黄连口服液质量标准研究

Study on the quality standard of Rhizoma Coptidis oral solution

目的:建立黄连口服液的质量标准。方法:采用薄层色谱对口服液中黄连进行薄层鉴别,采用高效液相色谱法测定口服液中盐酸小檗碱的含量。结果:薄层鉴别方法专属性强,盐酸小檗碱含量在0.326 0-1.630 0μg/m L范围内具有良好的线性关系,标准曲线回归方程为:Y=4.38×106X-4.75×104(R2=0.999 9,n=5);样品在12 h内稳定,RSD为0.36%;加样平均回收率为100.106%,RSD为0.826%;该方法精密度高,RSD为0.11%。结论:本质量标准可有效地控制黄连口服液的质量。

Objective: To establish the quality standard of Rhizoma Coptidis oral solution. Methods: Thin layer chromatography(TLC) was used to identify berberine and the content of berberine hydrochloride in oral solution was determined by HPLC.Results: Berberine hydrochloride had a good linear relationship within 0.326 0-1.630 0 μg/m L with a standard curve regression equation: Y=4.38×106X-4.75×104(r=0.999 9, n=5). The samples were stable within 12 h with RSD of 0.36%; The average recovery rate was 100.106% with RSD of 0.826%. The precision of this method was high with RSD of 0.11%.Conclusion: The established qualitative and quantitative methods are simple, accurate, reliable and reproducible, and can be effectively used for the quality control of Rhizoma Coptidis oral solution.