北豆根配方颗粒质量评价  

Quality evaluation for Beidougen Formula Granules

作　　者：曹桂云 庄雪松 宁波 林永强 王岱杰 崔伟亮 刘洪超 董晓弟 黄蒙蒙 孟兆青 CAO Gui-yun;ZHUANG Xue-song;NING Bo;LIN Yong-qiang;WANG Dai-jie;CUI Wei-liang;LIU Hong-chao;DONG Xiao-di;HUANG Meng-meng;MENG Zhao-qing(Shandong Provincal Technical Innovation Center for Traditional Chinese Medicine Treatment of Respiratory Diseases,Shandong Hongjitang Pharmaceutical Group Co.,Ltd.,Jinan 250103,China;Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China;Shandong Provincial Analysis and Test Center,Qilu University of Technology(Shandong Provincial Academy of Sciences),Jinan 250014,China)

机构地区：[1]山东宏济堂制药集团股份有限公司,山东省中医药治疗呼吸系统疾病技术创新中心,山东济南250103 [2]山东省食品药品检验研究院,山东济南250101 [3]齐鲁工业大学(山东省科学院),山东省分析测试中心,山东济南250014

出　　处：《中成药》2024年第3期717-723,共7页Chinese Traditional Patent Medicine

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511);泉城产业领军人才计划项目(2020);泉城“5150”引才倍增计划项目(2021)。

摘　　要：目的 评价北豆根配方颗粒质量。方法 制备15批标准汤剂和3批配方颗粒,测定出膏率及木兰花碱、蝙蝠葛苏林碱、蝙蝠葛碱含量、转移率,建立HPLC特征图谱,聚类分析进行化学模式识别。结果 3批配方颗粒出膏率为15.1%~16.6%,木兰花碱、蝙蝠葛苏林碱、蝙蝠葛碱含量分别为18.93~19.39、9.42~9.60、6.79~6.85 mg/g,三者从饮片到配方颗粒的转移率分别为34.42%~35.25%、43.81%~44.65%、27.27%~27.51%;特征图谱中有7个特征峰,相似度均大于0.95,与标准汤剂一致性良好,并符合相关限度要求。15批标准汤剂聚为2类,吉林、河北、山东产药材可用于配方颗粒制备。结论 该方法合理可靠,可为北豆根配方颗粒质量控制、临床应用提供参考。AIM To evaluate the quality of Beidougen Formula Granules.METHODS Fifteen batches of standard decoctions and three batches of formula granules were prepared,after which paste rate and contents,transfer rates of magnoflorine,daurisoline,dauricine were determined.HPLC specific chromatograms were established,and cluster analysis was adopted in chemical pattern recognition.RESULTS For three batches of formula granules,the paste rates were 15.1%-16.6%,the contents of magnoflorine,daurisoline,dauricine were 18.93-19.39,9.42-9.60,6.79-6.85 mg/g with the transfer rates of 34.42%-35.25%,43.81%-44.65%,27.27%-27.51%from decoction pieces to formula granules,respectively,and there were seven characteristic peaks in the specific chromatograms with the similarities of more than 0.95,which demonstrated good consistence with those of standard decoctions and accorded with related limit requirements.Fifteen batches of standard decoctions were clustered into two types,and the medicinal materials produced from Jilin,Hebei,Shangdong could be used for the preparation of formula granules.CONCLUSION This reasonable and reliable method can provide references for the quality control and clinical application of Beidougen Formula Granules.

关 键 词：北豆根配方颗粒 标准汤剂 含量测定 HPLC特征图谱 聚类分析 

分 类 号：R283.6[医药卫生—中药学]