诺氟沙星凝胶的制备及质量控制

The preparation and quality control of norfloxacin gel

目的 :制备能增加用药部位药物浓度的诺氟沙星凝胶。方法 :用CMC Na作凝胶基质 ,制备了诺氟沙星凝胶。采用紫外分光光度法 ,直接进行含量测定 ,检测波长 2 73nm ,线性范围 2 .0～ 8.0 μg·ml-1,r =0 .99996 ,建立了含量测定等质控方法。结果 :含量测定平均回收率为 10 0 .46 % ,RSD =1.93% (n =5 ) ,凝胶稳定无变化 ,临床应用 30例 ,疗效显著。结论 :制备该凝胶工艺简单 ,所得制剂质量可控 ,应用无刺激 。

OBJECTIVE:To develop the gel of norfloxacin.METHODS:The gel of norfloxacin was made mainly of CMC Na,besides norfloxacin.The content was determined by UV spectrophotometry at 273 nm,the standarol curve of niterendipine showed good linearity in the concentration range of 2.0 ～ 8.0 μg·ml -1 , r = 0.999 96 .RESULTS:In the test of content,the average rate of recovery was 100.46% and RSD = 1.93% ( n =5).The gel staying was natural temperature,no changes had been found.This medicine had great effect in the clinic of 30 cases.CONCLUSIONS:This medicine is easily produced.The quality of the gel is able to be controlled and the stability kept.It is a useful medicine for the clinic.