复方硝酸咪康唑乳膏的制备工艺与质量标准研究

目的　研制复方硝酸咪康唑乳膏 ,并制定合适的定量分析方法。方法　以单硬脂酸甘油酯、十八醇、液状石蜡为油脂性基质 ,以吐温 - 80为乳化剂 ,甘油为保湿剂 ,制成O/W型乳膏剂 ,以HPLC法测定本品中硝酸咪康唑及氢化可的松的含量。结果　含量测定方法中 ,硝酸咪康唑的平均回收率为 10 1 0 % ,RSD为 0 5 8% ,氢化可的松的平均回收率为 99 96 % ,RSD为 0 71%。结论　复方硝酸咪康唑乳膏工艺可行 ,HPLC法测定本品中硝酸咪康唑与氢化可的松的含量 ,操作简便 ,结果可靠

Study on preparation and quality standard of Compound Miconazole nitrate Cream

Objective To prepare Compound Miconazole nitrate Cream and establish a method for quality control of the cream.Methods Glycerol monstearate,stearylalcohol and liquidparaffin were used as the oil base,Tweens-80 was used as the emulsifying agent,glycerol was used as the protective mosit agent,the content of Miconazole nitrate and Hydrocortisone were determined by HPLC.Results The average recovery of Micronazole was 101.0% and RSD was 0.58%.The average recovery of Hydrocortisone was 99.96% and RSD was 0.71%.Conclusion The Compound Miconazole nitrate Cream can be prepared feasibly.The content of Miconazole nitrate and Hydrocortisone were determined by HPLC.The method is simple and accurate.