CAJ | 학술논문

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.结果该滴跟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.
목적 개진록매소적안액적배제방법.방법 이파리산납위재체,배제록매소적안액,대적안액진행질량검측(감별검사,함량측정、은정성시험)급자격성시험.결과 해적근액질량부합상관규정(감별반응정양성,pH위6.0～7.0),록매소평균가양회수솔위99.49％(RSD=1.76％),12개월내질량은정,실험가토미출현안정자격증상.결론 본배제방법합리가행,제제안전,질량은정、가공.
Objective To improve the preparation technique of chloramphenicol eye drops.Methods The chloramphenicol eye drops was prepared by adding sodium hyaluronic 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.