止咳平喘合剂质量标准研究

A study on quality standard of the Zhike Pingchuan mixture

目的:建立止咳平喘合剂的质量标准。方法:采用薄层色谱法(Thin-Layer Chromatography,TLC)分别对制剂中的鱼腥草、五味子进行定性鉴别,采用高效液相色谱法(High performance Liquid Chromatography,HPLC法)对主要有效成分五味子醇甲进行含量测定。结果:止咳平喘合剂中鱼腥草、五味子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,五味子醇甲在0.0155~0.1550 mg/ml(r=0.9999)范围内与峰面积呈良好的线性关系,平均加样回收率为98.49%,RSD=0.98%。结论:本研究建立的方法简便、准确、稳定,可作为止咳平喘合剂的质量控制标准。

Objective:To set up the quality standard of the Zhike Pingchuan mixture(止咳平喘合剂).Methods:Houttuynia cordata and Schisandra chinensis in the Zhike Pingchuan mixture were identified by TLC.The concentration of schisandrin was determined by HPLC.Results:For TLC,the chromatogram spots of Houttuynia cordata and Schisandra chinensis were well separated and without interference in their negative controls.Quantitative analysis of HPLC showed that the calibration curve of schisandrin demonstrated a good linear relationship in the range of 0.0155~0.1550 mg/mL(r=0.9999),and the average recovery rate was 98.49%,RSD=0.98%.Conclusion:The methods set up by this study are easy,accurate and stable,and can be used as the quality control standard of Zhike Pingchuan mixture.