海南医学院学报2024，Vol.30Issue(6)：413-420,8.DOI:10.13210/j.cnki.jhmu.20231206.001
舒心解郁颗粒制备工艺及关键成分含量测定研究
Study on the preparation process and determination of key components of Shu Xin Jie Yu Granules
摘要
Abstract
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.关键词
舒心解郁颗粒/工艺优化/指标成分/含量测定/正交实验Key words
Shu Xin Jie Yu Granules/Process optimization/Index ingredients/Extraction contents/Orthogonal experi-ments分类
医药卫生引用本文复制引用
谢先娇,彭灿,彭进城,左池靖,张静,梁万徽,汪杰,訾苗苗,韩双,方玲..舒心解郁颗粒制备工艺及关键成分含量测定研究[J].海南医学院学报,2024,30(6):413-420,8.基金项目
This study was supported by Anhui Red Cross Society of Traditional Chinese Medicine Inheritance,Innovation and Development Research Project Fund(2021ZYYB23),Research Fund Project of Anhui University of Chinese Medicine(2021LCTH07),Anhui Provincial Science and Technology Major Special Fund(202103a07020001) 安徽省红十字会中医药传承创新发展研究项目基金(2021ZYYB23) （2021ZYYB23）
安徽省中医药大学科研基金项目(2021LCTH07) （2021LCTH07）
安徽省科技重大专项项目基金(202103a07020001) （202103a07020001）
