哈西奈德凝胶剂的制备与质量控制

Preparation and Quality Control of Halcinonide Gel

目的制备哈西奈德凝胶剂并建立其质量控制方法。方法以壳聚糖为凝胶材料制备哈西奈德凝胶剂,采用高效液相色谱法测定其中哈西奈德含量。结果哈西奈德质量浓度在5.0～80.0μg/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率为100.24%,RSD=0.62%(n=6)。结论所采用的制备工艺简单,性质稳定,质量控制方法可行,适用于医院制剂室配制和临床使用。

Objective To study the preparation technology and to set up the quality control method of Halcinonide Gel.Methods Chitosan as gel material was used to prepare Halcinonide Gel.HPLC was used to determine the content of halcinonide.Results The linear relationship range of halcinonide was 5.0-80.0 μg/mL（r=0.999 9）.The average recovery rate was 100.24%,RSD was 0.62%（n=6）.Conclusion The preparation technology is simple with stable property and feasible quality control method,which is suitable for hospital preparation and application in clinic.