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目的：对诺甲滴耳液的制备及质量控制方法进行了研究。制定了制剂工艺和含量测定方法，并进行了临床疗效的观察。方法：采用UV和HPLC分别测定诺氟沙星和甲硝唑的含量，经采取和氯霉素滴耳液进行双盲对照，有显著差异（P＜0.01）;并对203例化脓性中耳炎患者的实验检查和临床观察。结果：测得诺氟沙星的平均回收率为99.0％，甲硝唑的平均回收率为98.7％。细菌转阴率达99％，有效率为98％.结论：该制剂处方设计合理，制备简单，分析方法可靠，快捷无相互干扰。
OBJECTIVE: To study the preparation and quality control of nautilus ear drops. Formulation of the preparation process and determination of content, and the clinical observation of the efficacy. Methods: The contents of norfloxacin and metronidazole were determined by UV and HPLC, respectively. The results of double-blind comparison with chloramphenicol ear drops showed significant difference (P <0.01); and 203 cases of suppurative otitis media The experimental examination and clinical observation. Results: The average recovery of norfloxacin was 99.0% and the average recovery of metronidazole was 98.7%. Bacteria negative conversion rate of 99%, the effective rate was 98% .Conclusion: The formulation of the prescription design is reasonable, simple preparation, analytical methods reliable, fast without mutual interference.