五味子配方颗粒制备工艺及质量标准研究

Study on Preparation Technology and Quality Standard of Schisandra Chinensis Formula Granule

目的:构建五味子配方颗粒制备工艺,总结五味子配方颗粒的质量标准。方法:以五味子醇甲浸膏得率、五味子醇甲转移率作为五味子配方颗粒评级指标,以加水倍数、提取时间、提取次数3个因素作为考察因素,设计L9(34)正交试验来设计五味子配方颗粒的提取工艺。对五味子提取液的干燥工艺进行优化,利用对五味子配方颗粒样本进行粒度、水分含量、干燥失重、溶化性、流动相、重复性、加样回收实验等指标观察来建立质量标准。结果:以加水8倍、煎煮时间0.5 h、煎煮3次作为五味子配方颗粒的提取工艺时,所制备的五味子配方颗粒各项质量检验指标均较好。结论:经正交试验设计的五味子配方颗粒制备工艺合理,质控方法简单易操作,重复性良好。

To establish the preparation technology of Schisandra chinensis formula granules and elucidate the quality standards for these granules.Method The extraction process of Schisandra chinensis formula granules was optimized using an L9(34)orthogonal test,with the yield of Schisandra chinensis A extract and the transfer rate of Schisandra chinensis A as evaluation criteria.The investigation factors included water addition ratio,extraction time,and extraction frequency.The drying process of Schisandra chinensis extract was optimized,and the quality standard was established by evaluating various parameters including particle size,moisture content,drying weight loss,solubility,mobile phase composition,repeatability analysis,addition recovery experiment and other indicators of Schisandra chinensis formula granule samples.Result The quality inspection indexes of the prepared Schisandra chinensis formula granules were enhanced when the extraction process involved 8-fold water,a decoction time of 0.5 hours,and triple decoction.Conclusion The preparation technology of Schisandra chinensis formula granules,designed through an orthogonal test,demonstrates rationality.Additionally,the quality control method is characterized by simplicity and ease of operation while exhibiting good repeatability.