地蒽酚水溶蜡棒的研制及含量测定

Preparation and Content Determination of Dithranol Water-soluble Wax Sticks

目的地蒽酚水溶蜡棒的研制及测定其地蒽酚含量。方法采用正交设计的方法筛选水溶蜡棒的最佳配比以及制备条件。采用分光光度法检测其稳定性及温湿度的影响等,并根据《中国药典》2010版,在450 nm波长处测定其吸光度,并计算含量。结果研制的地蒽酚水溶蜡棒性质稳定,地蒽酚浓度检测的线性范围为0.80～24.00μg/ml(r2=0.999 9)。平均回收率为100.8%。结论地蒽酚水溶蜡棒的制备工艺简单,所得水溶蜡棒稳定性好,同时分光光度法操作简便、快速,结果准确,可用于该制剂的含量测定。

Objective To prepare Dithranol water-soluble wax sticks and determine the content of Dithranol in the preparation. Methods Orthogonal design was used to select the optimum formulation and preparation conditions; UV- spectrophotometry was used to determine the influence of temperature and humidity on the stability. According to Chinese Pharmacopoeia （2010 edition）, the absorbance of the Dithranol was determined at wavelength of 450 nm to calculate the contents of dithranol in the water-soluble wax sticks. Results The prepared Dithranol wax sticks were very stable. The linearity range for Dithranol was 0.80～24.00μg/ml（r2=0.999 9） with average recovery of 100.8%. Conclusion The new preparation method of Dithranol wax sticks is simple, and the produced wax sticks is very stable. The established UV-spectrophotometric method is rapid, precise and suitable for the determination of Dithranol in the water-soluble wax sticks.