五倍子软膏的质量控制及稳定性考察

Quality control and stability study of Chinese Gall Ointment

目的建立五倍子软膏质量控制方法并考察其在常温和加速条件下的稳定性。方法采用薄层色谱(TLC)法和高效液相色谱(HPLC)法鉴别五倍子软膏中的没食子酸;采用显微镜法检查五倍子软膏的粒度;采用HPLC法测定五倍子软膏中没食子酸的含量。结果 TLC法及HPLC法鉴别没食子酸专属性强且重复性好。HPLC法测定没食子酸在0.153 2~0.612 8μg范围内与峰面积线性关系良好(r=0.999 7),平均回收率为100.23%,RSD=1.85%。三批中试样品在加速试验条件下第6个月性状发生变化;在常温下放置6个月各项指标均符合规定。结论五倍子软膏在常温下贮藏6个月质量稳定,建立的质量标准可用于五倍子软膏的质量控制。

Objective To establish the quality standard of Chinese Gall Ointment, and to investigate its stability under room temperature and accelerated condition. Methods Gallic acid in Chinese Gall Ointment was qualitatively identified by TLC and HPLC; the granularity of Chinese Gall Ointment was observed by microscope and content of gallic acid was measured by HPLC. Results The identification of gallic acid showed a strong specificity and good reproducibility.The gallic acid in the range of 0. 153 2 ~ 0. 612 8 μg showed good linear relation with the peak area（ r =0. 999 7）, and the average recovery rate was 100. 23%（ RSD = 1. 85%）. The appearance of Chinese Gall Ointment was changed after 6 months with accelerated condition, and the various index of pilot test samples met the quality standard under room temperature for 6 months. Conclusion Chinese Gall Ointment is stable at room temperature for 6months and the established quality standard can be used for quality control.