复方甲硝唑乳膏的制备及质量控制  

Preparation and Quality Control of Compound Metronidazole Cream

作　　者：段早红[1] 欧阳吉德 

机构地区：[1]湘南学院附属医院,郴州市423000 [2]湖南郴州市药品检验所,郴州市423000

出　　处：《中国药房》2007年第13期1005-1006,共2页China Pharmacy

摘　　要：目的:制备复方甲硝唑乳膏并建立其质量控制方法。方法:以甘油、硬脂酸等为基质制备乳膏;采用高效液相色谱法测定其中主药含量。结果:制备的乳膏性状、鉴别、检查等均符合2005年版《中国药典》相关规定;甲硝唑、氯霉素检测浓度线性范围分别为10·16～101·60(r=0·9995,n=6)、10·02～100·20mg·L-1(r=0·9999,n=6);平均回收率分别为96·82%(RSD=0·94%,n=6)、98·11%(RSD=0·85%,n=6)。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。OBJECTIVE: To prepare compound metronidazole cream and to establish a method for its quality control. METHODS: Compound metronidazole cream was prepared with glycerine and glyceryl monostearate as base material. The content determination was performed using HPLC. RESULTS: The cream prepared fitted the description of China Pharmacopeia (2005 edition) in property, identification and tests. The linear ranges of metronidazole and chloramphenicol were 10.16～101.60mg·L-1(r=0.999 5,n=6) and 10.02～100.20 mg·L-1 (r=...

关 键 词：复方甲硝唑乳膏 氯霉素 制备 质量控制 

分 类 号：R943[医药卫生—药剂学]