复方羊蛇颗粒处方药材提取工艺的优化研究

Optimization of extraction process of prescription medicinal materials of compound Yangshe granules

目的优化医院制剂复方羊蛇颗粒处方药材的提取工艺。方法建立处方中有效成分去乙酰车叶草酸甲酯、阿魏酸的高效液相定量方法,并以去乙酰车叶草酸甲酯、阿魏酸的含量以及提取物干浸膏得率为指标,采用星点设计—效应面法对复方羊蛇颗粒处方的浸膏提取工艺进行优化。结果建立的复方羊蛇颗粒中有效成分的高效液相定量方法符合方法学验证要求。通过星点设计—效应面法优化的最佳提取工艺为:提取溶媒的用量为处方药材量的12倍,醇沉浓度为73%,提取时间为每次60分钟。结论本研究成功建立了复方羊蛇颗粒有效成分的高效液相色谱定量方法,经优化后的提取工艺操作简单易行、重复性良好。

Objective Optimizing the extraction process of prescription medicinal materials of hospital preparation of compound Yangshe granules.Methods A high performance liquid chromatograph(HPLC)quantitative method was established for deacetyl asperulosidicacid methyl ester(DME)and ferulic acid(FC)of the active ingredient.Based on the content of DME,FC and the yield of extract,the extraction process of compound Yangshe granule extract was optimized using central composite design-response surface methodology.Results The established HPLC method of quantification of active components in compound Yangshe granules met the requirements of method validation.The optimal extraction process optimized by central composite design-response surface methodology were as follows:the weight of extraction solvent was 12 times of the medicinal slices,the alcohol concentration was 73%and the extraction time was 60 min.Conclusion In this study,the quantitative method of active components in compound Yangshe granule by HPLC has been successfully established,and the optimized extraction process is simple and easy to operate with good repeatability.