补金片质量标准研究

The Study on Quality Standard of Bujin Tablet

目的：完善补金片的质量标准。方法：采用TLC对红参、陈皮、当归、桔梗进行了鉴别；采用HPLC测定了红参中的人参皂苷Rg1、人参皂苷Re含量。结果：样品TLC色谱中，红参、陈皮、当归、桔梗的鉴别斑点清晰，重现性好。对红参中的人参皂苷Rg1、人参皂苷Re进行了含量测定，结果人参皂苷Rg1在0．18～2．01μg、人参皂苷Re在0．20～2．20μg，呈良好线性关系（r=0．9999），人参皂苷Rg1、人参皂苷Re的平均回收率分别为98．5％（RSD：1．3％）和100．1％（RSD=1．6％）。结论：本方法结果准确、操作简便，为该制剂的质量控制和标准提升提供了科学依据。

Objective： To perfect the quality standard of Bujin tablets. Methods： Identified red ginseng, dried tangerine peel, angelica, and balloonflower by TLC. The content of ginsenoside Rg1 and ginsenoside Re in red ginseng were determined by HPLC. Results： In TLC chromatography, the spots of red ginseng, dried tangerine peel, angelica, and balloonflower were clear and have a good reproducibility. In the content determination experiments, the results showed that it has a good linear relationship when ginsenoside Rg1 was in 0.18 - 2.01 μg and ginsenoside Re was0.20-2.20 μg （r =0.999 9）. The average recovery of ginsenoside Rg1 is 98.5 % （RSD =1.3 %）. The average recovery of ginsenoside Re is 100.1% （ RSD = 1.6 % ）. Conclusion： The results of this method are accurate and convenient which provide a scientific basis for the quality control and standards enhancing of Bujin tablets.