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目的：研制以氧氟沙星（ＯＦＬＸ）、盐酸麻黄碱为主药并配伍透明质酸（ＨＡ）的滴鼻剂。方法：ＨＰＬＣ法测定含量、稳定性试验及临床观察。结果：ＯＦＬＸ和盐酸麻黄碱含量测定的标准曲线分别是Ｃ＝１．４５５Ａ－０．００８９，＝０．９９９４（ｎ＝３）和Ｃ＝０．０３８７－０．０００１，＝０．９９９４（ｎ＝３），回收率（ｘ±ｓ）分别为１０１．１±１．８０％（ｎ＝３）和１０１．０±０．４８％（ｎ＝３）。稳定性试验显示，处方中氧氟沙星对光较敏感，制剂在４０℃、７５％ＲＨ条件下３个月无明显变化。３所医院临床疗效观察１３０例，总有效率９１．９％。结论：本制剂处方合理，质控方法可靠，疗效满意。贮存期暂定２年。
Objective: To develop nasal drops containing OFLX, ephedrine hydrochloride as main drug and hyaluronic acid (HA). Methods: HPLC method was used to determine the content, stability and clinical observation. Results: The standard curves of OFLX and ephedrine hydrochloride were C = 1.455A-0.0089, = 0.9994 (n = 3) and C = 0.0387-0.0001, respectively = 3). The recoveries (x ± s) were 101.1 ± 1.80% (n = 3) and 101.0 ± 0.48% (n = 3), respectively. Stability tests showed that ofloxacin prescription sensitive to light, preparations at 40 ℃, 75% RH conditions 3 months no significant change. The clinical efficacy of three hospitals observed in 130 cases, the total effective rate was 91.9%. Conclusion: The preparation prescription is reasonable, the quality control method is reliable, the curative effect is satisfactory. Provisional storage period of 2 years.