HPLC法测定兰柏消炎膏中盐酸小檗碱的含量

Determination of Berberine Hydrochloride in Lanbai Xiaoyan Ointment by HPLC

目的:制备以黄柏为君药的兰柏消炎方的软膏剂,经过高效液相色谱法测定君药黄柏中的盐酸小檗碱的含量,为该制剂的工业化生产与质量控制提供参考。方法:以黄柏、侧柏叶、大黄、薄荷、泽兰等为主药制备兰柏消炎膏,采用高效液相色谱法测定其盐酸小檗碱的含量,以45∶55的比例将乙腈与0.1%的磷酸溶液混合,作为流动相溶液,其中每100 mL的流动相溶液中需要添加0.1 g的十二烷基磺酸钠。以1.0 mL·min^(-1)的流速操作,每次的采集量设定为10μL,并且所采集的光谱范围是265 nm,柱温为25℃的色谱条件下检测对兰柏消炎膏中的盐酸小檗碱进行测定,并进行方法学考察。结果:在该色谱条件下,溶剂和阴性溶液对盐酸小檗碱的测定无吸收峰的干扰。盐酸小檗碱的峰面积在11.8~141.6μg·mL^(-1)的浓度范围内呈现出上升趋势,其回归方程Y=38905X-65.441,R^(2)=0.9957,这表明盐酸小檗碱的峰面积与其浓度之间存在着良好的线性关联。结论:建立的盐酸小檗碱含量测定方法简便合理、准确,稳定可行,可用于兰柏消炎膏的质量控制。

Objective:Prepare the Salve of Lanbai Xiaoyan Formula with Phellodendron amurense as the sovereign medicine,and determine the content of Berberine hydrochloride in the sovereign medicine Phellodendron amurense by High-performance liquid chromatography,providing reference for the industrial production and quality control of this preparation.Methods:The content of berberine hydrochloride was determined by high performance liquid chromatography(HPLC).Acetonitrile was mixed with 0.1%phosphoric acid solution at a ratio of 45∶55,and 0.1 g sodium dodecyl sulfonate was added to every 100 mL of mobile phase solution.At the flow rate of 1.0 mL·min^(-1),the collection amount was set to 10μL each time,and the spectral range of the collection was 265 nm,and the column temperature was 25℃for the determination of berberine hydrochloride in Lambo Xiaoyan paste,and the methodology was investigated.Results:Under this chromatographic condition,the solvent and negative solution have no interference with the absorption peak in the determination of Berberine hydrochloride.The peak area of berberine hydrochloride showed an increasing trend in the concentration range of 11.8~141.6μg·L^(-1),and its regression equation Y=38905X-65.441,R^(2)=0.9957,indicating that there was a good linear correlation between the peak area of berberine hydrochloride and its concentration.Conclusion:The established method for the determination of berberine hydrochloride is simple,feasible,accurate,stable and reasonable,and can be used for the quality control of Lambai anti-inflammatory paste.