【摘要】 目的 建立中草药漱口颗粒的质量标准。方法 采用薄层色谱法对方中骨碎补、蒲公英、紫花地丁、甘草进行定性鉴别。采用高效液相色谱法测定制剂中秦皮乙素的含量，色谱柱为Welch Ultimate XB C18柱（250 mm×4.6 mm,5μm），流动相为乙腈-0.1%甲酸溶液（10∶90,V/V），流速为1.0 mL/min，检测波长为344 nm，柱温为30℃，进样量为10μL。结果 骨碎补、蒲公英、紫花地丁、甘草的薄层色谱斑点清晰，分离度好，且阴性对照无干扰。秦皮乙素质量浓度在9.2～64.4μg/mL范围内与峰面积线性关系良好（R~2=0.999 7,n=7）；精密度、稳定性、重复性试验结果的RSD均低于4.0%；平均加样回收率为104.65%,RSD为4.60%(n=6)。3批样品中秦皮乙素的含量分别为0.907,0.851,0.817 mg/g(n=3)。结论 所建立的方法操作简便、重复性好，可用于中草药漱口颗粒的质量控制。更多还原

【Abstract】 Objective To establish the quality standard for Chinese Herbal Gargle Granules.MethodsThin-layer chromatography（TLC） was used to qualitatively identify the ingredients in the prescription,including Drynariae Rhizoma,Taraxaci Herba,Viole Herba,and Glycyrrhizae Radix et Rhizoma.High-performance liquid chromatography （HPLC） was used to determine the content of quercetin in the preparation,the chromatographic column was Welch Ultimate XB C₁₈column （250 mm×4.6 mm,5μm）,the mobile phase was acetonitrile-0.1%formic acid solution （10∶90,V/V）,the flow rate was 1.0 m L/min,the detection wavelength was 344 nm,the column temperature was 30℃，and the injection volume was 10μL.ResultsThe TLC identification spots of Drynariae Rhizoma,Taraxaci Herba,Viole Herba,and Glycyrrhizae Radix et Rhizoma were clear,with good separation,and the negative control had no interference.The linear range of quercetin was 9.2-64.4μg/m L （R²=0.999 7,n=7）.The RSDs of precision,stability,and repeatability test results were all lower than 4.0%.The average recovery rate of quercetin was 104.65%with an RSD of 4.60%（n=6）.The content of quercetin in three batches of samples were 0.907,0.851,0.817 mg/g （n=3）,respectively.ConclusionThe established method is simple and reproducible,which can be used for quality control of Chinese Herbal Gargle Granules.更多还原