【摘要】 目的 建立补肺防感合剂的质量标准。方法 采用薄层色谱法对制剂中的黄芪、甘草、陈皮进行定性鉴别；采用高效液相色谱法测定黄芪甲苷含量，色谱柱为Waters Xbridge C₁₈柱（250 mm×4.6 mm,5μm），流动相为乙腈-水（32∶68,V/V），流速为1.0 mL/min，柱温为35℃，检测器为蒸发光散射检测器，进样量为20μL（供试品溶液、阴性对照品溶液）和10μL（对照品溶液）。结果 薄层色谱图中，黄芪、甘草、陈皮的特征斑点显色清晰，分离度好，且阴性对照无干扰。黄芪甲苷的进样量在0.584 3～5.842 8μg范围内与峰面积线性关系良好（r=0.999 7,n=7）；精密度、稳定性、重复性试验结果的RSD均小于2%；平均回收率为92.68%,RSD为5.13%（n=6）。3批样品中黄芪甲苷的平均含量分别为44.22,42.31,41.01μg/mL（n=4）。结论 所建立的方法操作简便、结果准确、重复性好，可用于补肺防感合剂的质量控制。暂订补肺防感合剂中每1 mL以黄芪甲苷计不得低于29.76μg。更多还原

【Abstract】 Objective To establish the quality standard of Bufei Fanggan Mixture.MethodsThin-layer chromatography （TLC）method was used to qualitatively identify Astragali Radix,Glycyrrhizae Radix et Rhizoma,and Citri Reticulatae Pericarpium in the preparation.High-performance liquid chromatography （HPLC） method was used to determine the content of astragalosideⅣ.The chromatographic column was Waters Xbridge C₁₈column （250 mm×4.6 mm,5μm）,the mobile phase was acetonitrile-water（32∶68,V/V）,the flow rate was 1.0 mL/min,the column temperature was 35℃，the evaporative light scattering detector was adopted,the injection volume was 20μL （test solution,negative reference solution） and 10μL （reference solution）.ResultsIn the TLC chromatograms,the characteristic spots of Astragali Radix,Glycyrrhizae Radix et Rhizoma,and Citri Reticulatae Pericarpium showed clear color,good separation,and had no interference from the negative control.The linear range of astragalosideⅣwas0.584 3-5.842 8μg （r=0.999 7,n=7）.The RSDs of precision,stability,and repeatability test results were all lower than2%.The average recovery of astragalosideⅣwas 92.68%with an RSD of 5.13%（n=6）.The average contents of astragalosideⅣin the three batches of samples were 44.22,42.31,and 41.01μg/mL （n=4）,respectively.ConclusionThe established method is simple,accurate,and has good reproducibility,which can be used for quality control of Bufei Fanggan Mixture.The content of astragalosideⅣin every 1 mL of Bufei Fanggan Mixture should not be lower than 29.76μg.更多还原