双黄连口服液中绿原酸含量的影响因素研究

为找出双黄连口服液中绿原酸含量下降过快的原因,通过改进工艺达到改善双黄连口服液中绿原酸稳定性的目的。采用HPLC法测定各样品中的绿原酸含量,考察金银花提取、精制等环节的处理方法;通过拆分处方考察处方中其他药味及添加的各种辅料,如缓冲液、抗氧剂、增溶剂、络合剂对绿原酸稳定性的影响。结果表明:金银花混提、单提和提取温度对绿原酸的提取效率无显著影响;pH值是影响口服液中绿原酸含量变化的主要因素,通过调节口服液pH值的方法,改进了双黄连口服液的制备工艺,口服液中绿原酸的稳定性增强。考察了黄芩苷、缓冲液、抗氧化剂、增溶剂和络合剂5个影响绿原酸含量的因素,明确了缓冲液的影响最大,黄芩苷、抗氧化剂、增溶剂和络合剂影响较小。

Study on the influence factors for chlorogenic acid content in Shuanghuanglian oral liquid

This paper aims to find the reason of the decrease of chlorogenic acid in Shuanghuanglian oral liquid, and to enhance the stability of chlorogenic acid by improving the preparation process. The extraction method of Lonicerae japonicae flos, concomitance ingredients and excipients such as buffer, antioxidant, solubilizer and complexing agent which may affect the stability of chlorogenic acid were studied by HPLC method. Result shows that the mixed extraction, single extraction and extraction temperature have no significant effect on the extraction yeild; the main influence factor of chlorogenic acid content is the pH value of Shuanghuanglian oral liquid,and the stability of chlorogenic acid can be enhanced by adjusting the pH value of oral liquid; five factors including baicalin, buffer, antioxidant, solubilizer and complexing agent which may affect the content of chlorogenic acid are studied. It is concluded that buffer has obvious effect on the content of chlorogenic acid, while the other four factors have no significant effect.