论文部分内容阅读
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 To improve the quality stability of chloramphenicol eye drops and ensure the safe and effective use of medicines by the people. Methods Chloramphenicol ophthalmic drops in this area were sampled and measured. UV light at 254nm and 365nm were respectively measured and placed at a temperature of 40 ℃ for a certain period of time. Chloramphenicol (2005), “Chinese Pharmacopoeia” Determination of the content under the eye drops, the method of determination of the relevant substances. Results The unqualified rate of chloramphenicol eye drops was 95.83%. The main unqualified item was chloramphenicol diol. After being exposed to ultraviolet light for 40 days, the content of chloramphenicol decreased, The content of diol increased, p-nitrobenzaldehyde was more affected by ultraviolet light and temperature had less effect on it. Conclusion ① chloramphenicol eye drops storage conditions should be stored below 20 ℃ in the shade changed to the refrigerator to preserve [1]; ② chloramphenicol eye drops worth of research and improvement of the process.