基于质控与药效统一的扁蕾颗粒标准提升探讨  

Discussion on improving the standard of Bianlei granules based on the unification of quality control and efficacy

作　　者：杨玲霞 顾海燕 施玉茜 马潇 刘婷婷[2] 李冬华 Yang Lingxia;Gu Haiyan;Shi Yuqian;Ma Xiao;Liu Tingting;Li Donghua(Gansu Provincial Institute of Drug Control,Lanzhou 730070,China;The Medicine Division of First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710065,China;NMPA Key Laboratory for Quality Control of TCM,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,兰州730070 [2]西安交通大学第一附属医院药学部,西安710065 [3]国家药品监督管理局中药材及饮片质量控制重点实验室,兰州730070

出　　处：《分析仪器》2024年第5期78-81,共4页Analytical Instrumentation

基　　金：甘肃省药品科研项目(2022GSMPA0075);国家中药材及饮片质量控制重点实验室项目(2023GSMPA-KL06);甘肃省药品监督管理局项目(2022GSMPA0017)。

摘　　要：采用薄层色谱法,对扁蕾颗粒中齐墩果酸进行定性鉴别;采用萃取重量法测定扁蕾颗粒中乙酸乙酯提取物;采用高效液相色谱法测定药效成分木犀草素的含量。色谱柱为Agilent C18柱(250mm×4.6mm,5μm),流动相为甲醇-0.1%磷酸溶液(50:50),V/V;流速1.0mL/min;检测波长为350nm;柱温:25℃。薄层色谱图谱获得斑点较多,分离效果好,阴性对照无干扰;乙酸乙酯提取物为2.56mg/g~2.87mg/g;木犀草素在0.11μg~1.06μg范围内呈良好的线性关系,平均加样回收率为98.10%,RSD为2.05%(n=6)。该方法科学合理,简单易行,可较为全面的评价扁蕾颗粒质量。The oleanolic acid in Bianlei granules was qualitatively identified by thin layer chromatography.Determination of ethyl acetate extract in Bianlei granules by extraction gravimetry.The content of luteolin was determined by HPLC.The chromatographic column was a Agilent C18 column.The mobile phase is methanol-0.1%phosphoric acid solution(50:50),V/V,and the flow was 1.0mL/min,the detection wavelength was 350nm,and the column temperature was 25℃.Thin layer chromatography obtained more spots,the separation effect was good,negative control had no interference.Ethyl acetate extract was 2.56mg/g-2.87mg/g.Luteolin showed a good linear relationship in the range of 0.11μg to 1.06μg.The average recovery rate was 98.10%,RSD was 2.05%(n=6).The method is scientific,reasonable,simple and feasible,and can be used to evaluate the quality of Bianlei granules comprehensively.

关 键 词：扁蕾颗粒 质控与药效统一 薄层色谱 萃取重量法 乙酸乙酯提取物 高效液相色谱 多指标质量评价 

分 类 号：R29[医药卫生—民族医学]