氟甲栓的制备及质量控制

Preparation and Quality Control of Norfloxacin and Metronidazole Suppository

目的:制备氟甲栓并建立其质量控制方法。方法:以聚乙二醇为基质,甲硝唑、诺氟沙星为主药制备栓剂;采用高效液相色谱法同时测定其中主药的含量;并考察该制剂室温放置12个月的稳定性。结果:所制制剂为乳白色至淡黄色的圆锥形栓,鉴别、检查均符合2005年版《中国药典》中的相关规定;甲硝唑、诺氟沙星检测浓度的线性范围分别为8.32～41.60、2.08～10.40μg·mL-(1r=0.9999),平均回收率分别为98.23%、98.69%,日内、日间平均RSD分别为0.70%、0.62%,0.76%、0.65%;制剂12个月时各项指标未见明显变化。结论:该制剂制备工艺简便可行,质量稳定可控。

OBJECTIVE：To prepare norfloxacin and metronidazole suppository and establish a method for its quality control. METHODS：Suppository was prepared with PEG as matrix, metronidazole and norfloxacin as main ingredients. The contents of metronidazole and norfloxacin were determined by HPLC. The stability of preparation keeping for 12 months at room temperature was observed. RESULTS： The preparation assumed ivory or faint yellow conic suppository and its property was up to the standard stated in Chinese Pharmacopeia （2005 edition） in identification and test. The linear range of metronidazole and norfloxacin were 8.32±41.60 ug·mL^-1 （r=0.999 9）and 2.08-10.40 ug·mL^-1（r=0.999 9）with average recovery rates at 98.23% and 98.69%, respectively. The mean intra-day RSD and inter--day RSD were 0.70%, 0.62% and 0.76%, 0.65%, respectively. No significant change was noted in each index of suppository at 12th month. CONCLUSION： The preparation is simple in preparation process, and controllable in quality.