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目的:制备鼻泪道植入剂并建立其质量控制方法。方法:以氧氟沙星为主药,聚乙烯醇、甘油为辅料制备鼻泪道植入剂;采用紫外分光光度法测定其中主药含量。结果:所制制剂为微黄色条状固体,鉴别、检查等均符合2005年版《中国药典》相关规定;氧氟沙星检测浓度的线性范围为5.0~15.0μg·mL-1(r=0.999 8),平均回收率为99.67%(RSD=0.62%,n=9)。结论:本制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare nasolacrimal duct implants and to establish their quality control method. Methods: Ofloxacin as the main drug, polyvinyl alcohol, glycerol as adjunct to prepare nasolacrimal duct implants; UV spectrophotometric determination of the main drug content. Results: The preparation was yellowish bar solid. The identification, examination and so on were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of ofloxacin was 5.0 ~ 15.0μg · mL-1 (r = 0.999 8 ), The average recovery was 99.67% (RSD = 0.62%, n = 9). Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.