复方环丙沙星烧伤凝胶的制备及质量控制
LISHIZHEN MEDICINE AND MATERIA MEDICA RESEARCH(2004)
Abstract
目的:研究复方环丙沙星烧伤凝胶的制备及质量控制.方法:采用卡波姆940为基质制成凝胶剂.用高效液相色谱法测定凝胶中环丙沙星的含量,采用Kromasil C18色谱柱,以0.025 mol/L磷酸-乙腈(425∶75)为流动相,流速为0.95 ml·min-1,检测波长为277 nm.结果:环丙沙星在25.06~250.6 μg·min-1范围内,峰面积与其浓度线性关系良好(r=0.999 9),平均回收率为99.6%,重复性试验RSD1.4%(n=3),检测限为0.625 μg·min-1.结论:该制剂处方合理,制备工艺简便、稳定性好,质量易于控制.
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