清热止痢合剂质量标准提升研究

Improvement of Quality Standard of Qingre Zhili Mixture

目的提升清热止痢合剂的质量标准。方法采用薄层色谱(TLC)法对清热止痢合剂中的白头翁、儿茶、关黄柏、黄连、黄芩进行定性鉴别;采用高效液相色谱(HPLC)法测定没食子酸、葛根素、芍药苷、黄芩苷的含量。结果白头翁、儿茶、关黄柏、黄连、黄芩TLC特征斑点清晰,分离度好,专属性强;没食子酸、葛根素、芍药苷、黄芩苷的质量浓度分别在4.557 1~41.014 3μg/m L,3.450 0~31.050 0μg/m L,10.907 1~98.164 3μg/m L,18.500 0~166.500 0μg/m L范围内与峰面积线性关系良好(r≥0.999 4),平均加样回收率分别为100.43%,100.71%,98.28%,100.65%,RSD分别为0.86%,1.60%,0.84%,1.16%(n=6)。结论该方法准确可靠,重复性好,可用于清热止痢合剂的质量控制。

Objective To improve the quality standard of Qingre Zhili Mixture.Methods Thin-layer chromatography(TLC)method was used for qualitative identification of Qingre Zhili Mixture.High-performance liquid chromatography(HPLC)method was used for the content determination of gallic acid,puerarin,paeoniflorin and baicalin in this preparation.Results The TLC spots of Radix Pulsatillae,Acacia catechu,Cortex Phellodendri,Rhizoma Coptidis and Radix Scutellariae were clear,the separation was good,and the specificity was strong.Gallic acid,puerarin,paeoniflorin and baicalin showed good linear relationships in the ranges of 4.5571-41.0143μg/m L,3.4500-31.0500μg/m L,10.9071-98.1643μg/m L and 18.5000-166.5000μg/m L(r≥0.9994),respectively.The average recoveries were 100.43%,100.71%,98.28%and 100.65%with RSDs of 0.86%,1.60%,0.84%and 1.16%(n=6).Conclusion This method is accurate,reliable and reproducible,which can be used for the quality control of Qingre Zhili Mixture.