【摘要】 目的:制备环丙沙星温度敏感原位凝胶,并建立其质量控制方法。方法:以环丙沙星为主药,通过考察相变温度得出以16%泊洛沙姆407为适宜基质处方制备凝胶;采用紫外分光光度法测定其中环丙沙星的含量,并进行初步稳定性考察。结果:所制制剂为透明度高、流动性良好的凝胶剂;环丙沙星检测浓度的线性范围为1.92～9.60μg.mL-1,平均回收率为99.73%(RSD=1.80%);稳定性考察制剂外观无变化。结论:本制剂制备工艺简单可行,质量稳定可控。更多还原

【Abstract】 OBJECTIVE:To prepare Ciprofloxacin in situ thermosensitive gels and to establish its quality control method.METHODS:The ciprofloxaci in situ thermosensitive gels were prepared with ciprofloxacin as chief ingredient with 16% poloxamer407 selected as the base material through investigating the phase transition temperature.The concentration of ciprofloxacin was determined by ultraviolet spectrophotometry.The preliminary stability of the gels were investigated.RESULTS:The gels were found to be of high transparency and good fluidity.The linear range of ciprofloxacin was 1.92～9.60 μg·mL-1,and the average recovery was 99.73%(RSD=1.80%).The preparation was stable in apperance in the stability test.CONCLUSION:The preparation is simple and feasible in technology,and its quality is stable and controllable.更多还原