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目的:制备复方莫西沙星滴耳液并建立其质量控制方法。方法:以甘油、水、乙醇为混合溶媒进行配制;采用高效液相色谱法同时测定其中2主药的含量并考察其质量稳定性。结果:所制制剂为淡黄色微黏稠澄明液体,检查符合2005年版《中国药典》相关规定;盐酸莫西沙星、醋酸地塞米松进样量的线性范围分别为0.3～2.4、0.03～0.24μg(r=0.9999,n=5),平均回收率分别为99.39%(RSD=0.99%)、98.46%(RSD=0.54%);室温贮存6个月后质量稳定,长期留样观察还在继续进行。结论:本制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare compound moxifloxacin ear drops and establish its quality control method. Methods: Glycerol, water and ethanol were used as the mixed solvents. The content of 2 main drugs and the stability of the 2 drugs were determined simultaneously by high performance liquid chromatography. Results: The preparation was light yellow micro-viscous clear liquid, which was in accordance with the relevant regulations of the 2005 edition of Chinese Pharmacopoeia. The linear range of the injected amount of moxifloxacin hydrochloride and dexamethasone acetate was 0.3-2.4,0.03-0.24μg r = 0.9999, n = 5). The average recoveries were 99.39% (RSD = 0.99%) and 98.46% (RSD = 0.54%) respectively. After 6 months storage at room temperature, the quality was stable. Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.