加替沙星热敏型凝胶滴眼液的制备与质量控制  

The preparation and Quality Control of Gatifloxacin Thermosensitive Ocular Gel

作　　者：吴丽萌[1] 朱国婵[2] 陈光龙[1] 钟浩明 

机构地区：[1]深圳市宝安人民医院药剂科,深圳518101 [2]深圳市中医院药学部,深圳518033 [3]广东省梅县食品药品监督管理局,梅州514000

出　　处：《中国医药导刊》2009年第11期1975-1976,共2页Chinese Journal of Medicinal Guide

摘　　要：目的:制备加替沙星热敏型眼用凝胶,并建立其质量控制方法。方法:以泊洛沙姆P407为热敏型材料加替沙星为主药制备加替沙星热敏凝胶,采用紫外分光光度法测定加替沙星含量,并观察产品的稳定性。结果:所制得制剂为透明度高,流动性好的凝胶剂,加替沙星检测浓度线性范围为1.25～80.00μg/ml(r=0.9989,n=7),回收率99.17%,RSD=0.72%;泊洛沙姆P407在处方中的浓度为19%,产品室温观察1年质量稳定。结论:该制剂制备简单、质量稳定可控。Objective：To prepare the gatifloxacin thermosensitive ocular gel and to establish its quality control method.Methods：The ocular gel was prepared with gatifloxacin as the principal drug and poloxamer P407 as the thermosensitive material.The content of gatifloxacin was measured by ultraviolet spectrophotometry,its stability was investigated as well.Results：The gels were found to be of high transparency and good fluidity.The detected concentration of gatifioxacin was in the linear range of 1.25 to 80.00μg/ml（r=0.9989,n=7）.The recovery rate was 99.17%,RSD=0.72%.The concentration of P407 in prescription was 19%,The quality of the product was stable after observation under room temperature for a year.Conclusions：The preparation is simple,its quality is stable and controllable.

关 键 词：加替沙星 泊洛沙姆P407 热敏型眼用凝胶 紫外分光光度法 制备与质量控制 

分 类 号：R944.1[医药卫生—药剂学]