跌打红药片质量标准研究

Study on Quality Standard of Dieda Hongyao Tablets

目的建立跌打红药片的质量标准。方法采用薄层色谱法鉴别本制剂中的白芷、川芎、当归药材,采用HPLC法测定本制剂中三七皂苷R1和人参皂苷Rg1的含量。结果薄层色谱法可鉴别出白芷、川芎、当归的特征斑点。HPLC法测定三七皂苷R1和人参皂苷Rg1的线性范围分别为0.525 5μg^1.577μg(r=0.9991,n=5)和2.103μg^6.308μg(r=0.9993,n=5);平均加样回收率分别为97.94%,2.55%;RSD分别为98.91%,2.62%。结论本方法简便可行、专属性强、重复性好,可用于本制剂的质量控制。

Objective To establish the quality standard of Diedahongyao tablets. Methods Baizhi, Chuanshun and Danggui in the tablets were identified by TLC , and the contents of Saponins R1 and Ginsenosides Rg1 were determined by HPLC. Results TLC spots are clear and good, the contents of Saponins R1 and Ginsenosides Rg1 were determined , the calibration curves of Saponins R1 and Ginsenosides Rg1 were linear in the range of 0. 525 5 - 1. 577 μg （ r = 0. 999 1 ,n = 5 ） and 2. 103 - 6. 308 μg （ r = 0. 999 3, n = 5 ） , respectively. The average recoveries and RSD of saponins R1 and ginsenosides Rg1 were 97.94% , 2.55% and 98.91% ,2.62% ,respectively. Conclusion The methods are simple, accurate, specific and reproducible, it can be used for the quality control of Diedahongyao tablets.