复方参术健胃胶囊的质量传递规律研究  

Study on Quality Transfer Law of Compound ShenZhu JianWei Capsules

作　　者：朱应成 余静 江玲丽[1] 刘亮镜 徐斌 ZHU Ying-cheng;YU Jing;JIANG Ling-li;LIU Liang-jing;XU Bin(Preparation Center,The Affiliated Hospital of Anhui College of Traditional Chinese Medicine,Wuhu Hospital of Traditional Chinese Medicine,Wuhu 241000,China)

机构地区：[1]安徽中医药高等专科学校附属医院芜湖市中医医院制剂中心,安徽芜湖241000

出　　处：《海峡药学》2025年第1期1-4,共4页Strait Pharmaceutical Journal

基　　金：芜湖市“华佗计划”卫生高层次人才分层培养项目(芜卫组[2023]111号);芜湖市科技计划项目(2022cg42);芜湖市科技计划项目(2023yf109);安徽中医药高等专科学校自然科学研究项目(ZRKXY2022F07)。

摘　　要：目的研究复方参术健胃胶囊在制备过程中的质量传递规律。方法建立HPLC法测定复方参术健胃胶囊中2种成分(芍药内酯苷、芍药苷)的含量,选取提取浓缩、干燥粉碎、制粒等配制工艺作为质量监控点,运用HPLC法对复方参术健胃胶囊在制备过程中芍药内酯苷、芍药苷的变化情况进行追踪,比较转移率的相对变化趋势。结果芍药内酯苷、芍药苷在不同生产步骤中损失量各不相同,从饮片到成品芍药内酯苷、芍药苷的绝对转移率分别为79.3%、17.8%。结论该研究结果为复方参术健胃胶囊全产业链质量控制体系的建立提供方法,为药材及成药产品质量的提升提供质量控制方法。OBJECTIVE To Study the quality transfer law during the production process of Compound ShenZhu JianWei Capsules.METHODS An HPLC method was used to determine the content of two components(albiflorin,paeoniflorin)in Compound ShenZhu JianWei Capsules.The key process points of extraction,concentration,drying,and granulation,were selected as monitoring points.The dynamic content changes of albiflorin,paeoniflorin during production process of Compound ShenZhu JianWei Capsules was tracked using HPLC.The relative change trend of transfer rate was compared.RESULTS The losses amount of albiflorin,paeoniflorin in the whole production process was different.The transfer rate from drinking sheet to finish product was albiflorin 79.3%,paeoniflorin 17.8%.CONCLUSION The results of this study provide a methodology for the establishment of the quality control system for the whole industry chain of Compound ShenZhu JianWei Capsules,and quality control methods for the improvement of the quality of medicinal materials and finished medicine products.

关 键 词：复方参术健胃胶囊 质量传递 芍药内酯苷 芍药苷 

分 类 号：R94[医药卫生—药剂学]