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复方硝酸咪康唑乳膏的制备工艺与质量标准研究 被引量:6

Study on preparation and quality standard of Compound Miconazole nitrate Cream
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摘要 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 。 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.
出处 《齐鲁药事》 2005年第2期114-115,共2页 qilu pharmaceutical affairs
关键词 复方硝酸咪康唑乳膏 制备工艺 HPLC 硝酸咪康唑 氢化可的松 Compound Miconazole nitrate Cream preparation HPLC Miconazole nitrate Hydrocortisone
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  • 1.中国临床用药须知:2000年版二部[M].,.474-475.
  • 2.《中国药典》2000年版二部[M].,..

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