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氯霉素氢化可的松乳膏的制备及质量控制
引用本文:方焱,张善堂,陈象青,肖明,屈建.氯霉素氢化可的松乳膏的制备及质量控制[J].中国药房,2007,18(16):1245-1246.
作者姓名:方焱  张善堂  陈象青  肖明  屈建
作者单位:安徽省立医院药剂科,合肥市,230001
摘    要:目的:制备氯霉素氢化可的松乳膏并建立其质量控制方法。方法:以水包油基质制备乳膏;采用高效液相色谱法测定其中主药含量。结果:所制制剂各项检查均符合2005年版《中国药典》相关规定;氯霉素、氢化可的松线性范围分别为50.10~400.80(r=0.9997)、25.08~200.64μg.mL-1(r=0.9997);平均回收率分别为100.5%(RSD=2.1%)、100.4%(RSD=1.7%)。结论:本制剂制备工艺简便可行,质量稳定可控。

关 键 词:氯霉素氢化可的松乳膏  制备  质量控制
文章编号:1001-0408(2007)16-1245-02
收稿时间:2006-11-30
修稿时间:2006-11-302007-03-14

Preparation and Quality Control of Chloramphenicol and Hydrocortisone Cream
FANG Yan,ZHANG Shantang,CHEN Xiangqing,XIAO Ming,QU Jian.Preparation and Quality Control of Chloramphenicol and Hydrocortisone Cream[J].China Pharmacy,2007,18(16):1245-1246.
Authors:FANG Yan  ZHANG Shantang  CHEN Xiangqing  XIAO Ming  QU Jian
Abstract:OBJECTIVE:To prepare chloramphenicol and hydrocortisone cream and to establish a method for its quality control.METHODS:The cream was prepared with O/W as base.The content of the cream was derermiend by HPLC.RESU_ LTS:The prepared cream was up to the standard stated in China Pharmacopeia.The linear range of chloramphenicol vs.hydro_cortisone was 50.10~400.80(r=0.999 7)vs.25.08~200.64μg·mL-1(r=0.999 7),and the average recoveries were 100.5%(RSD=2.1%)and 100.4%(RSD=1.7%),respectively.CONCLUSION:The preparation process of chloramphenicol and hydrocortisone cream is simple and its quality is stable and controllable.
Keywords:Chloramphenicol and hydrocortisone cream  Preparatlon  Quallty control
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