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通络补肾合剂质量标准研究

A study on quality standard of the Tongluo Bushen Mixture
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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.
作者 田英 车景超 徐平 Tian Ying
出处 《中医临床研究》 2019年第16期14-16,共3页 Clinical Journal Of Chinese Medicine
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 The Tongluo Bushen mixture Quality standard TLC HPLC
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