止痢宁片质量控制方法研究

Study on Method of Quality Control for Zhilining Pill

目的建立止痢宁片的质量标准。方法采用薄层色谱法对处方中的主要药味苦参、木香进行鉴别,并用高效液相色谱法测定其脱水穿心莲内酯的含量。结果止痢宁片的苦参、木香薄层色谱中,在与对照品相应的位置上,显相同颜色的斑点;脱水穿心莲内酯进样量在0.062～1.550μg范围内与峰面积积分值线性关系良好(r=1.0000),平均加样回收率为98.00%(RSD=0.90%)。结论本方法简便、准确、稳定、可靠、重现性好,可用于本品的质量控制。

Objective To establish the quality standard for Zhilining pill. Methods TLC was employed to identify Radix Sophorae Flavescentis and Radix Aucklandiae while the content of dehydroandrographolide in Zhilining pill was detemined by HPLC. Results TLC findings of Radix Sophorae Flavescentis and Radix Aucklandiae showed the spots of same colors as those developed in the corresponding places of control medical materials. Good liner was observed when the samplesize of dehydroandrographolide was within the range of 0.062-1.550 μg （r=1.0000）. The average recovery rate was 98.00% with RSD=0.90%. Conclusion The method is simple, accurate, stable, reliable and with good reproducibility, which can be used for the quality control of Zhilining pill.