【摘要】 目的:制备甲磺酸帕珠沙星眼用凝胶并建立其质量控制方法。方法:以甲磺酸帕珠沙星为主药,聚乙烯醇为基质制备眼用凝胶;采用高效液相色谱法测定其中主药的含量,并考察其稳定性。结果:所制制剂为淡黄色胶体,鉴别、检查均符合2005年版《中国药典》中的相关规定;甲磺酸帕珠沙星检测浓度的线性范围为20.0～80.0μg·mL-1(r=0.9999),平均回收率为98.67%(RSD=0.79%,n=3);室温放置2个月,样品均未发生分层。结论:该制备工艺简便、可行,质量控制方法操作快速,结果准确可靠。更多还原

【Abstract】 OBJECTIVE:To prepare pazufloxacin mesilate ophthalmic gel and to establish its quality control method.METHODS:The gel was prepared with pazufloxacin mesilate ophthalmic as principal agent and with PVA-124 as base material.The content of pazufloxacin mesilate was determined by HPLC and the stability of the gel was investigated as well.RESULTS:The prepared gel was yellowish liquid and its property fitted the description of Chinese Pharmacopeia(2005 edition).The linear range of pazufloxacin mesilate was 20.0～80.0 μg·mL-1(r=0.999 9),and the average recovery was 98.67%(RSD=0.79%,n=3).No stratification was noted for the sample within 2-month storage under room temperature.CONCLUSION:The preparation technique of the pazufloxacin mesilate ophthalmic gel is simple and feasible,its quality control method is rapid and the determination result is accurate and reliable.更多还原