地冰凝胶的制备与质量控制

Preparation and Quality Control of Dibing Gel

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。

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.