氯霉素滴眼液质量稳定性的考察

Stability of Chloramphenicol Eye Drops Quality Inspection

目的促进氯霉素滴眼液质量稳定性的提高,保证人民用药安全有效。方法对本辖区内经营的氯霉素滴眼液进行抽样测定并分别置254nm和365nm的紫外光灯及40℃的温度下放置一定时间进行测定研究,采用《中国药典》2005年版二部氯霉素滴眼液项下的含量测定、有关物质检查的方法测定。结果抽验的氯霉素滴眼液不合格率为95.83%,主要不合格项目为氯霉素二醇物,经紫外光灯照射、40℃放置一定时间后,氯霉素的含量下降,氯霉素二醇物含量增加,对硝基苯甲醛受紫外光的影响较大而温度对其影响较小。结论①氯霉素滴眼液的储存条件应由20℃以下的阴凉处存放更改为冰箱内保存[1];②氯霉素滴眼液的处方工艺值得研究和改进。

Objective The promotion chloromycetin drop eye liquid quantity stable enhancement, guaranteed that the people apply drugs safely effective. Methods The chloromyeetin drop eye fluid which manages to this area of jurisdiction in carries on the sampling determination juxtaposes 254 nm and the 365 nm ultraviolet ray lamp and 40℃ under the temperature to lay aside certain time to conduct the determination research, uses ＂the Chinese Pharmacopoeia＂ in 2005 the version two chloromycetin drop eye fluid item of under content determination, the related material inspection method determination. Results The spot check chloromycetin drop eye fluid fraction defective is 95.83%, mainly the unqualified project is ehloromycetin two mellow; After ultraviolet ray lamp illumination, the chloromycetin content drop, ehloromycetin two mellow, Irradiated by ultra-violet lights ,40℃ heating temperature after a certain period of time, decrease the content of chloramphenicol, chloramphenicol diol content increased Nitrobenzaldehyde influenced by ultra-violet light and temperature effects smaller. Conclusion Ist,The chloromycetin drop eye fluid＇ s storage condition should preserve by 20℃ the following shade depositing change for the refrigerator in 2nd, The chloromycetin drop eye fluid＇ s prescription craft is worth studying and the improvement.