妇科用环吡酮胺乳膏剂制备与含量测定的研究  

Research on the Preparation and Content Determination of Ciclopirox Gynecological Cream

作　　者：胡寒阳 卢山 何静思 薛大权 HU Hanyang;LU Shan;HE Jingsi;XUE Daquan(College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 43006)

机构地区：[1]湖北中医药大学药学院,湖北武汉430065

出　　处：《湖北中医药大学学报》2017年第6期50-54,共5页Journal of Hubei University of Chinese Medicine

基　　金：湖北省科技厅自然科学基金(项目编号:2014CFB243)

摘　　要：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:1.0mL/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.

关 键 词：妇科用环吡酮胺乳膏 含量测定 稳定性 

分 类 号：R286[医药卫生—中药学]