酮康唑霜的制备与质量研究

Preparation of ketoconazole cream and study on its quality control

本文方法改进了酮康唑霜的配方，并用一阶导致光谱法测定了霜剂中主成分的含量，以３０９ｎｍ为测定波长，可排除基质及尼泊金乙酯、亚硫酸钠等的干扰，快速简便，方法的平均回收率为９９．３％，ＲＳＤ为０．５８％。对制备的酮康唑霜进行稳定性实验以及常温放置９个月观察，外观及主药含量未见明显变化。

he improvement of the composition and preparation of ketoconazole cream was made and reported in this paper, first derivative spectrophotometry was employed to determine ketoconazole in the cream with 309±1nm as assay wavelength. The interference resulting form the base, sodium sulfite and parahydroxybenzoester, etc. was eliminated. The average recovery was 99.28%(RSD 0.58%). There was no change in the characteristics and content of the prepared samples after 9 mths.