复方甲硝唑中空栓的制备及质量控制

目的:制备复方甲硝唑中空栓并建立其质量控制方法。方法:以半合成脂肪酸甘油酯为基质制成中空栓;用双波长倍率减差法和等吸收双波长法同时测定其主药甲硝唑和氧氟沙星的含量。结果:甲硝唑和氧氟沙星检测浓度线性范围分别为6. 0～18. 0、3 .0～9 .0μg/ml ,平均回收率分别为100 .98 %、99 .56 % (n=5) ,相对标准差分别为0 .82 %、0 .80 %。结论:本方法简便、准确、重现性好,可用于复方甲硝唑中空栓的质量控制。

Preparation and Quality Control of the Compound Metronidazole Hollow Suppository

OBJECTIVE:To prepare and establish quality control for the compo und metronidazole hollow suppository.METHODS:The compound metronidazole hollow suppository was prepared with semisynthesis fatty acid glyceride as ground substance;The contents of metronidazole and ofloxacin were determined by dual-wave length K-ratio method and equivalent absorption dual-wave length method.RESULTS:The detecting concentration linear range of metronidazole and ofloxacin were6.0～18.0μg/ml and3.0～9.0μg/ml respectively,the average recovery were100.98%and99.56%(n=5)respectively,RSD were0.82%?0.80%respectively.CONCLUSION:This method is convenient,accurate and reproducible,which can be used for the quality control of compound metronidazole suppository.