司氟沙星凝胶的制备与质量考察

Preparation and quality controlling of sparfloxacin gel

目的 :研制司氟沙星凝胶。方法 :用卡波姆 940作凝胶基质制备司氟沙星凝胶 ,建立了酸碱度、卫生学、含量测定等质量控制标准 ,对制剂进行了质量控制。结果 :pH值7.0～ 8.0 ,卫生学检查符合规定 ,含量测定平均回收率为 10 0 .5 2 % ,RSD为 2 .11% (n =5 ) ,并且凝胶稳定无变化。结论 :本方法设计合理 ,稳定性好 ,疗效好 ,尚无不良反应 。

OBJECTIVE:To develop the gel of sparfloxacin.METHODS:Using carbopol 940 as the stroma,the gel of sparfloxacin had been developed.RESULTS:The pH value was 7.0 ～ 8.0 the average rate of recovery with 100.52 % and RSD was 2.11 %( n =5).CONCLUSIONS:The design of the gels formulation is reasonable .The clinical therapy of sparfloxacin vaginal suppository is reliable with none of adverse reaction.The gel is stable and useful for the clinic. [