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地冰凝胶的制备与质量控制
引用本文:洪清,袁曦,陈庆伟,朱善岚. 地冰凝胶的制备与质量控制[J]. 中国药房, 2005, 16(1): 32-33
作者姓名:洪清  袁曦  陈庆伟  朱善岚
作者单位:1. 福建医科大学附属第一医院药剂科,福州市,350005
2. 福州市药品检验所,福州市,350001
摘    要:目的 :制备地冰凝胶 ,并建立其质量控制方法。方法 :以0 5%卡波姆940作为凝胶基质 ,采用高效液相色谱法测定制剂中醋酸地塞米松的含量 ,并进行稳定性考察和皮肤刺激性试验。结果 :醋酸地塞米松检测浓度在20~120μg/ml范围内线性关系良好 ,平均回收率为101 1% ,RSD=0 92% ;制剂稳定性良好 ,对皮肤无刺激作用。结论 :该制剂处方合理 ,制备工艺简便 ,质量控制方法简单、准确。

关 键 词:凝胶  醋酸地塞米松  冰片  高效液相色谱法
文章编号:1001-0408(2005)01-0032-02
修稿时间:2004-03-31

Preparation and Quality Control of Dibing Gel
HONG Qing,YUAN Xi,ZHU Shanlan. Preparation and Quality Control of Dibing Gel[J]. China Pharmacy, 2005, 16(1): 32-33
Authors:HONG Qing  YUAN Xi  ZHU Shanlan
Abstract:OBJECTIVE:To prepare Dibing gel and establish its quality control method.METHODS:The0.5%Carbopol940was taken as the base of gel.The content of dexamethasone acetate was determined by HPLC.The stability and the skin irritation test were studied,too.RESULTS:The calibration curve of dexamethasone acetate was linear in the range of20~120μg/ml.The average recovery of dexamethasone acetate was101.1%,RSD=0.92%.The preparation was stable and had no irritation to skin.CONCLUSION:The gel was resonable in formulation,convenient in preparation technique,and simple and accurate in method of quality control.
Keywords:Gel  Dexamethasone acetate  Borneol  HPLC
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