复方氧氟沙星含漱液的制备及质量控制  

Preparation and Quality Control of Compound Ofloxacin Gargle

作　　者：黄静雯[1] 李寅[1] 孙树周[2] 

机构地区：[1]广州市番禺区人民医院,广州市511400 [2]广州市药品检验所第五分所,广州市511400

出　　处：《中国药房》2006年第10期749-751,共3页China Pharmacy

摘　　要：目的:制备复方氧氟沙星含漱液,并建立其质量控制方法。方法:以替硝唑、氧氟沙星、浓薄荷水、甘油、纯化水制备复方氧氟沙星含漱液;采用差示分光光度法,不经分离测得替硝唑含量,再利用吸收度加和原理,按公式计算氧氟沙星含量。结果:制备的含漱液为淡黄绿色澄明液体;替硝唑、氧氟沙星平均回收率分别为98.92%(RSD=0.35%)、99.18%(RSD=0.54%);2组分含量在3mo内无显著下降。结论:本制剂制备方法简单,含量测定方法简便,稳定性良好,适用于基层医院推广。OBJECTIVE： To prepare compound ofloxacin gargle, and to establish a method for its quality control. METHODS： Compound oflorxacin gargle was prepared with tinidazole, ofloxcin, heavy peppermint water, glycerol and purified water. Differential spectrophotometry was employed to determine the content of tinidazole without isolation, and then the content of ofloxcin was calculated by formula on the basis of absorbability additivity principle.RESULTS： The prepared gargle was light green yellow clear liquid. The average recovery rates of tinidazole and ofloxacin were 98.92% （RSD = 0.35% ） and 99.18% （RSD = 0.54% ）, respectively. No distinct decrease in content of these two components was found in 3 month test. CONCLUSION： The established method of preparation is simple, and that of content determination is convenient as well as that preparation is stable, which can be widely used in hospitals at primary level.

关 键 词：复方氧氟沙星含漱液 替硝唑 氧氟沙星 含量 稳定性 

分 类 号：R927.11[医药卫生—药学] R944.1