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目的:制备盐酸莫西沙星即型凝胶滴眼剂并建立其质量控制方法。方法:以盐酸莫西沙星为主药制备滴眼剂;采用高效液相色谱法测定其中主药含量,并进行家兔刺激性实验。结果:所制制剂为无色或淡黄色澄明液体,检查符合2005年版《中国药典》中的相关规定;盐酸莫西沙星检测浓度的线性范围为0.4~3.2μg.mL-1(r=0.999 4),平均回收率为99.99%(RSD=0.343%);该制剂对家兔眼未见刺激性发生。结论:本制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare moxifloxacin hydrochloride gel-type eye drop and to establish its quality control method. Methods: The eye drops were prepared with moxifloxacin hydrochloride as the main drug. The content of the main drug was determined by high performance liquid chromatography (HPLC) and the stimulating experiment was conducted in rabbits. Results: The preparation was colorless or light yellow clear liquid and the test was in accordance with the relevant regulations of the 2005 edition of Chinese Pharmacopoeia. The linear range of the concentration of moxifloxacin hydrochloride was 0.4-3.2μg.mL-1 (r = 0.999 4 ), The average recovery was 99.99% (RSD = 0.343%); the preparation of rabbits eye irritation occurred. Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.