盐酸平阳霉素水溶蜡棒的研制及含量测定

摘要

Objiective To prepare pingyangmycin water-soluble wax stick and to establish its content determination method. Method The formula was optimized by orthogonal experiment and the content of pingyangmycin in wax stick was determined by high performance liquid chromatography (HPLC). Results The formula of pingyangmycin wax stick matrix was optimized as 1 g of alcohol ethoxylate and 1 g of S 40. Pingyangmycin was added when the temperature of the matrix raised to 70℃and stirred for 20 min. The linear range of pingyangmycin determined by HPLC was 34.4~172μg/mL,the regression equations was y=8298.9 x-34996(r=0.9999),and the average recovery of pingyangmycin was 102.67%(n=9). Conclusion The Preparing procedure of pingyangmycin water-soluble wax sticks is simple and stable. The HPLC method for determining the content of pingyangmycin in water-soluble wax sticks is simple, fast and accurate.%目的：制备盐酸平阳霉素的水溶蜡棒，并建立蜡棒中盐酸平阳霉素含量测定方法。方法采用正交设计试验对蜡棒基质的配比及制备条件进行筛选，用高效液相色谱法对蜡棒中平阳霉素的含量进行测定。结果盐酸平阳霉素蜡棒基质处方为平平加与硬脂酸聚烃氧(40)脂质量比为1∶1，在温度70℃时加入主药，搅拌时间为20 min，制成蜡棒；高效液相色谱法测定蜡棒中盐酸平阳霉素含量在34.4～172μg/mL线性关系良好，回归方程为y=8298.9 x-34996（r=0.9999），平均回收率为102.67％（n=9）。结论盐酸平阳霉素水溶蜡棒的制备工艺简单，性质稳定；利用高效液相色谱法测定蜡棒中平阳霉素含量的方法简便、快速，结果准确。