玉蝉颗粒制备工艺与质量标准研究

Study on Preparation Technology and Quality Standard of Yuchan Granules

目的:优化玉蝉颗粒的制备工艺并确立制剂的质量标准。方法:以药材提取时的加水量、提取时间、提取次数为考察指标,采用正交试验优化提取工艺并优选制粒所用辅料和方法。建立处方中四味药材的薄层色谱鉴别和牛蒡苷的高效液相色谱含量测定方法。结果:通过正交试验优化得到的最佳生产工艺为药材饮片加15倍量水,煎煮两次,每次1.5小时。制粒的优选辅料为麦芽糊精,浸膏与麦芽糊精的比例为1∶0.7,以95%乙醇为润湿剂。四味药材的薄层色谱鉴别斑点清晰,阴性无干扰。牛蒡苷的平均回收率为95.70%,RSD为0.51%。结论:优化的制剂制备工艺简便,得膏率高,颗粒性质稳定。所建立的薄层色谱鉴别和含量测定方法可以对玉蝉颗粒质量进行很好的控制,为该制剂的研究提供了依据。

Objective:To optimize the preparation technology of yuchan granules and determine its quality standard.Methods:Orthogonal experiment was used to optimize the extraction process with the water addition,extraction time and extraction times as the indexes.Optimize the auxiliary materials and methods used in granulation.To establish a method for identification of four medicinal materials by TLC and determination of arctiin by HPLC.Results:Through orthogonal experiment,the optimal production process was as follows:adding 15 times the amount of water,decocting twice,1.5 hours each time.The optimal excipient for granulation is maltodextrin,the ratio of extract to maltodextrin is 1∶0.7,95%ethanol was used as wetting agent.The spots of four medicinal materials were identified clearly by TLC,negative without interference.The average recovery of arctiin was 95.70%,RSD=0.51%.Conclusion:The optimized preparation process is simple,the extract yield is high and the particle properties are stable.The established TLC identification and content determination methods can control the quality of yuchan granules well and provide a basis for the study of this preparation.