阿奇霉素滴耳液的研制及质量控制

Preparation and Quality Control of Azithromycin Ear Drops

目的:制备阿奇霉素滴耳液。方法:以阿奇霉素为主药,采用硫酸呈色分光光度法测定制剂中阿奇霉素的含量。并进行了制荆的稳定性试验和刺激性试验。结果:阿奇霉素滴耳液的平均回收率为(100．79±0．54)％。90 d内制剂中阿奇霉素含量在合格范围内,外观无明显变化。刺激性试验结果表明无明显刺激性。结论:该制剂制备工艺简单,性质稳定,质量可靠,可满足临床需求。

Objective： To prepare the azithromycin ear drops. Method： Azithromycin was the main drug. The content of azithromycin in the ear drops was determined by sulfuric acid color reaction sepectraphotometric method. The experiments of stability and stimulation of the preparation were done. Result： The average recovery of azithromycin ear drops was 100.79% ± 0.54%. In 90 days, the content of azithromycin ear drops was in qualified limit. The appearance had no apparent changes. The stimulation experiment indicated that it has no stimulation. Conclusion. The technology of preparation is simple and stable. Its quality can be controlled and it can meet the need of clinical use.