通络补肾合剂质量标准研究  

A study on quality standard of the Tongluo Bushen Mixture

作　　者：田英 车景超 徐平 Tian Ying

机构地区：[1]山东青岛中西医结合医院

出　　处：《中医临床研究》2019年第16期14-16,共3页Clinical Journal Of Chinese Medicine

摘　　要：目的:建立通络补肾合剂的质量标准。方法:采用薄层色谱法分别对制剂中的续断、苏木进行定性鉴别,采用高效液相色谱法(High Performance Liquid Chromatography,HPLC)对主要有效成分淫羊藿苷进行含量测定。结果:通络补肾合剂中续断、苏木的薄层色谱鉴别斑点清晰,重现性好,无空白干扰;HPLC法含量测定结果显示,淫羊藿苷在0.0207~0.2070 mg·mL^-1(r=0.9996)范围内与峰面积呈良好的线性关系,平均加样回收率为98.19%(6例),相对标准偏差(RSD)=1.01%。结论:本研究建立的方法简便、准确、稳定,可作为通络补肾合剂的质量控制标准。Objective: To set up the quality standard of the Tongluo Bushen mixture (通络补肾合剂). Methods: Xudaun (续断) and Sumu (苏木) in the Tongluo Bushen mixture were identified by TLC. The concentration of Yinyanghuogan (淫羊藿苷) was determined by HPLC. Results: The chromatogram spots of Xudaun and Sumuwere were well separated, without interference in their negative controls. Quantitative analysis of HPLC showed that the calibration curve of Yinyanghuogan demonstrated a good linear relationship in the range of 0.0207~0.2070 mg·mL^-1(r=0.9996), and the average recovery rate was 98.19%, RSD=1.01%. Conclusion: The methods set up by this study are easy, accurate and stable, and can be used as the quality control standard of the Tongluo Bushen mixture.

关 键 词：通络补肾合剂 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]