小儿泻痢片质量标准

Quality Standard of Xiao'er Xieli Tablet

目的:建立小儿泻痢片质量标准。方法:采用薄层色谱法对处方中的白芍进行定性鉴别;采用高效液相色谱法测定黄连中盐酸小糪碱含量。结果:TLC鉴别分离度好,阴性对照无干扰。HPLC分析过程中,盐酸小檗碱与样品中其他组分分离效果好,盐酸小檗碱进样浓度在0.03～0.48 g.L-1具有良好线性关系(r=0.999 9),平均回收率97.36%,RSD 1.41%(n=6)。结论:采用此法测定小儿泻痢片黄连中的盐酸小檗碱含量,准确可靠,简便易行,所建的标准可用于小儿泻痢片的质量控制。

Objective： To establish the quality standard of Xiao＇er Xieli tablet.Method： Radix paeoniae alba was identified by TLC.The content of berberine hydrochloride was determined by HPLC.Result： The TLC sports were clear and well-separated.The linear range of berberine hydrochloride was 0.03-0.48 g·L-1（r=0.999 9）,the average recovery was 97.36%（RSD 1.41%,n=6）.Conclusion： The method is practicable,simple and sensitive.It can be used for the quality control of Xiao＇er Xieli Tablet.