Study on the moulding process and quality standard of classical prescription of Yihuang decoction granules based on mixture design

LU Fang-qi; YU Ling-jing; CHEN Nuo; LIU Yi-peng; WU Wei; WU Cheng-chao; ZHONG Shao-hui; LU Li-rong; HUANG Shi-wen; CHENG Jian-ming

doi:10.20251/j.cnki.1003-3734.2025.05.012

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 27.7～554 μg·mL-1 for allantoin,5.02～100.4 μg·mL-1 for gallic acid,10.44～208.8 μg·mL-1 for genipinoside and 5.46～109.2 μg·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.