摘要
目的改进氯霉素滴眼液的配制方法。方法以玻璃酸钠为载体,配制氯霉素滴眼液,对滴眼液进行质量检测(鉴别检查,含量测定、稳定性试验)及刺激性试验。结果该滴眼液质量符合相关规定(鉴别反应呈阳性,pH为6.0—7.0),氯霉素平均加样回收率为99.49%(RSD=1.76%),12个月内质量稳定,实验家兔未出现眼睛刺激症状。结论本配制方法合理可行,制剂安全,质量稳定、可控。
Objective To improve the preparation technique of chloramphenicol eye drops. Methods The ehloramphenieol eye drops was prepared by adding sodium hyaluronie acid as a carrier. Its quality and irratant effect on rabbit eyes was tested. Results The quality of the chloramphenicol eye drops prepared by improved technique was compliant with the rules. The average recovery of chloramphenicol was 99.49% ( relative standard difference = 1.76% ), and the preparation was kept stable for 12 months; furthermore, it did not show significant irritation to rabbit eyes. Conclusions The method is feasible and convenient. The preparation is safe for clinic application as the quality is stable and can be controlled.
出处
《中国医药》
2013年第5期678-679,共2页
China Medicine
关键词
氯霉素滴眼液
玻璃酸钠
配制
改进
Chloramphenicol eye drops
Sodium hyaluronic acid
Preparation
Improvement