制霉素软膏的质量控制及稳定性研究  

Quality control and stability of Nystatin ointment

作　　者：蒋正立[1] 何仁[1] 张芳[1] 

机构地区：[1]浙江省台州医院,临海317000

出　　处：《海峡药学》2009年第12期83-85,共3页Strait Pharmaceutical Journal

摘　　要：目的建立制霉素软膏的质量控制方法并研究其稳定性。方法以单软膏二号为基质制备制霉素软膏,用紫外分光光度法测定制剂中制霉素的含量,以经典恒温法考察其稳定性,并建立制剂的其他质量控制指标。结果制霉素在304nm波长处有最大吸收,浓度线性范围为4.632～13.896μg.mL-1(r=0.9999),平均回收率为100.67%,平均RSD为0.56%,在冷处贮藏有效期近3个月。结论该方法简便、快速,结果准确,适用于该制剂的质量控制。OBJECTIVE To establish the quality control method of Nystatin ointment and to study its stability.METHODS To prepare the Nystatin ointment with unguentum simplex NO.Ⅱ as Matrix,determine the content of Nystatin with UV-Spectrometry and set up other quality control indicators.To study its stability with Classical constant temperature method.RESULTS Nystatin has a maximum absorption at 304nm,the linear range was 4.632～13.896μg·mL-1（r=0.9999）,the average recovery was 100.67% and the average RSD was 0.56%,and the Validity period was near three months in the cold storage.CONCLUSION The method was simple,accurate,rapid,and suitable for quality control of Nystatin ointment.

关 键 词：制霉素 质量控制 稳定性 

分 类 号：TQ460.4[化学工程—制药化工]