复方炉甘石混悬剂的制备和质量控制方法

目的 改进炉甘石洗剂的制备方法,提高混悬剂的物理稳定性及其疗效,建立紫外分光光度法测定混悬剂中地塞米松磷酸钠的含量.方法 利用过滤法获取地塞米松磷酸钠,采用紫外分光光度法测定地塞米松磷酸钠的含量.结果 地塞米松磷酸钠质量浓度的线性范围为7.458～37.290 μg/mL,回归方程为Y=-1.972×10-2 +0.029 41C(r =0.999 9,n=5),平均回收率为99.53％,RSD为1.62％.结论 改进后的炉甘石洗剂稳定性和疗效良好,紫外分光光度法适用于测定制剂中的地塞米松磷酸钠的含量,符合质量控制要求,方法简便、灵敏,测定结果准确.

Preparation and Methodological Investigation of Compound Calamine Suspension

Objective To improve the preparation method of calamine lotion, to enhance the stability and the curative effect of calamine suspension and to establish a UV- spectrophotometry method for the determination of the content of dexamethasone sodium phosphate in the calamine suspension. Methods The filtration method was adopted to obtain dexamethasone sodium phosphate and the content of dexamethasone sodium phosphate was determined by the UV speetrophotometry. Results The linear range of dexamethasone sodium phosphate was 7. 458 - 37. 290 I.Lg/mL. The regression equation was Y = 1. 972 × 10-2 ＋ 0. 029 41 C（ r = 0. 999 9, n = 5）. The average recovery rate was 99.53%, RSD 1.62%. Conclusion The improved calamine suspension has good stability and good curative effect. The UV- spectrophotometry method is suitable to determine the content of dexamethasone sodium phosphate in this preparation, and is accorded with the requirement of the quality control, which is simple and sensitive with accurate dectection result.