加替沙星热敏型凝胶滴眼液的制备与质量控制  

Preparation and Quality Control of Gatifloxacin Thermosensitive Ocular Gel

作　　者：吴丽萌[1] 朱国婵[2] 陈光龙[1] 

机构地区：[1]广东省深圳市宝安区人民医院药剂科,广东深圳518101 [2]广东省深圳市中医院药学部,广东深圳518033

出　　处：《中国药业》2009年第23期34-35,共2页China Pharmaceuticals

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,并考察产品的稳定性。结果所得制剂为透明度高、流动性好的凝胶剂;加替沙星检测质量浓度线性范围为1.25～80.00μg/m L(r=0.9989,n=7),平均回收率99.80%,RSD=0.82%(n=9);泊洛沙姆P407在处方中的质量分数为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（TSOG） 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 gatifloxacin was in the linear range of 1.25- 80. 00 μg/mL（r =0. 998 9, n = 7）. The recovery rate was 99.80%, RSD=0.82% （n=9）.The concentration of P407 in prescription was 19%.The product quality was stable after observation under room temperature for a year. Conclusion 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 

分 类 号：R943[医药卫生—药剂学] R988.1[医药卫生—药学]