满山红配方颗粒提取工艺优化及质量标准研究

Optimization of extraction process and establishment of quality standard for Folium Rhododendri Daurici formula granules

对满山红配方颗粒的提取工艺进行优化,并建立了相应的质量标准,为其临床应用奠定基础。采用单因素试验结合Box-Behnken响应面法进行研究,以出膏率和杜鹃素含量为评价指标,对提取次数、提取时间和加水倍数进行考察,利用高效液相色谱法(HPLC)对杜鹃素含量进行定量测定,得出各因素对出膏率和杜鹃素含量的影响程度,并依据《中华人民共和国药典》2020年版,采用薄层鉴别法对满山红进行定性分析。通过Box-Behnken中心组和设计模型分析回归模型方差以及响应面图,确认满山红的最佳提取条件为:提取4次,提取时间2 h,加水18倍。薄层鉴别法显示,满山红斑点清晰,重现性佳,高效液相色谱法也显示出高度的准确性和重复性。优化后的满山红配方颗粒提取工艺操作简便、稳定可行,为满山红的深度开发和利用提供了科学依据。

The purpose was to optimize the extraction process of Folium Rhododendri Daurici formula granules and establish the corresponding quality standard to lay the foundation for its clinical application.A single-factor test combined with Box-Behnken response surface method was used to investigate the extraction times,extraction time,and water addition times with the evaluation indexes of cream yield and farrerol content,and the farrerol content was quantitatively and accurately determined by high-performance liquid chromatography(HPLC),so as to find out the influences of various factors on the cream yield and farrerol content and qualitatively analyze them according to the pharmacopoeia of Folium Rhododendri Daurici.The results were analyzed by the Box-Behnen method.The optimal extraction conditions of Folium Rhododendri Daurici were confirmed by Box-Behnken central group and design model analysis of the variance of the regression model and the response surface plots:4 extractions for 2 h and 18 times of water.The thin-layer identification method showed clear and reproducible spots of Folium Rhododendri Daurici,and the high-performance liquid chromatography method also showed a high degree of accuracy and reproducibility.The optimized extraction process of Folium Rhododendri Daurici formula granules is not only easy to operate,stable and feasible,but also has a good application prospect,which provides a scientific basis for the deep development and utilization of Folium Rhododendri Daurici.