔眼刺激性实验表明 ,本制剂对家兔眼睛无刺激性 ,符合《中国药典》对滴眼剂的质量要求。结论
OBJECTIVE:Preparation of levofloxacin eyedrops METHODS:Levofloxacin eyedrops was prepared with benzalkonium as bacteriostat,NaCl as osmotic-pressure regulating agent and PVP as thickener The content was determined with HPLC and the stability was observed in the range of 60℃～90℃ with 5℃ as a gradient RESULTS:Both the within-day and between-day RSDs were less than 3% The expected period of validity would be 1 5 years Irritation test showed that this preparation was not irritant to rabbit's eyes The preparation met the criterion in Chinese Pharmacopeia CONCLUSION:The Levofloxacin eyedrops is stable in quality
出处
《中国药房》
CAS
CSCD
2003年第11期663-665,共3页
China Pharmacy
关键词
左旋氧氟沙星
稳定性
缓释
滴眼剂
Levofloxacin
stability
sustained-release
eyedrops
