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目的:制备复方氧氟沙星眼用凝胶剂并建立质量控制方法。方法:采用卡波姆940作基质制备眼用凝胶剂,采用 HPLC同时测定氧氟沙星和阿昔洛韦的含量。结果:所得的制剂外观透明,所建立的含量测定方法,氧氟沙星和阿昔洛韦的回收率分别为99.84%(RSD=0.57%)和99.74%(RSD=0.75%)。结论:本法制备眼用凝胶的工艺可行,制剂质量稳定。
Objective: To prepare compound ofloxacin ophthalmic gel and to establish a quality control method. Methods: Carbomer 940 was used as matrix to prepare ophthalmic gel and the contents of ofloxacin and acyclovir were determined simultaneously by HPLC. Results: The obtained preparations showed clear appearance. The recoveries of ofloxacin and acyclovir were 99.84% (RSD = 0.57%) and 99.74% (RSD = 0 .75%). Conclusion: The method of preparing ophthalmic gel is feasible and the quality of preparation is stable.