不同厂家三黄片中盐酸小檗碱溶出度的比较

Comparision of Dissolution Rates of Berberine Hydrochloride in Sanhuang Tablets Produced by Different Factories

目的对市售的10个厂家生产的三黄片中盐酸小檗碱的溶出度进行比较,并探讨各厂家生产的三黄片的质量差异。方法采用紫外分光光度(UV)法进行含量测定,用桨法对各厂家生产的三黄片中盐酸小檗碱进行溶出度试验,计算溶出率并分别绘制累积溶出曲线,并对各溶出曲线进行方程拟合。结果以0.1 mol/L盐酸溶液为溶出介质,各厂家生产的三黄片溶出度有明显的差异。结论不同厂家的三黄片中盐酸小檗碱的含量及溶出度存在显著差异,故有必要对市售的三黄片进行溶出度检查,从而控制药品质量,保证临床用药安全、有效、稳定。

Objective To compare the dissolution rates of berberine hydrochloride in Sanhuang Tablets produced by 10 manufacturers and to investigate the quality differences of Sanhuang Tablets produced by various manufacturers. Methods Ultraviolet（UV） spectropho- tometry was used to determine the content,and the slurry method was adopted to conduct the dissolution test on berberine hydrochloride in Sanhuang Tablets. The dissolution rates were calculated and the cumulative dissolution curves were drawn,and the various dissolution curves were performed the fitting equation. Results With 0.1 mol/L hydrochloric acid solution as the dissolution medium,the dissolu- tion rate of Sanhuang Tablets produced by various manufacturers had the remarkable difference. Conclusion The content and dissolution of berberine hydrochloride in Sanhuang Tablets produced by different manufacturers are significantly different, so it is necessary to con- duct the dissolution test on Sanhuang Tablets in market, so as to control the quality of drugs and ensure the safety, effectiveness and stability of clinical medication.