甲磺酸加替沙星凝胶的制备与质量控制  

Preparation and Quality Control of Gatifloxacin Mesylate Gel

作　　者：曹剑波[1] 徐敏[1] 钱金娥[1] 许晓东[1] 耿帆[1] 曹莺 周燕[1] 

机构地区：[1]张家港市第一人民医院,江苏张家港215600

出　　处：《中国药师》2005年第8期669-670,共2页China Pharmacist

基　　金：江苏省药学会奥赛康临床药学研究基金资助课题(2003-016)

摘　　要：目的:制备甲磺酸加替沙星凝胶剂,建立其质量控制方法。方法:以甲壳胺作凝胶基质制备甲磺酸加替沙星凝胶, 用紫外分光光度法在λ=292 nm处测定甲磺酸加替沙星凝胶的含量。并且建立了性状、鉴别、pH值、卫生学等质量控制方法。结果:甲磺酸加替沙星的pH值5．0～6．5,卫生学检查合格,线性范围为2．0-12．0μg·ml-1,含量测定平均回收率99,83％、 RSB=0．42％(n=9)。结论:该凝胶设计合理,工艺简单,质量控制方法可靠,质量稳定,具有应用方便,作用持久的特点,适于临床应用。Objective： To prepare Gatifloxacin Mesylate gel and to establish a quality control method of the gel. Method： Chitosan was used to prepare gatifloxacin mesylate gel. The content of catifloxacin mesylate gel was determined by spectrophotometers （ λ = 292 nm）. The quality control was established referring to the property, identification, pH value and hygiene. Result： The pH value of gatifloxacin mesylate was 5.0-6.5. The hygiene examination was qualified. The linear range was 2.0-12.0 μg·ml^-1 , the average recovery was 99.83% , RSD was 0.42% （n =9）. Conclusion： The method has been designed reasonably and simply. The quality control is reliable. The gel is stable in quality, convenient in use, permanent in function and suitable for clinical application.

关 键 词：甲磺酸加替沙星 凝胶 制备 质量控制 

分 类 号：R944.9[医药卫生—药剂学]