【摘要】 目的 :建立复方奥硝唑栓剂的制备方法及质量控制标准。方法 :筛选基质 ,确定栓剂中主药成分及基质的组成与比例 ,并采用高效液相色谱法的内标法同时测定栓剂中奥硝唑及左氧氟沙星的含量。结果 :以奥硝唑及左氧氟沙星为主药 ,使用水溶性基质制备栓剂 ;奥硝唑及左氧氟沙星的平均回收率分别为100 65 %、98 86 % ,其相对标准差分别为2 20 %、1 28 %。结论 :该制剂制备工艺简单、质量稳定 ,质量控制方法简便、准确、精密度好。更多还原

【Abstract】 OBJECTIVE:To develop the preparation technic of compound ornidazole suppository and establish the quality standard.METHODS:The proper base material was picked out and the proportion of main ingredients to base material in suppository was defined.The contents of ornidazole and levofloxacin were determined by HPLC with an internal stanˉdard.RESULTS:The suppository was prepared with ornidazole and levofloxacin as main ingredient,and water-soluble base as materials.The average recovery rates of ornidazole and levofloxacin were100.65%(RSD=2.20%)and98.86%(RSD=1.28%)respectively.CONCLUSION:The preparation is simple in preparation technic,stable in quality,and convenient,accuˉrate and precise in quality control.更多还原