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目的 制备环吡酮胺妇科用乳膏并对其成品质量进行考察.方法 根据正交试验法优化环吡酮胺乳膏基质处方;建立HPLC测定制剂含量的方法,用十八烷基硅烷键合硅胶为填充剂;检测波长:304nm;流动相:乙腈-甲醇-缓冲液(25∶45∶30),流速:1.0 mL/min;柱温:25℃.结果 环吡酮胺在此色谱条件下系统适应性良好,浓度范围在29.2～233.6μg/mL时,线性关系良好,回归方程为A=492.195C-1.5233(r=0.9999),平均回收率、含量测定的RSD均小于2.0％.结论 制备妇科用环吡酮胺乳膏,含量测定、稳定性是可行的.“,”Objective To prepare ciclopirox gynecological cream and detect its product quality.Methods The formulation of ciclopirox olamine cream was optimized of by orthogonal test method;the method of determination of drug content by HPLC was established,octadecylsilane chemically bonded silica was used as filler;detection wavelength:304 nm;the mobile phase was acetonitrile methanol buffer (25∶45∶30),flow rate:1 mL/min;column temperature:25 degrees centigrade for chromatographic conditions.Results Under this chromatographic conditions system,ciclopiroxolamine had good adaptability,the concentration was in the range of 29.2 ～ 233.6g/mL with good linear relationship,the regression equation was A=492.195C-1.5233 (r=0.9999),the average recovery rate,the determination of RSD％ was less than 2％.The preparation ofciclopirox olamine cream was stable and safe.Conclusion It is feasible to prepare ciclopirox gynecological cream and determinate its content and stability.