复方奥硝唑中空栓的制备及质量控制

Preparation and Quality Control of Compound Ornidazole Hollow Type Suppository

摘要: 目的制备复方奥硝唑中空栓剂,并建立质量控制方法。方法以混合脂肪酸甘油酯为基质制备中空栓剂;采用等吸收-双波长法同时测定其主药奥硝唑和左氧氟沙星的含量;对制剂进行卫生学、刺激性及稳定性等试验。结果奥硝唑和左氧氟沙星的平均回收率(n=9)分别为99.7%,100.2%,其他各项检查均符合栓剂的有关规定。结论本制剂制备工艺简单,性质稳定,质量可控。

Abstract: OBJECTIVE To prepare and establish quality control for the compound ornidazole hollow type suppository.METHODSThe compound ornidazole hollow type suppository was prepared with mixable fatty acid glyceride as basic;The contents of ornidazole and levofloxacin were determined by equivalent absorption dual-wavelength method;The tests of hygienic, stimulation and stability were carried out. RESULTSThe average recovery of ornidazole and levofloxacin were 99.7%(n=9),100.2%(n=9),other tests accord with the standard of suppository. CONCLUSIONThe preparation of the Hollow Suppository is simple. And its quality can be well controlled.