不同厂家三黄片中黄芩苷、盐酸小檗碱的溶出度

Dissolution of Baicalin and Berberine Hydrochloride in Sanhuang Tablets from Different Pharmaceutical Factories

目的建立三黄片中黄芩苷、盐酸小檗碱溶出度测定方法并考察市售不同厂家的三黄片中黄芩苷、盐酸小檗碱的溶出度情况。方法采用高效液相色谱法进行含量测定,色谱条件为色谱柱:Grace C18柱(250mm×4.6 mm,5μm),流动相:甲醇-乙腈-0.025 mol/L磷酸液(用三乙胺调pH=3.0±0.1)=25∶20∶55;柱温为30℃;检测波长为265 nm;流速0.8 ml/min。筛选出溶出度测定条件,计算并分别绘制黄芩苷与盐酸小檗碱的累积溶出曲线,且对各曲线进行相似因子的比较及溶出模型拟合。结果溶出度测定条件为:采用桨法,转速100 r/min,以0.1 mol/L盐酸溶液加0.5%十二烷基硫酸钠为溶出介质。测定结果显示,不同厂家三黄片中黄芩苷和盐酸小檗碱的溶出曲线相似因子f2值大多小于50,且两成分的体外溶出模型拟合不统一。结论不同厂家的三黄片中黄芩苷、盐酸小檗碱的溶出度存在显著性差异,这可能是由于各厂家生产工艺不尽相同所致。中成药的质量控制应增加主要成分的溶出度检测,应探寻适宜的溶出模型以检测中药的溶出度。

Objective To establish a method for determining the dissolution of baicalin and berberine hydrochloride in Sanhuang Tablets from different pharmaceutical factories,and research their dissolution behavior.Methods The contents of baicalin and berberine hydrochloride were determined by high performance liquid chromatography.The Grace-C18（4.5 mm×250 mm,5 μm）column was used,the mobile phase was methanol-acetonitrile-0.025 mol/L phosphoric acid（with triethylamine to adjust pH=3.0±0.1）=（25∶20∶55）,the column temperature was set at 30 ℃,the detection wavelength was 265 nm,and flow velocity was 0.8 ml/min.The determination conditions of dissolution were selected;accumulation dissolution curves were calculated,drawn and compared by similarity factor values（f2）,and the model simulation was done.Results The determination conditions of dissolution included paddle method with the rotating speed of 100 r/min and 0.1 mol/L hydrochloric acid plus 0.5% sodium dodecyl sulfate as dissolution medium.The results of determination showed that most of f2 values of baicalin and berberine hydrochloride dissolution curves of Sanhuang Tablets from different pharmaceutical factories were less than 50.The dissolution model simulations of this two components were not uniform.Conclusion There is significant difference in baicalin and berberine hydrochloride dissolution among Sanhuang Tablets from different pharmaceutical factories.It may result from different process of different factories.The dissolution of the main components should be added to the quality control systems of Chinese patent medicines,and an appropriate dissolution mechanism model should be sought to describe the dissolution behavior of traditional Chinese medicine.