硝酸益康栓制备工艺与质量控制

Preparation and quality control of econazole nitrate suppositories

目的研制硝酸益康栓工艺,并制定合适的定量分析方法。方法以半合成脂肪酸甘油脂为基质制备硝酸益康唑栓,以HPLC法测定本品中硝酸益康唑的含量。结果硝酸益康唑的平均回收率为100.1%,RSD为1.13%。结论硝酸益康唑栓工艺可行,HPLC法测定本品中硝酸益康栓的含量可作为控制本品质量的指标。

Objective To establish the preparation and quality control of econazole nitrate suppositories. Methods Econazole nitrate suppositories were prepared and determined by the HPLC. Results The average of recovery and RSD were 100.1 % and 1.13% respectively. Conclusion The process of econazole nitrate suppositories was built up. Determination of econazole nitrate suppositories by HPLC can be used as method of econazole nitrate suppositories.