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目的:减轻复方诺氟沙星滴耳液的刺激性,改进质控标准。方法:在原处方的基础上减少冰醋酸和乙醇的用量,加入适量甘油,适当提高pH值;采用HPLC法同时测定诺氟沙星和地塞米松的含量。考察新处方滴耳液的稳定性、刺激性和临床疗效。结果:与原处方对比,新处方滴耳液稳定性不变,刺激性降低,总有效率提高;诺氟沙星平均回收率为99.2％,RSD为0.75％(n=5),地塞米松平均回收率为98.4％,RSD为0.98％(n=5)。结论:新处方滴耳液制备方法可行,质控方法可靠,临床疗效理想。
Objective: To reduce the irritation of compound norfloxacin ear drops and improve the quality control standards. Methods: The dosage of glacial acetic acid and ethanol was reduced on the basis of the original prescription, glycerin was added to raise the pH value appropriately. The content of norfloxacin and dexamethasone were simultaneously determined by HPLC. Investigate the stability of the new prescription ear drops, irritation and clinical efficacy. Results: Compared with the original prescription, the stability of new prescription ear drops was unchanged, irritation decreased and the total effective rate increased. The average recovery of norfloxacin was 99.2%, the RSD was 0.75% (n = 5), dexamethasone The average recovery was 98.4% with a RSD of 0.98% (n = 5). Conclusion: The preparation of new prescription ear drops is feasible, the quality control method is reliable and the clinical curative effect is satisfactory.