黄芪桂枝五物颗粒的质量控制方法研究  

Study on Quality Control Method of Huangqi Guizhi Wuwu Granules

作　　者：刘杨 刘昊 王立和 洪曼 姜雯钰 葛胜宇 关皎 冯波 朱鹤云 金莉莉[1] LIU Yang;LIU Hao;WANG Lihe;HONG Man;JIANG Wenyu;GE Shengyu;GUAN Jiao;FENG Bo;ZHU Heyun;JIN Lili(School of Pharmacy,Yanbian University,Yanji,Jilin Province 133002;School of Pharmacy,Jilin Medical University,Jilin City,Jilin Province 132013;Jilin Luwang Pharmaceutical Co.,Ltd,Jilin City,Jilin Province 13201 China)

机构地区：[1]延边大学药学院,吉林延吉133002 [2]吉林医药学院药学院,吉林吉林132013 [3]吉林市鹿王制药股份有限公司,吉林吉林132013

出　　处：《吉林医药学院学报》2024年第6期401-405,422,共6页Journal of Jilin Medical University

基　　金：国家自然科学基金项目(81703683);吉林省科技厅项目(YDZJ202101ZYTS074,YDZJ202301ZYTS188);吉林省人社厅创新创业人才项目(2023QN35);吉林医药学院大学生创新创业训练计划项目(X202313706075)。

摘　　要：目的建立黄芪桂枝五物颗粒的质量控制方法,为该制剂的质量控制研究提供依据。方法采用薄层色谱法定性鉴别黄芪桂枝五物颗粒中的黄芪和白芍;采用中国药典四部通则方法对黄芪桂枝五物颗粒的粒度、水分和溶化性等性状进行制剂学检查;采用高效液相色谱法对黄芪桂枝五物颗粒中毛蕊异黄酮葡萄糖苷进行含量测定。结果建立了黄芪桂枝五物颗粒中黄芪、白芍的定性鉴别方法,斑点清晰,阴性对照无干扰;黄芪桂枝五物颗粒的粒度、水分和溶化性等性状检查结果均符合中国药典标准要求;毛蕊异黄酮葡萄糖苷在5~250 mg/L范围内线性关系良好(r=0.9994),平均回收率为98.9%,6批黄芪桂枝五物颗粒中毛蕊异黄酮葡萄糖苷的含量范围为0.0659~0.0770 mg/g。结论本研究采用的薄层色谱方法、制剂学检查方法和高效液相色谱方法专属性强、重复性好,可为黄芪桂枝五物颗粒的质量控制研究提供依据。Objective To establish a quality control method of Huangqi Guizhi Wuwu Granules(HGWG),and provide a basis for the quality control research of the preparation.Methods Astragali Radix and Paeoniae Radix Alba in HGWG were qualitatively identified by thin layer chromatography;The particle size,water content and solubility of HGWG granules were examined by the method of general principles of Chinese Pharmacopoeia(VolumeⅣ);The content of calycosin-7-O-β-D-glucoside in HGWG was determined by high performance liquid chromatography.Results In this study,the qualitative identification methods of Astragali Radix and Paeoniae Radix Alba in HGWG were established,the spots were clear,and the negative control had no interference;The results of particle size,water content and solubility of HGWG were in line with the requirements of Chinese Pharmacopoeia standards;The linear range of calycosin-7-O-β-Dglucoside was 5-250 mg/L(r=0.9994),the average recovery was 98.9%and the content range of calycosin-7-O-β-D-glucoside in 6 batches of HGWG was 0.0659-0.0770 mg/g.Conclusion The thin layer chromatography method,preparation examination method and high performance liquid chromatography method used in this study have strong specificity and good repeatability,which can provide a basis for the quality control of HGWG.

关 键 词：黄芪桂枝五物颗粒 质量控制 毛蕊异黄酮葡萄糖苷 薄层色谱法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]