痔宁栓的制备及质量控制

Preparation and quality control of Zhining Suppository

目的探讨痔宁栓制备工艺，并制定其质量控制方法。方法采用水提醇沉和单味水提相结合的提取方法制备痔宁栓，应用薄层色谱法分别对痔宁栓中主要成分进行鉴别，采用HPLC法对其没食子酸进行了含量测定。结果在薄层色谱中能检出五倍子和黄柏，没食子酸在0．051～0．256μg／mL线性关系良好（r=0．9996），平均回收率为98．92％，RSD为1．87％。结论该栓剂制备方法简便易行，质量控制方法可靠。

Objective To investigate preparation and establish the quality control methods of Zhining Suppository. Methods The Zhining suppository was prepared with the method water-ext racting and alcohol-precipitating combined with single water-extracting, Main components of the Zhining suppository were used identified by TLC and the content of Gallic acid in the suppository was determined by HPLC. Results The methods could identify Galla ehinensis and Cortex Phellodendri, Gallic acid showed a good linear relationship in the range of 0.051 - 0.256 μg/mL （r=0.9996）, the average recovery of Gallic acide was 98.92%（RSD=1.87%）. Conclusion The preparation method was easy to operate, the quality was stable and controllable.