杞黄醒脑颗粒质量标准  

Quality standard of Qihuang Xingnao Granules

作　　者：邵珍珍 赵紫薇 刘晓梦 李丽丽 张亚莉[3] 哈婧[1] SHAO Zhenzhen;ZHAO Ziwei;LIU Xiaomeng;LI Lili;ZHANG Yali;HA Jing(School of Chemical and Pharmaceutical Engineering,Hebei University of Science and Technology,Shijiazhuang 050018,China;Hebei Yuzhilin Pharmaceutical Company Limited,Xingtai 054400,China;College of Sciences,Hebei University of Science and Technology,Shijiazhuang 050018,China)

机构地区：[1]河北科技大学化学与制药工程学院,河北石家庄050018 [2]河北御芝林药业有限公司,河北邢台054400 [3]河北科技大学理学院,河北石家庄050018

出　　处：《河北大学学报（自然科学版）》2024年第4期373-381,共9页Journal of Hebei University(Natural Science Edition)

基　　金：河北省自然科学基金资助项目(H20200824)。

摘　　要：建立杞黄醒脑颗粒的质量标准,为其质量控制提供依据.采用薄层色谱法(TLC)对杞黄醒脑颗粒中枸杞子、淫羊藿、丹参、仙茅、当归、何首乌进行鉴别,采用高效液相色谱法(HPLC)测定制剂中二苯乙烯苷的含量.色谱柱Waters Bridge C 18柱(4.6×250 mm,5μL),流动相为甲醇-水(体积比36∶64),检测波长320 nm,流速1.0 mL/min,柱温30℃.结果表明枸杞子、淫羊藿、丹参、仙茅、当归、何首乌的TLC图谱主斑点清晰,分离度好,阴性对照无干扰;二苯乙烯苷在0.1956~2.9340μg(R 2=0.9995,n=6)内线性关系良好,精密度、重复性、稳定性的RSD均小于2.0%,加样回收率为96.38%~100.19%,RSD为1.48%.该质量标准项目设置合理,操作便捷、准确,可用于杞黄醒脑颗粒的质量控制.The quality standard of Qihuang Xingnao Granule is established to provide reference for its quality control.Thin layer chromatography(TLC)was used to identify Barbary wolfberry,Epimedium,Salvia miltiorrhiza,Rhizoma curculiginis,Angelica sinensis and Polygonum multiflorum in the granules.The content of diphenylvinyl glycosides in the preparation was determined by high performance liquid chromatography(HPLC).The HPLC conditions were:Waters Bridge C 18 column(4.6×250 nm,5μL),methanol-water(36∶64),detection wavelength of 320 nm,flow rate of 1.0 mL/min,and a column temperature of 30℃.The main TLC spots of Barbary wolfberry,Epimedium,Salvia miltiorrhiza,Rhizoma curculiginis,Angelica sinensis and Polygonum multiflorum were clear,the separation was good,and the negative control had no interference.The stilbenside was linearly related in the range of 0.1956 to 2.9340μg(R 2=0.9995,n=6),the RSD of precision,repeatability and stability was less than 2.0%,the sample recovery rate ranged from 96.38%to 100.19%,and the RSD was 1.48%.The quality standard project is set reasonably,convenient and accurate,and can be used for the quality control of Qihuang Xingnao Granules.

关 键 词：杞黄醒脑颗粒 质量标准 二苯乙烯苷 薄层色谱法 高效液相色谱法 

分 类 号：R927[医药卫生—药学] R917