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复方地塞米松搽剂的制备及质量控制
引用本文:刘广军,吴慧英,翁春梅,刘旻虹,丁建.复方地塞米松搽剂的制备及质量控制[J].中国药房,2005,16(20):1551-1552.
作者姓名:刘广军  吴慧英  翁春梅  刘旻虹  丁建
作者单位:1. 江苏常州市第二人民医院,常州市,213003
2. 江苏常州市药品检验所,常州市,213003
摘    要:目的:制备复方地塞米松搽剂并建立其质量控制方法。方法:以氮酮为促透剂、乙醇为溶剂制备复方地塞米松搽剂,采用高效液相色谱法测定制剂中主药醋酸地塞米松和维生素E的含量。结果:醋酸地塞米松、维生素E检测浓度分别在2~40μg/ml、80~800μg/ml范围内呈良好线性关系,平均回收率分别为100·5%(RSD=0·82%)、98·6%(RSD=0·59%)。结论:该制剂处方合理,质量控制方法简便、准确。

关 键 词:复方地塞米松搽剂  制备  质量控制  高效液相色谱法
文章编号:1001-0408(2005)20-1551-02
收稿时间:2005-04-27
修稿时间:2005-06-06

Preparation and Quality Control of Compound Dexamethasone Liniment
LIU Guangjun,WU Huiying,WENG Chunmei,LIU Minghong,DING Jian.Preparation and Quality Control of Compound Dexamethasone Liniment[J].China Pharmacy,2005,16(20):1551-1552.
Authors:LIU Guangjun  WU Huiying  WENG Chunmei  LIU Minghong  DING Jian
Abstract:OBJECTIVE:To establish a method for preparation and quality control of compound dexamethasone liniment.METHODS:The compound dexamethasone liniment were prepared with dexamethasone acetate and vitamin E,the contents were determined by HPLC.RESULTS:The calibration curves of dexamethasone acetate and vitamin E were linear in the range of2~40μg/ml and80~800μg/ml respectively,and their average recoveries were100.5%(RSD=0.82%)and98.6%(RSD=0.59%)respectively.CONCLUSION:The preparation is reasonable in formula,simple and accurate in quality control.
Keywords:Compound dexamethasone liniment  Preparation  Quality control  HPLC
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