加味三核颗粒质量控制研究

Study on the Quality Control of Modified Sanhe Granules

目的建立加味三核颗粒的质量控制方法。方法采用薄层色谱(TLC)法对加味三核颗粒中黄柏、补骨脂、蛇床子、水红花子进行定性鉴别;采用高效液相(HPLC)法测定加味三核颗粒中盐酸小檗碱的含量,Gemini C_(18)(4.6 mm×250 mm,5μm)色谱柱;乙腈∶0.1%磷酸溶液(50∶50)(每1000 mL加十二烷基苯磺酸钠0.1 g)为流动相;检测波长265 nm;进样量10μL;流速1.0 mL/min。结果薄层鉴别的色谱图斑点清晰,特征斑点专属性强,阴性对照无干扰;盐酸小檗碱进样量在640~6400 ng与峰面积具有良好的线性关系,r=0.9998,平均回收率为100.56%,RSD=1.46%。结论所建的质量控制方法简单、专属性强,重现性好,可作为加味三核颗粒的质量控制方法。

Objective To establish a quality control method for modified Sanhe granules.Methods Thin layer chromatography(TLC)was used to qualitatively identify Phelendri chinensis,Psoralea psoraleae,Fructus Cnidii and Fructus safflower in modified Sanhe granules.The content of berberine hydrochloride in modified Sanhe granules was determined by HPLC on a Gemini C_(18)(4.6mm×250mm,5μm)column.Acetonitrile:0.1%phosphoric acid solution(50:50)(0.1g of sodium dodecylbenzene sulfonate per 1000mL)as mobile phase.The detection wavelength was 265nm.Injection volume was 10μL.Flow rate was 1.0 mL/min.Results The chromatogram of TLC identification showed clear spots,strong specificity of characteristic spots,and no interference of negative control.In the range of 640ng~6400ng,berberine hydrochloride has a good linear relationship with the peak area,r=0.9998,the average recovery is 100.56%,RSD=1.46%.Conclusion The established quality control method is simple,specific and reproducible,and can be used for the quality control of modified Sanhe granules.