舒心解郁颗粒制备工艺及关键成分含量测定研究OACSTPCD

Objective:To study the preparation process of Shu Xin Jie Yu Granules.A method utilizing high-performance liquid chromatography has been adopted to determine the seven components in the Shu Xin Jie Yu Granules.This approach estab-lishes a scientific basis for quality evaluation and clinical application.Methods:The Orthogonal Test was used to optimize the ex-traction process of prescription Chinese medicinal materials,taking the leaching rate as an index.The molding process was also op-timized by investigating the excipients,drug-to-excipient ratio,wetting agent,and drying temperature.The HPLC method was used to determine the presence of Senkyunolide I,Ferulic Acid,Spironolactone,Paeoniflorin,3,5-O-Dicaffeoylquinic Acid,Chlorogenic Acid,and Gallic Acid within the preparation.Results:The optimal extraction process was determined by adding 12 times the amount of water for 40 minutes each time and extracting three times.For the molding process,dextrin was used as an ex-cipient in a 1:1.8 drug-to-excipient ratio.To act as a wetting agent,80%ethanol was used,and drying was carried out at 65℃.The preferred preparation process yielded six batches of Shu Xin Jie Yu Granules.A method was also developed for ascertaining the quantities of Senkyunolide I,Ferulic Acid,Spironolactone,Paeoniflorin,3,5-O-dicaffeoylquinic Acid,Chlorogenic Acid,and Gallic Acid present in the end-products,as well as for determining the index constituents found in the Granules.Conclusion:The process of preparing Shu Xin Jie Yu Granules,as established by this study,is stable and reasonable,with a high success rate of molding.This method is practical for the mass production of the Shu Xin Jie Yu Granules.The content determination method de-veloped through this study is simple,reproducible,and reliable,providing a reference for quality control studies on Shu Xin Jie Yu Granules and similar traditional Chinese medicine compound preparations.