黄连琥珀清心丸质量标准研究  

A study on the quality standards of Huanglian Hupo Qingxin pills

作　　者：张潇丹[1] 贺晓东 高燕[1] 杨龙飞[1] 张冠群[1] 于子翔 柳明君 王雅菲 更藏加 赵渤年 ZHANG Xiaodan;HE Xiaodong;GAO Yan;YANG Longfei;ZHANG Guanqun;YU Zixiang;LIU Mingjun;WANG Yafei;GENG Zangjia;ZHAO Bonian(Shandong University of Traditional Chinese Medicine Institute of Pharmaceutical Research Collaborative Innovation Center for Ecological Protection and High Quality Development of Characteristic Traditional Chinese Medicine in the Yellow River Basin,Jinan 250355,China;Qingdao Shanghe Traditional Chinese Medicine Hospital Co.,Ltd.,Qingdao 266200,China;Institute of Acupuncture and Moxibustion and Massage,Shandong University of Traditional Chinese Medicine,Jinan 250355,China;School of Pharmacy,Southwest Minzu University,Chengdu 610041,China)

机构地区：[1]山东中医药大学药物研究院黄河流域特色中药生态保护和高质量发展协同创新中心,山东济南250355 [2]青岛上和中医医院,山东青岛266200 [3]山东中医药大学针灸推拿学院,山东济南250355 [4]西南民族大学药学院,四川成都610041

出　　处：《山东科学》2024年第4期17-25,共9页Shandong Science

基　　金：山东省重点研发计划项目(2021CXGC010511)。

摘　　要：为了建立黄连琥珀清心丸的定性定量检测方法,并为后续建立其质量标准提供依据,对方中的沉香、广枣、诃子、黄连、木棉花、肉豆蔻6味药进行显微鉴别;对诃子进行薄层鉴别;使用高效液相色谱法(HPLC)对盐酸小檗碱进行质量分数测定。建立了黄连琥珀清心丸的显微鉴别、薄层鉴别,方中盐酸小檗碱在0.0180~0.9020 mg/mL范围内呈良好的线性关系,质量分数检测方法科学、灵敏、重复性好,精密度、稳定性、重复性试验中相对标准偏差均小于3.0%,加样回收实验平均回收率为101.29%,相对标准偏差为2.30%,所建立的质量标准操作简便、重复性好,可用于黄连琥珀清心丸的质量标准研究。To establish a method for the qualitative and quantitative assay of Huanglian Hupo Qingxin pills and provide abasis for the subsequent establishment of quality standards,the six ingredients in the formula(Aquilariae Lignum Resinatum,Fructus Choerospondiatis,Terminalia Chebula,CoptidisRhizoma,Flos Gossampini,and Semen Myristicae)were identified through microscopical observation.Thin-layer chromatography was used to identify Terminalia Chebula.Berberine hydrochloride concentration was assessed using high-performance liquid chromatography.Microscopical and thin-layer identifications of Huanglian Hupo Qingxin pills were conducted,which revealed a berberine hydrochloride concentration of 0.0180~0.9020 mg/mL,exhibiting a good linear relationship.The assay method was found to bescientific,sensitive,and reproducible,with relative standard deviations(RSDs)for precision,stability,and reproducibility tests all below 3.0%.The average recovery rate from spike-and-recovery testing was 101.29%,with an RSD of 2.30%.The established quality standardis simple and reproducible and can be used for studying the quality standards of Huanglian Hupo Qingxin pills.

关 键 词：黄连琥珀清心丸 质量标准 显微鉴别 薄层色谱 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]