北豆根配方颗粒质量标准的研究  

Quality standard for Beidougen Formula Granules

作　　者：胡辉 刘源才 龚华梦 HU Hui;LIU Yuan-cai;GONG Hua-meng(Jing Brand Bio-medicine Co.,Ltd.,Huangshi 435100,China;Jing Brand Research Institute,Huangshi 435100,China;Hubei Provincial Key Laboratory for Quality and Safety of Traditional Chinese Medicine Health Food,Daye 435100,China)

机构地区：[1]劲牌生物医药有限公司,湖北黄石435100 [2]劲牌研究院,湖北黄石435100 [3]中药保健食品质量与安全湖北省重点实验室,湖北大冶435100

出　　处：《中成药》2019年第1期38-43,共6页Chinese Traditional Patent Medicine

基　　金：湖北省技术创新专项重大项目(2016ACA142)

摘　　要：目的建立北豆根配方颗粒(北豆根)的质量标准。方法 TLC法进行定性鉴别,热浸法测定醇浸出物含有量,HPLC法测定蝙蝠葛苏林碱、蝙蝠葛碱含有量,并建立10批样品指纹图谱。结果 TLC斑点清晰,专属性强。醇浸出物平均含有量为42. 70%。蝙蝠葛苏林碱、蝙蝠葛碱分别在13. 23～211. 68 mg/L (R^2=0. 999 85)、21. 67～346. 72 mg/L (R^2=0. 999 16)范围内线性关系良好,平均加样回收率分别为104. 19%(RSD=0. 98%)、98. 29%(RSD=2. 78%)。10批样品指纹图谱相似度均大于0. 927。结论该方法简便可行,重复性好,可用于北豆根配方颗粒的质量控制。AIM To establish the quality standard for Beidougen Formula Granules( Menispermi Rhizoma).METHODS TLC was used for qualitative determination,hot dipping method and HPLC were adopted in the content determination of ethanol extract and daurisoline,dauricine,respectively,and the fingerprints of ten batches of samples were established. RESULTS The TLC spots were clear with strong specificity. The average content of ethanol extract was 42. 70%. Daurisoline and dauricine showed good linear relationships within the ranges of13. 23-211. 68 mg/L( R^2= 0. 999 85) and 21. 67-346. 72 mg/L( R^2= 0. 999 16),whose average recoveries were104. 19%( RSD = 0. 98%) and 98. 29%( RSD = 2. 78%),respectively. The fingerprints of ten batches of samples all exhibited the similarites of more than 0. 927. CONCLUSION This simple,feasible and reproducible method can be used for the quality control of Beidougen Formula Granules.

关 键 词：北豆根配方颗粒 醇浸出物 蝙蝠葛苏林碱 蝙蝠葛碱 指纹图谱 TLC 热浸法 HPLC 

分 类 号：R927.2[医药卫生—药学]