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目的:制备甲磺酸加替沙星凝胶剂,建立其质量控制方法。方法:以甲壳胺作凝胶基质制备甲磺酸加替沙星凝胶, 用紫外分光光度法在λ=292 nm处测定甲磺酸加替沙星凝胶的含量。并且建立了性状、鉴别、pH值、卫生学等质量控制方法。结果:甲磺酸加替沙星的pH值5．0～6．5,卫生学检查合格,线性范围为2．0-12．0μg·ml-1,含量测定平均回收率99,83％、 RSB=0．42％(n=9)。结论:该凝胶设计合理,工艺简单,质量控制方法可靠,质量稳定,具有应用方便,作用持久的特点,适于临床应用。
Objective: To prepare gatifloxacin mesylate gel and establish its quality control method. Methods: Gatifloxacin mesylate gel was prepared by using chitosan as gel matrix. The content of gatifloxacin mesylate gel was measured by UV spectrophotometry at λ = 292 nm. And the establishment of traits, identification, pH, hygiene and other quality control methods. Results: The pH values of gatifloxacin mesylate ranged from 5.0 to 6.5. The hygroscopicity was within the range of 2.0-12.0μg · ml-1. The average recovery was 99.83% RSB = 0.42% (n = 9). Conclusion: The gel is reasonable in design, simple in process, reliable in quality control and stable in quality. It has the characteristics of convenient application and lasting effect and is suitable for clinical application.