复方曲安奈德乳膏的制备及质量研究

Preparation and quality research of compound triamcinolone acetonide cream

目的制备复方曲安奈德乳膏,建立其质量控制标准。方法以曲安奈德益和硝酸益康唑为主药制备成乳膏,用高效液相色谱法测定两种主药的含量,并制定其质量标准。结果曲安奈德益和硝酸益康唑含量分别在(8.105～40.525)μg/ml(r=0.9998,n=5)和(82.96～414.80)μg/ml(r=0.9996,n=5)范围内,与峰面积线性关系良好;平均回收率分别为100.1%和99.75%,RSD分别为0.13%(n=5)和0.69%(n=5)。结论复方曲安奈德乳膏性质稳定,质量控制方法简便,含量测定方法准确。

Objective To investigate the preparation compound triamcinolone acetonide cream and establish the quality standard of it. Methods Triamcinolone acetonide and econazole nitrate were determined by HPLC. Results The calibration curves were linear in the range of （8.105-40.525）μg/ml for triamcinolone acetonide and （82.96-414.80）μg/ml for econazole nitrate,respectively. The recoveries of triamcinolone acetonide and econazole nitrate were 100.1% and 99.75% ,respectively. Conclusion The cream showed a good stability.The method is simple and convenient in operation.