【摘要】 目的：采用混料设计的方法，对易黄汤颗粒进行成型工艺研究，并制定其质量控制方法。方法：以易黄汤颗粒的一次成型率、吸湿率以及休止角为评价指标对辅料进行筛选，进而采用D-最优混料设计法优选药辅最佳配比。建立易黄汤颗粒中5种药味的TLC鉴别方法和测定没食子酸、尿囊素、小檗碱、京尼平苷酸含量的HPLC法，完善其质量控制标准。结果：优选的辅料为可溶性淀粉和糊精，分别建立成型率、休止角以及吸湿率与药辅配比的回归方程，最终得到最佳药辅比为干膏粉∶可溶性淀粉∶糊精=0.5∶0.21∶0.29。颗粒中山药、芡实、白果、黄柏和车前子饮片的TLC斑点清晰，且阴性无干扰。尿囊素27.7～554μg·mL^-1、没食子酸5.02～100.4μg·mL^-1、京尼平苷酸10.44～208.8μg·mL^-1、小檗碱5.46～109.2μg·mL^-1之间呈良好的线性关系。尿囊素、没食子酸、京尼平苷酸、小檗碱的平均回收率分别为103.64%,101.27%,98.31%,99.72%。结论：优选的辅料及其配比在保证高成型率的同时能减小颗粒吸湿率以及改善颗粒流动性，适合商业规模生产。建立的质量控制方法准确可靠，可为后续易黄汤颗粒的生产及质量评价提供基础。更多还原

【Abstract】 Objective:To study the moulding process of Yihuang decoction granules by the method of mixture design and establish the quality control method.Methods:The moulding rate,moisture absorption rate and angle of repose of Yihuang decoction granules were used as the evaluation metrics to select the auxiliary ingredients,and the D-optimal mix design method was used to select the optimal ratio of drug and supplement.To improve the quality control standards,TLC methods was established for the identification of Yihuang decoction granules and a high performance liquid chromatography （HPLC） method was applied for the determination of the contents of gallic acid,allantoin,berberine and genipinoside.Results:The preferred excipients were soluble starch and dextrin.The regression equations of moulding rate,the angle of repose and the moisture absorption rate with the ratio of excipients were respectively established.The optimal ratio of drug and excipients was finally obtained:dry paste powder∶soluble starch∶dextrin=0.5∶0.21∶0.29.The TLC spots representing yam,fructus gorgonzola,white fructus,cortex phellodendri and psyllium in the granules were clear without interference to negative.Good linearity was observed between 27.7～554μg·mL^-1 for allantoin,5.02～100.4μg·mL^-1 for gallic acid,10.44～208.8μg·mL^-1 for genipinoside and 5.46～109.2μg·mL^-1 for berberine.The average recoveries of allantoin,gallic acid,genipinoside and berberine were 103.64%,101.27%,98.31%and 99.72%,respecitvely.Conclusion:The preferred excipients and their ratios can reduce the moisture absorption rate of the granules,as well as improve the flowability of the granules,in the meantime ensuring the high moulding rate,which are suitable for the commercial scale production.The established quality control method is accurate and reliable,which can lay the foundation for the subsequent production of Yihuang decoction granules and the quality evaluation.更多还原